Orlando – In elderly patients with aortoiliac peripheral artery disease, adding supervised exercise to optimal medical therapy offers better treadmill walking performance than does aortoiliac stenting. On the other hand, aortoiliac stenting plus optimal medical care results in better quality of life than does supervised exercise, according to the 6-month results of the CLEVER (Claudication vs. Endoluminal Revascularization) trial. “This idea that you can go home and walk isn't, and hasn't been, effective,” coauthor Dr. Alan Hirsch said at the annual scientific sessions of the American Heart Association. CLEVER is the first prospective, head-to-head, comparative trial of three guideline-recommended interventions: supervised exercise, stenting, and optimal medical therapy. CLEVER randomized 111 patients to either optimal medical care, (OMC) including cilostazol (Pletal) 100 mg twice daily, plus advice about home exercise and diet with monthly coordinator contact; OMC plus supervised exercise for 1 hour thrice weekly for 26 weeks; or OMC plus aortoiliac stenting. All patients had moderate to severe claudication. The patients averaged 64 years of age. Their baseline ankle-brachial index was 0.68, peak walking time was about 5 minutes, and claudication-onset time was 1.5 minutes. The primary endpoint of change in peak walking time from baseline to 6 months was just 1.2 minutes in the OMC group, compared with 5.8 minutes in the supervised exercise group and a clinically significant 3.7 minutes in the stenting group, said Dr. Hirsch, director of the vascular medicine program at the University of Minnesota in Minneapolis. The changes were significantly different between supervised exercise and OMC (4.6 minutes), stenting and OMC (2.5 minutes), and supervised exercise and stenting (2.1 minutes). Self-reported quality-of-life scores on the Walking Impairment Questionnaire and Peripheral Artery Questionnaire improved significantly with supervised exercise plus stenting, compared with OMC for most domains including walking distance, walking speed, stair climbing, physical limitation, social limitation, and summary score. The improvements were significantly greater with stenting than with supervised exercise for three of the four domains that were evaluated on each questionnaire. Dr. Hirsch said the quality-of-life finding raises questions that CLEVER was not designed to answer, and he hoped the trial would inspire future research. Invited discussant Dr. Michael Conte, codirector of the Heart and Vascular Center at the University of California San Francisco, said, “We actually have a lot of evidence that supervised exercise works, but we don't have reimbursement. “So until we get reimbursement, we will not be able to offer this to our patients, and the Medicare beneficiaries are the largest group with PAD.” Dr. Conte added that reimbursement for stenting is significant and not linked to outcomes, and providers and industry are therefore incentivized to provide invasive treatments. The study, led by Dr. Timothy Murphy, medical director of the vascular research center at Brown University in Providence, R.I., was simultaneously published online in Circulation. Dr. Hirsch reported support for this trial and other research from Cordis/Johnson & Johnson, eV3, Boston Scientific, Otsuka America, Abbott Vascular, Cytokinetics, and Viromed, AstraZeneca, Merck, Novartis, and Pozen. Dr. Conte reported that he had no conflict of interest.
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