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

Study Questions:

What are the benefits of optimal medical care (OMC), supervised exercise (SE), and stent revascularization (ST) on both walking outcomes and measures of quality of life (QOL) in patients with claudication due to aortoiliac peripheral artery disease (PAD)?

Methods:

The CLEVER (Claudication: Exercise Versus Endoluminal Revascularization) trial investigators randomly assigned 111 patients with aortoiliac PAD to receive one of three treatments: OMC, OMC plus SE, or OMC plus ST. The primary endpoint was the change in peak walking time on a graded treadmill test at 6 months compared with baseline. Secondary endpoints 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. The primary endpoint was assessed by use of sequential pairwise analysis of covariance (ANCOVA).

Results:

At the 6-month follow-up, change in peak walking time (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 QOL 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 vs. 73 ± 139 vs. −6 ± 109 steps per hour), but these differences were not statistically significant.

Conclusions:

The authors concluded that SE results in superior treadmill walking performance than ST, even for those with aortoiliac PAD.

Perspective:

This study suggests that for a population with advanced aortoiliac PAD, changes in peak walking time over 6 months were greater among those who received SE than those revascularized with stent. However, the greatest improvements in self-reported QOL were observed in the stented cohort. This apparent discordance between the treadmill outcome and QOL limit the trial’s impact on clinical practice, and an exercise regimen should be recommended for all patients with PAD irrespective of revascularization. Future studies will need to assess longer-term functional status and clinical outcomes, given the possible training effect of supervised exercise on walking time, thus favoring the primary endpoint.

Clinical Topics: Diabetes and Cardiometabolic Disease, Invasive Cardiovascular Angiography and Intervention, Prevention, Vascular Medicine, Interventions and Vascular Medicine, Exercise

Keywords: Intermittent Claudication, Walking, Quality of Life, Cardiology, Peripheral Arterial Disease, Pregnancy, Stents, Exercise Test


< Back to Listings