Comparison of the short-term risk of bleeding and arterial thromboembolic events in nonvalvular atrial fibrillation patients newly treated with dabigatran or rivaroxaban versus vitamin K antagonists: a French nationwide propensity-matched cohort study.
Comparison of the short-term risk of bleeding and arterial thromboembolic events in nonvalvular atrial fibrillation patients newly treated with dabigatran or rivaroxaban versus vitamin K antagonists: a French nationwide propensity-matched cohort study.
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DOI：
10.1161/circulationaha.115.015710
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发表时间：
2015-09-29
期刊：
影响因子：
37.8
通讯作者：
Zureik M
中科院分区：
文献类型：
--
作者：
Maura G;Blotière PO;Bouillon K;Billionnet C;Ricordeau P;Alla F;Zureik M
补充数字内容可在文本中找到。在抗凝治疗的早期阶段，比较了非维生素K拮抗剂（VKA）口服抗凝剂达比加群或利伐沙班与VKA在未接受过抗凝剂治疗的非瓣膜性房颤患者中的安全性和有效性。通过使用法国医学管理数据库（SNIIRAM和PMSI），这项全国性队列研究纳入了2012年7月至11月期间开始达比加群或利伐沙班治疗或2011年7月至11月期间开始VKA治疗的非瓣膜性房颤患者。排除了存在口服抗凝剂禁忌症的患者。达比加群和利伐沙班新使用者与VKA新使用者的倾向评分匹配比例为1：2。患者随访长达90天，直至结局、死亡、失访或入选年份的12月31日。使用考克斯回归模型，在意向治疗分析中估计出血和动脉血栓栓塞事件住院的风险比。人群包括19 713例VKA、8443例达比加群和4651例利伐沙班新使用者。所有达比加群和利伐沙班治疗患者分别与16 014和9301例VKA治疗患者匹配。在达比加群、利伐沙班及其VKA匹配治疗患者中，随访期间分别观察到55和122、31和68起出血事件以及33和58、12和28起动脉血栓栓塞事件。匹配后，未观察到达比加群与VKA新使用者之间出血（风险比，0.88; 95%置信区间，0.64-1.21）或血栓栓塞（风险比，1.10; 95%置信区间，0.72-1.69）风险的统计学显著差异。利伐沙班和VKA新使用者之间的出血（风险比，0.98; 95%置信区间，0.64-1.51）和缺血（风险比，0.93; 95%置信区间，0.47-1.85）风险相当。在这项倾向匹配的队列研究中，我们的研究结果表明，医生在非瓣膜性房颤患者中开始使用非VKA口服抗凝剂或VKA时应谨慎。
Supplemental Digital Content is available in the text. The safety and effectiveness of non–vitamin K antagonist (VKA) oral anticoagulants, dabigatran or rivaroxaban, were compared with VKA in anticoagulant-naive patients with nonvalvular atrial fibrillation during the early phase of anticoagulant therapy. With the use of the French medico-administrative databases (SNIIRAM and PMSI), this nationwide cohort study included patients with nonvalvular atrial fibrillation who initiated dabigatran or rivaroxaban between July and November 2012 or VKA between July and November 2011. Patients presenting a contraindication to oral anticoagulants were excluded. Dabigatran and rivaroxaban new users were matched to VKA new users by the use of 1:2 matching on the propensity score. Patients were followed for up to 90 days until outcome, death, loss to follow-up, or December 31 of the inclusion year. Hazard ratios of hospitalizations for bleeding and arterial thromboembolic events were estimated in an intent-to-treat analysis using Cox regression models. The population was composed of 19 713 VKA, 8443 dabigatran, and 4651 rivaroxaban new users. All dabigatran- and rivaroxaban-treated patients were matched to 16 014 and 9301 VKA-treated patients, respectively. Among dabigatran-, rivaroxaban-, and their VKA-matched–treated patients, 55 and 122 and 31 and 68 bleeding events and 33 and 58 and 12 and 28 arterial thromboembolic events were observed during follow-up, respectively. After matching, no statistically significant difference in bleeding (hazard ratio, 0.88; 95% confidence interval, 0.64–1.21) or thromboembolic (hazard ratio, 1.10; 95% confidence interval, 0.72–1.69) risk was observed between dabigatran and VKA new users. Bleeding (hazard ratio, 0.98; 95% confidence interval, 0.64–1.51) and ischemic (hazard ratio, 0.93; 95% confidence interval, 0.47–1.85) risks were comparable between rivaroxaban and VKA new users. In this propensity-matched cohort study, our findings suggest that physicians should exercise caution when initiating either non-VKA oral anticoagulants or VKA in patients with nonvalvular atrial fibrillation.