单用硫酸氯吡格雷及联合华法林预防股腘动脉经皮腔内血管成形术后再狭窄的随机对照研究

A prospective randomized control clinical trial about clopidogrel combined with warfarin versus clopidogrel alone in the prevention of restenosis after femoral-popliteal artery angioplasty

目的对比单用抗血小板药物硫酸氯吡格雷（氯吡格雷）与抗凝药物华法林联合氯吡格雷两种抗栓治疗策略对预防股恫动脉经皮腔内血管成形术（PTA）术后再狭窄的疗效。方法将2008年1月至2009年5月就诊的50例股咽动脉病变患者在术前随机分为单药组（单药组25例30条肢体）与联合组（联合组25例33条肢体），接受下肢动脉PTA治疗后，分别采取不同的术后药物治疗。术后第3、6、12个月随访患肢靶血管再狭窄程度和临床结局。结果随访3个月单药组再狭窄率16．7％，联合组再狭窄率18．2％，两组间差异无统计学意义（x2=0．025，P=0．874）；6个月单药组累积再狭窄率36．7％，联合组累积再狭窄率36．4％，两组间差异无统计学意义（x2=0．001，P=0．98）；12个月单药组累积再狭窄率53．3％，联合组累积再狭窄率42．4％，两组间差异无统计学意义（x2=0．75，P=0．387）。对重症肢体缺血亚组进行分析，随访12个月，单药组累积再狭窄率为8／10，联合组累积再狭窄率为6／12，两组间差异无统计学意义（x2=1．023，P=0．312）。结论股胭动脉PTA或PTA＋支架植入术后单用氯吡格雷与氯吡格雷联合华法林有相似的早中期血管累积再狭窄率。

Objective Using two antithrombotic treatment （clopidogrel vs. clopidogrel combined warfarin ） strategies after femoral-popliteal artery angioplasty prospectively, to evaluate which strategy is more effective for the restenosis prevention. Methods Totally 50 patients referred for endovascular treatment （including the percutaneous transluminal angioplasty （PTA） and stent implantation ） of the superficial femoral artei7 and popliteal artery from January 2008 to May 2009 were randomly divided into elopidogrel group （group A, 25 cases, 30 limbs） and clopidogrel plus warfarin group （group B, 25 cases, 33 limbs） before operation. Clinical outcomes and restenosis rate of the target lesions were evaluated at 3, 6 and 12 months after operation. Results Totally 88 patients were screened for participation in the study, 56 patients were included after the follow-up of 12 months. At 3 months, the rates of restenosis were 16. 7% in group A and 18.2% in group B （ X2 = 0. 025, P = 0. 874）. At 6 months, the accumulated restenosis rates were 36. 7% in group A and 36. 4% in group B （X2 =0. 001, P =0. 98）. At 12 months, the accumulated restenosis rates were 53.3% in group A and 42.4% in group B （ X2 = 0. 75, P = 0. 387）. Analysis for the critical limb ischemia sub-group showed that follow-up of 12 months, the accumulated restenosis rate was 8/10 in group A and 6/12 in group B （ X2 ~ 1. 023, P = 0. 312） . Conclusion The elopidogrel alone treatment for PTA or PTA plus stent implantation of femoral popliteal artery has no statistically significant difference in comparison with the elopidogrel combined warfarin treatment in terms of the cumulative vascular restenosis rate at 3, 6, 12 months postoperatively.