直接口服抗凝剂在脆弱的静脉血栓栓塞患者中的安全性和有效性：一项回顾性队列观察研究。
Safety and effectiveness of direct oral anticoagulants in fragile patients with venous thromboembolism: a retrospective cohort observational study.
作者信息
Park Hojong, Park Sang Jun, Kim Hyangkyoung
机构信息
Department of Surgery, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
Department of Surgery, Ewha Womans University Medical Center, Ewha Womans University College of Medicine, Seoul, Korea.
出版信息
Ann Surg Treat Res. 2025 Mar;108(3):168-176. doi: 10.4174/astr.2025.108.3.168. Epub 2025 Feb 28.
PURPOSE
The use of direct oral anticoagulants (DOACs) is challenging in fragile patients, including those with cancer, chronic kidney disease (CKD), and old age. We aimed to compare the safety of DOACs in terms of bleeding complications in these patients.
METHODS
Using hospital data from 2013 to 2019, we compared the risk of bleeding and major bleeding, including intracranial bleeding, any bleeding requiring transfusion, and all-cause bleeding, in patients with venous thromboembolism (VTE) who were naïve to DOAC (n = 12,369) and warfarin (n = 4,123). Hazard ratios (HRs) for the clinical outcomes were analyzed using Cox regression analysis, with warfarin as a reference.
RESULTS
The study included 4,078 eligible patients, predominantly female (54.1%), with a mean age of 62.5 years. DOACs were the primary treatment in 74.1% of the patients. DOAC treatment was associated with lower all-cause mortality compared to warfarin (HR, 0.799; 95% confidence interval [CI], 0.707-0.904). Although rates of recurrent VTE or major bleeding did not significantly differ between the groups, DOAC-treated patients had lower bleeding risk (HR, 0.562; 95% CI, 0.393-0.805; P = 0.002). The individual DOAC drugs did not differ significantly in terms of composite outcomes, recurrence, or bleeding events.
CONCLUSION
DOAC showed comparable outcomes with warfarin in the fragile patient population.
目的
在包括癌症、慢性肾脏病（CKD）和老年患者在内的脆弱患者中，直接口服抗凝剂（DOACs）的使用具有挑战性。我们旨在比较DOACs在这些患者中出血并发症方面的安全性。
方法
利用2013年至2019年的医院数据，我们比较了初治DOAC（n = 12,369）和华法林（n = 4,123）的静脉血栓栓塞（VTE）患者的出血风险和大出血风险，包括颅内出血、任何需要输血的出血以及全因出血。使用Cox回归分析以华法林为对照分析临床结局的风险比（HRs）。
结果
该研究纳入了4,078例符合条件的患者，主要为女性（54.1%），平均年龄62.5岁。74.1%的患者将DOACs作为主要治疗药物。与华法林相比，DOAC治疗与较低的全因死亡率相关（HR，0.799；95%置信区间[CI]，0.707 - 0.904）。尽管两组之间复发性VTE或大出血的发生率没有显著差异，但接受DOAC治疗的患者出血风险较低（HR，0.562；95% CI，0.393 - 0.805；P = 0.002）。各DOAC药物在综合结局、复发或出血事件方面没有显著差异。
结论
在脆弱患者群体中，DOAC与华法林的结局相当。
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