Aspirin for the Prevention of Recurrent Venous Thromboembolism The INSPIRE Collaboration
Aspirin for the Prevention of Recurrent Venous Thromboembolism The INSPIRE Collaboration
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DOI：
10.1161/circulationaha.114.008828
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发表时间：
2014-09-23
期刊：
影响因子：
37.8
通讯作者：
Brighton, Timothy A.
中科院分区：
文献类型：
--
作者：
Simes, John;Becattini, Cecilia;Brighton, Timothy A.
背景：在首次发生非诱发性静脉血栓栓塞（VTE）的患者中，在停止抗凝治疗后，VTE复发的风险仍然很高。阿司匹林预防静脉血栓复发性栓塞（华法林和阿司匹林[WARFASA]）和阿司匹林预防静脉血栓复发性栓塞（ASPIRE）试验表明阿司匹林降低了这种风险，但它们不能单独检测特定结果或亚组的治疗效果。方法和结果：在这些试验的结果已知之前，计划对这些试验进行个体患者数据分析，以评估阿司匹林与安慰剂对复发性静脉血栓栓塞、主要血管事件（复发性静脉血栓栓塞、心肌梗死、中风和心血管疾病死亡）和出血的总体和预先确定的亚组的影响。对于静脉血栓栓塞的主要分析是有意使用事件时间数据进行治疗。在1224例患者中，193例在30.4个月的中位随访期间发生静脉血栓栓塞复发。阿司匹林减少静脉血栓栓塞复发（7.5%/年vs . 5.1%/年；风险比[HR]， 0.68； 95%可信区间[CI]， 0.51-0.90； P=0.008），包括深静脉血栓形成（HR, 0.66; 95% CI, 0.47-0.92； P=0.01）和肺栓塞（HR, 0.66; 95% CI, 0.41-1.06； P=0.08）。阿司匹林减少主要血管事件（8.7%/年vs 5.7%/年；HR, 0.66; 95% CI, 0.50-0.86； P=0.002）。大出血率较低（安慰剂组为0.4%/年，阿司匹林组为0.5%/年）。调整治疗依从性后，静脉血栓栓塞复发减少42% （HR, 0.58; 95% CI, 0.40-0.85； P=0.005）。预先指定的亚组分析表明，男性和老年患者的相对风险降低相似，但绝对风险降低幅度更大。结论：在广泛的非诱发性静脉血栓栓塞患者中，抗凝治疗后服用阿司匹林可使复发的总风险降低三分之一以上，而不会显著增加出血的风险。
Background-In patients with a first unprovoked venous thromboembolism (VTE) the risk of recurrent VTE remains high after anticoagulant treatment is discontinued. The Aspirin for the Prevention of Recurrent Venous Thromboembolism (the Warfarin and Aspirin [WARFASA]) and the Aspirin to Prevent Recurrent Venous Thromboembolism (ASPIRE) trials showed that aspirin reduces this risk, but they were not individually powered to detect treatment effects for particular outcomes or subgroups.Methods and Results-An individual patient data analysis of these trials was planned, before their results were known, to assess the effect of aspirin versus placebo on recurrent VTE, major vascular events (recurrent VTE, myocardial infarction, stroke, and cardiovascular disease death) and bleeding, overall and within predefined subgroups. The primary analysis, for VTE, was by intention to treat using time-to-event data. Of 1224 patients, 193 had recurrent VTE over 30.4 months' median follow-up. Aspirin reduced recurrent VTE (7.5%/yr versus 5.1%/yr; hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.51-0.90; P=0.008), including both deep-vein thrombosis (HR, 0.66; 95% CI, 0.47-0.92; P=0.01) and pulmonary embolism (HR, 0.66; 95% CI, 0.41-1.06; P=0.08). Aspirin reduced major vascular events (8.7%/yr versus 5.7%/yr; HR, 0.66; 95% CI, 0.50-0.86; P=0.002). The major bleeding rate was low (0.4%/yr for placebo and 0.5%/yr for aspirin). After adjustment for treatment adherence, recurrent VTE was reduced by 42% (HR, 0.58; 95% CI, 0.40-0.85; P=0.005). Prespecified subgroup analyses indicate similar relative, but larger absolute, risk reductions in men and older patients.Conclusions-Aspirin after anticoagulant treatment reduces the overall risk of recurrence by more than a third in a broad cross-section of patients with a first unprovoked VTE, without significantly increasing the risk of bleeding.