Effect of aspirin versus clopidogrel on walking exercise performance in intermittent claudication-a double-blind randomized multicenter trial

Elisabeth Singer, Stephan Imfeld, Daniel Staub, Ulrich Hoffmann, Ivo Buschmann, Karl-Heinz Labs, Kurt A Jaeger, Elisabeth Singer, Stephan Imfeld, Daniel Staub, Ulrich Hoffmann, Ivo Buschmann, Karl-Heinz Labs, Kurt A Jaeger

Abstract

Background: This study sought to determine possible effects of different antiplatelet therapies on walking exercise performance in intermittent claudication. Aspirin, in contrast to clopidogrel, interferes with processes that increase collateral conductance in an ischemic animal model.

Methods and results: Patients with stable intermittent claudication were recruited from 21 centers in Switzerland and Germany and randomized to either aspirin or clopidogrel treatment. They participated in a 3-month rehabilitation program (electronically monitored, home-based, 1-hour daily walking sessions at a speed of approximately 120 steps/min). Walking distance was assessed by treadmill tests (3.2 km/h; 12% grade) at baseline and after 12 weeks. A total of 229 of 259 patients with a mean age of 66.2±7.7 years completed the study according to the protocol. A total of 24.5% were females, 20.1% diabetics, and 85.6% were active/ex-smokers. The baseline characteristics were a median (interquartile range) ankle/brachial index of 0.69 (0.57±0.8), an initial claudication distance (ICD) of 98 m (70 to 151 m), and an absolute claudication distance (ACD) of 162 m (113 to 302 m). Training resulted in a median increase of initial claudication distance by 33.5 m (33.3%) in the clopidogrel group and 29 m (33.9%) in the aspirin group. The values for absolute claudication distance were 60.5 m (34.9%) and 75 m (35.3%), respectively (p(ICD)=0.42 and p(ACD)=0.66).

Conclusions: Treatment with aspirin did not show a difference in initial claudication distance or absolute claudication distance improvements compared with clopidogrel after a 3-month walking rehabilitation program. (J Am Heart Assoc. 2012;1:51-56.)

Clinical trial registration: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00189618, URL: https://EudraCT.ema.europa.eu, Unique identifier: 2004-005041-35.

Keywords: antiplatelet therapy; claudication; exercise training; peripheral artery disease.

Figures

Figure 1.
Figure 1.
Consolidated Standards of Reporting Trials (CONSORT) flow diagram of patients through each stage of the trial.
Figure 2.
Figure 2.
Boxplot for initial (ICD) and absolute (ACD) claudication percent change for both patient groups under aspirin and clopidogrel after 3 months training. There are no significant differences between the treatment group improvements. ICD indicates initial claudication distance; ACD, absolute claudication distance.

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