Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis - A randomized controlled trial
Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis - A randomized controlled trial
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DOI：
10.1001/jama.299.18.2164
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发表时间：
2008-05-14
影响因子：
120.7
通讯作者：
Feldman, Harold I.
中科院分区：
文献类型：
--
作者：
Dember, Laura M.;Beck, Gerald J.;Feldman, Harold I.
与合成移植物或中心静脉导管相比，动静脉瘘是血液透析首选的血管通路类型，因为它具有较低的血栓和感染率以及较低的医疗费用。由于血栓形成或不成熟导致的早期瘘失败是血液透析患者中增加瘘患病率的障碍。小型的、不确定的试验表明抗血小板药物可以减少新瘘管的血栓形成。目的探讨氯吡格雷是否能降低血液透析瘘管的早期失败。设计、环境和参与者：2003- 2007年在美国9个学术和社区肾脏病实践中心进行的随机、双盲、安慰剂对照试验。877名患有终末期肾脏疾病或晚期慢性肾脏疾病的参与者被随访至瘘管形成后150至180天或透析开始后30天，以较晚者为准。干预参与者被随机分配接受氯吡格雷（300 mg负荷剂量，随后每日75 mg剂量；n= 441）或安慰剂（n= 436），从瘘管形成后1天内开始，为期6周。主要观察指标主要观察指标为瘘管血栓形成，6周时通过体格检查确定。次要结果是瘘管不适合透析。适用性定义为在12个透析疗程中的8次中，在透析机血泵速率为300 mL/ min或更高的情况下使用瘘管。结果877名受试者根据干预效果的停止规则随机分组后停止入组。氯吡格雷组有53名（12.2%）患者发生了瘘管血栓形成，安慰剂组有84名（19.5%）患者发生了瘘管血栓形成(相对危险度，0.63；95%可信区间，0.46- 0.97；P=。018)。氯吡格雷组和安慰剂组未能达到透析适宜性的差异无统计学意义(分别为61.8% vs 59.5%；相对危险度为1.05；95%可信区间为0.941.17；P=。40)。结论氯吡格雷降低了新发动静脉瘘早期血栓形成的频率，但没有增加适合透析的瘘管比例。试验注册临床试验。标识符：NCT00067119。
Context The arteriovenous fistula is the preferred type of vascular access for hemodialysis because of lower thrombosis and infection rates and lower health care expenditures compared with synthetic grafts or central venous catheters. Early failure of fistulas due to thrombosis or inadequate maturation is a barrier to increasing the prevalence of fistulas among patients treated with hemodialysis. Small, inconclusive trials have suggested that antiplatelet agents may reduce thrombosis of new fistulas.Objective To determine whether clopidogrel reduces early failure of hemodialysis fistulas.Design, Setting, and Participants Randomized, double- blind, placebo-controlled trial conducted at 9 US centers composed of academic and community nephrology practices in 2003- 2007. Eight hundred seventy- seven participants with end-stage renal disease or advanced chronic kidney disease were followed up until 150 to 180 days after fistula creation or 30 days after initiation of dialysis, whichever occurred later.Intervention Participants were randomly assigned to receive clopidogrel ( 300- mg loading dose followed by daily dose of 75 mg; n= 441) or placebo ( n= 436) for 6 weeks starting within 1 day after fistula creation.Main Outcome Measures The primary outcome was fistula thrombosis, determined by physical examination at 6 weeks. The secondary outcome was failure of the fistula to become suitable for dialysis. Suitability was defined as use of the fistula at a dialysis machine blood pump rate of 300 mL/ min or more during 8 of 12 dialysis sessions.Results Enrollment was stopped after 877 participants were randomized based on a stopping rule for intervention efficacy. Fistula thrombosis occurred in 53 ( 12.2%) participants assigned to clopidogrel compared with 84 ( 19.5%) participants assigned to placebo ( relative risk, 0.63; 95% confidence interval, 0.46- 0.97; P=. 018). Failure to attain suitability for dialysis did not differ between the clopidogrel and placebo groups ( 61.8% vs 59.5%, respectively; relative risk, 1.05; 95% confidence interval, 0.941.17; P=. 40).Conclusion Clopidogrel reduces the frequency of early thrombosis of new arteriovenous fistulas but does not increase the proportion of fistulas that become suitable for dialysis.Trial Registration clinicaltrials. gov Identifier: NCT00067119.