Claudication : Exercise Versus Endoluminal Revascularization Research Articles

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<i>Circulation</i> Editors’ Picks

Correlation of Patient-reported Symptom Outcomes and Treadmill Test Outcomes after Treatment for Aortoiliac Claudication

PurposeTo 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). Materials and MethodsFive scales of the Peripheral Artery Questionnaire and Walking Impairment Questionnaire were correlated with peak walking time and treadmill claudication onset time. ResultsThe 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. ConclusionsDisease-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.

Circulation Editors’ Picks

<i>Circulation</i> Editors’ Picks

Letter by Malyar et al 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”

HomeCirculationVol. 126, No. 7Letter by Malyar et al 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 AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBLetter by Malyar et al 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” Nasser M. Malyar, MD, Matthias Meyborg, MD and Holger Reinecke, MD, PhD Nasser M. MalyarNasser M. Malyar Division of Angiology Department of Cardiology and Angiology University Hospital Muenster Muenster, Germany (Malyar, Meyborg, Reinecke) Search for more papers by this author , Matthias MeyborgMatthias Meyborg Division of Angiology Department of Cardiology and Angiology University Hospital Muenster Muenster, Germany (Malyar, Meyborg, Reinecke) Search for more papers by this author and Holger ReineckeHolger Reinecke Division of Angiology Department of Cardiology and Angiology University Hospital Muenster Muenster, Germany (Malyar, Meyborg, Reinecke) Search for more papers by this author Originally published14 Aug 2012https://doi.org/10.1161/CIRCULATIONAHA.112.100594Circulation. 2012;126:e101To the Editor:We read with great interest the eagerly awaited results of the first prospective, multicenter, randomized, controlled trial presented by Murphy et al1 comparing the benefit of optimal medical care, supervised exercise (SE), and stent revascularization (ST) on both walking outcomes and measures of quality of life in patients with claudication resulting from aortoiliac peripheral artery disease.The 6-month results of the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) study confirm unequivocally the beneficial effect of SE on walking measures. The authors concluded that SE shows a superior clinical benefit compared with ST. However, from our point of view, the presented data do not justify such a firm conclusion exclusively in favor of SE. Because the results of this trial will have a marked impact on the decision making of how to treat patients worldwide with claudication resulting from aortoiliac peripheral artery disease, one has to put the results of the CLEVER study in perspective: The main goal of current therapeutic strategies in patients with claudication resulting from aortoiliac peripheral artery disease is to release symptoms, regain lost ambulatory function, and to improve the overall quality of life. Even though the primary end point of the study (ie, improvement in peak walking time on a treadmill) was greatest for SE, it is noteworthy that the increase in treadmill performance is not equal to the patients' perceived performance in everyday life, and even less an improvement in quality of life. It is also essential to concern the value and efficacy of interventional measures in patients with claudication resulting from aortoiliac peripheral artery disease in terms of improvement of quality of life. In CLEVER, in terms of daily ambulatory activity as well as in most of the disease-specific quality of life measures, ST resulted in a significantly greater benefit than SE. At the 6-month follow-up, the claudication-free rate after ST was double the rate in the exercise group (42% versus 21%). Moreover, Walking Impairment Questionnaire (WIP) pain severity (P =0.014), WIQ walking distance (P =0.029), Peripheral Artery Questionnaire (PAQ) symptoms (P =0.002), and PAQ quality of life (P =0.006) were all significantly better in patients treated with ST.Another important aspect of a recommended intervention measure is its practicability in a broader spectrum of patients. SE requires consequent daily discipline, patience, strict adherence, and, of course, supervision of all these patients. Compared with one-stop ST, SE requires much greater logistic efforts. Moreover, SE is generally not reimbursed by health insurance companies despite substantial evidence for the clinical benefit of exercise programs. In this context, it would have been interesting to evaluate the effect of a combined strategy (ie, SE after ST). At our institution, we recommend exercise training (preferably supervised, but if not available, at least home-based exercise) to all our patients with manifest atherosclerotic disease, and of course also in those who have undergone ST.We congratulate Murphy and colleagues on this landmark study, but we conclude from CLEVER that ST is, in many ways, superior—and more practicable—than SE in most patients with claudication resulting from aortoiliac peripheral artery disease. Without a doubt, the pros and cons of available strategies should be elucidated for each individual patient, concerning her or his specific complaints and needs.Malyar Nasser M., MDMatthias Meyborg, MDHolger Reinecke, MD, PhD Division of Angiology Department of Cardiology and Angiology University Hospital Muenster Muenster, GermanyDisclosuresHolger Reinecke has received speaker honoraria from Sanofi-Aventis, Daiichi-Sankyo, The Medicine Company, Cordis, and Novartis. He has also received research grants from the German Federal Ministry for Education and Research (BMBF).

