Shinya Okazaki

Recent clinical trials have demonstrated that aggressive lipid lowering by statins could prevent recurrent events after acute coronary syndrome (ACS). We hypothesized that this efficacy was caused by a significant reduction in plaque volume by aggressive LDL cholesterol (LCL-C) lowering. The present study investigated the effect of early statin treatment on plaque volume of a nonculprit lesion by serial volumetric intravascular ultrasound in patients with ACS.Seventy patients with ACS were enrolled. All patients underwent emergency coronary angiography and percutaneous coronary intervention (PCI). They were randomized to intensive lipid-lowering therapy (n=35; atorvastatin 20 mg/d) or control (n=35) groups after PCI. Volumetric intravascular ultrasound analyses were performed at baseline and 6-month follow-up for a non-PCI site in 48 patients (atorvastatin, n=24; control, n=24). LDL-C level was significantly decreased by 41.7% in the atorvastatin group compared with the control group, in which LDL-C was increased by 0.7% (P<0.0001). Plaque volume was significantly reduced in the atorvastatin group (13.1+/-12.8% decrease) compared with the control group (8.7+/-14.9% increase; P<0.0001). Percent change in plaque volume showed a significant positive correlation with follow-up LDL-C level (R=0.456, P=0.0011) and percent LDL-C reduction (R=0.612, P<0.0001), even in patients with baseline LDL-C <125 mg/dL.Early aggressive lipid-lowering therapy by atorvastatin for 6 months significantly reduced the plaque volume in patients with ACS. Percent change in plaque volume showed a significant positive correlation with percent LDL-C reduction, even in patients with low baseline LDL-C.

ContextThe short-term effects of early treatment with statins in patients after the onset of acute coronary syndromes (ACS) for the outcomes of death, myocardial infarction (MI), and stroke are unclear.ObjectiveTo evaluate relevant outcomes of patients from randomized controlled trials comparing early statin therapy with placebo or usual care at 1 and 4 months following ACS.Data Sources and Study SelectionSystematic search of electronic databases (MEDLINE, EMBASE, PASCAL, Cochrane Central Register) from their inception to August 2005, which was supplemented by contact with experts in the field. Two reviewers independently determined the eligibility of randomized controlled trials that compared treatment with statins with a control, were initiated within 14 days after onset of ACS, and had a minimal follow-up of 30 days. Trials with cerivastatin were only included in a sensitivity analysis.Data ExtractionInformation on baseline characteristics of included trials and patients, reported methodological quality, lipid levels, and clinical outcome was independently extracted by 2 investigators. Investigators from each included trial contributed additional data if necessary.Data SynthesisTwelve trials involving 13 024 patients with ACS were included in the meta-analysis. The risk ratios for the combined end point of death, MI, and stroke for patients treated with early statin therapy compared with control therapy were 0.93 (95% confidence interval [CI], 0.80-1.09; P = .39) at 1 month and 0.93 (95% CI, 0.81-1.07; P = .30) at 4 months following ACS. There were no statistically significant risk reductions from statins for total death, total MI, total stroke, cardiovascular death, fatal or nonfatal MI, or revascularization procedures (percutaneous coronary intervention or coronary artery bypass graft surgery). Sensitivity analyses with restriction to trials of high quality or with additional data from a large trial using cerivastatin indicated summary risk ratios even closer to 1.ConclusionBased on available evidence, initiation of statin therapy within 14 days following onset of ACS does not reduce death, MI, or stroke up to 4 months.

Malnutrition has been identified as an important predictor of poor clinical outcomes in patients with heart failure. The aim of this study is to examine the prognostic impact of nutritional status in patients with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI). The impact of nutrition, assessed using the geriatric nutritional risk index (GNRI) calculated by serum albumin and body mass index, was evaluated in 2,853 patients with CAD who underwent their first PCI between 2000 and 2011. Patients were assigned to tertiles based on their GNRI levels. The incidences of all-cause death and cardiac death were assessed. The median GNRI values were 101 (interquartile range 95 to 106). Lower GNRI levels were associated with older age and higher prevalence of acute coronary syndrome and chronic kidney disease. During the median follow-up period of 7.4 years, Kaplan-Meier curves showed ongoing divergence in rates of mortality among tertiles (GNRI <98: 35.1%; 98 to 104: 20.6%; ≥104: 12.1%; log-rank p <0.0001). Stratification analysis by age also showed that the lowest GNRI tertile was associated with mortality in both patients <65 years and those ≥65 years. After adjusting for established cardiovascular risk factors, lower GNRI was an independent predictor of all-cause death (hazard ratio 1.55 per 10 decrease, 95% confidence interval 1.30 to 1.84, p <0.0001) and cardiac death (hazard ratio 1.44, 95% confidence interval 1.08 to 1.90, p = 0.01). In conclusion, nutritional status was associated with long-term clinical outcomes in CAD patients after PCI. Evaluation of GNRI carries important prognostic information and may guide the therapeutic approach to such patients.

Malnutrition has recently been reported to correlate with prognosis in patients with heart failure. However, the prognostic significance of nutritional status in patients with stable coronary artery disease (CAD) is unknown. The present study sought to examine the association between nutritional status assessed by the prognostic nutritional index (PNI) and cardiovascular outcomes in patients with stable CAD.A total of 1988 patients with stable CAD who underwent elective percutaneous coronary intervention (PCI) between 2000 and 2011 were examined. The PNI was calculated as 10×serum albumin (g/dL)+0.005×total lymphocyte count (per mm3). Patients were assigned to tertiles based on their PNI. The incidence of major adverse cardiac events (MACE), including all-cause death and non-fatal myocardial infarction, was evaluated.The median PNI was 48.9 (interquartile range: 45.5-52.1). During the median follow-up of 7.5 years, Kaplan-Meier analysis showed that patients with lower PNI tertiles had higher rates of MACE (PNI <46.7: 35.5%; 46.7-50.8: 22.3%; >50.8: 16.0%; log-rank p<0.0001). After adjusting for other risk factors, the PNI was independently associated with MACE (hazard ratio 2.05 per 10 PNI decrease, 95% confidence interval: 1.66-2.54, p<0.0001). Adding the PNI to a baseline model with established risk factors improved the C-index (p=0.03), net reclassification improvement (p=0.03), and integrated discrimination improvement (p=0.0001).The PNI was significantly associated with long-term cardiovascular outcomes in patients with stable CAD. Assessing PNI may be useful for risk stratification of CAD patients undergoing elective PCI.

Background: The patency and complications in aorto-iliac (AI) stenting remain poorly understood. The aim of this paper was to investigate the safety and efficacy after AI stenting. Methods and Results: This study was performed as a large-scale multicenter, retrospective registry. A total of 2,147 consecutive patients with AI disease were enrolled. The safety endpoints were procedure success, complications and 30-day mortality. The efficacy endpoints were primary, assisted primary and secondary patency, overall survival, freedom from major adverse cardiovascular events (MACE; all-cause death, myocardial infarction and stroke), and major adverse cardiovascular and limb events (MACLE; any repeat revascularization for limb and leg amputation in addition to MACE). Procedure success, complication rate and 30-day mortality were 97.6%, 6.4% and 0.7%. Primary patency was 92.5%, 82.6% and 77.5% at 1, 3 and 5 years, assisted primary patency was 97.0%, 92.7% and 91.9% at 1, 3 and 5 years and secondary patency was 99.0%, 98.7% and 98.5% at 1, 3 and 5 years. The overall survival rate was 95.0%, 87.6%, and 79.3% at 1, 3 and 5 years. The cause of death was cardiovascular in 44.1%. Freedom from MACE (MACLE) was 93.3% (89.9%), 84.4% (76.7%), and 74.9% (66.8%) at 1, 3 and 5 years. Female gender, diabetes, renal failure, absence of aspirin, reference vessel diameter <8.0mm and outflow lesion were found to be independent predictors of primary patency. Conclusions: The safety and efficacy after AI stenting are feasible compared to surgical reconstruction. (Circ J 2012; 76: 2697–2704)

Recently, malnutrition has been shown to be related to worse clinical outcomes in patients with heart failure. However, the association between nutritional status and clinical outcomes in patients with coronary artery disease (CAD) remains unclear. We investigated the prognostic value of malnutrition assessed by the Controlling Nutritional Status (CONUT; range 0–12, higher = worse, consisting of serum albumin, cholesterol and lymphocytes) score in patients with CAD. The CONUT score was measured on admission in a total of 1987 patients with stable CAD who underwent elective percutaneous coronary intervention (PCI) between 2000 and 2011. Patients were divided into two groups according to their CONUT score (0–1 vs. ≥2). The incidence of major adverse cardiac events (MACE), including all-cause death and non-fatal myocardial infarction, was evaluated. The median CONUT score was 1 (interquartile range 0–2). During the median follow-up of 7.4 years, 342 MACE occurred (17.2%). Kaplan–Meier curves revealed that patients with high CONUT scores had higher rates of MACE (log-rank p < 0.0001). High CONUT scores showed a significant increase in the incidence of MACE compared with low CONUT scores, even after adjusting for confounding factors (hazard ratio: 1.64, 95% confidence interval 1.30–2.07, p < 0.0001). Adding CONUT scores to a baseline model with established risk factors improved the C-index (p = 0.02), net reclassification improvement (p = 0.004) and integrated discrimination improvement (p = 0.0003). Nutritional status assessed by the CONUT score was significantly associated with long-term clinical outcomes in patients with CAD. Pre-PCI assessment of the CONUT score may provide useful prognostic information.

The ESTABLISH trial found using volumetric intravascular ultrasound that atorvastatin therapy started early and continued for 6 months significantly reduced plaque volume in patients with acute coronary syndrome (ACS). However, the benefits of early statin administration on long-term outcomes remain unclear. We therefore examined whether the early initiation of statin in patients with ACS improves long-term prognosis.The Extended-ESTABLISH trial included 180 patients with ACS who underwent emergency percutaneous coronary intervention (PCI). These patients were randomized here to groups given either early intensive lipid-lowering therapy (n=90; atorvastatin 20 mg/day) or standard care (control, n=90) within 48 h of events. Baseline characteristics between the two groups did not significantly differ at the time of ACS onset. Six months after PCI, all patients were treated with statins to achieve an LDL-C value of <100 mg/dL. We compared the first occurrence of major adverse cardiac and cerebrovascular events (MACCE). Prognostic data were fully documented during the entire follow-up period (mean, 1538+/-707 days). Cumulative event-free survival was significantly higher in the atorvastatin, than in the control group (p=0.041; log-rank test). Furthermore, by adjusting for validated prognosticators, early statin administration was identified as a good predictor of MACCE (HR 0.46, 95%CI 0.23-0.86; p=0.015).In-hospital initiation of statin therapy immediately after ACS conferred long-term benefits and 6 months of intensive lipid-lowering therapy improved long-term clinical outcomes after PCI in patients with ACS.

Background and aims An elevated neutrophil-to-lymphocyte ratio (NLR) has been associated with worse clinical outcomes in patients with acute coronary syndrome. However, the long-term prognostic value of NLR in stable coronary artery disease (CAD) after percutaneous coronary intervention (PCI) has not been fully investigated. The aim of this study was to determine whether NLR is an independent predictor of long-term cardiac outcomes after PCI. Methods A total of 2070 patients with CAD who underwent elective PCI were enrolled in the study. Patients were divided into three groups by NLR tertile (<1.7, 1.7–2.5, and 2.5<). Incidences of all-cause death and cardiac death were evaluated. Results During follow-up (median, 7.4 years), 300 patients (14.5%) died. Kaplan-Meier curves revealed ongoing divergence in rates of all-cause death and cardiac death among tertiles (both log-rank p < 0.01). In multivariate analysis, using the lowest tertile as reference, the highest tertile remained significantly associated with greater incidences of all-cause death (hazard ratio (HR), 1.73; 95% confidence interval (CI), 1.29–2.34; p = 0.0002). Continuous NLR values were also an independent predictor of all-cause death (HR, 1.87 per log NLR 1 increase; 95% CI, 1.50–2.32; p < 0.0001) and cardiac death (HR, 2.11; 95% CI, 1.46–3.05; p < 0.0001). Adding NLR values to a baseline model with established risk factors improved the C-index (p = 0.002), net reclassification improvement (p = 0.008) and integrated discrimination improvement (p = 0.0001) for all-cause death. Conclusions Elevated NLR was an independent predictor of long-term cardiovascular outcomes after elective PCI. Assessing pre-PCI NLR may be useful for risk stratification of stable CAD.

Both inflammation and malnutrition have been reported to be closely linked to atherosclerosis, especially in patients with chronic kidney disease (CKD). The combined effects of serum albumin and C-reactive protein (CRP) on clinical outcomes after percutaneous coronary intervention (PCI) were investigated.Methods and Results:A total of 2,164 all-comer patients with coronary artery disease who underwent their first PCI and had data available for preprocedural serum albumin and hs-CRP levels between 2000 and 2011 were studied. Patients were assigned to 4 groups according to their median serum albumin and CRP levels (4.1 g/dL and 0.10 mg/dL, respectively). The incidence of major adverse cardiac events (MACE), including all-cause death and non-fatal myocardial infarction (MI), was evaluated. During a median follow-up period of 7.5 years, 331 cases of MACE (15.3%), including 270 deaths and 61 non-fatal MIs, occurred. Kaplan-Meier curves showed that the rates of MACE differed significantly among the groups (log-rank P<0.0001), even stratified by with or without CKD (both log-rank P<0.0001). After adjustment for established cardiovascular risk factors, low serum albumin with high CRP levels was associated with adverse cardiac events (hazard ratio 2.55, 95% confidence interval 1.72-3,88, P<0.0001, high albumin/low CRP group as reference).The presence of both low serum albumin and high CRP levels conferred a synergistic adverse effect on the risk for long-term MACE in patients undergoing PCI.

We evaluated diagnostic accuracy of CT-fractional flow reserve (CT-FFR) computed on-site with a new vendor workstation, against invasive FFR as the reference standard.Retrospective analyses compared CT-FFR of 104 vessels with 30-90% diameter stenosis in 75 patients imaged using single-rotation 320 detector-row coronary CT angiography (CCTA) with invasive FFR performed within 90 days. Prospective ECG-gated CCTA included exposure of 70-99% of the R-R interval. CT-FFR was computed on-site within the same physical space as the CT scanner and reading room. The diagnostic accuracy of CCTA >50% and CT-FFR ≤0.8 to detect hemodynamically significant stenosis, defined as FFR ≤0.8, was determined, as was the correlation of CT-FFR to FFR and instantaneous wave-free ratio (iFR). Forty-four vessels (42.3%) had an invasive FFR ≤0.8. The sensitivity, specificity, positive, and negative predictive value of CT-FFR ≤0.8 vs. CCTA >50% to detect hemodynamically significant stenosis defined as FFR ≤0.8 were 90.9% vs. 70.5%, 78.3% vs. 43.3%, 75.5% vs. 47.7%, and 92.2% vs. 66.7%, respectively. Area under the curve of CT-FFR was significantly higher than CCTA >50% [0.85, 95% confidence interval (CI): 0.76-0.91 vs. 0.57, 95% CI: 0.47-0.67; P < 0.0001]. The correlation coefficient between CT-FFR and iFR was r = 0.62 (95% CI: 0.40-0.77, P < 0.0001) and that between CT-FFR and invasive FFR was r = 0.52 (95% CI: 0.28-0.70, P = 0.0001). CT-FFR inter- and intra-observer correlations were excellent (r = 0.83 and r = 0.82, respectively).Locally computed CT-FFR based on fluid structure interaction has excellent diagnostic accuracy to detect a significant FFR ≤0.8 compared with conventional CCTA and high reproducibility.

