Claudication: Exercise Versus Endoluminal Revascularization | Clinical Trial - CLEVER

Description:

The goal of the trial was to compare three treatment strategies for patients with claudication due to aortoiliac disease.

Contribution to the Literature: The CLEVER trial showed that a supervised exercise program or stenting are good options for the primary treatment of claudication.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients with moderate to severe claudication (defined as ability to walk on graded treadmill 2-11 minutes) due to hemodynamically significant aortoiliac disease (with or without femoropopliteal disease)
  • Number of screened applicants: 999
  • Number of enrollees: 111
  • Duration of follow-up: 6 months, 18 months
  • Mean patient age: 62 years
  • Percentage female: 27%

Exclusions:

  • Comorbid conditions that limit walking
  • Rest pain or tissue loss
  • Aortoiliac occlusion from level of renal arteries to inguinal ligament

Primary Endpoints:

  • Peak walking time on a graded treadmill test

Secondary Endpoints:

  • Free-living step activity
  • Quality of life
  • Cardiovascular disease markers
  • Major adverse cardiac events

Drug/Procedures Used:

Patients with claudication due to hemodynamically significant aortoiliac disease were randomized to optimal medical care alone (n = 22), stent revascularization (n = 46), or supervised exercise (n = 43). A fourth arm that included a supervised exercise program plus stent revascularization was dropped to enhance enrollment.

Patients in the optimal medical care group received cilostazol 100 mg twice daily, and written/oral advice about exercise.

Patients in the stent group received optimal medical care, plus stent revascularization of the aortoiliac arteries.

Patients in the supervised exercise program received optimal medical care, plus 78 weeks of supervised exercise (hourly sessions 3 times per week).

Concomitant Medications:

At baseline, the use of aspirin was 96%, thienopyridine was 41%, and statin 82%.

Principal Findings:

Overall, 111 patients were randomized. The mean age was 62 years, 27% were women, 24% had diabetes, 32% had prior myocardial infarction, 5% had prior endovascular lower extremity revascularization, and 5% had prior open lower extremity revascularization. The mean blood pressure was 136/77 mm Hg, mean low-density lipoprotein cholesterol was 105 mg/dl, mean glycated hemoglobin was 6.3%, mean ankle-brachial index (ABI) was 0.7, and mean body mass index was 28 kg/m2. A total occlusion was present in 38% of the stent group.

At 18 months, the change in peak walking time was 0.2 minutes with optimal medical therapy, 3.2 minutes with stent revascularization, and 5.0 minutes with a supervised exercise program (p = 0.4 for stent and exercise groups combined vs. optimal medical therapy). There was no difference between stent and exercise program groups (p = 0.16).

Change in ABI over the follow-up period was 0.01, 0.29, and 0.03, respectively.

At 6 months, patient-assessed quality of life was highest in the stent group, intermediate with supervised exercise, and lowest with optimal medical therapy alone. At 18 months, some quality-of-life measures still favored stenting.

Interpretation:

Among patients with moderate to severe claudication due to aortoiliac disease, either a supervised exercise program or stent revascularization was associated with the largest increase in treadmill walking time. In communities that are able to provide supervised exercise, this can serve as an initial choice for treatment of claudication. However, if supervised exercise programs are not available, stent revascularization remains a good option to reduce claudication symptoms.

References:

Murphy TP, Cutlip DE, Regensteiner JG, et al., on behalf of the CLEVER Study Investigators. 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. Circulation 2011;Nov 16:[Epub ahead of print].

Presented by Dr. Alan Hirsch at the American Heart Association Scientific Sessions, Orlando, FL, November 16, 2011.

Murphy TP, Cutlip DE, Regensteiner JG, et al. Supervised Exercise, Stent Revascularization, or Medical Therapy for Claudication Due to Aortoiliac Peripheral Artery Disease: The CLEVER Study. J Am Coll Cardiol 2015;65:999-1009.

Editorial Comment: Sobieszczyk PS, Beckman JA. Intervention or Exercise? The Answer Is Yes! J Am Coll Cardiol 2015;65:1010-1012.

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

Keywords: Intermittent Claudication, Myocardial Infarction, Ankle Brachial Index, Exercise, Blood Pressure, Lower Extremity, Tetrazoles, Stents, Hemoglobin A, Glycosylated, Cholesterol, Walking, Body Mass Index, Quality of Life, Diabetes Mellitus


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