期刊
JOURNAL OF ENDOVASCULAR THERAPY
卷 20, 期 5, 页码 699-706出版社
SAGE PUBLICATIONS INC
DOI: 10.1583/13-4275MR.1
关键词
randomized controlled trial; placebo-controlled trial; peripheral artery disease; atherosclerosis; stenosis; occlusion; balloon angioplasty; stent; antiplatelet therapy; clopidogrel; aspirin; target lesion revascularization; mortality; restenosis
资金
- Sanofi-Aventis S.A., Paris, France
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.
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