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Supervised exercise, stent revascularization superior to optimal medical care for claudication at 18 months
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At 18 months, supervised exercise and stent revascularization were associated with better outcomes than optimal medical care alone in patients with claudication due to aortoiliac peripheral artery disease, according to new findings from the CLEVER study.
Researchers analyzed 79 of the 111 patients with aortoiliac PAD enrolled in the CLEVER study who completed 18-month clinical and treadmill follow-up assessments. Patients were randomly assigned to optimal medical care, which consisted of cilostazol (Pletal, Otsuka Pharmaceuticals) plus home exercise counseling; optimal medical care plus 6 months of supervised exercise followed by 1 year of telephone-based exercise counseling; or optimal medical care plus stent revascularization.
Two favorable therapies
Outcomes of interest included treadmill-based walking performance and quality-of-life metrics.
From baseline to 18 months, compared with optimal medical care alone, improvement in peak walking time was greater among patients assigned optimal medical care plus supervised exercise (5 minutes vs. 0.2 minutes; P < .001) and optimal medical care plus stent revascularization (3.2 minutes vs. 0.2 minutes; P = .04). The researchers found no significant difference between the supervised exercise and stent revascularization groups in improvement in peak walking time (P = .16).
Improvement in claudication onset time was greater in the supervised exercise group vs. the optimal medical care group (P = .03), but there were no significant differences between the stent revascularization group and the optimal medical care group (P = .12) or between the supervised exercise group and the stent revascularization group (P = .77), the researchers found.
Of seven quality-of-life endpoints assessed, the stent revascularization group had better scores than the optimal medical care group in six, while the supervised exercise group had better scores than the optimal medical care group in four.
“These data provide strong support in favor of comparable access to both [supervised exercise and stent revascularization] to improve the primary ischemic symptom of PAD, claudication,” Timothy P. Murphy, MD, from the department of diagnostic imaging at the vascular disease research center at Rhode Island Hospital, Providence, R.I., and colleagues wrote.
Options limited by reimbursement
Endovascular therapy has become the default treatment option for claudication caused by aortoiliac occlusive disease in the United States, mainly because there is no reimbursement for supervised exercise therapy, but also because it is short in duration and makes patients feel better quickly, Piotr S. Sobieszczyk, MD, and Joshua A. Beckman, MD, both from the cardiovascular division at Brigham and Women’s Hospital, wrote in a related editorial.
“In contrast to pitting one treatment against another, it might be better to treat claudication like hypertension, where practitioners use as many treatments as needed to bring the patient to goal,” they wrote. “The demonstration that the results are durable in patients with claudication in the CLEVER study should spur a change in coverage by federal and private insurers to make supervised exercise therapy and follow-up care available to all patients who need them.” – by Erik Swain
Disclosure: The study was supported by the NHLBI, Boston Scientific, Cordis/Johnson & Johnson and ev3. Study medication was donated by Otsuka America, pedometers were donated by Omron Healthcare and print materials on diet and exercise were donated by Krames Staywell. Murphy reports receiving research grant support from Abbott Vascular, Cordis/Johnson & Johnson and Otsuka Pharmaceuticals. Beckman reports receiving a research grant from Bristol-Myers Squibb and consulting for AstraZeneca, Bristol-Myers Squibb, Merck and Novartis. Sobieszczyk reports no relevant financial disclosures.
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