Drug-eluting stent (DES) implantation is routine during coronary revascularization because DES significantly reduce rates of restenosis and target lesion revascularization compared with bare metal stent (BMS). However, available DES have limitations, such as late thrombosis because of delayed healing with poorer endothelialization and persistent local inflammation. Statins can inhibit cell proliferation, inflammation, and restore endothelial function. The present study evaluated the ability of stent-based cerivastatin delivery to reduce stent-induced inflammatory responses and adverse effects on endothelial function, and to inhibit neointimal hyperplasia in a porcine coronary model.Pigs were randomized into groups in which the coronary arteries (9 pigs, 18 coronaries in each group) had either a cerivastatin-eluting stent (CES) or a BMS. All animals survived without any adverse effects. Inflammatory cell infiltration evaluated using scanning electron microscopy on day 3 after stenting was significantly decreased in the treated vessels (inflammation score: 1.15+/-0.12 vs 2.43+/-0.34, p<0.0001). At day 28, endothelial function with intracoronary infusion of bradykinin was preserved in both the CES and BMS groups. Volumetric intravascular ultrasound images revealed decreased intimal volume in the CES group (28.3+/-5.4 vs 75.9+/-4.2 mm3, p<0.0001). Histomorphometric analysis showed reduced neointimal area (1.74+/-0.45 vs 3.83+/-0.51 mm2, p<0.0001) in the CES group despite similar injury scores (1.77+/-0.30 vs 1.77+/-0.22, p=0.97).In porcine coronary arteries CES significantly decreased neointimal hyperplasia with a decreased early inflammatory response and without endothelial dysfunction.

Cardiovascular risk remains uncertain in patients with cardiovascular disease despite achieving target lipid levels. Serum levels of lipoprotein(a) [Lp(a)] can be risk factors for adverse events. The aim of this study was to determine the role of Lp(a) as a residual risk factor in patients who achieve target lipid levels by the time of treatment by percutaneous coronary intervention (PCI). A total of 3,508 patients were treated by PCI from 1997 to 2011 at our institution. Among them, we analyzed consecutive 569 patients who achieved target lipid levels of low-density lipoprotein cholesterol <100 mg/dl, high-density lipoprotein cholesterol ≥40 mg/dl, and triglycerides <150 mg/dl at PCI. A total of 411 eligible patients were assigned to groups according to Lp(a) levels of ≥30 mg/dl (high Lp(a); n = 119) or <30 mg/dl (low Lp(a); n = 292). The primary outcome was a composite of all-cause death and acute coronary syndrome. The median follow-up period was 4.7 years. Cumulative event-free survival was significantly worse for the group with high Lp(a) than with low Lp(a) group (p = 0.04). Multivariate analysis selected a high Lp(a) level as an independent predictor of primary outcomes (hazard ratio 1.68, 95% confidence interval 1.03 to 2.70, p = 0.04). In conclusion, a high Lp(a) value (≥30 mg/dl) could be associated with a poor prognosis after PCI even for patients who achieved target lipid levels. Cardiovascular risk remains uncertain in patients with cardiovascular disease despite achieving target lipid levels. Serum levels of lipoprotein(a) [Lp(a)] can be risk factors for adverse events. The aim of this study was to determine the role of Lp(a) as a residual risk factor in patients who achieve target lipid levels by the time of treatment by percutaneous coronary intervention (PCI). A total of 3,508 patients were treated by PCI from 1997 to 2011 at our institution. Among them, we analyzed consecutive 569 patients who achieved target lipid levels of low-density lipoprotein cholesterol <100 mg/dl, high-density lipoprotein cholesterol ≥40 mg/dl, and triglycerides <150 mg/dl at PCI. A total of 411 eligible patients were assigned to groups according to Lp(a) levels of ≥30 mg/dl (high Lp(a); n = 119) or <30 mg/dl (low Lp(a); n = 292). The primary outcome was a composite of all-cause death and acute coronary syndrome. The median follow-up period was 4.7 years. Cumulative event-free survival was significantly worse for the group with high Lp(a) than with low Lp(a) group (p = 0.04). Multivariate analysis selected a high Lp(a) level as an independent predictor of primary outcomes (hazard ratio 1.68, 95% confidence interval 1.03 to 2.70, p = 0.04). In conclusion, a high Lp(a) value (≥30 mg/dl) could be associated with a poor prognosis after PCI even for patients who achieved target lipid levels.

No nutritional index has been firmly established yet in patients with coronary artery disease (CAD). In this study, we propose a simple to calculate nutritional indicator in patients who underwent percutaneous coronary intervention (PCI) by using parameters routinely measured in CAD and evaluated its prognostic implication.This study is a retrospective observational analysis of a prospective database. The subjects were consecutive 3567 patients underwent their first PCI between 2000 and 2013 at Juntendo University Hospital in Tokyo. The median of the follow-up period was 6.3 years (range: 0-13.6 years). The novel nutritional index was calculated by the formula; Triglycerides (TG) × Total Cholesterol (TC) × Body Weight (BW) Index (TCBI) = TG × TC × BW / 1000 (TG and TC: mg/dl, and BW: kg).The Spearman non-parametric correlation coefficient between TCBI and the most often used conventional nutritional index, Geriatric Nutritional Risk Index (GNRI), was 0.355, indicating modest correlation. Moreover, Unadjusted Kaplan-Meier analysis showed higher all-cause mortality, cardiovascular mortality, and cancer mortality in patients with low TCBI. Consistently, elevation of TCBI was associated with reduced all-cause (hazard ratio: 0.86, 95%CI: 0.77-0.96, p < 0.001), cardiovascular (0.78, 0.66-0.92, p = 0.003), and cancer mortality (0.76, 0.58-0.99, p = 0.041) in patients after PCI by multivariate Cox proportional hazard analyses.TCBI, a novel and easy to calculate nutrition index, is a useful prognostic indicator in patients with CAD.

Background and aims Although an elevated mean platelet volume (MPV) has been associated with poor clinical outcomes after acute coronary syndrome (ACS), the association between MPV and long-term outcomes in patients with stable coronary artery disease (CAD) remains uncertain. We aimed to investigate the impact of pre-procedural MPV levels in patients following elective percutaneous coronary intervention (PCI). Methods We studied 2872 stable CAD patients who underwent their first PCI and who had available data on pre-procedural MPV between 2002 and 2016. Patients were divided into quartiles based on their MPV. The incidences of major adverse cardiac events (MACE), including all-cause death and non-fatal myocardial infarction, were evaluated. Results The median MPV was 10.4 fL (interquartile range: 9.8–11.0). During a median follow-up of 5.6 years, 498 (17.3%) MACE were identified, with a cumulative incidence significantly higher in the lowest MPV group than in other groups (p < 0.01). After adjustment for platelet count and the other cardiovascular risk factors, the lowest MPV group had a significantly higher risk of MACE compared with the highest MPV groups (hazard ratio: 1.43, 95% confidence interval 1.10–1.86, p = 0.009). Decreasing MPV as a continuous variable was associated with the incidence of MACE (hazard ratio: 1.16 per 1 fL decrease, 95% confidence interval 1.04–1.30, p = 0.007). Conclusions Contrary to previous studies on ACS patients, this study showed that a low MPV was associated with worse clinical outcomes among stable CAD patients.

Although an elevated neutrophil to lymphocyte ratio (NLR) has been associated with the adverse outcomes of coronary artery disease (CAD), less is known about its prognostic value among patients with low high-sensitivity C-reactive protein (hs-CRP) levels. We enrolled 2,591 consecutive patients with stable CAD who underwent elective percutaneous coronary intervention (PCI) and had available data on preprocedural hs-CRP and NLR between 2000 and 2016. Of these patients, 1,951 with low-grade hs-CRP levels (< 2.0 mg/L) were divided into quartiles based on the NLR values. The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke after the index PCI. Clinical follow-up data were obtained up to 5 years. The median NLR was 1.9 (interquartile range: 1.5-2.5). During the follow-up, 102 events occurred (5.2%), with a cumulative incidence that was significantly higher in the highest NLR group than in the other groups (log-rank, P = 0.02). After adjusting for the other cardiovascular risk factors, the risk for the primary endpoint was significantly higher for the highest than in the lowest NLR group (HR 1.97, 95% CI 1.09-3.54, P = 0.02). Increasing NLR as a continuous variable was associated with the incidence of adverse cardiovascular events (HR 1.85 per log 1 NLR increase, 95% CI 1.19-2.88, P = 0.007). In conclusion, the adverse long-term clinical outcomes of CAD patients with low-grade hs-CRP levels has been independently predicted by increased NLR level. NLR could be useful for risk stratification of CAD patients with increased inflammatory marker levels.

The prevalence of metabolic syndrome (MS), regarded as an important risk factor for coronary artery disease, is growing. However, the relationship between MS and long-term outcomes after percutaneous coronary intervention (PCI) in the Japanese patient population remains unknown.Seven-hundred and forty-eight consecutive patients who underwent PCI were assessed. Patients were categorized by the presence or absence of MS using the NCEP-ATPIII definition (for obesity, a body mass index >or=25 kg/m(2) was used). Kaplan-Meier estimation and Cox proportional hazards model were used for unadjusted and adjusted analyses for all cause mortality and cardiac events. The progress of 318 (42.5%) patients with MS and 430 (57.5%) patients without MS was analyzed. The mean follow-up was 12.0+/-3.6 years. Overall, there were 88 (11.8%) deaths from all causes, and there were no significant differences between the 2 groups. The occurrence of cardiac events was significantly higher in the MS group than that in the no MS group (25.5% vs 15.6%, hazard ratio 2.23; 95% confidence interval 1.59-3.11; p<0.001).The presence of MS significantly increased the risks of subsequent cardiac events among patients who underwent PCI.

Background Chronic kidney disease (CKD) is associated with increased risk for cardiovascular disease. The predictive power of traditional risk factors for cardiovascular disease is diminished in patients with CKD. The serum level of lipoprotein(a) [Lp(a)] can be a risk factor for adverse events, but the clinical implications of Lp(a) in patients with CKD who have been treated by percutaneous coronary intervention (PCI) remain uncertain. We aimed to determine the role of Lp(a) on long-term outcomes in patients with CKD after PCI. Methods We analyzed data from 904 patients with CKD among 3508 patients who underwent a first PCI between 1997 and 2011 at our institution. We divided patients into 2 groups [high (n = 454) or low (n = 450)] according to median levels of Lp(a). The primary outcome was a composite of all-cause death and acute coronary syndrome (ACS). Results The baseline characteristics of the groups were similar and the median follow-up period was 4.7 years. Cumulative event-free survival was significantly worse for the group with high, than low Lp(a) (P = 0.01). Multivariable analysis indicated a high Lp(a) level as an independent predictor of primary outcomes (hazard ratio, 1.35; 95% CI, 1.01–1.82; P = 0.04). Conclusions A high Lp(a) value is associated with a poor prognosis after PCI for patients with CKD.

Aims: Cardiovascular risk persists despite intensive lipid lowering therapy using statins. Serum levels of lipoprotein (a) [Lp(a)] can be a residual cardiovascular risk for adverse events. Aim of the present study was to evaluate the impact of Lp(a) on long-term clinical outcomes in patients treated with statin after percutaneous coronary intervention.

Background:High-sensitivity C-reactive protein (hs-CRP) has been used to predict the risk of adverse cardiac events in patients with coronary artery disease (CAD) after percutaneous coronary intervention (PCI). Less is known, however, about the association between hs-CRP and long-term outcome after PCI in the Japanese population.

Background:Rotational atherectomy (RA) is an adjunct tool for the management of heavily calcified coronary lesions during percutaneous coronary intervention (PCI), but the long-term clinical outcomes of RA use remain unclear in this drug-eluting stent era.

<h2>Abstract</h2><h3>Background</h3> Fractional flow reserve (FFR) is an established method for assessing functional myocardial ischemia. Recently, the resting full-cycle ratio (RFR) has been introduced as a non-hyperemic index of functional coronary stenosis. However, the effects of clinical characteristics on discordance between RFR and FFR have not been fully evaluated. We aimed to identify clinical characteristics that influence FFR–RFR concordance. <h3>Methods</h3> We included 410 patients with 573 intermediate coronary lesions who underwent clinically indicated invasive coronary angiography, as well as assessments of FFR and RFR. Receiver-operating characteristic (ROC) curves were created to assess the optimal cut-off values of RFR for predicting FFR ≤0.80. <h3>Results</h3> RFR exhibited a strong correlation with FFR (r = 0.66, <i>p</i> < 0.0001). ROC analysis identified an optimal RFR cut-off value of 0.92 for categorization based on an FFR cut-off value of 0.8. The discordance of FFR >0.8 and RFR ≤0.92 (high FFR/low RFR) was observed in 112 lesions (20.9%), whereas the discordance of FFR ≤0.8 and RFR >0.92 (low FFR/high RFR) was observed in 35 lesions (6.5%). Higher rate of hemodialysis and lower hemoglobin levels were observed in the high FFR/low RFR group. Multivariate analyses identified female sex, left anterior descending artery (LAD) lesions, and hemodialysis as significant predictors of high FFR/low RFR. Conversely, body surface area and non-LAD lesions were significantly associated with low FFR/high RFR. Hemodialysis [odds ratio (OR): 2.41, 95% confidence interval (CI) 1.31–4.41; <i>p</i> = 0.005] and LAD lesions (OR: 1.86, 95% CI: 1.25–2.79; <i>p</i> = 0.002) were identified as independent predictors of overall FFR–RFR discordance. <h3>Conclusions</h3> RFR exhibited good diagnostic performance in the identification of functionally significant stenosis. However, RFR may overestimate functional severity in patients undergoing hemodialysis or in those with LAD lesions. Further prospective trials are required to demonstrate the non-inferiority of RFR to FFR.

Aim: The usefulness of drugs to treat plaque regression is assessed by intravascular ultrasound (IVUS); however, the impact of plaque regression on clinical outcomes in patients with acute coronary syndrome (ACS) has not been established; therefore, we investigated the relationship between coronary plaque regression and long-term clinical outcomes.Methods: We analyzed data from 86 patients who underwent percutaneous coronary intervention (PCI) and who were assessed in detail at baseline and at 6 months of follow-up by measuring proximal non-culprit sites of PCI lesions using volumetric IVUS. Patients were divided according to changes in plaque volume over 6 months into one group with plaque regression (n =55; 64.0%) and another with progression (n =31; 36.0%). They were followed up observationally for a mean of 1,736 days.Results: Baseline characteristics at the time of ACS were similar between the groups. The probability of event-free survival was significantly higher in the regression group than in the progression group as estimated by the Kaplan-Meier method (Log-rank test, p =0.032). Furthermore, the Cox hazards model revealed the relative contribution of plaque regression as a predictor of cardiovascular events (hazard ratio: 0.26; 95% CI, 0.07 to 0.83; p =0.023).Conclusions: Plaque regression determined by volumetric IVUS over a period of 6 months was associated with a lower rate of cardiovascular events among patients with ACS. This study also demonstrated that plaque regression could be a surrogate marker of future cardiovascular events.

To investigate the perioperative and long-term outcomes of endovascular therapy (EVT) for subclavian artery disease in a large-scale multicenter study.The study analyzed the outcomes from a multicenter retrospective registry (SubClavian Artery disease treated with endovascuLar therapy; muLticenter retrOsPective registry: SCALLOP) of 718 consecutive patients with upper extremity artery disease who underwent EVT between January 2003 and December 2012 at 37 Japanese cardiovascular centers. Of the 718 patients enrolled in the registry, 162 patients were excluded, leaving 553 patients (mean 70±7 years, range 41-91; 405 men) who underwent primary EVT for de novo subclavian artery disease (560 arms).Procedure success was achieved in 96.8% (100% for stenoses, 91% for total occlusions). The perioperative complication rate was 9.2%. Stroke was found in 1.8%, with ipsilateral posterior infarction accounting for 0.9%. The 30-day mortality was 0.7%. The mean follow-up was 39±24 months. Primary patency estimates were 90.6%±1.3%, 83.4%±1.8%, and 80.5%±2.2% at 1, 3, and 5 years, respectively. There was no significant difference in primary patency between stenotic and occlusive lesions. Secondary patency estimates were 99.2%±0.4%, 98.2%±0.6%, and 97.7%±0.8% at 1, 3, and 5 years, respectively. The respective overall survival rates were 94.6%±1.0%, 86.8%±1.7%, and 79.0%±2.4%. There were 86 deaths during follow-up, of which half were due to cardiovascular causes. On multivariate analysis, critical hand ischemia (hazard ratio [HR] 4.6, 95% CI 2.06 to 10.2, p<0.001), cerebrovascular disease (HR 1.9, 95% CI 1.14 to 3.06, p=0.01), current smoking (HR 1.8, 95% 1.14 to 2.79, p=0.01), and lesion length (in 1-cm increments; HR 1.02, 95% CI 1.00 to 1.04, p=0.03) were negative independent predictors of primary patency, while IVUS use (HR 0.6, 95% CI 0.30 to 0.96, p=0.04) was a positive predictor of primary patency.Primary angioplasty/stenting for subclavian artery disease afforded acceptable outcomes in terms of perioperative complications and long-term patency.

