Suzanne Goldberg

Claudication is a common and disabling symptom of peripheral artery disease that can be treated with medication, supervised exercise (SE), or stent revascularization (ST).We randomly assigned 111 patients with aortoiliac peripheral artery disease to receive 1 of 3 treatments: optimal medical care (OMC), OMC plus SE, or OMC plus ST. The primary end point was the change in peak walking time on a graded treadmill test at 6 months compared with baseline. Secondary end points included free-living step activity, quality of life with the Walking Impairment Questionnaire, Peripheral Artery Questionnaire, Medical Outcomes Study 12-Item Short Form, and cardiovascular risk factors. At the 6-month follow-up, change in peak walking time (the primary end point) was greatest for SE, intermediate for ST, and least with OMC (mean change versus baseline, 5.8±4.6, 3.7±4.9, and 1.2±2.6 minutes, respectively; P<0.001 for the comparison of SE versus OMC, P=0.02 for ST versus OMC, and P=0.04 for SE versus ST). Although disease-specific quality of life as assessed by the Walking Impairment Questionnaire and Peripheral Artery Questionnaire also improved with both SE and ST compared with OMC, for most scales, the extent of improvement was greater with ST than SE. Free-living step activity increased more with ST than with either SE or OMC alone (114±274 versus 73±139 versus -6±109 steps per hour), but these differences were not statistically significant.SE results in superior treadmill walking performance than ST, even for those with aortoiliac peripheral artery disease. The contrast between better walking performance for SE and better patient-reported quality of life for ST warrants further study.URL: http://clinicaltrials.gov/ct/show/NCT00132743?order=1. Unique identifier: NCT00132743.

Treatment for claudication that is due to aortoiliac peripheral artery disease (PAD) often relies on stent revascularization (ST). However, supervised exercise (SE) is known to provide comparable short-term (6-month) improvements in functional status and quality of life. Longer-term outcomes are not known. The goal of this study was to report the longer-term (18-month) efficacy of SE compared with ST and optimal medical care (OMC). Of 111 patients with aortoiliac PAD randomly assigned to receive OMC, OMC plus SE, or OMC plus ST, 79 completed the 18-month clinical and treadmill follow-up assessment. SE consisted of 6 months of SE and an additional year of telephone-based exercise counseling. Primary clinical outcomes included objective treadmill-based walking performance and subjective quality of life. Peak walking time improved from baseline to 18 months for both SE (5.0 ± 5.4 min) and ST (3.2 ± 4.7 min) significantly more than for OMC (0.2 ± 2.1 min; p < 0.001 and p = 0.04, respectively). The difference between SE and ST was not significant (p = 0.16). Improvement in claudication onset time was greater for SE compared with OMC, but not for ST compared with OMC. Many disease-specific quality-of-life scales demonstrated durable improvements that were greater for ST compared with SE or OMC. Both SE and ST had better 18-month outcomes than OMC. SE and ST provided comparable durable improvement in functional status and in quality of life up to 18 months. The durability of claudication exercise interventions merits its consideration as a primary PAD claudication treatment. (Claudication: Exercise Versus Endoluminal Revascularization [CLEVER]; NCT00132743)

