Low-Dose Aspirin for Preventing Recurrent Venous Thromboembolism
Low-Dose Aspirin for Preventing Recurrent Venous Thromboembolism
复制标题
DOI：
10.1056/nejmoa1210384
复制
发表时间：
2012-11-22
影响因子：
158.5
通讯作者：
Simes, John
中科院分区：
文献类型：
--
作者：
Brighton, Timothy A.;Eikelboom, John W.;Simes, John
背景：首次发生无端静脉血栓栓塞的患者在停用抗凝剂后复发的风险很高。阿司匹林可能是有效的，在防止复发的静脉血栓栓塞症。METHODS我们随机分配822例患者谁完成了初始抗凝治疗后，第一次发作的无端静脉血栓栓塞症接受阿司匹林，剂量为100毫克，每天，或安慰剂长达4年。主要结果是静脉血栓栓塞的复发。在37.2个月的中位随访期内，411例安慰剂组患者中有73例静脉血栓栓塞复发，411例阿司匹林组患者中有57例静脉血栓栓塞复发。（发生率为每年6.5% vs.每年4.8%;阿司匹林的风险比为0.74; 95%置信区间[CI]为0.52 - 1.05; P = 0.09）。阿司匹林降低了两个预先设定的次要复合结局的发生率：静脉血栓栓塞、心肌梗死、中风或心血管死亡的发生率降低了34%（安慰剂组每年发生率为8.0%，阿司匹林组每年发生率为5.2%;阿司匹林组风险比为0.66; 95% CI为0.48 - 0.92;静脉血栓栓塞、心肌梗死、卒中、大出血或任何原因的死亡率降低了33%（风险比，0.67; 95%CI，0.49 - 0.91; P = 0.01）。在大出血或临床相关的非大出血事件发生率方面，组间无显著差异（安慰剂组每年发生率为0.6%，阿司匹林组每年发生率为1.1%，P = 0.22）或严重不良事件。没有显著降低静脉血栓栓塞的复发率，但显著降低了主要血管事件的发生率，改善了净临床获益。这些结果证实了早期的证据表明，阿司匹林的治疗效益时，它是给病人最初的抗凝治疗后，第一次发作的无端静脉血栓栓塞。（由国家卫生和医学研究理事会[澳大利亚]和其他机构资助;澳大利亚新西兰临床试验注册编号ACTRN 12605000004662。）
BACKGROUNDPatients who have had a first episode of unprovoked venous thromboembolism have a high risk of recurrence after anticoagulants are discontinued. Aspirin may be effective in preventing a recurrence of venous thromboembolism.METHODSWe randomly assigned 822 patients who had completed initial anticoagulant therapy after a first episode of unprovoked venous thromboembolism to receive aspirin, at a dose of 100 mg daily, or placebo for up to 4 years. The primary outcome was a recurrence of venous thromboembolism.RESULTSDuring a median follow-up period of 37.2 months, venous thromboembolism re-curred in 73 of 411 patients assigned to placebo and in 57 of 411 assigned to aspirin (a rate of 6.5% per year vs. 4.8% per year; hazard ratio with aspirin, 0.74; 95% confidence interval [CI], 0.52 to 1.05; P = 0.09). Aspirin reduced the rate of the two prespecified secondary composite outcomes: the rate of venous thromboembolism, myocardial infarction, stroke, or cardiovascular death was reduced by 34% (a rate of 8.0% per year with placebo vs. 5.2% per year with aspirin; hazard ratio with aspirin, 0.66; 95% CI, 0.48 to 0.92; P = 0.01), and the rate of venous thromboembolism, myocardial infarction, stroke, major bleeding, or death from any cause was reduced by 33% (hazard ratio, 0.67; 95% CI, 0.49 to 0.91; P = 0.01). There was no significant between-group difference in the rates of major or clinically relevant nonmajor bleeding episodes (rate of 0.6% per year with placebo vs. 1.1% per year with aspirin, P = 0.22) or serious adverse events.CONCLUSIONSIn this study, aspirin, as compared with placebo, did not significantly reduce the rate of recurrence of venous thromboembolism but resulted in a significant reduction in the rate of major vascular events, with improved net clinical benefit. These results substantiate earlier evidence of a therapeutic benefit of aspirin when it is given to patients after initial anticoagulant therapy for a first episode of unprovoked venous thromboembolism. (Funded by National Health and Medical Research Council [Australia] and others; Australian New Zealand Clinical Trials Registry number, ACTRN12605000004662.)