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

Eur Radiol. 2012 Sep;22(9):1998-2006. doi: 10.1007/s00330-012-2441-2. Epub 2012 May 10.

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 β-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 β-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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angioplasty / adverse effects*
  • Aspirin / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Peripheral Arterial Disease / complications
  • Peripheral Arterial Disease / surgery*
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Thrombosis / drug therapy*
  • Thrombosis / etiology*
  • Treatment Outcome

Substances

  • Platelet Aggregation Inhibitors
  • Aspirin