It is unclear whether achieving multiple risk factor (RF) goals through protocol-guided intensive medical therapy is feasible or improves outcomes in type 2 diabetes mellitus.This study sought to quantify the relationship between achieved RF goals in the BARI 2D (Bypass Angioplasty Investigation Revascularization 2 Diabetes) trial and cardiovascular events/survival.We performed a nonrandomized analysis of survival/cardiovascular events and control of 6 RFs (no smoking, non-high-density lipoprotein cholesterol <130 mg/dl, triglycerides <150 mg/dl, blood pressure [systolic <130 mm Hg; diastolic <80 mm Hg], glycosylated hemoglobin <7%) in BARI 2D. Cox models with time-varying number of RFs in control were adjusted for baseline number of RFs in control, clinical characteristics, and trial randomization assignments.In 2,265 patients (mean age 62 years, 29% women) followed up for 5 years, the mean ± SD number of RFs in control improved from 3.5 ± 1.4 at baseline to 4.2 ± 1.3 at 5 years (p < 0.0001). The number of RFs in control during the trial was strongly related to death (global p = 0.0010) and the composite of death, myocardial infarction, and stroke (global p = 0.0035) in fully adjusted models. Participants with 0 to 2 RFs in control during follow-up had a 2-fold higher risk of death (hazard ratio: 2.0; 95% confidence interval: 1.3 to 3.3; p = 0.0031) and a 1.7-fold higher risk of the composite endpoint (hazard ratio: 1.7; 95% confidence interval: 1.2 to 2.5; p = 0.0043), compared with those with 6 RFs in control.Simultaneous control of multiple RFs through protocol-guided intensive medical therapy is feasible and relates to cardiovascular morbidity and mortality in patients with coronary disease and type 2 diabetes mellitus. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes [BARI 2D]; NCT00006305).

The extent of coronary disease affects clinical outcomes and may predict the effectiveness of coronary revascularization with either coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI). The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score quantifies the extent of coronary disease.This study sought to determine whether SYNTAX scores predicted outcomes and the effectiveness of coronary revascularization compared with medical therapy in the BARI-2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial.Baseline SYNTAX scores were retrospectively calculated for BARI-2D patients without prior revascularization (N = 1,550) by angiographic laboratory investigators masked to patient characteristics and outcomes. The primary outcome was major cardiovascular events (a composite of death, myocardial infarction, and stroke) over 5 years.A mid/high SYNTAX score (≥23) was associated with a higher risk of major cardiovascular events (hazard ratio: 1.36, confidence interval: 1.07 to 1.75, p = 0.01). Patients in the CABG stratum had significantly higher SYNTAX scores: 36% had mid/high SYNTAX scores compared with 13% in the PCI stratum (p < 0.001). Among patients with low SYNTAX scores (≤22), major cardiovascular events did not differ significantly between revascularization and medical therapy, either in the CABG stratum (26.1% vs. 29.9%, p = 0.41) or in the PCI stratum (17.8% vs. 19.2%, p = 0.84). Among patients with mid/high SYNTAX scores, however, major cardiovascular events were lower after revascularization than with medical therapy in the CABG stratum (15.3% vs. 30.3%, p = 0.02), but not in the PCI stratum (35.6% vs. 26.5%, p = 0.12).Among patients with diabetes and stable ischemic heart disease, higher SYNTAX scores predict higher rates of major cardiovascular events and were associated with more favorable outcomes of revascularization compared with medical therapy among patients suitable for CABG. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes; NCT00006305).

Background— Despite observations suggesting a benefit for late opening of totally occluded infarct-related arteries after myocardial infarction, the Occluded Artery Trial (OAT) demonstrated no reduction in the composite of death, reinfarction, and class IV heart failure over a 2.9-year mean follow-up. Follow-up was extended to determine whether late trends would favor either treatment group. Methods and Results— OAT randomized 2201 stable patients with infarct-related artery total occlusion &gt;24 hours (calendar days 3–28) after myocardial infarction. Patients with severe inducible ischemia, rest angina, class III-IV heart failure, and 3-vessel/left main disease were excluded. We conducted extended follow-up of enrolled patients for an additional 3 years for the primary end point and angina (6-year median survivor follow-up; longest, 9 years; 12 234 patient-years). Rates of the primary end point (hazard ratio, 1.06; 95% confidence interval, 0.88–1.28), fatal and nonfatal myocardial infarction (hazard ratio, 1.25; 95% confidence interval, 0.89–1.75), death, and class IV heart failure were similar for the percutaneous coronary intervention (PCI) and medical therapy alone groups. No interactions between baseline characteristics and treatment group on outcomes were observed. The vast majority of patients at each follow-up visit did not report angina. There was less angina in the PCI group through early in follow-up; by 3 years, the between group difference was consistently &lt;4 patients per 100 treated and not significantly different, although there was a trend toward less angina in the PCI group at 3 and 5 years. The 7-year rate of PCI of the infarct-related artery during follow-up was 11.1% for the PCI group compared with 14.7% for the medical therapy alone group (hazard ratio, 0.79; 95% confidence interval, 0.61–1.01; P =0.06). Conclusions— Extended follow-up of the OAT cohort provides robust evidence for no reduction of long-term rates of clinical events after routine PCI in stable patients with a totally occluded infarct-related artery and without severe inducible ischemia in the subacute phase after myocardial infarction. Clinical Trial Registration— http://www.clinicaltrials.gov . Unique identifier: NCT00004562.

