Randomized controlled trial of clopidogrel plus aspirin to prevent hemodialysis access graft thrombosis
Randomized controlled trial of clopidogrel plus aspirin to prevent hemodialysis access graft thrombosis
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DOI：
10.1097/01.asn.0000081661.10246.33
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发表时间：
2003-09-01
影响因子：
13.6
通讯作者：
Peduzzi, PN
中科院分区：
文献类型：
--
作者：
Kaufman, JS;O'Connor, TZ;Peduzzi, PN
血液透析血管通路移植物血栓形成是一个主要的医疗和经济负担。实验和临床模型提示抗血小板药物在预防血栓形成中的作用。本研究旨在确定阿司匹林与氯吡格雷联用预防移植物血栓形成的疗效。该研究是一项随机双盲试验，在退伍军人事务医疗中心的30个血液透析单位进行。接受血液透析并在手臂上移植聚四氟乙烯的参与者被随机分配接受双安慰剂或阿司匹林（325毫克）和氯吡狗格雷（75毫克）。在接受研究药物治疗的同时，对参与者进行至少2年的监测。根据数据安全和监测委员会的建议，在对200名参与者进行随机分组后，由于接受阿司匹林和氯吡格雷治疗的参与者出血风险显著增加，研究停止。与接受安慰剂的受试者相比，这些受试者出血事件的累积发生率显著更高[风险比，1.98；95%置信区间（CI）， 1。19 ~ 3.28；P = 0.007]。安慰剂组23名受试者和积极治疗组44名受试者出现出血事件（P = 0.006）。积极治疗在预防血栓形成方面没有显著的益处（风险比，0.81;95% CI， 0.47至1.40;P = 0.45），尽管在没有经历过移植物血栓形成的参与者中有获益的趋势（风险比，0.52;95% CI， 0.22至1.26;P = 0.14）。在血液透析人群中，阿司匹林和氯吡格雷治疗与出血风险显著增加相关，并且可能不会降低移植物血栓形成的频率。
Thrombosis of hemodialysis vascular access grafts represents a major medical and economic burden. Experimental and clinical models suggest a role for antiplatelet agents in the prevention of thrombosis. The study was designed to determine the efficacy of the combination of aspirin and clopidogrel in the prevention of graft thrombosis. The study was a randomized, double-blind trial conducted at 30 hemodialysis units at Veterans Affairs medical centers. Participants undergoing hemodialysis with a polytetrafluoroethylene graft in the arm were randomized to receive either double placebos or aspirin (325 mg) and clopi-dogrel (75 mg) daily. Participants were to be monitored while receiving study medications for a minimum of 2 yr. The study was stopped after randomization of 200 participants, as recommended by the Data Safety and Monitoring Board because of a significantly increased risk of bleeding among the participants receiving aspirin and clopidogrel therapy. The cumulative incidence of bleeding events was significantly greater for those participants, compared with participants receiving placebos [hazard ratio, 1.98; 95% confidence interval (CI), 1. 19 to 3.28; P = 0.007]. Twenty-three participants in the placebo group and 44 participants in the active treatment group experienced a bleeding event (P = 0.006). There was no significant benefit of active treatment in the prevention of thrombosis (hazard ratio, 0.81; 95% CI, 0.47 to 1.40; P = 0.45), although there was a trend toward a benefit among participants who had not experienced previous graft thrombosis (hazard ratio, 0.52; 95% CI, 0.22 to 1.26; P = 0.14). In the hemodialysis population, therapy with aspirin and clopidogrel was associated with a significantly increased risk of bleeding and probably would not result in a reduced frequency of graft thrombosis.