Zhang Guangjing, Wu Yipeng, Gao Luxia, Xiao Zhiqiang, Chen Xi
Department of Cardiology, The First Affiliated Hospital of Sanming, Fujian Medical University, Sanming, Fujian, China.
Clin Appl Thromb Hemost. 2025 Jan-Dec;31:10760296251368889. doi: 10.1177/10760296251368889. Epub 2025 Aug 21.
BackgroundThe management of atrial fibrillation (AF) in patients with a history of intracranial hemorrhage (ICH) presents a significant clinical challenge. Although oral anticoagulants (OACs), have been shown to effectively reduce thromboembolic events in AF patients, their use in survivors of ICH raises concerns regarding the risk of recurrent bleeding. In this study, we conduct a systematic review of randomized controlled trials (RCTs) to assess the safety and efficacy of OAC therapy in AF patients following ICH.MethodsWe searched PubMed/Embase for RCTs assessing OACs in AF patients with ICH history. Efficacy outcomes included ischemic stroke, major vascular events, stroke or vascular death, major embolic events, and all-cause mortality.ResultsA total of three RCTs with 623 participants were included. Compared to no anticoagulation or antiplatelet therapy alone, OAC did not significantly reduce the risk of ischemic stroke (HR = 0.27, 95% CI [0.02, 3.92], = .13), but it significantly reduced the occurrence of major vascular events (HR = 0.65, 95% CI [0.43, 0.98], = .04). However, OACs significantly increased the risk of recurrent ICH (HR = 4.05, 95% CI [1.62, 10.17], = .003) and major bleeding events (HR = 3.70, 95% CI [1.64, 8.35], = .002). No significant effect was observed on stroke or vascular death (HR = 0.74, 95% CI [0.39, 1.41], = .36).ConclusionsOACs can reduce the risk of major vascular events, but they significantly increase the risk of bleeding, particularly recurrent ICH. Clinical decision-making should be individualized, carefully evaluating the thromboembolic and bleeding risks for each patient. Further high-quality RCTs are needed to validate these findings.
背景
有颅内出血(ICH)病史的心房颤动(AF)患者的管理是一项重大的临床挑战。尽管口服抗凝药(OAC)已被证明能有效降低AF患者的血栓栓塞事件,但在ICH幸存者中使用OAC会引发对再发出血风险的担忧。在本研究中,我们对随机对照试验(RCT)进行系统评价,以评估OAC治疗在ICH后AF患者中的安全性和有效性。
方法
我们在PubMed/Embase中检索评估有ICH病史的AF患者使用OAC的RCT。疗效指标包括缺血性卒中、主要血管事件、卒中或血管性死亡、主要栓塞事件和全因死亡率。
结果
共纳入3项RCT,623名参与者。与不进行抗凝或单独使用抗血小板治疗相比,OAC并未显著降低缺血性卒中风险(HR = 0.27,95%CI[0.02,3.92],P = 0.13),但显著降低了主要血管事件的发生率(HR = 0.65,95%CI[0.43,0.98],P = 0.04)。然而,OAC显著增加了再发ICH风险(HR = 4.05,95%CI[1.62,10.17],P = 0.003)和主要出血事件风险(HR = 3.70,95%CI[1.64,8.35],P = 0.002)。未观察到对卒中和血管性死亡的显著影响(HR = 0.74,95%CI[0.39,1.41],P = 0.36)。
结论
OAC可降低主要血管事件风险,但显著增加出血风险,尤其是再发ICH。临床决策应个体化,仔细评估每位患者的血栓栓塞和出血风险。需要进一步的高质量RCT来验证这些发现。