New surgical procedures, imaging modalities, and medical devices have improved therapy for many patients and made treatment possible for others who have had few options in the past. In February 2004, the National Heart, Lung, and Blood Institute's (NHLBI) Advisory Council proposed that the institute evaluate the status and future directions in cardiac surgery. In response to this recommendation, the NHLBI convened a working group of cardiac surgeons on May 7 and 8, 2004, to assess the state of cardiac surgery research, identify critical gaps in current knowledge, determine areas of opportunity, and obtain specific recommendations for future research activities. The working group discussed surgical revascularization, novel surgical approaches, valvular research directions, biotechnology and cell-based therapy, heart failure, imaging modalities, and barriers to clinical research and presents its recommendations here.

Current dosing practices for warfarin are empiric and result in the need for frequent dose changes as the international normalized ratio gets too high or too low. As a result, patients are put at increased risk for thromboembolism, bleeding, and premature discontinuation of anticoagulation therapy. Prior research has identified clinical and genetic factors that can alter warfarin dose requirements, but few randomized clinical trials have examined the utility of using clinical and genetic information to improve anticoagulation control or clinical outcomes among a large, diverse group of patients initiating warfarin.The COAG trial is a multicenter, double-blind, randomized trial comparing 2 approaches to guiding warfarin therapy initiation: initiation of warfarin therapy based on algorithms using clinical information plus an individual's genotype using genes known to influence warfarin response ("genotype-guided dosing") versus only clinical information ("clinical-guided dosing") (www.clinicaltrials.gov Identifier: NCT00839657).The COAG trial design is described. The study hypothesis is that, among 1,022 enrolled patients, genotype-guided dosing relative to clinical-guided dosing during the initial dosing period will increase the percentage of time that patients spend in the therapeutic international normalized ratio range in the first 4 weeks of therapy.The COAG will determine if genetic information provides added benefit above and beyond clinical information alone.

To examine the relationship between objective treadmill test outcomes and subjective symptom outcomes among patients with claudication treated with stent revascularization (ST) compared with supervised exercise (SE).Five scales of the Peripheral Artery Questionnaire and Walking Impairment Questionnaire were correlated with peak walking time and treadmill claudication onset time.The correlation between change in disease-specific quality of life (QOL) and change in peak walking time differed according to treatment group, with statistically significant correlations for all five scales for the ST group and weaker trends for the SE group, only one of which was statistically significant. In contrast, improvements in disease-specific QOL correlated well with increases in claudication onset time, with no significant interaction with treatment group for any of the five scales.Disease-specific QOL results at 6 months in the Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study show that improved maximal treadmill walking in patients with claudication treated with SE correlated poorly with self-reported symptom relief. Conversely, patients treated with ST showed good correlation between improved maximal treadmill walking and self-reported symptom improvement. The correlation between claudication onset time and self-reported symptom relief was good across treatment groups. This finding indicates that traditional objective treadmill test outcomes may not correlate well with symptom relief in patients with claudication. Future studies should investigate these data and improve understanding of patient relevance of traditional objective treadmill-based treatment outcomes.

