Supervised Exercise Versus Primary Stenting for Claudication Resulting From Aortoiliac Peripheral Artery Disease

Abstract

Background Claudication is a common and disabling symptom of peripheral artery disease that can be treated with medication, supervised exercise or stent revascularization. Methods We randomly assigned 111 patients with aortoiliac peripheral artery disease to receive one of three treatments: optimal medical care [OMC], OMC plus supervised exercise [(SE], or OMC plus stent revascularization [ST]. The primary endpoint was the change in peak walking time (PWT) on a graded treadmill test at 6 months as compared with baseline. Secondary endpoints included free-living step activity, quality of life (QOL) using the Walking Impairment Questionnaire (WIQ) and Peripheral Artery Questionnaire (PAQ), and cardiovascular risk factors. Results At six month follow-up, change in PWT (the primary endpoint) was greatest for SE, intermediate for ST, and least with OMC (mean change vs. baseline 5.8±4.6, 3.7±4.9, and 1.2±2.6 minutes, respectively; p<0.001 for the comparison of SE vs. OMC; p=0.02 for ST vs. OMC; and p=0.04 for SE vs. ST). Although disease-specific quality of life as assessed by the WIQ and PAQ 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 vs. 73±139 vs. −6±109 steps/hour) but these differences were not statistically significant. Conclusions Supervised exercise treatment results in superior treadmill walking performance than stent placement, even for those with aortoiliac PAD. The contrast between better walking performance for SE and better patient-reported QOL for ST warrants further study.

Vascular specialist response to medicare evidence development coverage advisory committee (MEDCAC) panel on peripheral artery disease of the lower extremities

“…Recent data from the CLEVER and IRONIC trials demonstrate that endovascular intervention is complimentary to optimal medical therapy, and is associated with significant improvement in walking distance, quality of life as measured by the walking impairment questionnaire (WIQ), peripheral artery questionnaire, and physical limitation and quality of life scales [12]. The recent AHRQ review found that endovascular intervention, when added to exercise, improves both maximum walking distance and initial claudication distance more than endovascular intervention or exercise alone.…”

Resumen de los ensayos clínicos presentados en las Sesiones Científicas Anuales de la American Heart Association (Orlando, Estados Unidos, 12-16 de noviembre de 2011)

“…CLEVER: efectividad comparativa del tratamiento de la claudicación: resultados a 6 meses 29 Presentado por: Alan T. Hirsch, Minneapolis, Minnesota, Estados Unidos.…”

Treatment of Intermittent Claudication due to Peripheral Arterial Disease

“…This study showed at 6-month follow-up that the greatest increase in treadmill walking performance occurred in the patients randomized to optimal medical therapy plus supervised exercise [20]. Seventy-nine of the 111 patients (71%) in the CLEVER study completed the 18-month clinical and treadmill follow-up assessment [21].…”

“…The Claudication Exercise Versus Endoluminal Revascularization (CLEVER) study randomized 111 patients with intermittent claudication due to aortoiliac peripheral arterial disease to optimal medical therapy, optimal medical therapy plus supervised exercise, or optimal medical therapy plus stent revascularization [20]. This study showed at 6-month follow-up that the greatest increase in treadmill walking performance occurred in the patients randomized to optimal medical therapy plus supervised exercise [20].…”