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

TLDR

Claudication, a disabling symptom of peripheral artery disease, is commonly treated with medication, supervised exercise, or stent revascularization, and this randomized study of 111 aortoiliac patients compared optimal medical care alone, with added supervised exercise, or with stent placement, highlighting a trade‑off between improved walking performance with exercise and better quality‑of‑life outcomes with stenting. The trial measured the primary endpoint of change in peak treadmill walking time at six months, with secondary endpoints of free‑living step activity, quality‑of‑life scores, and cardiovascular risk factors. At six months, supervised exercise produced the largest increase in peak walking time (5.8 min), followed by stenting (3.7 min) and optimal medical care (1.2 min), with exercise outperforming stenting (P = 0.04); however, stenting yielded greater improvements in most quality‑of‑life scales, while step activity rose more with stenting but not significantly. Trial registered at ClinicalTrials.gov (NCT00132743).

Abstract

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.