Management of peripheral arterial interventions with mono or dual antiplatelet therapy--the MIRROR study: a randomised and double-blinded clinical trial.

ABSTRACT

OBJECTIVES: To investigate the influence of dual antiplatelet therapy vs. aspirin alone on local platelet activation and clinical endpoints in patients with PAD treated with endovascular therapy. METHODS: Patients received either 500 mg aspirin and 300 mg clopidogrel before intervention followed by a daily dose of 100 mg aspirin and 75 mg clopidogrel for 6 months, or the same doses of aspirin plus placebo instead of clopidogrel. Primary endpoints were local concentrations of platelet activation markers ß-thromboglobulin and CD40L, and the rate of patient's resistant to clopidogrel. Secondary endpoints included the clinical development 6 months after the intervention. RESULTS: Eighty patients, 40 in each group, were enrolled. The median peri-interventional concentration of ß-TG was 224.5 vs. 365.5 (P = 0.03) in the clopidogrel and placebo group. The concentration of CD40L was 127 and 206.5 (P = 0.05). Thirty per cent of patients who had received clopidogrel were resistant. Two clopidogrel and eight placebo patients required TLR (P = 0.04). The clopidogrel patients who needed revascularisation were both resistant to clopidogrel. Minor bleeding complications occurred in one clopidogrel and two placebo patients. CONCLUSION: Dual antiplatetet therapy reduces peri-interventional platelet activation and improves functional outcome without higher bleeding complications. An individual tailored dual antiplatelet therapy seems desirable for endovascularly treated patients with PAD.