Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study.
Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study.
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DOI：
10.1136/bmj.j4323
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发表时间：
2017-10-17
期刊：
影响因子：
--
通讯作者：
Canadian Network for Observational Drug Effect Studies (CNODES) Investigators
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文献类型：
--
作者：
Jun M;Lix LM;Durand M;Dahl M;Paterson JM;Dormuth CR;Ernst P;Yao S;Renoux C;Tamim H;Wu C;Mahmud SM;Hemmelgarn BR;Canadian Network for Observational Drug Effect Studies (CNODES) Investigators
目的比较直接口服抗凝剂（DOAC）与华法林治疗静脉血栓栓塞症的安全性。 设计回顾性匹配队列研究，在2009年1月1日至2016年3月31日期间进行。 基于社区设置，使用加拿大和美国六个司法管辖区的医疗保健数据。 参与者59525名成年人（12489名DOAC使用者; 47036名华法林使用者），新诊断为静脉血栓栓塞，并在诊断后30天内开具DOAC或华法林处方。 主要结局指标包括治疗开始后90天内因大出血住院或急诊就诊和全因死亡率。使用倾向评分匹配和共享虚弱模型来估计DOAC与华法林相比结局的校正风险比。在每个研究中心独立进行分析，使用荟萃分析方法估计各研究中心的合并风险比。 结果在59525名参与者中，1967名（3.3%）发生了大出血，1029名（1.7%）在平均85.2天的随访中死亡。DOAC与华法林使用相比，大出血的风险相似（合并风险比0.92，95%置信区间0.82 - 1.03），总体趋势有利于DOAC的使用。与华法林相比，DOAC的死亡风险无差异（合并风险比为0.99，0.84 - 1.16）。没有证据表明各中心、慢性肾脏疾病患者和非慢性肾脏疾病患者之间、各年龄组或男性和女性患者之间存在异质性。 结论：在对发生静脉血栓栓塞的成人患者的分析中，与华法林相比，DOAC治疗与治疗前90天内大出血或全因死亡风险增加无关。 临床试验NCT 02833987。
Objective To determine the safety of direct oral anticoagulant (DOAC) use compared with warfarin use for the treatment of venous thromboembolism. Design Retrospective matched cohort study conducted between 1 January 2009 and 31 March 2016. Setting Community based, using healthcare data from six jurisdictions in Canada and the United States. Participants 59 525 adults (12 489 DOAC users; 47 036 warfarin users) with a new diagnosis of venous thromboembolism and a prescription for a DOAC or warfarin within 30 days of diagnosis. Main outcome measures Outcomes included hospital admission or emergency department visit for major bleeding and all cause mortality within 90 days after starting treatment. Propensity score matching and shared frailty models were used to estimate adjusted hazard ratios of the outcomes comparing DOACs with warfarin. Analyses were conducted independently at each site, with meta-analytical methods used to estimate pooled hazard ratios across sites. Results Of the 59 525 participants, 1967 (3.3%) had a major bleed and 1029 (1.7%) died over a mean follow-up of 85.2 days. The risk of major bleeding was similar for DOAC compared with warfarin use (pooled hazard ratio 0.92, 95% confidence interval 0.82 to 1.03), with the overall direction of the association favouring DOAC use. No difference was found in the risk of death (pooled hazard ratio 0.99, 0.84 to 1.16) for DOACs compared with warfarin use. There was no evidence of heterogeneity across centres, between patients with and without chronic kidney disease, across age groups, or between male and female patients. Conclusions In this analysis of adults with incident venous thromboembolism, treatment with DOACs, compared with warfarin, was not associated with an increased risk of major bleeding or all cause mortality in the first 90 days of treatment. Trial registration Clinical trials NCT02833987.
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