To explore the relationship between gender, native artery diameters, and outcomes of stent revascularization (ST) in the "Claudication: Exercise versus Endoluminal Revascularization" trial.A comparative analysis was performed of the impact of gender, age, weight, height, body mass index, and body surface area on revascularization outcomes at baseline and 6months in 55 arterial segments of aorta, common iliac artery, and external iliac artery (EIA).Women demonstrated smaller diameter of the EIA. However, the clinical outcomes of revascularization were not negatively affected by the gender-based differences.Gender-based differences are unlikely to significantly impact outcome of ST.

Patients with severe ventricular dysfunction make up a special subset of patients who undergo coronary artery bypass procedures. For these patients, the risk associated with the bypass procedure is relatively high, but the opportunity-for-survival benefit is also greater. We studied 61 consecutive coronary artery bypass patients with preoperative ejection fractions < or = 25%, and further compared several subgroups: Group I (n = 30) ejection fractions ranged from 21% to 25%; Group II (n = 23) ejection fractions ranged from 16% to 20.9%; and Group III (n = 8) ejection fractions ranged from 10% to 15.9%. The overall mortality rate was 8% (5/61), with no deaths in Group III. The 41% (25/61) of patients who received left internal mammary artery conduits experienced a higher mortality rate, yet it did not differ significantly from that of patients who received only saphenous vein conduits. Intraaortic balloon pumps were placed in 48% (29/61) of the patients, with a progressively higher incidence in patients with poorer ventricular function (P < 0.05). Most intraaortic balloon pumps (59%) were placed intraoperatively. Two patients underwent placement of left ventricular assist devices, and 1 of these survived. Coronary artery bypass grafting in patients with poor ventricular function carries a substantial, but acceptable, mortality risk. Use of the left internal mammary artery did not improve perioperative mortality, and may have a negative impact in the early postoperative period. Intraaortic balloon pump use was most common in those patients with the worst ventricular function. Prophylactic intraaortic balloon pump use may be justified in candidates with ejection fractions < 20%.

Predictors of in-hospital mortality after myocardial infarction (MI) have been reported as a dichotomy: survival versus death. Predictors of time from admission to death have not been reported. 7,337 patients were enrolled in a prospective multi-center registry of acute MI. In-hospital mortality

Introduction: BARI 2D evaluated the efficacy of prompt coronary revascularization on a background of protocol-guided aggressive medical therapy (AMT) among patients with Type 2 diabetes including f...

Purpose The CLEVER Study (Claudication: Exercise Vs. Endoluminal Revascularization) previously reported superior treadmill peak walking time at 6 months when claudicants are treated with supervised exercise compared with stent revascularization. Conversely, it also showed better symptom improvement at 6 months for stent than supervised exercise. The purpose of this post-hoc analysis is to examine the relationship of disease-specific QOL (i.e., symptom) improvement with treadmill test outcomes, using data from CLEVER Study participants. Materials and Methods Multivariable regression analyses were done on treadmill test walking performance (peak walking performance and claudication onset time) using the 5 scales of the Peripheral Artery Questionnaire (PAQ) and Walking Impairment Questionnaire (WIQ), to examine the correlation and treatment group interaction effects. Results The correlation between change in symptoms and change in peak treadmill test walking performance showed a significant interaction effect with treatment group. Symptom improvement correlated with peak treadmill walking performance for those treated with stents but not for those treated with supervised exercise. There was a much larger improvement in symptoms for each minute of improvement in peak treadmill walking for stent compared with supervised exercise. In contrast, there was no significant treatment group interaction for claudication onset time on the treadmill, and improvements in symptoms correlated well with increases in claudication onset time, with no significant interaction with treatment group for any of the 5 scales. Conclusion Six month results from the CLEVER study show that although supervised exercise resulted in superior peak treadmill walking than stent revascularization, peak treadmill walking did not correlate with improved symptoms in that treatment group, whereas it did for the stent group. Treadmill claudication onset time may be a better endpoint for claudication treatment strategy trials, because symptom improvement and walking performance are both measured by it, independent of treatment group.

