Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, 3609 Forbes Ave, Pittsburgh, PA, 15216, USA.
Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.
Am J Cardiovasc Drugs. 2020 Oct;20(5):471-479. doi: 10.1007/s40256-019-00388-8.
In patients with atrial fibrillation (AF) who survive an anticoagulant-related intracranial hemorrhage (ICH), the benefits of restarting oral anticoagulation (OAC) remain unclear.
In this study, we sought to determine the effectiveness and safety associated with resumption of OAC in atrial fibrillation patients who survive an ICH.
Using 2010-2016 Medicare claims data, we identified patients with non-valvular AF who experienced an OAC-related ICH and survived at least 6 weeks after the ICH (n = 1502). The primary outcomes included the composite of ischemic stroke and transient ischemic attack (TIA), thromboembolism (TE), a composite of ischemic stroke/TIA and TE, recurrent ICH, and all-cause mortality. We constructed Cox proportional hazard models to evaluate the association between post-ICH OAC resumption, which was measured in a time-dependent manner, and the risk of primary outcomes, while controlling for a comprehensive list of covariates.
Among patients who survived an ICH, 69% reinitiated OAC within 6 weeks of the event, and among those who resumed OAC, 83% restarted warfarin. There was no significant difference in the risk of ischemic stroke/TIA (hazard ratio [HR] 0.87, 95% confidence interval [CI] 0.62-1.21), TE (HR 0.85, 95% CI 0.55-1.32), and ischemic stroke/TIA/TE (HR 0.81, 95% CI 0.61-1.07) between post-ICH OAC use and non-use. Post-ICH OAC use was associated with a lower risk of recurrent ICH (HR 0.62, 95% CI 0.41-0.95) and all-cause mortality (HR 0.48, 95% CI 0.37-0.62) compared with non-OAC use.
In AF patients who survived an ICH, restarting OAC was not associated with a greater risk of recurrent ICH. Evidence from randomized controlled studies is needed to further clarify the clinical benefit of restarting OAC in this high-risk population. Further evaluation of which individuals benefit from restarting OAC is also needed to provide more clinical guidance.
在抗凝相关颅内出血（ICH）后存活的心房颤动（AF）患者中，重新开始口服抗凝治疗（OAC）的益处仍不清楚。
本研究旨在确定 AF 患者在 ICH 后存活并重新开始 OAC 治疗与相关的有效性和安全性。
使用 2010-2016 年 Medicare 理赔数据，我们确定了经历 OAC 相关 ICH 且在 ICH 后至少存活 6 周的非瓣膜性 AF 患者（n=1502）。主要结局包括缺血性卒中和短暂性脑缺血发作（TIA）的复合结局、血栓栓塞（TE）、缺血性卒中和 TE 的复合结局、复发性 ICH 和全因死亡率。我们构建了 Cox 比例风险模型来评估 OAC 恢复（以时间依赖性方式衡量）与主要结局风险之间的关联，同时控制了一整套协变量。
在 ICH 后存活的患者中，69%在事件发生后 6 周内重新开始 OAC，在重新开始 OAC 的患者中，83%重新开始使用华法林。ICH 后使用 OAC 与不使用 OAC 相比，缺血性卒中和 TIA（风险比 [HR]0.87，95%置信区间 [CI]0.62-1.21）、TE（HR0.85，95%CI0.55-1.32）和缺血性卒中和 TIA/TE（HR0.81，95%CI0.61-1.07）的风险无显著差异。与不使用 OAC 相比，ICH 后使用 OAC 与复发性 ICH（HR0.62，95%CI0.41-0.95）和全因死亡率（HR0.48，95%CI0.37-0.62）降低相关。
在 ICH 后存活的 AF 患者中，重新开始 OAC 与复发性 ICH 风险增加无关。需要随机对照研究的证据来进一步阐明在这一高危人群中重新开始 OAC 的临床获益。还需要进一步评估哪些个体从重新开始 OAC 中获益，以提供更多的临床指导。
