Effect of Dipyridamole plus Aspirin on Hemodialysis Graft Patency
Effect of Dipyridamole plus Aspirin on Hemodialysis Graft Patency
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DOI：
10.1056/nejmoa0805840
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发表时间：
2009-05-21
影响因子：
158.5
通讯作者：
Feldman, Harold I.
中科院分区：
文献类型：
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作者：
Dixon, Bradley S.;Beck, Gerald J.;Feldman, Harold I.
研究背景移植物动静脉狭窄导致血栓形成是血液透析患者并发症的主要原因。手术干预可以恢复通畅性，但费用昂贵。虽然没有被证实的药理学治疗，双嘧达莫可能是有前途的，因为它已知的血管抗增殖活性。METHODS我们进行了一项随机，双盲，安慰剂对照试验的缓释双嘧达莫，剂量为200毫克，阿司匹林，剂量为25毫克，每天两次后，放置一个新的动静脉移植，直到主要结果，初级无辅助开放性的丧失（即，没有血栓形成或需要干预）。次要结局是累积移植物失败和死亡。主要和次要的结果进行了分析与使用的考克斯比例风险回归调整预先指定的协variators. ESTA在美国的13个中心，649例患者被随机分配到接受双嘧达莫加阿司匹林（321例）或安慰剂（328例）超过4.5年的一段时间，6个月的后续行动。安慰剂组1年时一期无辅助通畅率为23%（95%置信区间[CI]，18 - 28），双嘧达莫-阿司匹林组为28%（95% CI，23 - 34），绝对差异为5个百分点。双嘧达莫联合阿司匹林治疗显著延长了一期无辅助通畅的持续时间（风险比，0.82; 95%CI，0.68 - 0.98; P = 0.03），并抑制了狭窄。累积移植失败，死亡，复合移植失败或死亡，严重不良事件（包括出血）的发生率没有显着差异研究groups.CONCLUSIONSTreatment与潘生丁加阿司匹林有显着的，但适度的效果，在降低狭窄的风险，并提高新创建的移植物的主要独立通畅的持续时间。（ClinicalTrials.gov编号，NCT 00067119。）
BACKGROUNDArteriovenous graft stenosis leading to thrombosis is a major cause of complications in patients undergoing hemodialysis. Procedural interventions may restore patency but are costly. Although there is no proven pharmacologic therapy, dipyridamole may be promising because of its known vascular antiproliferative activity.METHODSWe conducted a randomized, double-blind, placebo-controlled trial of extended-release dipyridamole, at a dose of 200 mg, and aspirin, at a dose of 25 mg, given twice daily after the placement of a new arteriovenous graft until the primary outcome, loss of primary unassisted patency (i.e., patency without thrombosis or requirement for intervention), was reached. Secondary outcomes were cumulative graft failure and death. Primary and secondary outcomes were analyzed with the use of a Cox proportional-hazards regression with adjustment for prespecified covariates.RESULTSAt 13 centers in the United States, 649 patients were randomly assigned to receive dipyridamole plus aspirin (321 patients) or placebo (328 patients) over a period of 4.5 years, with 6 additional months of follow-up. The incidence of primary unassisted patency at 1 year was 23% (95% confidence interval [CI], 18 to 28) in the placebo group and 28% (95% CI, 23 to 34) in the dipyridamole-aspirin group, an absolute difference of 5 percentage points. Treatment with dipyridamole plus aspirin significantly prolonged the duration of primary unassisted patency (hazard ratio, 0.82; 95% CI, 0.68 to 0.98; P = 0.03) and inhibited stenosis. The incidences of cumulative graft failure, death, the composite of graft failure or death, and serious adverse events (including bleeding) did not differ significantly between study groups.CONCLUSIONSTreatment with dipyridamole plus aspirin had a significant but modest effect in reducing the risk of stenosis and improving the duration of primary unassisted patency of newly created grafts. (ClinicalTrials.gov number, NCT00067119.)