Background Treatment for claudication that is due to aortoiliac peripheral artery disease (PAD) often relies on stent revascularization (ST). However, supervised exercise (SE) is known to provide comparable short-term (6-month) improvements in functional status and quality of life. Longer-term outcomes are not known. Objectives The goal of this study was to report the longer-term (18-month) efficacy of SE compared with ST and optimal medical care (OMC). Methods Of 111 patients with aortoiliac PAD randomly assigned to receive OMC, OMC plus SE, or OMC plus ST, 79 completed the 18-month clinical and treadmill follow-up assessment. SE consisted of 6 months of SE and an additional year of telephone-based exercise counseling. Primary clinical outcomes included objective treadmill-based walking performance and subjective quality of life. Results Peak walking time improved from baseline to 18 months for both SE (5.0 ± 5.4 min) and ST (3.2 ± 4.7 min) significantly more than for OMC (0.2 ± 2.1 min; p < 0.001 and p = 0.04, respectively). The difference between SE and ST was not significant (p = 0.16). Improvement in claudication onset time was greater for SE compared with OMC, but not for ST compared with OMC. Many disease-specific quality-of-life scales demonstrated durable improvements that were greater for ST compared with SE or OMC. Conclusions Both SE and ST had better 18-month outcomes than OMC. SE and ST provided comparable durable improvement in functional status and in quality of life up to 18 months. The durability of claudication exercise interventions merits its consideration as a primary PAD claudication treatment.
Bibliographical noteFunding Information:
The CLEVER study was a randomized, multicenter clinical trial conducted at 29 centers in the United States and Canada. The study was designed to test the hypothesis that ST plus optimal medical care (OMC) and SE plus OMT would be associated with a greater improvement in peak walking time (PWT) on a graded treadmill test than with OMT alone. The CLEVER study secondarily tested whether ST plus OMT resulted in more improvement in PWT than SE plus OMC. The study was approved by the U.S. Food and Drug Administration, the Canadian Therapeutic Products Directorate, and institutional review boards at all participating centers, and was supported by the National Institutes of Health National Heart, Lung, and Blood Institute. The study has been registered as NCT00132743 since August 19, 2005, and was overseen by an independent data safety and monitoring committee. Details of the study design, methods, and early results were published previously (16,17) . The lead author wrote the first draft of the manuscript, and all coauthors participated in and approved subsequent revisions.
- ankle-brachial index
- exercise rehabilitation
- quality of life