BackgroundAdmission glucose levels have proven to be a predictor in patients with acute myocardial infarction and elevated glycosylated hemoglobin A1c (HbA1c) is associated with an increased risk of cardiovascular disease, even in patients without diabetes. However, the effect of both admission glucose and HbA1c levels on clinical outcomes in non-diabetic patients with acute coronary syndrome (ACS) has not been fully elucidated. We evaluated the combined effect of admission glucose and HbA1c values on long-term clinical outcomes in non-diabetic patients with ACS treated with percutaneous coronary intervention (PCI).Methods and resultsThis was an observational study of 452 consecutive non-diabetic patients with ACS who underwent PCI between January 1997 and December 2006. The patients were assigned to four groups according to the median values of admission glucose and HbA1c. The primary endpoint comprising a composite of all-cause death and non-fatal MI was compared among the four groups. The primary endpoint occurred in 13.3% of the participants during a median follow-up period of 4.7 years. The cumulative incidence rate of primary endpoint significantly differed among the groups (p = 0.048). Multivariable Cox regression analysis showed that the combination of elevated admission glucose and HbA1c was independently associated with long-term clinical outcomes.ConclusionsCombined admission glucose and HbA1c values were independently associated with clinical outcomes in non-diabetic patients with ACS treated with PCI.

Percutaneous coronary intervention (PCI) has become an established treatment for coronary artery disease. In patients receiving a drug-eluting stent (DES), dual antiplatelet therapy (DAPT) is recommended for at least 12 months. However, DAPT is a risk factor for bleeding, and risk stratification for bleeding is very important for patients with an implanted DES. The HAS-BLED score has been proposed as a practical tool to assess the bleeding risk of patients with atrial fibrillation. The aims of the study were to assess whether the HAS-BLED score has predictive value for major bleeding and survival in patients after PCI using a DES. A total of 2,171 patients were treated by PCI from 2004 to 2011 at our institution. Of these, 1,207 consecutive patients with an implanted DES were analyzed. The patients were classified into 2 groups based on the HAS-BLED score (high ≥3, low 0 to 2). The primary outcome was major bleeding and death. There were several severe co-morbidities in the high HAS-BLED score group compared with the low group. The median follow-up period was 3.6 years (interquartile range 1.5 to 5.4 years). The incidence of both death and major bleeding was higher in the high HAS-BLED score group than in the low HAS-BLED score group. On multivariate Cox proportional hazards regression analysis, high HAS-BLED score was associated with both death and major bleeding. In conclusion, the HAS-BLED score could predict the risk of bleeding and mortality for patients who underwent PCI independent of the presence of atrial fibrillation.

Patients with diabetes mellitus (DM) are at twofold to fourfold higher cardiovascular risk than those without DM. Serum levels of lipoprotein(a) (Lp(a)) can be risk factors for adverse events. However, the clinical implications of Lp(a) in patients with DM who underwent percutaneous coronary intervention (PCI) is unknown. The aim of the study was to determine the role of Lp(a) in patients with DM who underwent PCI. A total of 3,508 patients were treated by PCI from 1997 to 2011 at our institution. Among them, we analyzed consecutive 1,546 patients with DM. Eligible 1,136 patients were divided into 2 groups (high Lp(a) [n = 575] and low Lp(a) [n = 561]) by the median of Lp(a) levels. The number of chronic kidney disease, multivessel disease, and the level of LDL-C were higher in the group with high Lp(a) than with low Lp(a). The median follow-up period was 4.7 years. Event rate of all-cause death was same between the 2 groups (p = 0.37). However, cumulative incidence of cardiac death and acute coronary syndrome was significantly higher in the high Lp(a) than in the low Lp(a) group (p = 0.03). Multivariable analysis selected a high Lp(a) level as an independent predictor of cardiac death and acute coronary syndrome (hazard ratio 1.20; 95% confidence interval 1.00 to 1.42; p = 0.04). In conclusion, a high Lp(a) value could be associated with advanced cardiac events after PCI for patients with DM. Patients with diabetes mellitus (DM) are at twofold to fourfold higher cardiovascular risk than those without DM. Serum levels of lipoprotein(a) (Lp(a)) can be risk factors for adverse events. However, the clinical implications of Lp(a) in patients with DM who underwent percutaneous coronary intervention (PCI) is unknown. The aim of the study was to determine the role of Lp(a) in patients with DM who underwent PCI. A total of 3,508 patients were treated by PCI from 1997 to 2011 at our institution. Among them, we analyzed consecutive 1,546 patients with DM. Eligible 1,136 patients were divided into 2 groups (high Lp(a) [n = 575] and low Lp(a) [n = 561]) by the median of Lp(a) levels. The number of chronic kidney disease, multivessel disease, and the level of LDL-C were higher in the group with high Lp(a) than with low Lp(a). The median follow-up period was 4.7 years. Event rate of all-cause death was same between the 2 groups (p = 0.37). However, cumulative incidence of cardiac death and acute coronary syndrome was significantly higher in the high Lp(a) than in the low Lp(a) group (p = 0.03). Multivariable analysis selected a high Lp(a) level as an independent predictor of cardiac death and acute coronary syndrome (hazard ratio 1.20; 95% confidence interval 1.00 to 1.42; p = 0.04). In conclusion, a high Lp(a) value could be associated with advanced cardiac events after PCI for patients with DM.

Background and aims Female has been demonstrated to be at higher risk following percutaneous coronary intervention (PCI) compared with male in unadjusted analyses. However, conflicting results were observed after adjustment of confounding factors. Particularly, more recent studies reported that gender differences have diminished possibly by evolution of PCI-related devices and evidence-based medical therapy. We aimed to examine gender differences in long-term clinical outcomes following PCI during time period of 25 years. Methods This was a single center retrospective study in which consecutive patients who received the first PCI in our institution between January 1984 and December 2008 were analyzed. A composite of all-cause death and acute coronary syndrome (ACS) at 5-year after the index PCI was compared between genders. The endpoint was also examined in plain-old balloon angioplasty (POBA)-, bare metal stent (BMS)- and drug-eluting stent (DES)-eras separately. Results A total of 3531 patients (female; 605, male; 2926) were analyzed. The female patients had higher risk profiles than the male in terms of age, comorbid diseases, a prevalence of ACS, while male patients had a higher percentage of smoking, lower left ventricular ejection fraction (LVEF) and lower percentages of secondary prevention drugs. Gender difference was not observed in 5-year all-cause death and ACS in multivariable Cox regression analysis. After controlling variables, age, body mass index, hemoglobin value and LVEF were associated with the clinical outcomes in both genders. Conclusion Gender difference was not observed in the long-term all-cause death and ACS in patients following PCI.

Appropriate regimens of antithrombotic therapy for patients with atrial fibrillation (AF) and coronary artery disease (CAD) have not yet been established.To compare the total number of thrombotic and/or bleeding events between rivaroxaban monotherapy and combined rivaroxaban and antiplatelet therapy in such patients.This was a post hoc secondary analysis of the Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease (AFIRE) open-label, randomized clinical trial. This multicenter analysis was conducted from February 23, 2015, to July 31, 2018. Patients with AF and stable CAD who had undergone percutaneous coronary intervention or coronary artery bypass grafting 1 or more years earlier or who had angiographically confirmed CAD not requiring revascularization were enrolled. Data were analyzed from September 1, 2020, to March 26, 2021.Rivaroxaban monotherapy or combined rivaroxaban and antiplatelet therapy.The total incidence of thrombotic, bleeding, and fatal events was compared between the groups. Cox regression analyses were used to estimate the risk of subsequent events in the 2 groups, with the status of thrombotic or bleeding events that had occurred by the time of death used as a time-dependent variable.A total of 2215 patients (mean [SD] age, 74 [8.2] years; 1751 men [79.1%]) were included in the modified intention-to-treat analysis. The total event rates for the rivaroxaban monotherapy group (1107 [50.0%]) and the combination-therapy group (1108 [50.0%]) were 12.2% (135 of 1107) and 19.2% (213 of 1108), respectively, during a median follow-up of 24.1 (IQR, 17.3-31.5) months. The mortality rate was 3.7% (41 of 1107) in the monotherapy group and 6.6% (73 of 1108) in the combination-therapy group. Rivaroxaban monotherapy was associated with a lower risk of total events compared with combination therapy (hazard ratio, 0.62; 95% CI, 0.48-0.80; P < .001). Monotherapy was an independent factor associated with a lower risk of subsequent events compared with combination therapy. The mortality risk after a bleeding event (monotherapy, 75% [6 of 8]; combination therapy, 62.1% [18 of 29]) was higher than that after a thrombotic event (monotherapy, 25% [2 of 8]; combination therapy, 37.9% [11 of 29]).Rivaroxaban monotherapy was associated with lower risks of total thrombotic and/or bleeding events than combination therapy in patients with AF and stable CAD. Tapered antithrombotic therapy with a sole anticoagulant should be considered in these patients.ClinicalTrials.gov Identifier: NCT02642419.

Obesity is a major risk factor for cardiovascular disease; however, a paradoxical effect of obesity has been reported in patients with heart failure or myocardial infarction. Although several studies have suggested the same obesity paradox in patients undergoing transcatheter aortic valve replacement (TAVR), they included a limited number of underweight patients.This study aimed to clarify the effect of being underweight on TAVR outcomes.We retrospectively analyzed 1,693 consecutive patients undergoing TAVR between 2010 and 2020. The patients were categorized according to body mass index: underweight (<18.5 kg/m2; n = 242), normal weight (18.5 to 25 kg/m2; n = 1,055), and overweight (>25 kg/m2; n = 396). We compared midterm outcomes after TAVR among the 3 groups; all clinical events were in accordance with the Valve Academic Research Consortium-2 criteria.Underweight patients were more likely to be women and have severe heart failure symptoms, peripheral artery disease, anemia, hypoalbuminemia, and pulmonary dysfunction. They also had lower ejection fractions, smaller aortic valve areas, and higher surgical risk scores. Device failure, life-threatening bleeding, major vascular complications, and 30-day mortality occurred more frequently in underweight patients. The midterm survival rate of the underweight group was inferior to those of the other 2 groups (P < 0.0001; average follow-up, 717 days). In the multivariate analysis, underweight was associated with noncardiovascular mortality (HR: 1.78; 95% CI: 1.16-2.75) but not cardiovascular mortality (HR: 1.28; 95% CI: 0.58-1.88) after TAVR.Underweight patients had a worse midterm prognosis, demonstrating the obesity paradox in this TAVR population. (Outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis: multi-center registry; UMIN000031133).

Objective Lipoprotein-associated phospholipase A2 (Lp-PLA2) is a vascular-specific inflammatory enzyme, of which increases are associated with cardiovascular events. However, the relationship between circulating Lp-PLA2 levels and coronary plaque volume has not been clarified in patients with acute coronary syndrome (ACS). Methods We studied 40 patients with ACS (age, 61.4 ± 8.0 years; male, 87.5%; statin use, 45.0%) who had undergone successful percutaneous coronary intervention (PCI). Plaque volume (PV) in non-culprit sites of PCI lesions was precisely determined using grayscale intravascular ultrasound (IVUS) at onset and at six months later. We then analyzed associations among PV, lipid profiles and Lp-PLA2 levels. Results Circulating Lp-PLA2 levels and PV significantly decreased between baseline and six months of follow-up (458.6 ± 166.7 IU/L vs. 378.4 ± 158.5 IU/L, p < 0.001 and 82.2 ± 34.8 mm3 vs. 77.3 ± 33.1 mm3, p < 0.001, respectively). The % change in PV positively and significantly correlated with % change in LDL-C and in the LDL-C/HDL-C ratio (r = 0.444, p = 0.004 and r = 0.462, p = 0.003, respectively). Furthermore, % changes in Lp-PLA2 and in PV correlated even more closely (r = 0.496, p = 0.001). The absolute change in PV also significantly correlated with the change in Lp-PLA2 levels (r = 0.404, p = 0.009). Conclusions Circulating Lp-PLA2 levels are associated with changes in coronary plaque determined by IVUS in patients with ACS.

Background: A previous study reported that amlodipine retarded coronary plaque progression in patients with coronary artery disease. The goal of this multicenter study was to determine which calcium-channel blockers (CCBs) other than amlodipine attenuated the progression of plaque volume (PV) accessed by intravascular ultrasound (IVUS). Methods and Results: ALPS-J was a prospective, randomized open-label study conducted at 5 centers. Patients who had hypertension and were scheduled for coronary intervention were enrolled. Subjects were randomly assigned to receive 16mg/day of azelnidipine or 5mg/day of amlodipine administered for 48 weeks. The primary endpoint was the percent change in coronary PV measured by IVUS. Between 2007 and 2009, 199 patients were enrolled; 115 had evaluable IVUS images at both baseline and after 48 weeks of treatment. Blood pressure significantly reduced to 128/68mmHg at follow-up. The lipid profiles in the 2 groups were comparable (low-density lipoprotein cholesterol: 97mg/dl). The %change in PV showed a significant regression of 4.67 and 4.85% in the azelnidipine and amlodipine groups, respectively. The upper limit of the 95% confidence interval of the mean difference in %change PV between the 2 groups (0.18%, 95% confidence interval 4.62 to 4.98%) did not exceed the pre-defined non-inferiority margin of 6.525%. Conclusions: ALPS-J demonstrated that azelnidipine was not inferior to amlodipine for primary efficacy. In addition to standard medical therapy, dihydropyridine CCBs will retard PV progression in hypertensive patients. (Circ J 2011; 75: 1071-1079)

BackgroundLimited data exist regarding the long-term prognosis of percutaneous coronary intervention (PCI) in young adults. The aim of this study was to retrospectively assess the long-term clinical outcomes in young patients who underwent PCI.Methods and resultsBetween 1985 and 2011, 7649 consecutive patients underwent PCI, and data from 69 young adults (age ≤40 years) and 4255 old adults (age ≧65 years) were analyzed. A Cox proportional hazards regression analysis was used to determine the independent predictors of a composite endpoint that included all-cause death and acute coronary syndrome (ACS) during the follow-up period. The mean age of the 69 young patients was 36.1 ± 4.9 years, and 96% of them were men. Approximately 30% were current smokers, and their body mass index (BMI) was 26.7 ± 5.0 kg/m2. The prevalence of diabetes and hypertension was 33% and 48%, respectively. All patients had ≥1 conventional cardiovascular risk factor. At a median follow-up of 9.8 years, the overall death rate was 5.8%, and new-onset ACS occurred in 8.7%. Current smoking was an independent predictor of the composite endpoint (hazard ratio 4.46, confidence interval 1.08–19.1, p = 0.04) for young adults.ConclusionCurrent smoking and obesity (high BMI) are the important clinical characteristics in young Japanese coronary heart disease patients who undergo PCI. The long-term prognosis in young patients is acceptable, but current smoking is a significant independent predictor of death and the recurrence of ACS in young Japanese coronary heart disease patients who are obese.

Although there is increasing evidence of the effectiveness of endovascular therapy for complex aortoiliac (AI) occlusive disease, it is not universally applied to TASC D lesions.A total of 2096 patients, 2601 limbs with AI occlusive disease, were enrolled. The lesions were categorized as TASC D (395) or TASC A-C (2206), and we compared baseline data, procedure, and follow-up result between the 2 groups.The success rate of the procedure was significantly lower in the TASC D group (91.6% vs 99.3%, P < .01), and more procedure complications occurred in the TASC D group (11.1% vs 5.2%, P < .01). The results of a 5-year follow-up revealed no significant difference in primary patency (77.9% vs 77.1%, P = .17) and major adverse cardiovascular and limb events (MACLE; 30.5% vs 33.4%, P = .42) between the 2 groups. A multivariate analysis revealed complications and critical limb ischemia are independent predictors of MACLE in the TASC D group.The success rate of the procedure was lower in the TASC D group. Complications were more frequent in the TASC D group, and they were related to MACLE.

