Hu Wei, Cai Huiya, Zhang Jinhua
Department of Pharmacy, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 310009, China.
Department of Pharmacy, The Second Hospital of Zhangzhou, Zhangzhou, 363199, China.
Eur J Clin Pharmacol. 2022 Jul;78(7):1057-1067. doi: 10.1007/s00228-022-03300-7. Epub 2022 Mar 16.
The objective of present study was to compare the safety and efficacy of resuming direct-acting oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) and prior gastrointestinal bleeding (GIB).
PubMed, Embase, Web of Science, and the Cochrane Library were searched from their inception until 2 June 2021 for observational cohort studies in patients with AF, who resumed VKAs or DOACs after a history of GIB. Studies that reported data on clinical outcomes including risk of recurrent GIB, thromboembolic events, or all-cause mortality were included. A network meta-analysis was performed to calculate the pooled hazard ratio (HR) and associated 95% credible intervals (CIs), using a random effects model in a Bayesian framework.
A total of 10 studies were included in the final analysis, including 59,244 AF patients with prior GIB, of whom 27,793 resumed DOACs, 24,635 resumed warfarin, and 6816 did not resume anticoagulation. Compared with no resumption of anticoagulation, resumption of warfarin was associated with an increased risk of recurrent GIB (HR 1.33, 95% CI: 1.06-1.70), but no increased risk of recurrent GIB was found with resumption of DOACs (HR 1.22, 95% CI: 0.88-1.71); among individual DOACs, only rivaroxaban was associated with an increased risk of recurrent GIB (HR 1.67, 95% CI: 1.16-2.65). Compared with no resumption of anticoagulation, resumption of DOACs and warfarin was associated with a significant reduction in all-cause mortality (HR 0.57, 95% CI: 0.40-0.84; HR 0.58, 95% CI: 0.44-0.79), but no statistically significant reduction in thromboembolic events (HR 0.69, 95% CI: 0.4-1.2; HR 0.83, 95% CI: 0.55-1.29).
In AF patients with prior GIB, resumption of DOACs may be safer, except for rivaroxaban.
本研究的目的是比较房颤(AF)合并既往胃肠道出血(GIB)患者重新开始使用直接口服抗凝剂(DOACs)和维生素K拮抗剂(VKAs)的安全性和有效性。
检索PubMed、Embase、Web of Science和Cochrane图书馆自建库至2021年6月2日期间关于房颤患者在有GIB病史后重新开始使用VKAs或DOACs的观察性队列研究。纳入报告临床结局数据(包括复发性GIB风险、血栓栓塞事件或全因死亡率) 的研究。采用贝叶斯框架下的随机效应模型进行网络荟萃分析,以计算合并风险比(HR)及相关的95%可信区间(CI)。
最终分析共纳入10项研究,包括59244例有既往GIB的房颤患者,其中27793例重新开始使用DOACs,24635例重新开始使用华法林,6816例未重新开始抗凝治疗。与未重新开始抗凝治疗相比,重新开始使用华法林会增加复发性GIB的风险(HR 1.33,95%CI:1.06 - 1.70),但重新开始使用DOACs未发现复发性GIB风险增加(HR1.22,95%CI:0.88 - 1.71);在个别DOACs中,只有利伐沙班会增加复发性GIB的风险(HR 1.67,95%CI:1.16 - 2.65)。与未重新开始抗凝治疗相比,重新开始使用DOACs和华法林与全因死亡率显著降低相关(HR 0.57,95%CI:0.40 - 0.84;HR 0.58,95%CI:0.44 - 0.79),但血栓栓塞事件无统计学显著降低(HR 0.69,95%CI:0.4 - 1.2;HR 0.83,95%CI:0.55 - 1.29)。
在有既往GIB的房颤患者中,除利伐沙班外,重新开始使用DOACs可能更安全。