HomeCirculationVol. 126, No. 7Response to Letters Regarding Article, “Supervised Exercise Versus Primary Stenting for Claudication Resulting From Aortoiliac Peripheral Artery Disease: Six-Month Outcomes From the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) Study” Free AccessReplyPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReplyPDF/EPUBResponse to Letters Regarding Article, “Supervised Exercise Versus Primary Stenting for Claudication Resulting From Aortoiliac Peripheral Artery Disease: Six-Month Outcomes From the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) Study” Timothy P. Murphy, MD and Joselyn Cerezo, MD Donald E. Cutlip, MD and Matthew R. Reynolds, MD, MSc Judith G. Regensteiner, PhD Emile R. Mohler, MD David J. Cohen, MD Joseph M. Massaro, PhD Beth A. Lewis, PhD Niki C. Oldenburg, PH, Michael W. Steffes, MD and Alan T. Hirsch, MD Claudia C. Thum, MA Suzanne Goldberg, MSN Michael R. Jaff, DO Anthony J. Comerota, MD Jonathan Ehrman, PhD Diane Treat-Jacobson, RN, PhD and Ulf Bronas, PhD M. Eileen Walsh, RN, PhD Dalynn T. Badenhop, PhD Tracie Collins, MD Timothy P. MurphyTimothy P. Murphy Rhode Island Hospital Providence, RI (Murphy, Cerezo) Search for more papers by this author and Joselyn CerezoJoselyn Cerezo Rhode Island Hospital Providence, RI (Murphy, Cerezo) Search for more papers by this author Donald E. CutlipDonald E. Cutlip Beth Israel Deaconess Medical Center Boston, MA (Cutlip, Reynolds) Search for more papers by this author and Matthew R. ReynoldsMatthew R. Reynolds Beth Israel Deaconess Medical Center Boston, MA (Cutlip, Reynolds) Search for more papers by this author Judith G. RegensteinerJudith G. Regensteiner University of Colorado School of Medicine Aurora, CO (Regensteiner) Search for more papers by this author Emile R. MohlerEmile R. Mohler University of Pennsylvania Philadelphia, PA (Mohler) Search for more papers by this author David J. CohenDavid J. Cohen University of Missouri–Kansas City Kansas City, MO (Cohen) Search for more papers by this author Joseph M. MassaroJoseph M. Massaro Boston University Boston, MA (Massaro) Search for more papers by this author Beth A. LewisBeth A. Lewis University of Minnesota School of Kinesiology Minneapolis, MN (Lewis) Search for more papers by this author Niki C. OldenburgNiki C. Oldenburg University of Minnesota Medical School Minneapolis, MN (Oldenburg, Steffes, Hirsch) Search for more papers by this author , Michael W. SteffesMichael W. Steffes University of Minnesota Medical School Minneapolis, MN (Oldenburg, Steffes, Hirsch) Search for more papers by this author and Alan T. HirschAlan T. Hirsch University of Minnesota Medical School Minneapolis, MN (Oldenburg, Steffes, Hirsch) Search for more papers by this author Claudia C. ThumClaudia C. Thum Harvard Clinical Research Institute Boston, MA (Thum) Search for more papers by this author Suzanne GoldbergSuzanne Goldberg National Heart, Lung, and Blood Institute Bethesda, MD (Goldberg) Search for more papers by this author Michael R. JaffMichael R. Jaff Massachusetts General Hospital Boston, MA (Jaff) Search for more papers by this author Anthony J. ComerotaAnthony J. Comerota Jobst Vascular Center Toledo, OH (Comerota) Search for more papers by this author Jonathan EhrmanJonathan Ehrman Henry Ford Hospital Detroit, MI (Ehrman) Search for more papers by this author Diane Treat-JacobsonDiane Treat-Jacobson University of Minnesota School of Nursing Minneapolis, MN (Treat-Jacobson, Bronas) Search for more papers by this author and Ulf BronasUlf Bronas University of Minnesota School of Nursing Minneapolis, MN (Treat-Jacobson, Bronas) Search for more papers by this author M. Eileen WalshM. Eileen Walsh University of Toledo College of Nursing Toledo, OH (Walsh) Search for more papers by this author Dalynn T. BadenhopDalynn T. Badenhop University of Toledo Health Science Campus Toledo, OH (Badenhop) Search for more papers by this author Tracie CollinsTracie Collins University of Kansas School of Medicine–Witchita Department of Preventive Medicine and Public Health Witchita, KS (Collins) Search for more papers by this author Originally published14 Aug 2012https://doi.org/10.1161/CIRCULATIONAHA.112.113704Circulation. 