Abstract Background and Hypothesis Japan is an aging society, and the number of nonagenarians with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) is increasing, but their outcomes have not been determined fully. Methods We prospectively enrolled 767 consecutive patients who underwent TAVI in three Japanese institutions. Clinical characteristics and outcomes of nonagenarians (n = 94) were evaluated and compared with those of patients aged &lt;90 years (n = 673). Results Prevalence of New York Heart Association (NYHA) class III/IV was not different between the two groups. Preoperative risk scores were significantly higher in nonagenarians compared with those in non‐nonagenarians, whereas the Clinical Frailty Scale was not different. Thirty‐day mortality tended to be higher ( P = .06) and major vascular complication was significantly higher in nonagenarians than in non‐nonagenarians ( P &lt; .05), but 3‐year mortality was equivalent between the two groups. Even after adjustment for covariates, female sex (hazard ratio, 0.41; 95% confidence interval: 0.25‐0.67), body mass index (0.87, 0.80‐0.94), and NYHA class III/IV (1.84, 1.06‐3.29) were associated with all‐cause mortality. Age ≥ 90 years was not associated with all‐cause mortality. Conclusions TAVI could be undertaken safely and effectively in nonagenarians, who had acceptable long‐term results compared with those for younger patients, although careful attention should be paid to major vascular complication.

Dipeptidyl-peptidase-4 inhibitors (DPP4i) have been the most used antidiabetic medications worldwide due to their good safety profiles and tolerability with a low risk of hypoglycemia, however, large cardiovascular outcome trials (CVOTs) have not shown any significant the prognostic superiority. On the contrary, since observational studies have suggested the effects of DPP4i are enhanced some populations, such as Asians and those who without overweight, their prognostic benefit is still under debate. The aim of this study was thus to assess the prognostic impact of DPP4i in patients with both diabetes and coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI) through the insulin-like growth factor-1 (IGF-1) axis, a substrate of DPP4. This single-center analysis involved consecutive Japanese diabetic patients who underwent PCI for the first time between 2008 and 2018 (n = 885). Primary and secondary endpoints were set as cardiovascular (CV) death and the composite of CV death, non-fatal myocardial infarction and ischemic stroke (3P-MACE). Serum levels of IGF-1 and its main binding protein (insulin-like growth factor binding protein-3: IGFBP-3) were measured. In consequences, unadjusted Kaplan-Meier analyses revealed reduced incidences of CV-death and 3P-MACE by DPP4i, which was particularly enhanced in patients who were not overweight (BMI ≤ 25). Multivariate Cox hazard analyses consistently indicated reduced risks of CV death by DPP4i at PCI (hazard ratio (HR) 0.39, 95% confidence interval (CI) 0.16-0.82, p = 0.01) and 3P-MACE (HR 0.47, 95% CI 0.25-0.84, p = 0.01), respectively. Moreover, elevated IGF-1 activity indicated by the IGF-1/IGFBP-3 ratio was associated with decreased risks of both endpoints and it was significantly higher in patients with DPP4i (p < 0.0001). In conclusion, the findings of the present study indicate beneficial effects of DPP4i to improve outcomes in Japanese diabetic patients following PCI, which might be mediated by DPP4-IGF-1 axis.

Metabolic syndrome (MS) is highly prevalent and an established key risk factor for coronary artery disease, regardless of the presence or absence of diabetes mellitus (DM). Long-term follow-up studies have addressed the influence of MS with and without DM on the prognosis of patients undergoing percutaneous coronary intervention (PCI). We classified 748 consecutive patients who had undergone PCI into four groups as follows: neither DM nor MS, DM alone, MS alone, and both DM and MS. Post hoc analyses were conducted using prospectively collected clinical data. Multivariate Cox regression was used to evaluate the risk within each group for all-cause mortality and composite cardiac events (cardiac death, non-fatal acute coronary syndrome), adjusting for age, gender, body mass index, low-density lipoprotein (LDL) cholesterol level, hypertension, smoking, prior coronary artery bypass graft, presentation of acute coronary syndrome, left ventricular ejection fraction, multivessel disease, and procedural success. The progress of 321 (42.9%) patients with neither DM nor MS, 109 (14.6%) patients with DM alone, 129 (17.2%) patients with MS alone, and 189 (25.3%) patients with both DM and MS was followed up for a mean of 12.0+/-3.6 years. Patients with both DM and MS had significant risk for increased all-cause mortality (2.10 [1.19-3.70]). Patients with MS alone (2.14 [1.31-3.50]) and with both DM and MS (1.87 [1.18-2.96]) were at significant risk for increased cardiac events. In conclusion, the risk of cardiac events is significantly increased in patients with metabolic syndrome following PCI, irrespective of DM.

Objective Restenosis after vascular intervention remains a major clinical problem. Circulating LR11 has been shown a novel marker of intimal smooth muscle cell (SMC) proliferation in human and animal studies. The present study was performed to clarify the clinical significance of circulating LR11 in patients with stable angina pectoris after coronary stenting. Methods and results We firstly investigated the circulating sLR11 levels for 28 days after arterial injury in mice, and then assessed time-dependent change in circulating sLR11 level after coronary stenting in a clinical study. Mouse sLR11 levels rapidly increased to 4.0-fold of the control value without cuff placement at postoperative day (POD) 14, and the levels gradually declined to 3.1-fold of the control value until POD 28 in mice. The circulating soluble LR11 levels were measured (before and at 14, 60 and 240 days after coronary stenting in a clinical study of 102 consecutive patients with stable angina pectoris who were treated with percutaneous coronary intervention. Circulating sLR11 levels were significantly increased on days 14 and 60 after the procedure and positively associated with the angiographic late loss index. Conclusions Our study suggested that circulating sLR11 levels may be a potential marker for angiographic late loss in patients after coronary stenting. Further mechanistic studies are expected to know the clinical significance of sLR11 as a novel marker for intimal SMC.

<h2>Abstract</h2><h3>Introduction</h3> C-reactive protein (CRP) is an established marker for vascular inflammation and predictor of adverse cardiovascular events, but the prognostic value of preprocedural CRP in coronary artery disease (CAD) patients who have undergone percutaneous coronary intervention (PCI) remains controversial. Furthermore, the impact of CRP levels during follow-up in CAD patients after PCI on long-term adverse clinical outcomes is uncertain. We evaluated the association between high-sensitivity (hs)-CRP values at follow-up angiography and long-term clinical outcomes in CAD patients after coronary intervention. <h3>Methods</h3> We prospectively enrolled 3507 consecutive CAD patients who underwent first PCI between 1997 and 2011 at our institution. We identified 2509 patients (71.5%) who underwent follow-up angiography (6–8 months after PCI). Of those, 1605 patients (45.8%) who had data available for hs-CRP at follow-up angiography were stratified into three groups according to tertiles of hs-CRP level at the time of follow-up angiography. The primary endpoint was composite of all-cause death and non-fatal acute coronary syndrome (ACS). <h3>Results</h3> Median follow-up was 1716 days. The cumulative incidence of all-cause death and ACS differed significantly among groups (log-rank, <i>p</i>=0.0002). Multivariate Cox regression analysis showed that a higher hs-CRP level at follow-up angiography was associated with a greater risk of all-cause death and ACS [adjusted hazard ratio (HR) for all-cause death and ACS 2.14, 95% confidence interval (CI) 1.43–3.27, <i>p</i>=0.0002. <h3>Conclusion</h3> Elevated hs-CRP levels during follow-up were significantly associated with higher frequencies of adverse long-term clinical outcomes in patients with CAD after PCI.

Malignancy is common in older adults undergoing transcatheter aortic valve implantation (TAVI), and may affect prognosis. The present study aimed to examine whether active cancer affects all-cause mortality rates among patients undergoing TAVI.This retrospective study examined data from 1,114 consecutive patients treated between April 2010 and June 2019. Patients with life expectancy of <1 year due to non-cardiac causes were excluded.Active cancer was defined as cancer under treatment or cured within 1 year, and was recognized in 62 patients (5.6%) with (n = 17) and without (n = 45) metastases. In multivariate analysis, being female (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.39-0.77, p < 0.001), body mass index (BMI) (HR = 0.92 per 1 kg/m2 increase, 95% CI 0.87-0.97, p = 0.001), New York Heart Association (NYHA) class III/IV (HR = 1.53, 95% CI 1.06-2.20, p = 0.022), atrial fibrillation (HR = 2.40, 95% CI 1.70-3.38, p < 0.001), albumin levels (HR = 0.41 per 1-g/dl, 95% CI 0.30-0.57, p < 0.001), and cancer metastasis (HR = 5.28, 95% CI 1.86-14.9, p = 0.001) were associated with all-cause mortality after TAVI.In patients undergoing TAVI, being female, high BMI, NYHA class III/IV, atrial fibrillation, albumin levels, and cancer metastasis were factors associated with mortality. Meanwhile, active cancer without metastasis was not associated with increased mortality rates. These findings would help clinical decision-making by patients and physicians.Clinical trial registration: UMIN000031133.

Sarcopenia, which is evaluated based on appendicular skeletal muscle mass (ASM) using dual-energy X-ray absorptiometry and bioelectrical impedance analysis, is a prognostic predictor for adverse outcomes in patients with coronary artery disease (CAD). However, a simple equation for estimating ASM is yet to be validated in clinical practice. We enrolled 2211 patients with CAD who underwent percutaneous coronary intervention at our hospital between 2010 and 2017. The mean age was 68 years and 81.5 % were men. Patients were divided into 2 groups based on each ASM index (ASMI): low; male < 7.3 and female < 5.0 and high; male ≥ 7.3 and female ≥ 5.0. ASM was calculated using the following equation: 0.193 × bodyweight + 0.107 × height − 4.157 × gender − 0.037 × age − 2.631. Primary endpoints were major adverse cardiac events (MACE, which includes cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure), and all-cause mortality. During the median follow-up period of 4.8 years, cumulative incidence of events were significantly higher in the low ASMI group. Cox proportional hazards model revealed that the low ASMI group had a significantly higher risk of primary endpoints than the high ASMI group (all-cause mortality; hazard ratio (HR): 2.13, 95 % confidence interval [CI]: 1.40–3.22, p < 0.001 and 4-point MACE; HR: 1.72, 95 % CI: 1.12–2.62, p = 0.01). Similar trends were observed after stratification by age of 65 years. Low ASMI, evaluated using the aforementioned equation, is an independent predictor of MACE and all-cause mortality in patients with CAD.

Abstract Purpose To compare the objective and subjective image quality and diagnostic performance for coronary stenosis of normal-dose model-based iterative reconstruction and reduced-dose super-resolution deep learning reconstruction in coronary CT angiography. Materials and Methods This single-center retrospective study included 52 patients (mean age, 68 years ± 10 [SD]; 41 men) who underwent serial coronary CT angiography and subsequent invasive coronary angiography between January and November 2022. The first 25 patients were scanned with a standard dose using model-based iterative reconstruction. The last 27 patients were scanned with a reduced dose using super-resolution deep learning reconstruction. Per-patient objective and subjective image qualities were compared. Diagnostic performance of model-based iterative reconstruction and super-resolution deep learning reconstruction to diagnose significant stenosis on coronary angiography was compared per-vessel using receiver operating characteristics curve analysis. Results The median tube current of super-resolution deep learning reconstruction was lower than that of model-based iterative reconstruction (median [IQR], 890 mA [680, 900] vs. 900 mA [895, 900], P = 0.03). Image noise of super-resolution deep learning reconstruction was lower than that of model-based iterative reconstruction (14.6 Hounsfield units ± 1.3 vs. 22.7 Hounsfield units ± 4.4, P &amp;lt; .001). Super-resolution deep learning reconstruction improved the overall subjective image quality compared with model-based iterative reconstruction (median [IQR], 4 [3, 4] vs 3 [3, 3], P = .006). No difference in the area under the receiver operating characteristic curve in diagnosing coronary stenosis using super-resolution deep learning reconstruction (0.96; 95% CI, 0.92-0.99) and model-based iterative reconstruction (0.96; 95% CI, 0.92-0.98; P = .98) was observed. Conclusion Our exploratory analysis suggests that super-resolution deep learning reconstruction could improve image quality with lower tube current settings than model-based iterative reconstruction with similar diagnostic performance to diagnose coronary stenosis in coronary CT angiography.

Abstract Background Since the complication of diabetes mellitus (DM) is a risk for adverse cardiovascular outcomes in patients with coronary artery disease (CAD), appropriate risk estimation is needed in diabetic patients following percutaneous coronary intervention (PCI). However, there is no useful biomarker to predict outcomes in this population. Although stromal cell derived factor-1α (SDF-1α), a circulating chemokine, was shown to have cardioprotective roles, the prognostic impact of SDF-1α in diabetic patients with CAD is yet to be fully elucidated. Moreover, roles of SDF-1α isoforms in outcome prediction remain unclear. Therefore, this study aimed to assess the prognostic implication of three forms of SDF-1α including total, active, and inactive forms of SDF-1α in patients with DM and after PCI. Methods This single-center retrospective analysis involved consecutive patients with diabetes who underwent PCI for the first time between 2008 and 2018 (n = 849). Primary and secondary outcome measures were all-cause death and the composite of cardiovascular death, non-fatal myocardial infarction, and ischemic stroke (3P-MACE), respectively. For determining plasma levels of SDF-1α, we measured not only total, but also the active type of SDF-1α by ELISA. Inactive isoform of the SDF-1α was calculated by subtracting the active isoform from total SDF-1α. Results Unadjusted Kaplan–Meier analyses revealed increased risk of both all-cause death and 3P-MACE in patients with elevated levels of inactive SDF-1α. However, plasma levels of total and active SDF-1α were not associated with cumulative incidences of outcome measures. Multivariate Cox hazard analyses repeatedly indicated the 1 higher log-transformed inactive SDF-1α was significantly associated with increased risk of all-cause death (hazard ratio (HR): 2.64, 95% confidence interval (CI): 1.28–5.34, p = 0.008) and 3P-MACE (HR: 2.51, 95% CI: 1.12–5.46, p = 0.02). Moreover, the predictive performance of inactive SDF-1α was higher than that of total SDF-1α (C-statistics of inactive and total SDF-1α for all-cause death: 0.631 vs 0.554, for 3P-MACE: 0.623 vs 0.524, respectively). Conclusion The study results indicate that elevated levels of plasma inactive SDF-1α might be a useful indicator of poor long-term outcomes in diabetic patients following PCI. Trial registration: This study describes a retrospective analysis of a prospective registry database of patients who underwent PCI at Juntendo University Hospital, Tokyo, Japan (Juntendo Physicians’ Alliance for Clinical Trials, J-PACT), which is publicly registered (University Medical Information Network Japan—Clinical Trials Registry, UMIN-CTR 000035587).

The purpose of this study was to test the hypothesis that plasma levels of adiponectin can predict angiographic in-stent restenosis after coronary stenting. We prospectively examined adiponectin levels in 127 consecutive patients undergoing elective coronary stenting. Restenosis was defined as more than 50% stenosis at follow-up study by quantitative coronary angiography. There were no significant differences in the clinical characteristics or angiographical findings between the groups with restenosis and no restenosis. The levels of adiponectin did not differ between the restenosis group and the no restenosis group (5.7 +/- 2.8 vs 5.9 +/- 3.6 microg/mL, p = 0.72). The plasma levels of adiponectin were not related with the late loss index after coronary stenting (r = 0.01, p = 0.89). The levels of adiponectin were significantly lower in men than in women (5.5 +/- 3.2 vs 8.8 +/- 3.7 microg/ mL, p < 0.001), and negatively correlated with body mass index (r = -0.21, p = 0.01). We analyzed adiponectin levels in male, female, obese, non-obese, diabetes, and non-diabetes patients, however, there were no significant differences between the restenosis group and no restenosis group. This study has demonstrated that the measurement of adiponectin could not predict angiographic restenosis after elective coronary stenting, whereas the plasma levels of adiponectin were associated with some coronary risk factors in patients with coronary artery disease.

