Twelve-month results of a randomized trial comparing mono with dual antiplatelet therapy in endovascularly treated patients with peripheral artery disease

J Endovasc Ther. 2013 Oct;20(5):699-706. doi: 10.1583/13-4275MR.1.


Purpose: To present the 12-month results of a trial investigating the effects of dual antiplatelet therapy on target lesion revascularization (TLR) after balloon angioplasty ± stenting in the femoropopliteal segment.

Methods: A prospective, randomized, single-center, double-blinded and placebo-controlled clinical trial randomly assigned 40 patients to receive pre- and postinterventional therapy with aspirin and clopidogrel. Another 40 patients received the same doses of aspirin and placebo instead of clopidogrel. Clopidogrel and placebo were stopped after 6 months, and patients remained on aspirin only. At 12 months after the intervention, 36 clopidogrel patients and 37 placebo patients were reevaluated.

Results: At 6 months, clopidogrel patients had significantly lower rates of TLR compared to placebo patients [2 (5%) vs. 8 (20%), p=0.04]. After stopping clopidogrel/placebo after 6 months, there was no significant difference in TLR at 12 months after treatment [9 (25%) clopidogrel vs. 12 (32.4%) placebo, p=0.35]. Mortality was 0 vs. 1 in the placebo group at 6 months (p=0.32) and 0 vs. 3 at 12 months (p=0.08).

Conclusion: In contrast to the first report of a reduction in the TLR at 6 months, this advantage of dual antiplatelet therapy does not persist after stopping clopidogrel. Prolonged dual therapy (>6 months) should be considered in patients who are at high risk for restenosis.

Trial registration: NCT00163267.

Publication types

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

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon* / adverse effects
  • Angioplasty, Balloon* / instrumentation
  • Aspirin / adverse effects
  • Aspirin / therapeutic use*
  • Clopidogrel
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Germany
  • Humans
  • Male
  • Middle Aged
  • Peripheral Arterial Disease / diagnosis
  • Peripheral Arterial Disease / therapy*
  • Platelet Aggregation Inhibitors / adverse effects
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Prospective Studies
  • Recurrence
  • Stents
  • Ticlopidine / adverse effects
  • Ticlopidine / analogs & derivatives*
  • Ticlopidine / therapeutic use
  • Time Factors
  • Treatment Outcome


  • Platelet Aggregation Inhibitors
  • Clopidogrel
  • Ticlopidine
  • Aspirin

Associated data