Patients with aortoiliac peripheral artery disease (PAD) and associated claudication (the limping that is the most-frequent symptom of this condition) show greater improvement in walking performance when treated with optimal medical therapy (OMT) combined with supervised exercise rather than with primary stent revascularization. These results, which come from the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) study, were published in Circulation and presented at the 2011 AHA Scientific Sessions.

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Claudication can severely limit ambulation, restrict patients to a sedentary lifestyle, and compromise quality of life. Treatment strategies include pharmacotherapy, supervised exercise rehabilitation, and lower-extremity revascularization, but the relative benefits of these options have not previously been compared in a randomized clinical trial. Investigators in the CLEVER study, therefore, recruited 111 patients with aortoiliac PAD and moderate-to-severe intermittent claudication (defined as the ability to walk for between 2 and 11 min on a graded treadmill test). All patients received OMT (cilostazol 100 mg twice daily and advice about home exercise and diet). Patients were then randomly allocated to receive either no additional treatment, primary stenting, or exercise supervision (for 1 h three times per week).

After 6 months, peak treadmill walking time (the primary end point) had increased by 1.2, 3.7, and 5.8 min in the OMT, primary stenting, and supervised-exercise groups, respectively. However, although supervised exercise resulted in the best improvement in treadmill-walking performance, patients in the stenting group reported the greatest enhancement of quality of life (assessed using the Walking Impairment Questionnaire and Peripheral Artery Questionnaire). The reasons for this discrepancy warrant further study.