Dipeptidyl peptidase-4 (DPP-4) inhibitors have anti-atherosclerotic and cardioprotective effects in vitro. However, the impact of DPP-4 inhibitors on coronary plaque remains unclear. We sought to assess the effect of sitagliptin on coronary plaque volume (PV) and stabilization in diabetic patients with acute coronary syndrome (ACS).The ESPECIAL-ACS was a prospective, randomized, open-label, parallel group study at 4 Japanese centers to assess the effect of 6-month treatment with sitagliptin on coronary plaque changes in non-culprit lesion in diabetic patients with ACS using serial intravascular ultrasound (IVUS) and integrated backscatter IVUS (IB-IVUS) analysis.A total of 41 patients were randomly allocated to either sitagliptin group (diet and exercise with sitagliptin 50-100mg daily, n=21) or control group (diet and exercise, n=20) within 72h after percutaneous coronary intervention, and underwent volumetric IVUS and IB-IVUS analyses at baseline and 6-month follow-up. At 6-month follow-up, the percent change in PV as primary endpoint was larger in the sitagliptin group than in the control group, but the difference was not statistically significant (-4.0±8.5% vs. -1.4±8.8%, p=0.35). In IB-IVUS analysis, the percent change in lipid PV significantly decreased in the sitagliptin group compared with the control group (-7.1±21.5% vs. 15.6±41.8%, p=0.03).Compared with diet and exercise therapy, sitagliptin did not significantly reduce coronary PV in diabetic patients with ACS at 6-month follow-up. However, the percent change in lipid PV significantly decreased in the sitagliptin group, suggesting that sitagliptin has a potential to stabilize the plaque vulnerability.

Coronary artery disease is a critical issue that requires physicians to consider appropriate treatment strategies, especially for elderly people who tend to have several comorbidities, including diabetes mellitus (DM) and multivessel disease (MVD). Several studies have been conducted comparing clinical outcomes between percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) in patients with DM and MVD. However, elderly people were excluded in those clinical studies. Therefore, there are no comparisons of clinical outcomes between CABG and PCI in elderly patients with DM and MVD. We compared all-cause mortality between PCI with drug-eluting stents (DES) and CABG in elderly patients with DM and MVD. A total of 483 (PCI; n = 256, CABG; n = 227) patients were analyzed. The median follow-up period was 1356 days (interquartile range of 810-1884). The all-cause mortality rate was not significantly different between CABG and PCI with DES groups. The CABG group had more patients with complex coronary lesions such as three-vessel disease or a left main trunk lesion. Older age, hemodialysis, and reduced LVEF were associated with increased long-term all-cause mortality in a multivariable Cox regression analysis. The rate of all-cause mortality was not significantly different between the PCI and CABG groups in elderly patients with DM and MVD in a single-center study.

Numerous studies have reported the relationship between elevated homocysteine (Hcy) levels and the risk of coronary artery disease. However, there is insufficient information about the effects of Hcy levels on long-term clinical outcomes in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).In the Juntendo-registry cohort from 2003 to 2004, pre-procedural Hcy levels and Hcy thiolactonase activity (HTlase) were measured in 315 consecutive all-comer patients who underwent PCI for stable coronary artery disease or acute coronary syndrome (ACS). Receiver-operating characteristic (ROC) curves were created to assess the optimal cut-off values of Hcy and HTlase. Multivariable Cox proportional hazard regression analysis was used to identify the predictors of clinical outcome. The primary endpoint was all-cause mortality.The patients' mean age was 66±9 years, and 82.5% were males. The median follow-up period was 10.5 years, and overall mortality was 24.5% (73 deaths). On ROC analysis, the optimal cut-off values of Hcy and HTlase were 13.5μmol/L and 230IU/L, respectively. Kaplan-Meier survival analysis showed associations of both higher Hcy levels and lower HTlase activity with worse prognosis (both log-rank p<0.001). On multivariate Cox proportional hazard regression analysis, higher Hcy was strongly associated with the primary outcome, and the adjusted hazard ratio was 3.3 (95% confidence interval, 1.8-5.6; p<0.001).Pre-procedural high Hcy levels and low HTlase activity were associated with worse long-term mortality in Japanese patients undergoing PCI. Moreover, Hcy levels are strongly predictive for mortality, independent of traditional risk factors. This may have implications for risk stratification and the therapeutic approach in this PCI era.

Postprandial hyperglycemia plays an important role in the pathogenesis of coronary artery disease and cardiovascular events. Serum 1,5-anhydroglucitol (1,5-AG) levels are known to be a clinical marker of postprandial hyperglycemia. However, the impact of 1,5-AG level on cardiovascular events has not been fully investigated.We enrolled 240 consecutive patients who had undergone first-time elective percutaneous coronary intervention (PCI) with follow-up angiography within 1 year. We excluded patients with a history of acute coronary syndrome, advanced chronic kidney disease (estimated glomerular filtration rate <30 mL/min/1.73 m2), or uncontrolled diabetes mellitus (HbA1c ≥7.0 %). Fasting blood glucose (FBS), HbA1c, and 1,5-AG levels were measured prior to PCI and at the time of follow-up angiography. Clinical events, including target lesion revascularization, target vessel revascularization, and revascularization of new lesions, were evaluated.Subjects were divided into two groups according to clinical outcomes: the Event (+) group (n = 40) and the Event (-) group (n = 200). No significant differences were observed, except for the number of diseased vessels and the prevalence of statin use, in baseline clinical characteristics between the two groups. Serum levels of 1,5-AG at follow-up were significantly lower in the Event (+) group than in the Event (-) group (P = 0.02). A significant reduction in 1,5-AG level from baseline to follow-up was observed in the Event (+) group compared with the Event (-) group (P = 0.04). The association between 1,5-AG levels at follow-up and clinical events remained significant after adjustment for independent variables, including FBS and HbA1c levels (P = 0.04).Low and exacerbated levels of 1,5-AG were associated with cardiovascular events in the present study, indicating that postprandial hyperglycemia is an important risk factor for adverse clinical events even in patients with HbA1c < 7.0 %, following first-time elective PCI.

Background and aims Low serum albumin level is reportedly associated with worse clinical outcomes in patients with chronic kidney disease (CKD). However, associations between decreased serum albumin level and outcomes in non-CKD patients with coronary artery disease (CAD) remain unclear. Therefore, we aimed to evaluate the prognostic value of serum albumin concentrations in stable CAD patients with preserved renal function. Methods and results We studied 1316 patients with CAD and preserved renal function (estimated glomerular filtration rate ≥60 mL/min/1.73 m2) who underwent their first PCI between 2000 and 2011 and had data available for pre-procedural serum albumin. Patients were assigned to quartiles based on pre-procedural albumin concentrations. The incidence of major adverse cardiac events (MACE), including all-cause death and non-fatal myocardial infarction, was evaluated. Mean albumin concentration was 4.1 ± 0.4 g/dL. During the median follow-up of 7.5 years, 181 events occurred (13.8%). Kaplan–Meier curves revealed that patients with decreased serum albumin concentrations showed a higher event rate for MACE (log-rank, p < 0.0001). Using the highest tertiles (>4.3 g/dL) as reference, adjusted hazard ratios were 1.97 (95% CI, 1.12–3.55), 1.77 (95% CI, 0.99–3.25), and 1.19 (95% CI, 0.68–2.15) for serum albumin concentrations of <3.9, 3.9–4.0, and 4.1–4.3 g/dL, respectively. Decreased serum albumin concentration was associated with MACE even after adjusting for other independent variables (HR, 2.21 per 1-g/dL decrease; 95% CI, 1.37–3.56, p = 0.001). Conclusion Decreased serum albumin concentration independently predicted worse long-term prognosis in non-CKD patients after PCI. Pre-procedural serum albumin concentration could offer a useful predictor for patients with CAD and preserved renal function.

Cardiac rehabilitation (CR) is an established multidisciplinary secondary preventive program. We investigated the effects of CR involving intensive physical activity (PA) on coronary plaque volume and components in patients with acute coronary syndrome (ACS).Methods and Results:We enrolled 32 consecutive patients with ACS in early phase II CR and randomly assigned them to an intensive CR group (n=18; CR participation ≥twice/week, daily PA ≥9,000 steps) or a standard CR group (n=14; CR participation ≥once/2weeks, daily PA ≥6,000 steps). Serial integrated backscatter intravascular ultrasound was performed for non-culprit lesions at baseline and after 8 months. Baseline clinical data were identical between the 2 groups. Unexpectedly, CR participation and PA did not differ significantly between the 2 groups, and there was no significant difference in plaque volume (PV) or components between the 2 groups. Subsequently, we classified the patients into 2 groups according to median PA (7,000 steps). There were significant differences in percent change of PV and of lipid volume between these 2 groups. In addition, these changes were negatively and independently correlated with PA.No significant difference was observed in PV or components between the intensive CR and the standard CR groups. Intensive PA, however, may retard coronary PV and ameliorate lipid component in patients with ACS participating in late phase II CR.

Background: A poor nutritional status has been gathering intense clinical interest recently as it has been suggested to associate with adverse outcomes in patients in the intensive care unit (ICU). However, there is still no established nutritional index dominantly used in clinical practice. We have previously proposed a novel nutritional index, which can be calculated using serum levels of triglycerides, total cholesterol, and body weight (TCBI). In this study, to expand the application of TCBI for critical patients, we investigated the usefulness of TCBI to predict prognosis in hemodynamically unstable patients with percutaneously implantable mechanical circulatory support (MCS) devices in the ICU. Patients and Methods: This is a retrospective analysis of a multicenter registry consisting of three Juntendo University hospitals in Japan involving patients who received MCS devices, including intra-aortic balloon pumping (IABP) with or without veno-arterial extracorporeal membrane oxygenation (VA-ECMO), between 2012 and 2016 (n = 439). The median follow-up period was 298 days. Results: Spearman’s correlation coefficient between TCBI and the geriatric nutritional risk index (GNRI) was 0.44 (p &lt; 0.0001), indicating a moderate positive correlation for these two variables. Unadjusted Kaplan–Meier analysis demonstrated reduced risks of all-cause and cardiovascular mortalities in patients with higher tertiles of TCBI. Furthermore, adjusted multivariate Cox proportional hazard analyses revealed that the highest tertile TCBI was an independent predictor for the reduced risk of all-cause mortality (hazard ratio (HR): 0.22, 95% confidence interval: 0.10–0.48, p &lt; 0.0001) and cardiovascular mortality (0.20, 0.09–0.45, p &lt; 0.0001). Conclusion: A novel and simple to calculate nutritional index, TCBI, can be applicable as a prognostic indicator in hemodynamically unstable patients requiring MCS devices.

Computed tomography fractional flow reserve (CT-FFR), which can be acquired on-site workstation using fluid structure interaction during the multiple optimal diastolic phase, has an incremental diagnostic value over conventional coronary computed tomography angiography (CCTA). However, the appropriate location for CT-FFR measurement remains to be clarified.A total of 115 consecutive patients with 149 vessels who underwent CCTA showing 30-90% stenosis with invasive FFR within 90 days were retrospectively analyzed. CT-FFR values were measured at three points: 1 and 2 cm distal to the target lesion (CT-FFR1cm, 2cm) and the vessel terminus (CT-FFRlowest). The diagnostic accuracies of CT-FFR ≤ 0.80 for detecting hemodynamically significant stenosis, defined as invasive FFR ≤ 0.80, were compered.Fifty-five vessels (36.9%) had invasive FFR ≤ 0.80. The accuracy and AUC for CT-FFR1cm and 2cm were comparable, while the AUC for CT-FFRlowest was significantly lower than CT-FFR1cm and 2cm. (lowest/1cm, 2 cm = 0.68 (95 %CI 0.63-0.73) vs 0.79 (0.72-0.86, p = 0.006), 0.80 (0.73-0.87, p = 0.002)) The sensitivity and negative predictive value of CT-FFRlowest were 100%. The reclassification rates from positive CT-FFRlowest to negative CT-FFR1cm and 2cm were 55.7% and 54.2%, respectively.The diagnostic performance of CT-FFR was comparable when measured at 1-to-2 cm distal to the target lesion, but significantly higher than CT-FFRlowest. The lesion-specific CT-FFR could reclassify false positive cases in patients with positive CT-FFRlowest, while all patients with negative CT-FFRlowest were diagnosed as negative by invasive FFR.

The association between modulation of detailed lipoprotein profiles and cholesterol ester transfer (CET) activity by peroxisome proliferator-activated receptor (PPAR)-a agonists in patients with coronary artery disease remains unclear. We assessed lipid profiles, plasma CET activity, and in-stent intimal hyperplasia after fenofibrate treatment in patients who underwent elective coronary stenting. Forty-three consecutive patients who underwent elective coronary stenting were randomized to the fenofibrate group (300 mg/day for 25 weeks, n = 22) or the control group (n = 21). At baseline and follow up, CET activity and lipoprotein profiles were measured, and quantitative coronary angiography was performed. In the fenofibrate group, the levels of large very low-density lipoprotein cholesterol, and small low-density lipoprotein (LDL) cholesterol decreased and those of small high-density lipoprotein (HDL) cholesterol increased. Besides, CET activity decreased independent of the effect of fenofibrate on total and LDL cholesterol. The reduction of CET activity significantly correlated with the increase in LDL particle size (r = 0.47, P = 0.03) and the decrease of triglycerides in large HDL subclasses (r = 0.48, P = 0.03). Although there were no significant differences in restenosis parameters between the two groups, low CET activity significantly correlated with the inhibition of neointimal hyperplasia (r = 0.56, P = 0.01). Fenofibrate inhibited CET activity and thereby improved atherogenic lipoprotein profiles, and reduced intimal hyperplasia after coronary stenting.

To evaluate changes in retinal and choroidal thickness changes after three intravitreal ranibizumab (IVR) injections for polypoidal choroidal vasculopathy (PCV) using enhanced depth-imaging-optical coherence tomography (EDI-OCT). In this retrospective, observational case series, EDI-OCT was used to measure changes in choroidal thickness at nine points in a lattice shape in the macula before and after introductory-stage IVR. Choroidal thickness was decreased at all nine points in the lattice shape, but was significantly decreased only at the fovea. The subfoveal choroidal thickness may be reduced by introductory-stage IVR in patients with PCV. In particular, choroidal thickness at the fovea was reduced during the early stage of treatment.

Cardiovascular risk persists despite intensive low-density lipoprotein cholesterol (LDL-C) reduction using statins. High-density lipoprotein (HDL-C) is inversely associated with coronary artery disease (CAD) that is independent of LDL-C levels. C-reactive protein (CRP) is an established marker of inflammation that can impair the protective function of HDL-C: however, the impact of inflammation on the association between HDL-C and long-term outcomes in patients with CAD under statin therapy remains uncertain. We prospectively enrolled 3,507 consecutive patients with CAD who underwent a first percutaneous coronary intervention (PCI) from 1997 to 2011 at our institution. We stratified 1,682 patients (48%) who had been treated with statin at the time of PCI into 4 groups according to HDL-C levels (cutoffs of 40 and 50 mg/dl for men and women, respectively) and a CRP cutoff of 2 mg/dl: (1) high HDL-C/low CRP, (2) high HDL-C/high CRP, (3) low HDL-C/low CRP, and (4) low HDL-C/high CRP comparing the rates of all-cause death among them. The median follow-up period was 1,985 days (interquartile range 916 to 3,183 days). During this period, 197 patients (11.7%) died because of cardiac death (n = 58), carcinoma (n = 61), stroke (n = 10), and other causes (n = 69). The rates of all-cause death significantly differed among the groups (log-rank test, p <0.0001). In multivariate Cox hazard regression analyses, low HDL-C with high CRP levels remained significantly associated with a higher rate of all-cause death even after adjustment for other co-variates (hazard ratio 2.38, 1.59 to 3.61, p <0.0001). Low HDL-C together with elevated CRP levels is significantly associated with long-term outcomes in patients who received statin therapy after PCI. Cardiovascular risk persists despite intensive low-density lipoprotein cholesterol (LDL-C) reduction using statins. High-density lipoprotein (HDL-C) is inversely associated with coronary artery disease (CAD) that is independent of LDL-C levels. C-reactive protein (CRP) is an established marker of inflammation that can impair the protective function of HDL-C: however, the impact of inflammation on the association between HDL-C and long-term outcomes in patients with CAD under statin therapy remains uncertain. We prospectively enrolled 3,507 consecutive patients with CAD who underwent a first percutaneous coronary intervention (PCI) from 1997 to 2011 at our institution. We stratified 1,682 patients (48%) who had been treated with statin at the time of PCI into 4 groups according to HDL-C levels (cutoffs of 40 and 50 mg/dl for men and women, respectively) and a CRP cutoff of 2 mg/dl: (1) high HDL-C/low CRP, (2) high HDL-C/high CRP, (3) low HDL-C/low CRP, and (4) low HDL-C/high CRP comparing the rates of all-cause death among them. The median follow-up period was 1,985 days (interquartile range 916 to 3,183 days). During this period, 197 patients (11.7%) died because of cardiac death (n = 58), carcinoma (n = 61), stroke (n = 10), and other causes (n = 69). The rates of all-cause death significantly differed among the groups (log-rank test, p <0.0001). In multivariate Cox hazard regression analyses, low HDL-C with high CRP levels remained significantly associated with a higher rate of all-cause death even after adjustment for other co-variates (hazard ratio 2.38, 1.59 to 3.61, p <0.0001). Low HDL-C together with elevated CRP levels is significantly associated with long-term outcomes in patients who received statin therapy after PCI.

