title: The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: rationale and methods.
abstract: Intermittent claudication is the primary symptom of peripheral arterial disease, affecting between 1 and 3 million Americans. Symptomatic improvement can be achieved by endovascular revascularization, but such procedures are invasive, expensive, and may be associated with procedural adverse events. Medical treatment options, including claudication medications and supervised exercise training, are also known to be effective, albeit also with associated limitations. The CLEVER (Claudication: Exercise Vs. Endoluminal Revascularization) study, funded by the Heart, Lung, and Blood Institute of the National Institutes of Health, is a prospective, multicenter, randomized, controlled clinical trial evaluating the relative efficacy, safety, and health economic impact of four treatment strategies for people with aortoiliac peripheral arterial disease and claudication. The treatment arms are: (1) optimal medical care (claudication pharmacotherapy); (2) primary stent placement; (3) supervised exercise rehabilitation; and (4) combined stenting with supervised exercise rehabilitation. The CLEVER study is a 5-year randomized, controlled clinical trial to be conducted at approximately 25 centers in the United States that will monitor 252 patients and their responses to treatment during an 18-month follow-up period. The primary end point is change in maximum walking duration on a graded treadmill test. Secondary end points include the change at 18 months in maximum walking duration from baseline, comparisons of free-living daily activity levels assessed by pedometer, health-related quality of life, and cost-effectiveness. Other analyses include the effect of these treatment strategies on anthropomorphic and physiologic variables, including body mass index, waist circumference, blood pressure, pulse pressure, and resting pulse as well as biochemical markers of cardiovascular health, including fasting lipids, fibrinogen, C-reactive protein, and hemoglobin A 1c values.
authors.affiliation: Rhode Island Hospital Vascular Disease Research Center and Brown Medical School Department of Diagnostic Imaging, Providence, RI 02903, USA. tmurphy@lifespan.org
authors.forename: Timothy P
authors.initials: TP
authors.lastname: Murphy
authors.forename: Alan T
authors.initials: AT
authors.lastname: Hirsch
authors.forename: John J
authors.initials: JJ
authors.lastname: Ricotta
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.forename: Emile
authors.initials: E
authors.lastname: Mohler
authors.forename: Judith G
authors.initials: JG
authors.lastname: Regensteiner
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Comerota
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
mesh_terms: D000203:Activities of Daily Living; D015415:Biomarkers / Q000097:blood; D002317:Cardiovascular Agents / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D005081:Exercise Therapy / Q000191:economics; D006801:Humans; D007383:Intermittent Claudication / Q000191:economics / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D018579:Patient Selection; D016491:Peripheral Vascular Diseases / Q000150:complications / Q000191:economics / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D015607:Stents / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014656:Vascular Surgical Procedures / Q000191:economics / Q000295:instrumentation*; D016138:Walking
chemical_list: D015415:Biomarkers; D002317:Cardiovascular Agents