Details

Autor(en) / Beteiligte

• Catalano, M
• Born, G
• Peto, R

Titel

Prevention of serious vascular events by aspirin amongst patients with peripheral arterial disease: randomized, double‐blind trial

Ist Teil von

• Journal of internal medicine, 2007-03, Vol.261 (3), p.276-284

Ort / Verlag

Oxford, UK: Blackwell Publishing Ltd

Erscheinungsjahr

2007

Quelle

MEDLINE

Beschreibungen/Notizen

• . 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.