The present study aimed to determine the effects of phase II (PII) comprehensive cardiac rehabilitation (CR) on coronary plaque volume in patients after acute coronary syndrome (ACS).We assigned 46 patients with ACS who had undergone standard phase I CR into groups who proceeded with PII-CR (PII-CR; n = 21) and those who did not (non-PII-CR; n = 25). We then measured anthropometric parameters and daily physical activity using a pedometer for up to 60 days. The isokinetic strength of the knee extensor and flexor muscles and exercise tolerance were tested and non-culprit lesions were analyzed using volumetric intravascular ultrasound at baseline and 6 months later.Baseline characteristics did not significantly differ between the two groups and exercise tolerance was significantly improved in both. Waist size and fat weight were significantly decreased, and muscle strength was significantly increased in the PII-CR group but not in the non-PII-CR group. The percent change in plaque volume (primary endpoint) did not differ significantly between the two groups. The percent change in plaque volume was significantly and negatively correlated with daily physical activity.Although risk factors, muscle strength, and exercise tolerance were improved by PII-CR, plaque regression did not differ significantly between the two study groups. A significant correlation between percent change in coronary plaque volume and physical activity was observed. A comprehensive phase II-CR, including frequent supervised exercise sessions and a program encouraging an increase in daily physical activity, may reduce plaque volume in patients after ACS (UMIN000006038).

BackgroundThe use of serial intravascular ultrasound (IVUS) for coronary atherosclerosis has offered valuable insight into plaque regression (PR) or progression. However, the beneficial effects of PR on the long-term clinical outcomes in patients with acute coronary syndrome (ACS) remain unclear. We aimed to evaluate the impact of coronary plaque change in patients following primary percutaneous coronary intervention.MethodsWe retrospectively analyzed data from 4 prospective clinical trials involving 173 patients with ACS who underwent serial IVUS of non-culprit lesions on statin treatment at baseline and at 6 or 8 months of follow-up. The relationship of the IVUS findings with the change in percent atheroma volume (PAV), on-treatment low-density lipoprotein cholesterol (LDL-C), and major adverse cardiac and cerebrovascular events (MACCE) were investigated.ResultsIn our serial IVUS analysis, baseline plaque volume and PAV were 79.6 mm3 and 46.0%, respectively. The overall change in PAV was −1.5% [interquartile range (IQR): −4.1% to 1.0%], and PR (i.e. PAV change from baseline <0) was observed in 67.1% of patients. They were followed up observationally for a mean of 3.5 years and a total of 37 MACCE occurred. The rate of MACCE tended to be lower in patients with PR than in those without PR (18.1% vs. 28.7%, p = 0.14). A multivariate Cox hazard model analysis demonstrated that achievement of both PR and on-treatment low LDL-C levels (<70 mg/dL) was the only significant independent predictor of MACCE (hazard ratio: 0.42, 95% confidence interval: 0.19–0.88; p = 0.02).ConclusionsAchievement of both PR and sufficient lowering of the LDL-C was clinically important in post-ACS management.

A low 1,5-anhydro-D-glucitol (AG) blood level is considered a clinical marker of postprandial hyperglycemia. Previous studies reported that 1,5-AG levels were associated with vascular endothelial dysfunction and coronary artery disease (CAD). However, the association between 1,5-AG levels and coronary artery plaque in patients with CAD is unclear.This study included 161 patients who underwent percutaneous coronary intervention for CAD. The culprit plaque characteristics and the extent of coronary calcification, which was measured by the angle of its arc, were assessed by preintervention intravascular ultrasound (IVUS). Patients with chronic kidney disease or glycosylated hemoglobin ≥ 7.0 were excluded. Patients were divided into 2 groups according to serum 1,5-AG levels (< 14.0 μg/mL vs. ≥ 14 μg/mL).The total atheroma volume and the presence of IVUS-attenuated plaque in the culprit lesions were similar between groups. Calcified plaques were frequently observed in the low 1,5-AG group (p = 0.06). Compared with the high 1,5-AG group, the low 1,5-AG group had significantly higher median maximum calcification (144° vs. 107°, p = 0.03) and more frequent calcified plaques with a maximum calcification angle of ≥ 180° (34.0% vs. 13.2%, p = 0.003). Multivariate logistic regression analysis showed that a low 1,5-AG level was a significant predictor of a greater calcification angle (> 180°) (OR 2.64, 95% CI 1.10-6.29, p = 0.03).Low 1,5-AG level, which indicated postprandial hyperglycemia, was associated with the severity of coronary artery calcification. Further studies are needed to clarify the effects of postprandial hyperglycemia on coronary artery calcification.

In the secondary prevention of cardiovascular (CV) disease in patients with diabetes, an optimal level of HbA1c, the most widely-used glycemic control indicator, for favorable clinical consequences still remains to be established. This study assessed the association between preprocedural HbA1c level and CV mortality in Japanese diabetic patients undergoing percutaneous coronary intervention (PCI).This is a retrospective observational study using a single-center prospective PCI database involving consecutive 4542 patients who underwent PCI between 2000 and 2016. Patients with any antidiabetic medication including insulin at PCI were included in the analysis (n = 1328). We divided the patients into 5 and 2 groups according to HbA1c level; HbA1c: < 6.5% (n = 267), 6.5-7.0% (n = 268), 7.0-7.5% (n = 262), 7.5-8.5% (n = 287) and ≥ 8.5% (n = 244), and 7.0% > and ≤ 7.0%, respectively. The primary outcome was CV mortality including sudden death. The median follow-up duration was 6.2 years.In the follow-up period, CV and sudden death occurred in 81 and 23 patients, respectively. While unadjusted Kaplan-Meier analysis showed no difference in cumulative CV mortality rate between patients binarized by preprocedural HbA1c 7.0%, analysis of the 5 groups of HbA1c showed significantly higher cumulative CV death in patients with HbA1c < 6.5% compared with those with 7.0-7.5% (P = 0.042). Multivariate Cox hazard analysis revealed a U-shaped relationship between preprocedural HbA1c level and risk of CV death, and the lowest risk was in the HbA1c 7.0-7.5% group (Hazard ratio of HbA1c < 6.5% compared to 7.0-7.5%: 2.97, 95% confidence interval: 1.33-7.25, P = 0.007). Similarly, univariate analysis revealed the lowest risk of sudden death was in the HbA1c 7.0-7.5% group.The findings indicate an increased risk of CV mortality by strict glycemic control (HbA1c < 6.5%) in the secondary prevention of CV disease in Japanese patients with medically-treated diabetes. Trial registration This study reports the retrospective analysis of a prospective registry database of patients who underwent PCI at Juntendo University Hospital, Tokyo, Japan (Juntendo Physicians' Alliance for Clinical Trials, J-PACT), which is publicly registered (University Medical Information Network Japan-Clinical Trials Registry UMIN-CTR 000035587).

Asians have a much lower incidence of adverse coronary events than Caucasians. We sought to evaluate the characteristics of coronary lipid-rich plaques (LRP) in Asian patients with acute coronary syndrome (ACS) and stable angina (SA). We also aimed to identify surrogate markers for the extent of LRP.We evaluated 207 patients (ACS, n = 75; SA, n = 132) who underwent percutaneous coronary intervention under near infrared spectroscopy intravascular ultrasound (NIRS-IVUS). Plaque characteristics and the extent of LRP [defined as a long segment with a 4-mm maximum lipid-core burden index (maxLCBI4mm)] on NIRS in de-novo culprit and non-culprit segments were analyzed.The ACS culprit lesions had a significantly higher maxLCBI4mm (median [interquartile range (IQR)]: 533 [385-745] vs. 361 [174-527], p < 0.001) than the SA culprit lesions. On multivariate logistic analysis, a large LRP (defined as maxLCBI4mm ≥ 400) was the strongest independent predictor of the ACS culprit segment (odds ratio, 3.87; 95% confidence interval, 1.95-8.02). In non-culprit segments, 19.8% of patients had at least one large LRP without a small lumen. No significant correlation was found between the extent of LRP and systematic biomarkers (hs-CRP, IL-6, TNF-α), whereas the extent of LRP was positively correlated with IVUS plaque burden (r = 0.24, p < 0.001).We confirmed that NIRS-IVUS plaque assessment could be useful to differentiate ACS from SA culprit lesions, and that a threshold maxLCBI4mm ≥ 400 was clinically suitable in Japanese patients. No surrogate maker for a high-risk LRP was found; consequently, direct intravascular evaluation of plaque characteristics remains important.

Previous studies showed that elevated apolipoprotein A1 (ApoA1) and high-density lipoprotein cholesterol (HDL-C) predicted reduced risk of cardiovascular-related (CV) mortality in patients following percutaneous coronary intervention (PCI). Nevertheless, as the association between ApoA1 and cancer mortality in this population has been rarely addressed, our study aimed to evaluate prognostic impact of ApoA1 on multiple types of cancer mortality after PCI. This is a retrospective analysis of a single-center prospective registry database of patients who underwent PCI between 2000 and 2018. The present study enrolled 3835 patients whose data of serum ApoA1 were available and they were divided into three groups according to the tertiles of the preprocedural level of ApoA1. The outcome measures were total, gastrointestinal, and lung cancer mortalities. The median and range of the follow-up period between the index PCI and latest follow-up were 5.9 and 0-17.8 years, respectively. Consequently, Kaplan-Meier analyses showed significantly higher rates of the cumulative incidences of total, gastrointestinal, and lung cancer mortality in the lowest ApoA1 tertile group compared to those in the highest. In contrast, there were no significant differences in all types of cancer mortality rates in the groups divided by the tertiles of HDL-C. Multivariable Cox proportional hazard regression analysis adjusted by cancer-related prognostic factors, such as smoking status, identified the elevated ApoA1 as an independent predictor of decreased risk of total and gastrointestinal cancer mortalities. Our study demonstrates the prognostic implication of preprocedural ApoA1 for predicting future risk of cancer mortality in patients undergoing PCI.

The prevalence of obsessive-compulsive disorder (OCD) was measured in 424 Japanese students using a Japanese version of the Maudsley Obsession-Compulsive Inventory (MOCI-J). Six students (1.7%) of 350 interviewed students were diagnosed as OCD according to DSM-III-R. When the cut-off point of the MOCI-J was 12, the sensitivity was 100% and the specificity was 96%. Our results suggest that individuals with OCD are not rare among the young Japanese population and that the MOCI-J is a useful tool for screening OCD.

Statins have been proven to reduce cardiac events and mortality. However, there are few studies dealing with the long-term efficacy of statin therapy following percutaneous coronary intervention (PCI).We collected data from 575 consecutive patients who underwent PCI between 1987 and 1992. The baseline data, mortality and incidence of cardiovascular events of patients given statins and those not given statins at the time of PCI were compared.There were 243 patients in the statin group and 332 patients in the non-statin group. During follow-up (11.0+/-3.0 years), 68 patients died. At about 10 years, statin use was significantly associated with lower all-cause mortality (8.2% versus 14.5%, P=0.023) and cardiac death (2.5% versus 6.9%, P=0.017). After adjusting for variables, statin use was found to be an independent predictor of death from all causes (hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.29-0.99, P=0.048) and cardiac death (HR 0.24, 95% CI 0.07-0.80, P=0.02).Statin use at the time of PCI was associated with a significantly reduced risk of death from all causes and cardiac death. Furthermore, this study provides evidence of a clinical benefit at about 10 years of statin use in patients who underwent PCI.

To evaluate the prognostic impact of preprocedural high-sensitivity C-reactive protein (hsCRP) levels on the long-term clinical outcomes after first-generation drug-eluting stent (DES) implantation in chronic kidney disease (CKD) patients with stable coronary artery disease (CAD).We found significant interaction between CKD and hsCRP levels (p=0.0138) in 1176 consecutive patients with stable CAD who were treated with first-generation DES implantation between 2004 and 2009 at our institution. Therefore, we separately analyzed data from patients with and without CKD who were assigned to tertiles based on preprocedural hsCRP levels. We evaluated the incidence of major adverse cardiovascular events (MACE) comprising all-cause death, nonfatal myocardial infarction, and target vessel revascularization after percutaneous coronary intervention during a median follow-up period of 1266 days. The rate of MACE significantly differed among the tertiles (log-rank p=0.0074) in the group with CKD. Multivariate Cox regression analysis significantly associated a higher hsCRP tertile with MACE in the CKD group (hazard ratio 2.39, 95% confidence interval 1.27-4.75, p=0.0062).Elevated preprocedural serum hsCRP levels might be associated with the long-term clinical outcomes of patients with stable CAD and CKD who were implanted with first-generation DES.

To investigate factors associated with 30-day perioperative complications (POC) after aorto-iliac (AI) stenting, and to compare follow-up cardiovascular prognosis between patients with and without POC.This was a retrospective multicenter study. We used a multicenter database of 2012 consecutive patients who successfully underwent AI stenting for peripheral arterial disease in 18 centers in Japan from January 2005 to December 2009 to analyze independent predictors of POC and impact of POC on prognosis by logistic regression and a Cox proportional hazard regression model, respectively.Mean age was 71 ± 9 years (median: 72 years; range: 37-98 years), and 1,636 patients (81%) were men. POC occurred in 126 patients (6.3%). In multivariate logistic regression analysis, old age (≥80 years), critical limb ischemia (CLI), and Trans Atlantic Inter-Societal Consensus (TASC) II class C/D were independently associated with POC with adjusted odds ratios and 95% confidence intervals (CI) of 1.9 (1.3-2.9), 2.3 (1.5-3.4), and 2.4 (1.6-3.4), respectively. Out of 2012 patients, 1995 were followed up for more than 30 days (mean: 2.6 ± 1.5 years; range: 2-2,393 days). In a Cox hazard regression model adjusted for baseline clinical characteristics, POC was positively and independently associated with follow-up major adverse cardiac events (adjusted hazard ratio [HR]: 1.9; 95% CI: 1.3-2.8; p = .002), but not with major adverse limb events and target lesion revascularization (adjusted HR: 1.4; 95% CI: 0.7-2.7; p = .25; and adjusted HR: 1.2; 95% CI 0.6-2.6; p = .568), respectively.Age >80 years, CLI, and TASC C/D lesion were positively associated with POC after AI stenting. Occurrence of POC appears to adversely affect follow-up cardiovascular, but not limb and vessel prognosis.

