Prevention of serious vascular events by aspirin amongst patients with peripheral arterial disease: randomized, double‐blind trial
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Abstract.Objective. To assess the prophylactic efficacy of aspirin and a high‐dose antioxidant vitamin combination in patients with peripheral arterial disease (PAD) in terms of reduction of the risk of a first vascular event (myocardial infarction, stroke, vascular death) and critical limb ischaemia.Design. Randomized, placebo‐controlled, double‐blind clinical trial with 2 × 2 factorial design.Setting. Thirty‐seven European angiology/vascular medicine units.Subjects. A total of 366 outpatients with stage I‐II PAD documented by angiography or ultrasound, with ankle/brachial index <0.85 or toe index <0.6; 210 patients completed the follow‐up.Interventions. Four treatment groups: (i) oral aspirin (100 mg daily), (ii) oral antioxidant vitamins (600 mg vitamin E, 250 mg vitamin C and 20 mg β‐carotene daily), (iii) both or (iv) neither, given for 2 years.Main outcome measure. Major vascular events (cardiovascular death, myocardial infarction or stroke) and critical leg ischaemia.Results. Seven of 185 patients allocated aspirin and 20 of 181 allocated placebo suffered a major vascular event (risk reduction 64%, P = 0.022); five and eight patients, respectively, suffered critical leg ischaemia (total 12 vs. 28, P = 0.014). There was no evidence that antioxidant vitamins were beneficial (16/185 vs. 11/181 vascular events). Neither treatment was associated with any significant increase in adverse events. Inclusion of this trial in a meta‐analysis of other randomized trials of anti‐platelet therapy in PAD makes the overall results highly significant (P < 0.001) and suggests that low‐dose aspirin reduces the incidence of vascular events by 26%.Conclusions. For the first time direct evidence shows that low‐dose aspirin should routinely be considered for PAD patients, including those with concomitant type 2 diabetes.
