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Prevention of serious vascular events by aspirin amongst patients with peripheral arterial disease: randomized, double-blind trial.
Critical Leg Ischaemia Prevention Study (CLIPS) Group *
[Article] Journal of Internal Medicine. 261(3):276-284, March 2007.

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Critical Leg Ischaemia Prevention Study (Clips) Group. Prevention of serious vascular events by aspirin amongst patients with peripheral arterial disease: randomized, double-blind trial.

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 x 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 [beta]-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.