Aspirin for Preventing the Recurrence of Venous Thromboembolism
Aspirin for Preventing the Recurrence of Venous Thromboembolism
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DOI：
10.1056/nejmoa1114238
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发表时间：
2012-05-24
影响因子：
158.5
通讯作者：
Prandoni, Paolo
中科院分区：
文献类型：
--
作者：
Becattini, Cecilia;Agnelli, Giancarlo;Prandoni, Paolo
背景：约20%的不明原因静脉血栓栓塞症患者在停用口服抗凝剂治疗后2年内复发。延长抗凝治疗可预防复发，但与出血增加相关。阿司匹林的好处是预防复发性静脉血栓栓塞症是unknow.MethodsIn这个多中心，促凝剂启动，双盲研究，首次无端静脉血栓栓塞谁已经完成了6至18个月的口服抗凝治疗的患者被随机分配到阿司匹林，100毫克，每天或安慰剂2年，延长研究治疗的选择。主要疗效指标为静脉血栓栓塞复发，主要安全性指标为大出血。结果205例接受阿司匹林治疗的患者中有28例静脉血栓栓塞复发，197例接受安慰剂治疗的患者中有43例静脉血栓栓塞复发（每年6.6% vs. 11.2%;风险比，0.58; 95%置信区间[CI]，0.36 - 0.93）（中位研究期，24.6个月）。在23.9个月的中位治疗期间，23名服用阿司匹林的患者和39名服用安慰剂的患者复发（每年5.9% vs. 11.0%;风险比，0.55; 95%CI，0.33 - 0.92）。每个治疗组各有1例患者发生大出血事件。不良事件在两个groups. Conclusions相似，阿司匹林降低复发的风险时，给予无故静脉血栓栓塞谁已停止抗凝治疗的患者，没有明显增加大出血的风险。
BackgroundAbout 20% of patients with unprovoked venous thromboembolism have a recurrence within 2 years after the withdrawal of oral anticoagulant therapy. Extending anticoagulation prevents recurrences but is associated with increased bleeding. The benefit of aspirin for the prevention of recurrent venous thromboembolism is unknown.MethodsIn this multicenter, investigator-initiated, double-blind study, patients with first-ever unprovoked venous thromboembolism who had completed 6 to 18 months of oral anticoagulant treatment were randomly assigned to aspirin, 100 mg daily, or placebo for 2 years, with the option of extending the study treatment. The primary efficacy outcome was recurrence of venous thromboembolism, and major bleeding was the primary safety outcome.ResultsVenous thromboembolism recurred in 28 of the 205 patients who received aspirin and in 43 of the 197 patients who received placebo (6.6% vs. 11.2% per year; hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.93) (median study period, 24.6 months). During a median treatment period of 23.9 months, 23 patients taking aspirin and 39 taking placebo had a recurrence (5.9% vs. 11.0% per year; hazard ratio, 0.55; 95% CI, 0.33 to 0.92). One patient in each treatment group had a major bleeding episode. Adverse events were similar in the two groups.Conclusions Aspirin reduced the risk of recurrence when given to patients with unprovoked venous thromboembolism who had discontinued anticoagulant treatment, with no apparent increase in the risk of major bleeding.