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(Circulation. 1995;92:614-621.)
© 1995 American Heart Association, Inc.
Articles |
Clinical Trials for Claudication
Assessment of Exercise Performance, Functional Status, and Clinical End Points
From the Department of Medicine, Section of Vascular Medicine, University of Colorado Health Sciences Center, Denver; the Vascular Medicine Program, University of Minnesota Medical School, Minneapolis; and the Department of Medicine, Harbor-UCLA Medical Center, Los Angeles, Calif.
Correspondence to William R. Hiatt, MD, Section of Vascular Medicine, University of Colorado Health Sciences Center, 4200 E Ninth Ave, Box B-180, Denver, CO 80262.
Key Words: peripheral vascular disease • tests • clinical trials • exercise
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Introduction |
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Peripheral arterial disease (PAD) affects a large proportion of the general population, with an age-adjusted prevalence of approximately 12% and a prevalence of intermittent claudication of 3% to 7%.1 2 In symptomatic persons, the limited lower extremity arterial supply cannot meet the dynamic metabolic demand of the muscles during ambulatory activities, resulting in the symptom of claudication. Claudication is associated with a severe limitation in walking ability,3 which may adversely affect social, leisure, and occupational activities in many patients.4
The treatment of all patients with PAD is initially directed at cardiovascular risk factor modification, since these individuals have a high future risk of cardiovascular mortality.5 Severely affected patients who have ischemic rest pain or tissue loss are candidates for interventional therapy (bypass surgery or angioplasty) to maintain limb viability.6 7 However, since the majority of patients with claudication are not at short-term risk of limb loss, the primary therapeutic goal is to improve exercise performance and community-based functional status.
The past decade has witnessed a marked increase in the evaluation and
utilization of therapies to treat patients with
claudication.8 Percutaneous transluminal angioplasty is
considered an appropriate intervention for patients with "earlier
stages of symptomatic disability" due to
claudication,9 and the American Heart Association has
recently recommended that invasive interventions are appropriate for
patients with incapacitating claudication.6 In addition,
there is increased interest in medical therapies for claudication.
Exercise training elicits well-established and clinically important
changes in treadmill exercise performance and community-based
walking ability.3 10 11 Recent
pharmacological advances
have led to a greater use
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