A prospective randomized controlled clinical trial on clopidogrel combined with warfarin versus clopidogrel alone in the prevention of restenosis after endovascular treatment of the femoropopliteal artery.

BACKGROUND: We sought to compare the effects of clopidogrel combined with warfarin with clopidogrel alone in the prevention of restenosis after endovascular treatment (EVT) of the femoropopliteal artery.
METHODS: Between June 2008 and May 2009, 88 consecutive patients referred for EVT were randomly divided into a clopidogrel group (42 cases) and a clopidogrel combined with warfarin group (46 cases) before the procedure. Examinations including staging of peripheral arterial disease by Rutherford, ankle-brachial index, and color duplex ultrasonography were performed at baseline, 1 week, 3 months, 6 months, and 12 months after procedure. At the same time, bleeding complications were observed.
RESULTS: Fifty patients (63 limbs) were included after 12 months of follow-up, in which 25 patients (30 limbs) were from the clopidogrel group and 25 patients (33 limbs) were from the combination group. At 3 months, the rates of restenosis on duplex ultrasonography were 17% in the clopidogrel group and 18% in the combination group (P = 1.0). At 6 months, the accumulated restenosis rates were 37% and 36% (P = 0.98), respectively. At 12 months, the accumulated restenosis rates were 53% and 42% (P = 0.523), respectively. The rate of clinical bleeding events was 21% (6/29) in the combination group compared with 7% (2/27) in the clopidogrel group, and there was no statistical difference (P = 0.3).
CONCLUSIONS: The combination of clopidogrel with warfarin was not more effective than clopidogrel alone in restenosis prevention for patients who underwent EVT. Instead, the combination of antiplatelet and anticoagulation therapy was inclined to increase the clinical bleeding events.

RCT Entities:   Population Interventions Outcomes