Serum levels of lipoprotein (a) (Lp(a)) could be a risk factor for adverse events in patients with coronary artery disease (CAD). However, the effect of Lp(a) on long-term outcomes in patients with left ventricular (LV) systolic dysfunction, possibly through the increased likelihood for development of heart failure (HF), remains to be elucidated. This study aimed to determine the prognostic impact of Lp(a) in patients with CAD and LV systolic dysfunction. Methods and Results: A total of 3,508 patients who underwent percutaneous coronary intervention were candidates. We analyzed 369 patients with LV systolic dysfunction (defined as LV ejection fraction <50%). They were assigned to groups according to a median level of Lp(a) (i.e., high Lp(a), ≥21.6 mg/dL, n=185; low Lp(a), <21.6 mg/dL, n=184). The primary outcome was a composite of all-cause death and readmission for acute coronary syndrome and/or HF. The median follow-up period was 5.1 years. Cumulative event-free survival was significantly worse for the group with high Lp(a) than for the group with low Lp(a) (P=0.005). In the multivariable analysis, a high Lp(a) level was an independent predictor of the primary outcomes (hazard ratio, 1.54; 95% confidence interval, 1.09-2.18; P=0.014).A high Lp(a) value could be associated with long-term adverse clinical outcomes among patients with CAD and LV systolic dysfunction.

Since the introduction of PCI in 1977, it has evolved along with advances in the technology, improvement in operator technique and establishment of medical therapy. However, little is known of the improvement in clinical outcome following PCI.Data from the Juntendo PCI Registry during 1984-2010 were analyzed. The patients were divided into 3 groups according to date of index PCI: POBA era, January 1984-December 1997; BMS era, January 1998-July 2004; and DES era, August 2004-February 2010. The primary endpoint was a composite of MACE including all-cause mortality, non-fatal MI, non-fatal stroke and revascularization. A total of 3,831 patients were examined (POBA era, n=1,147; BMS era, n=1,180; DES era, n=1,504). Mean age was highest in the DES era. The prevalence of diabetes and hypertension was higher in the DES and BMS eras than in the POBA era. Unadjusted cumulative event-free survival rate for 2-year MACE was significantly different across the 3 eras. Adjusted relative risk reduction for 2-year MACE was 56% in the DES era and 34% in the BMS era, both compared with the POBA era. Age, ACS, and LVEF were associated with the incidence of MACE.Clinical outcome of PCI improved across the 26-year study period, despite the higher patient risk profile in the recent era.

Few studies have investigated the clinical outcomes of rotational atherectomy (RA) prior to and during the drugeluting stent (DES) era. The goal of this study was to assess the long-term outcome after RA followed by DES and bare metal stent (BMS) implantation in complex calcified coronary lesions and to compare the outcomes among various DESs.This was a single center retrospective observational study. Consecutive 406 patients who underwent elective RA followed by BMS or DES implantation at our institution from 2001 to 2011 were included. This study compared the long-term outcomes after treatment with RA among BMS and 3 different DESs (sirolimus-eluting stent, paclitaxel-eluting stent, and everolimus-eluting stent) implantation.The mean follow-up period was 4.6 years. Patients with DES were older and exhibited more vessel disease, longer lesion length, and smaller vessel size. Patients with BMS had a significantly higher rate of target lesion revascularization, restenosis, and larger late lumen loss than those with DES. Composite events including mortality, ACS, and target vessel revascularization were significantly higher in the BMS-RA group than in the DES-RA group. After adjustment, BMS remained an independent predictor of MACE and ACS plus death in patients treated with RA. However, there were no significant differences in late lumen loss, restenosis rate, and MACE among the 3 DES.The combination of DES-RA has a favorable effect in both the angiographic and clinical outcomes compared with BMS-RA. However, no significant differences in late loss and events rates were observed among the 3 DES groups.

Background:The purpose of this study was to investigate if the transcatheter aortic valve replacement (TAVR) risk score can independently predict outcomes following TAVR, and to evaluate its predictive performance.

Background: High-sensitivity C-reactive protein (hs-CRP) is a well known risk factor for the development of cardiovascular disease and cancer. We investigated the long-term impact of hs-CRP on cancer mortality in patients with stable coronary artery disease (CAD).

Background A common complication of endovascular treatment for femoropopliteal lesions is bleeding at the vascular access site. Although risk factors of bleeding-associated complications at the approach site have been reported, the results have been inconclusive. Hence, this study aimed to assess the predictors of bleeding-associated complications at the approach site in patients undergoing endovascular treatment for femoropopliteal lesions. Methods This retrospective, single-center, observational study included consecutive patients who underwent endovascular treatment (n = 366, 75% male, 72.4±9.9 year) for peripheral arterial disease with claudication and critical limb ischemia in our hospital from January 2010 to December 2017. We divided the patients into bleeding and non-bleeding groups, depending on whether bleeding-associated complications occurred at the approach site. Bleeding-associated complications were defined according to the Bleeding Academic Research Consortium criteria types 2, 3, and 5. Results Altogether, 366 endovascular treatment procedures and 404 arterial accesses were performed for femoropopliteal lesions in 335 peripheral arterial disease patients with claudication and 69 critical limb ischemia patients. We recorded 35 postprocedural bleeding-associated complications at the approach site (9%), all of which were hematomas. The predictors of increased bleeding-associated complications were age ≥ 80 years (bleeding vs. non-bleeding group, 43% vs. 25%, p&lt;0.05) and antegrade cannulation of the common femoral artery (48% vs. 69%, p&lt;0.05). Ultrasound-guided puncture reduced bleeding-associated complications (odds ratio, 0.28; 95% confidence interval, 0.004–0.21; p&lt;0.05). In contrast, there was no significant difference in puncture site calcification between the groups (bleeding vs. non-bleeding groups, 29% vs. 21%, p = 0.29). Conclusion Ultrasound-guided puncture is associated with a decrease in bleeding-associated complications at the approach site, regardless of the presence of calcified plaque. It is particularly effective and should be more actively used in patients aged ≥80 years and for antegrade cannulation of the common femoral artery.

Apolipoprotein E (ApoE) strongly affects arteriosclerosis but has atheroprotective effects in combination with high-density lipoprotein cholesterol (HDL-C). The impact of the quantitative relationship between serum ApoE and HDL-C levels in patients with coronary artery disease (CAD) remains unclear.A total of 3632 consecutive patients who underwent their first intervention between 2000 and 2016 were included. They were categorized into normal and abnormal HDL-C groups based on the normal HDL-C value, and each group was subdivided into high and low ApoE subgroups based on the group-specific median ApoE value. We evaluated the incidence of major adverse cardiac and cerebrovascular events (MACCE), including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and all-cause deathResults: During a 6.4-year follow-up, 419 patients developed MACCE and 570 patients died. The interaction term between ApoE levels and HDL-C status in MACCE and all-cause death proved to be statistically significant. Kaplan-Meier analysis revealed that the cumulative incidence of MACCE was significantly higher for elevated pre-procedural ApoE levels than for reduced preprocedural ApoE levels in the normal HDL-C group. Conversely, the cumulative incidence of MACCE was significantly higher for reduced pre-procedural ApoE levels than for elevated pre-procedural ApoE levels in the abnormal HDL-C group. After adjustment for important covariates, multivariable Cox hazard analysis revealed that the serum ApoE level was a strongly independent predictor of MACCE; this was inversely related in both groups.Serum ApoE levels may have a paradoxical impact on the future cardiovascular risk depending on the HDL-C status in patients with CAD.

This study aimed to compare the coronary plaque characterization by cardiovascular magnetic resonance (CMR) and near-infrared spectroscopy (NIRS)-intravascular ultrasound (IVUS) (NIRS-IVUS), and to determine whether pre-percutaneous coronary intervention (PCI) evaluation using CMR identifies high-intensity plaques (HIPs) at risk of peri-procedural myocardial infarction (pMI). Although there is little evidence in comparison with NIRS-IVUS findings, which have recently been shown to identify vulnerable plaques, we inferred that CMR-derived HIPs would be associated with vulnerable plaque features identified on NIRS-IVUS.52 patients with stable coronary artery disease who underwent CMR with non-contrast T1-weighted imaging and PCI using NIRS-IVUS were studied. HIP was defined as a signal intensity of the coronary plaque-to-myocardial signal intensity ratio (PMR) ≥ 1.4, which was measured from the data of CMR images. We evaluated whether HIPs were associated with the NIRS-derived maximum 4-mm lipid-core burden index (maxLCBI4mm) and plaque morphology on IVUS, and assessed the incidence and predictor of pMI defined by the current Universal Definition using high-sensitive cardiac troponin-T.Of 62 lesions, HIPs were observed in 30 lesions (48%). The HIP group had a significantly higher remodeling index, plaque burden, and proportion of echo-lucent plaque and maxLCBI4mm ≥ 400 (known as large lipid-rich plaque [LRP]) than the non-HIP group. The correlation between the maxLCBI4mm and PMR was significantly positive (r = 0.51). In multivariable logistic regression analysis for prediction of HIP, NIRS-derived large LRP (odds ratio [OR] = 5.41; 95% confidence intervals [CIs] 1.65-17.8, p = 0.005) and IVUS-derived echo-lucent plaque (OR = 5.12; 95% CIs 1.11-23.6, p = 0.036) were strong independent predictors. Furthermore, pMI occurred in 14 of 30 lesions (47%) with HIP, compared to only 5 of 32 lesions (16%) without HIP (p = 0.005). In multivariable logistic regression analysis for prediction of incidence of pMI, CMR-derived HIP (OR = 5.68; 95% CIs 1.53-21.1, p = 0.009) was a strong independent predictor, but not NIRS-derived large LRP and IVUS-derived echo-lucent plaque.There is an important relationship between CMR-derived HIP and NIRS-derived large LRP. We also confirmed that non-contrast T1-weighted CMR imaging is useful for characterization of vulnerable plaque features as well as for pre-PCI risk stratification. Trial registration The ethics committee of Juntendo Clinical Research and Trial Center approved this study on January 26, 2021 (Reference Number 20-313).

Recent studies suggested short-term mortality after transcatheter edge-to-edge repair (TEER) was comparable between men and women. However, the gender-specific prognostic difference in the long-term follow-up after TEER is still unknown. To evaluate the impact of gender on long-term mortality after TEER for functional mitral regurgitation (FMR) using multicenter registry data. We retrospectively analyzed 1,233 patients (male 60.3%) who underwent TEER for FMR at 24 centers. The impact of gender on all-cause death and hospitalization for heart failure (HF) after TEER was evaluated using multivariate regression analysis and propensity score (PS) matching methods. During the 2-year follow-up, 207 all-cause death and 263 hospitalizations for HF were observed after TEER for FMR. Men had a significantly higher incidence of all-cause death than women (18.6% vs 14.1%, log-rank p = 0.03). After adjustment by multivariate Cox regression and PS matching, the male gender was significantly associated with a higher incidence of all-cause mortality after TEER than the female gender (hazard ratio 2.11, 95% confidence interval 1.42 to 3.14 in multivariate Cox regression; hazard ratio 1.89, 95% confidence interval 1.03 to 3.48 in PS matching). The gender-specific prognostic difference was even more pronounced after 1-year of TEER. On the contrary, there was no gender-related difference in hospitalization for HF after TEER. In conclusion, women with FMR had a better prognosis after TEER than men, whereas this was not observed in hospitalization for HF. This result might indicate that women with FMR are more likely to benefit from TEER.

Activated monocytes/macrophages, neutrophils, endothelial cells and smooth muscle cells participate in the restenosis processes. Monocytes/macrophages and neutrophils are activated by lipopolysaccharide (LPS) via CD14. Endothelial cells and smooth muscle cells are also stimulated by soluble CD14 (sCD14)-LPS complexes.We tested the hypothesis that C(-260)-->T polymorphism of the CD14 gene and sCD14 might be predictors for in-stent restenosis. We analyzed 129 consecutive patients who underwent elective coronary stenting. The restenosis was defined as > or =50% diameter stenosis at follow-up angiography.The prevalence of the T/T genotype and the concentration of sCD14 were significantly higher in the restenosis group than in the no-restenosis group. This CD14 polymorphism also affected the levels of sCD14, therefore, we divided the patients into four groups. The loss index was 24.8% in C/C or C/T and < or =50th percentile of sCD14, 35.9% in T/T and < or =50th percentile of sCD14, 44.2% in C/C or C/T and >50th percentile of sCD14, and 49.1% in T/T and >50th percentile of sCD14 (P=0.02). The restenosis rate was 10.0%, 26.7%, 26.2% and 50.0% in each group, respectively (P=0.003). In the multivariate analysis, T/T and >50th percentile of sCD14 was the independent predictor for in-stent restenosis.This study showed that the T/T genotype with a high level of sCD14 is an independent predictor of in-stent restenosis. The activation of monocytes/macrophages, endothelial cells and smooth muscle cells mediated by CD14 and/or sCD14 may play an important role in the restenosis processes.

Background Hemodialysis (HD) patients have heavy calcium deposits in their stenotic coronary arteries and worse post-percutaneous coronary intervention (PCI) prognoses than those who do not undergo HD. Rotational atherectomy (RA) facilitates PCI success in severely calcified lesions. We aimed to identify clinical and procedural characteristics that predict HD patients' long-term prognoses after PCI that included RA in the drug-eluting stent (DES) era. Methods This study included 302 patients who underwent regular HD from J2T Multicenter Registry database of 1090 consecutive patients who underwent RA to treat de novo calcified lesions at three university hospitals between 2004 and 2015. The primary endpoint was cardiovascular (CV) death. Results During the 5-year observation period, 59 CV deaths (19.5%) occurred. The CV death group and non-CV death group had comparable profiles except significantly lower left ventricular ejection fraction, higher brain natriuretic peptide (BNP), lower rate of RA burr upsizing, and lower rate of final thrombolysis in myocardial infarction (TIMI) 3 flow achievement in the CV death group. Cox regression analysis revealed that increasing ablation burr size (hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.13–0.81), final TIMI 3 flow (HR: 0.07; 95% CI: 0.02–0.28), lower BNP level, and optimal medication were independently associated with better CV mortality in HD patients. Conclusion In the DES era, oral medications at the time of PCI and stepwise calcium ablation were associated with improved long-term CV mortality in HD patients who are scheduled to undergo RA to treat severely calcified coronary artery stenoses, as therapeutic strategies.

Aim: Some randomized studies have shown a delay of up to a few years in the statin-related survival advantage, whereas others have demonstrated an early survival benefit for some patients. We examined the short-term effects of statins in patients with acute coronary syndrome (ACS), stratified according to baseline LDL-C.Methods: Patients with ACS (n=180) were randomized to receive 6 months of atorvastatin (20 mg) in the Extended-ESTABLISH trial. Six months after ACS onset, all patients were treated with statins to achieve an LDL-C value of < 100 mg/dL. Patient outcomes were analyzed with respect to LDL-C at the time of ACS onset: high baseline (≥100 mg/dL, n=124) or low baseline (< 100 mg/dL, n=56) LDL-C.Results: The cumulative incidence rates of major adverse cardiac and cerebrovascular events (MACCE) did not significantly differ between the early-statin and control groups in the high baseline groups at 6 months (p=0.158), whereas a significant benefit of early intensive statins appeared 1 year (p=0.034) later. In contrast, we found no significant short-term benefits of statins after either 6 months or 1 year in the low baseline group. Multivariate analysis showed that early intensive atorvastatin therapy was associated with a lower risk of MACCE at 1 year in the high baseline group (OR, 0.25; 95% CI, 0.05 to 0.83; p=0.035).Conclusions: The effects of 6 months of intensive lipid-lowering therapy appear after 1 year in patients with ACS and baseline LDL-C ≥100 mg/dL.