2012;126:e102–e103We thank the readers for the interest in our article1 and for their insightful comments. One such reader, Dr Maylar, comments that the 6-month data from the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) study do not justify a firm conclusion in favor of supervised exercise (SE). We note that the study was designed with a peak-walking-time, 6-month primary outcome end point; using this prespecified end point, SE provided a superior outcome to stent revascularization. However, high-quality comparative effectiveness research is always best designed to permit >1 clinical end point over relevant timeframes. In this context, we note that primary care and vascular specialty clinicians will evaluate both 6- and 18-month time points and the full range of outcomes achieved. As Dr Maylar points out, patient-centered outcomes were not as strongly positive for SE as the treadmill outcomes. The finding of more improvement in treadmill walking by SE participants but more symptom improvement in stent revascularization participants needs to be understood. We also agree that SE requires more commitment on the part of patients (but note that exercise would ideally be done by everyone anyway) and suspect that the discussion of the superiority of one treatment over the other may be misplaced. We think it is more likely that a better understanding of patient preferences will result in recommendations for SE in some patients and stent revascularization for others, as well as combination therapy.Another reader, Dr Franz, raises concerns that the slow rate of patient recruitment in the CLEVER study may reflect a strong degree of selection bias on the part of the investigators. We believe that the demographic, risk factor, hemodynamic, and functional status data are consistent with most other reported nonrandomized claudication treatment populations and note that recruitment for randomized treatment strategy trials is rarely easy. In this context, there is no objective reason to justify a selection bias concern. Moreover, in examining screening logs, it is clear that many patients screened were not eligible candidates for the study, as is often the case.The statement about futility is not true, because the study was stopped based on the Data Safety Monitoring Board decision that additional enrollment would be unlikely to change the primary outcome, which turned out to be positive, not negative. In fact, despite having a smaller sample size than originally planned, there are a large number of statistically significant differences between the treatment groups, and our baseline assumptions for how many participants would be needed to show a treatment effect were too conservative. Because we did not know the results before doing the study, this is not surprising. Readers should not interpret the results as somehow less statistically valid because there were fewer participants than originally planned. In hindsight, the final study sample size was more than adequate for the comparisons that were planned.Timothy P. Murphy, MDJoselyn Cerezo, MD Rhode Island Hospital Providence, RIDonald E. Cutlip, MDMatthew R. Reynolds, MD, MSc Beth Israel Deaconess Medical Center Boston, MAJudith G. Regensteiner, PhD University of Colorado School of Medicine Aurora, COEmile R. Mohler, MD University of Pennsylvania Philadelphia, PADavid J. Cohen, MD University of Missouri–Kansas City Kansas City, MOJoseph M. Massaro, PhD Boston University