Response 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”

We 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 …

Letter by Frans and Koelemay 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”

To the Editor: With great interest we read the long-awaited report of the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) study, a very relevant study for clinical practice. We compliment Murphy and colleagues for their well-written article and their effort in investigating the relative effectiveness of optimal medical care, supervised exercise, and stenting to relieve intermittent claudication resulting from an iliac artery obstruction.1 The bottom line of CLEVER is that at the 6-month follow-up, supervised exercise improves walking distance on a treadmill better, and that functional status and most domains of disease-specific quality of life improve more after …

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

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

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

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

Claudication: Exercise vs Endoluminal Revascularization (CLEVER) study update

Claudication: Exercise vs Endoluminal Revascularization (CLEVER) study update

Design of the multicenter standardized supervised exercise training intervention for the ‘CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study’

The CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study is the first randomized, controlled, clinical, multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication. In this report, the methods and dissemination techniques of the supervised exercise training intervention are described. A total of 217 participants are being recruited and randomized to one of three arms: (1) optimal medical care; (2) aortoiliac revascularization with stent; or (3) supervised exercise training. Of the enrolled patients, 84 will receive supervised exercise therapy. Supervised exercise will be administered according to a protocol designed by a central CLEVER exercise training committee based on validated methods previously used in single center randomized control trials. The protocol will be implemented at each site by an exercise committee member using training methods developed and standardized by the exercise training committee. The exercise training committee reviews progress and compliance with the protocol of each participant weekly. In conclusion, a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy, safety and cost-effectiveness for patients with claudication due to peripheral arterial disease (PAD) is being evaluated for the first time in CLEVER. The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication resulting from PAD and provide standardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice.

The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: Rationale and methods

Intermittent claudication is the primary symptom of peripheral arterial disease, affecting between 1 and 3 million Americans. Symptomatic improvement can be achieved by endovascular revascularization, but such procedures are invasive, expensive, and may be associated with procedural adverse events. Medical treatment options, including claudication medications and supervised exercise training, are also known to be effective, albeit also with associated limitations. The CLEVER (Claudication: Exercise Vs. Endoluminal Revascularization) study, funded by the Heart, Lung, and Blood Institute of the National Institutes of Health, is a prospective, multicenter, randomized, controlled clinical trial evaluating the relative efficacy, safety, and health economic impact of four treatment strategies for people with aortoiliac peripheral arterial disease and claudication. The treatment arms are: (1) optimal medical care (claudication pharmacotherapy); (2) primary stent placement; (3) supervised exercise rehabilitation; and (4) combined stenting with supervised exercise rehabilitation. The CLEVER study is a 5-year randomized, controlled clinical trial to be conducted at approximately 25 centers in the United States that will monitor 252 patients and their responses to treatment during an 18-month follow-up period. The primary end point is change in maximum walking duration on a graded treadmill test. Secondary end points include the change at 18 months in maximum walking duration from baseline, comparisons of free-living daily activity levels assessed by pedometer, health-related quality of life, and cost-effectiveness. Other analyses include the effect of these treatment strategies on anthropomorphic and physiologic variables, including body mass index, waist circumference, blood pressure, pulse pressure, and resting pulse as well as biochemical markers of cardiovascular health, including fasting lipids, fibrinogen, C-reactive protein, and hemoglobin A 1c values.