BackgroundThe prognostic long-term impact of body mass index (BMI) on East Asian patients with coronary artery disease remains unclear.MethodsAn observational retrospective cohort study was carried out involving 3571 patients who had undergone percutaneous coronary intervention (PCI) from 2000 to 2013. Patients were divided into the following five groups according to baseline BMI: Group 1 (underweight 1, BMI ≤20.0 kg/m2); Group 2 (underweight 2, BMI = 20.1–22.5 kg/m2); Group 3 (normal weight, BMI = 22.6–25.0 kg/m2); Group 4 (overweight 1, BMI = 25.1–27.5 kg/m2); and Group 5 (overweight 2, BMI ≥27.6 kg/m2). We then evaluated the association between BMI and both all-cause and cardiac death after PCI.ResultsThe ratio of patients in the five groups was as follows: Group 1, 9.2%; Group 2, 21.6%; Group 3, 34.1%; Group 4, 21.1%; and Group 5, 14.5%. A decrease in age was observed from underweight to overweight, as was an increased prevalence of hypertension, diabetes mellitus, dyslipidemia, and smoking. The median follow-up period was 6.3 years (interquartile range, 3.2–9.6 years). In total, 473 deaths (frequency, 13.2%) were identified, including 183 (5.1%) cardiac deaths during follow-up. In unadjusted Cox proportional hazard analysis, using normal weight as the reference, underweight, but not overweight, was associated with a greater risk of both all-cause and cardiac death. In an adjusted model, Group 1 had the highest risk for all-cause death (hazard ratio, 1.58; 95% confidence interval, 1.19–2.10; p = 0.0019); however, no significant differences were found for the risk of all-cause and cardiac death between normal weight and overweight patients.ConclusionThe results of the present long-term follow-up study do not support the so-called “obesity paradox,” but rather, suggest that underweight Japanese patients are at greater risk for all-cause mortality following PCI.

Triple antithrombotic therapy increases the risk of bleeding events in patients undergoing percutaneous coronary intervention (PCI) compared with dual anti-platelet therapy (DAPT). However, whether warfarin control is associated with reduced cardiovascular events and major bleeding events in patients undergoing PCI with triple antithrombotic therapy is uncertain.We investigated 1207 consecutive patients who underwent PCI between 2004 and 2011. Major bleeding complications and major adverse cardiac and cerebrovascular events (MACCE) defined as all-cause death, acute coronary syndrome, target vessel revascularization, and stroke were compared between groups of patients who received either triple antithrombotic therapy or DAPT.Triple antithrombotic therapy was administered to 95 (7.9%) patients. The mean international normalized ratio of prothrombin time (PT-INR) was 1.8. The target PT-INR level was set between 1.6 and 2.6 and the ratio (%) of time in the therapeutic range (TTR) was calculated. The median TTR was 78.4% (interquartile range, 67.4-87.6%). Kaplan-Meier survival curves showed that warfarin therapy was not associated with MACCE (p=0.89) and major bleeding (p=0.80). Multivariable Cox regression analysis revealed that triple antithrombotic therapy was not an independent predictor of MACCE and major bleeding.Triple antithrombotic therapy does not increase the occurrence of MACCE and major bleeding complications, if the warfarin dose is tightly controlled with a lower INR.

We sought to assess whether balloon angioplasty (BA) alone for small femoropopliteal disease improved the outcome following endovascular therapy as compared with stent implantation.The optimal strategy of endovascular therapy for small vessel arteries in femoropopliteal disease remains unclear.We performed a multicenter retrospective analysis of 337 consecutive patients (371 limbs) with femoropopliteal arteries 4.0 mm or less in diameter and 150 mm or less in length.Cumulative 3-year incidence of primary patency was significantly higher in the BA group than in the stent group (53.8% vs. 34.2%, P = 0.002). While assisted-primary patency and freedom from any major adverse limb events were also significantly higher in the BA group than in the stent group (70.9% vs. 44.2%, P < 0.001 and 60.6% vs. 36.4%, P = 0.001, respectively), secondary patency did not significantly differ between the two groups (86.9% vs. 86.9%, P = 0.67). Predictors of restenosis were diabetes mellitus (hazard ratio [HR], 1.61; 95% confidence interval [CI], 1.14-2.31; P = 0.01), no administration of cilostazol (HR, 1.50; 95% CI, 1.07-2.13; P = 0.02), stent implantation (HR, 1.68; 95% CI, 1.15-2.41; P = 0.01), and lesion length >75.0 mm(HR, 2.09; 95% CI, 1.50-2.92; P < 0.001).Lesions in small (<4.0 mm diameter) FP vessels demonstrated better primary patency at 3 years when successfully treated with balloon angioplasty alone as opposed to routine or bailout stenting. This difference was especially pronounced for lesions 75 to 150 mm in length.

<h2>Abstract</h2><h3>Background</h3> Serum levels of lipoprotein (a) [Lp(a)] have been reported as a residual risk marker for adverse events in patients with coronary artery disease (CAD). However, the prognostic impact of Lp(a) on long-term clinical outcomes among diabetic patients on statin therapy after percutaneous coronary intervention (PCI) remains unclear. <h3>Methods</h3> The present investigation was a single-center, observational, retrospective cohort study. Among consecutive patients with CAD who underwent first PCI in our institution from 2000 to 2016, we enrolled diabetic patients on statin treatment. As a result, 927 patients (81% men; mean age, 67 years) were enrolled and divided into 2 groups according to a median Lp(a) level of 19.5 mg/dL. The incidence of major adverse cardiac events (MACE), including all-cause death, non-fatal myocardial infarction (MI), and non-fatal cerebral infarction (CI), was evaluated. <h3>Result</h3> No significant differences were seen in age, sex, smoking habits, hypertension, chronic kidney disease, or body mass index between high and low Lp(a) groups. During follow-up (median, 5.0 years; interquartile range, 1.9–9.7 years), MACE occurred in 90 cases (17.6%), including 40 (7.9%) cardiac deaths, 18 (3.6%) non-fatal MI, and 37 (7.9%) non-fatal CI. Frequency of MACE was significantly higher in the high-Lp(a) group than in the low-Lp(a) group (log-rank test, <i>p</i> = 0.002). Higher Lp(a) level at the time of PCI was significantly associated with higher frequency of MACE, even after adjusting for other covariates, including other lipid profiles (hazard ratio, 1.91; 95% confidence interval, 1.20–3.09; <i>p</i> = 0.006). <h3>Conclusion</h3> Our results demonstrated that in diabetic patients with CAD on statin treatment, increased Lp(a) levels could offer a good residual lipid risk marker. Assessing Lp(a) levels may be useful for risk stratification of long-term clinical outcomes after PCI, especially in diabetic patients.

Current Japanese guidelines state the target level of low-density lipoprotein cholesterol (LDL-C) of <100mg/dL for secondary prevention of coronary artery disease (CAD). However, this level was set considering the results of trials mainly conducted in Western countries. In addition, the effect of achieving target LDL-C on secondary prevention is unknown.We examined the effects of achieving target LDL-C on clinical outcomes. Patients who underwent percutaneous coronary intervention at Juntendo University Hospital (Tokyo, Japan) from 2004 to 2010 and received follow-up coronary angiography (CAG) were analyzed. The study population was divided into two groups based on the follow-up LDL-C. The incidence of major adverse cardiovascular events within 3 years after the follow-up CAG was examined.A total of 1321 consecutive patients were enrolled. Sixty-three percent of the patients achieved the target LDL-C. The rate of 3-year events was lower in the group that achieved the target LDL-C (achieved group). The adjusted relative risk reduction in the achieved group was 26% (p=0.02). In the sub-analysis among the four groups stratified by baseline LDL-C of 140 and follow-up LDL-C of 100, the adjusted hazard ratio for 3-year events was 1.84 (95% confidence interval; 1.10-3.24)in Group 3 (baseline <140, follow-up ≥100) and 2.05 (1.18-3.74) Group 4 (baseline ≥140, follow-up ≥100) [Group 2 (baseline ≥140, follow-up <100) as reference].Our data suggested that follow-up LDL-C <100mg/dL was appropriate for secondary prevention of CAD in Japanese population.

Aim: Renal insufficiency is associated with worse clinical outcomes in patients with coronary artery disease. Since the introduction of percutaneous coronary intervention (PCI), the revascularization therapy has evolved with advances of devices, improvements in operator techniques, and the establishment of medical therapy. We examined temporal trends of the clinical outcomes following PCI in patients with renal insufficiency.

Background: Isolated ostial stenosis (IOS) of the left coronary artery is a rare disease of unknown etiology, and the long-term prognosis and angiographic characteristics of affected patients have not been fully studied. Methods and Results: The present study investigated 57 patients with stenosis of the left main trunk (LMT) who underwent coronary artery bypass grafting (CABG). They were categorized into 3 groups, based on the angiographic findings: Group I comprised 9 patients with IOS; Group II comprised 12 patients with left coronary ostial stenosis in the presence of distal vessel obstructions; Group III comprised 36 patients with stenosis of LMT excluding ostial stenosis and associated with distal vessel obstruction. The patients underwent serial angiography at 1, 5, and 10 years after CABG. Middle aged women with fewer coronary risk factors were more common in Group I compared with Groups II and III (P<0.01). The patency rate of the internal thoracic artery grafts was significantly higher in Groups II and III than in Group I (P<0.05). In Group I, the percentage stenosis of LMT lesions decreased significantly (P<0.05), but there was no difference in the other groups. Conclusions: IOS had clinical characteristics and time course distinct from those of atherosclerotic LMT disease. (Circ J 2009; 73: 1271-1277)

To compare the safety and efficacy of the S.M.A.R.T. Control stent vs. other stents in patients with symptomatic aortoiliac occlusive disease (AIOD) followed for up to 4 years.A subgroup analysis of data from a retrospective multicenter registry examined 2036 symptomatic patients (1659 men; mean age 71±8 years) who received stent-supported endovascular therapy for 2541 AIOD lesions between April 2005 and December 2009. The cohort was divided into the S.M.A.R.T. stent group (955 patients/1196 lesions) and the "other" stent group (1081 patients/1345 lesions). The main study outcomes of primary patency and event-free survival at 4 years were compared before and after propensity matching analysis. The rates for freedom from major amputation, surgical conversion, target lesion revascularization (TLR), and major adverse limb events were also assessed.The S.M.A.R.T. Control stent group had greater frequency of critical limb ischemia (CLI), TASC C/D lesions, and chronic total occlusions. The mean follow-up was 25±17 months in the S.M.A.R.T. group vs. 29±19 months in the other stent group. After propensity matching, 4-year primary patency (86% vs. 76%, p<0.001) and freedom from adverse limb events (93% vs. 90%, p=0.04) were greater in the S.M.A.R.T. Control stent group, while event-free survival rates (75% vs. 77%, p=0.50) were similar between groups. Univariate subgroup analysis showed that use of the S.M.A.R.T. stent was associated with greater primary patency in patients with renal insufficiency (serum creatinine >1.5 mg/dL) and CLI.After propensity matching analysis, the durability of the S.M.A.R.T. stent was superior to that of other stents, which might reflect differing design characteristics.

Rationale: Cases of severe disopyramide poisoning are rare and few have been reported. We report a case in which activated-charcoal column hemoperfusion was dramatically effective for life-threatening disopyramide poisoning. Patient concerns: A teenage girl who had overdosed on disopyramide (total dose, 4950 mg) was brought to our hospital. She was resuscitated from short period cardiopulmonary arrest and subsequently showed severe cardiogenic shock and ventricular arrhythmia. Diagnoses: Disopyramide poisoning (self-evident). Interventions: As hemodynamics remained unstable after providing percutaneous cardiopulmonary support and intra-aortic balloon pumping, we attempted direct hemoperfusion using a coated activated-charcoal hemoperfusion column. Outcomes: Hemodynamics including electrocardiography and serum disopyramide concentration were dramatically improved, and the patient was ambulatory by hospital day 14. Lessons: Because disopyramide has low molecular weight and a small distribution volume, blood purification is considered to be the most effective therapy. We selected direct hemoperfusion for relatively high protein-binding rate. In fact, clinical status was dramatically improved, and the calculated half-life of the direct hemoperfusion phase was the shortest of all phases. In cases of severe or life-threatening disopyramide poisoning, blood purification therapy including direct hemoperfusion using a coated activated-charcoal column should be performed.

A novel algorithm has been developed for the on-site analysis of CT-fractional flow reserve (CT-FFR) using fluid structural interactions. There have been no reports on the factors affecting the diagnostic performance of CT-FFR using this algorithm. We evaluated the factors predictive of false-positive CT-FFR findings compared to invasive FFR as a reference standard.The subjects were 66 consecutive cases (81 vessels) who underwent invasive FFR assessment within 90 days of the detection of 30-90% stenosis of one vessel of the major coronary artery, from among patients with suspected coronary arterial disease who underwent one-rotation scanning by 320-row coronary CT angiography (CCTA). The prospective CCTA mode was used for all patients, with the X-ray exposure set in a range of 70-99% of the RR interval. The FFR was calculated on-site from multiple cardiac phases. Factors associated with a false-positive finding of functional stenosis on CT-FFR, defined as an invasive FFR of ≤0.80, were evaluated using logistic regression analysis.Thirty-nine vessels (48.1%) had an invasive FFR of ≤0.80. CT-FFR and invasive FFR values disagreed in 13 vessels in 13 patients. The values were false positive in 12 of the vessels. In an analysis of patient characteristics, the body mass index (odds ratio, 1.33; 95%CI, 1.06-1.67; p = 0.01) and Image noise (odds ratio, 1.18; 95%CI, 1.01-1.40; p = 0.04) were predictive of false-positive findings. The presence of calcified plaque (odds ratio, 5.16; 95%CI, 1.06-20.85; p = 0.01) was the only significant predictive factor in a vessel-based analysis of lesion characteristics.The presence of calcified plaque exerted a significant effect on the diagnostic performance of CT-FFR, and did so independently of the degree of calcification indicated by the Agatston score.

We aimed to assess the impact of scoring balloon angioplasty (SBA) after rotational atherectomy (RA) on long-term clinical outcomes in patients who underwent percutaneous coronary intervention (PCI) using second-generation drug-eluting stents (DES). The long-term outcomes associated with SBA after RA in severely calcified lesions is unknown.Using the J2T ROTA registry data, we evaluated the clinical events of patients who underwent PCI using RA for heavily calcified lesions from January 2004 to December 2015. A total of 307 patients who underwent PCI with second-generation DES were analyzed and divided into the SBA (n = 96) and conventional balloon angioplasty (CBA) groups (n = 211). Eighty-two and 189 patients comprised the "SBA after small burr (SBA-SB)" and "CBA after small burr (CBA-SB)" subgroups, respectively, for the subgroup analysis. Study endpoints were incidence of 3-year major adverse cardiac events (MACE), target vessel revascularization (TVR), and target lesion revascularization (TLR).Kaplan-Meier analysis revealed that the incidence of 3-year cumulative MACE, TVR, and TLR were comparable between groups, and that the incidences of 3-year cumulative MACE, TVR, and TLR were significantly lower in the SBA-SB subgroup than in the CBA-SB subgroup (log-rank p = 0.008; log-rank p = 0.047; log-rank p = 0.045; respectively). Multivariate Cox regression model indicated that SBA after RA was an independent predictor of MACE (hazard ratio: 0.337; 95% confidence interval: 0.139 to 0.817; p = 0.016).Additional SBA following RA was associated with lower MACE incidence in patients undergoing RA with a small-sized burr.

Although on-site workstation-based CT fractional flow reserve (CT-FFR) is an emerging method for assessing vessel-specific ischemia in coronary artery disease, severe calcification is a significant factor affecting CT-FFR's diagnostic performance. The subtraction method significantly improves the diagnostic value with respect to anatomic stenosis for patients with severe calcification in coronary CT angiography (CCTA). We evaluated the diagnostic capability of CT-FFR using the subtraction method (subtraction CT-FFR) in patients with severe calcification. This study included 32 patients with 45 lesions with severe calcification (Agatston score >400) who underwent both CCTA and subtraction CCTA using 320-row area detector CT and also received invasive FFR within 90 days. The diagnostic capabilities of CT-FFR and subtraction CT-FFR were compared. The sensitivities, specificities, positive predictive values (PPVs), and negative predictive values (NPVs) of CT-FFR vs. subtraction CT-FFR for detecting hemodynamically significant stenosis, defined as FFR ≤ 0.8, were 84.6% vs. 92.3%, 59.4% vs. 75.0%, 45.8% vs. 60.0%, and 90.5% vs. 96.0%, respectively. The area under the curve for subtraction CT-FFR was significantly higher than for CT-FFR (0.84 vs. 0.70) (p = 0.04). The inter-observer and intra-observer variabilities of subtraction CT-FFR were 0.76 and 0.75, respectively. In patients with severe calcification, subtraction CT-FFR had an incremental diagnostic value over CT-FFR, increasing the specificity and PPV while maintaining the sensitivity and NPV with high reproducibility.