Boston, MABeth A. Lewis, PhD University of Minnesota School of Kinesiology Minneapolis, MNNiki C. Oldenburg, Dr PHMichael W. Steffes, MDAlan T. Hirsch, MD University of Minnesota Medical School Minneapolis, MNClaudia C. Thum, MA Harvard Clinical Research Institute Boston, MASuzanne Goldberg, MSN National Heart, Lung, and Blood Institute Bethesda, MDMichael R. Jaff, DO Massachusetts General Hospital Boston, MAAnthony J. Comerota, MD Jobst Vascular Center Toledo, OHJonathan Ehrman, PhD Henry Ford Hospital Detroit, MIDiane Treat-Jacobson, RN, PhDUlf Bronas, PhD University of Minnesota School of Nursing Minneapolis, MNM. Eileen Walsh, RN, PhD University of Toledo College of Nursing Toledo, OHDalynn T. Badenhop, PhD University of Toledo Health Science Campus Toledo, OHTracie Collins, MD University of Kansas School of Medicine–Witchita Department of Preventive Medicine and Public Health Witchita, KSDisclosuresDr Murphy has received research grant support from Abbott Vascular, Cordis/Johnson & Johnson, and Otsuka Pharmaceuticals and consultant fees from MicroVention-Terumo. Dr Cohen has received research grant support from Medtronic, Boston Scientific, Abbott Vascular, and Medrad and consultant fees from Medtronic. Dr Reynolds has received consultant fees from Medtronic. Dr Jaff has equity in Micell Technologies and PQ Bypass, has board membership at VIVA Physicians, and is a consultant for Becker Venture Services Group, Abbott Vascular, Cordis/Johnson & Johnson, eV3/Covidien, and Medtronic. Dr Comerota serves on the advisory committee for Bristol-Myers Squibb, Aastrom, Covidien, AngioDynamics, Otsuka Pharmaceuticals, ConvaTec, Sanofi-Aventis, Cook Group, Servier, ZymoGenetics, and Vessix Vascular (formerly Minnow Medical), has been a consultant to Aastrom, AngioDynamics, ConvaTec, Cook Group, Covidien, Bristol-Myers Squibb, Sanofi-Aventis, and Talecris Plasma Resources, and has received grant/research support from Aastrom, Abbott Vascular, Baxter, Bristol-Myers Squibb, Boehringer Ingelheim, BSN Medical, Colorado Prevention Center, CVRx, Daiichi Sankyo, eV3/Covidien, Johnson & Johnson, Lombard Medical, Medtronic, National Institutes of Health, Pfizer, Sanofi-Aventis, Schering-Plough, and Talecris Plasma Resources. Dr Treat-Jacobson has received research grant support from the National Heart, Lung, and Blood Institute/Exercise Training for Claudication: Arm Ergometry Versus Treadmill Walking Study. Dr Collins has been a Data Safety Monitoring Board Member for Viromed BioPharma/Synteract. Dr Hirsch has received research grant support from Cytokinetics, Viromed BioPharma/Synteract, and Abbott Vascular and consultant fees from Merck, Pozen, Novartis, and AstraZeneca. The other authors report no conflicts.Reference1. Murphy T, Cutlip D, Regensteiner J, Mohler E, Cohen D, Reynolds M, Massaro J, Lewis B, Cerezo J, Oldenburg N, Thum C MA, Goldberg S, Jaff M, Steffes M, Comerota A, Ehrman J, Treat-Jacobson D, Walsh ME, Collins T, Badenhop D, Bronas U, Hirsch AT; CLEVER Study Investigators.Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) Study. Circulation. 2012; 125: 130– 139.LinkGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetails August 14, 2012Vol 126, Issue 7 Advertisement Article InformationMetrics © 2012 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.112.113704 Originally publishedAugust 14, 2012 PDF download Advertisement SubjectsTreatment

Over 1 million Americans have peripheral artery disease (PAD) and symptom-limiting claudication. The NHLBI-sponsored CLEVER study of patients with aorto-iliac PAD and claudication demonstrated better functional (treadmill) performance for SE compared with ST as the six-month primary outcome. Quality of life results favored ST over SE. Yet, the long-term durability of these outcomes may better define the benefit and risk of these strategies.