Sablot Denis, Gaillard Nicolas, Belahsen Faouzi, Lamelo Sara Rivas, Dumitrana Adrian, Plantard Carole, Daghmouri Mohamed Aziz, Chaouch Mohamed Ali
Neurology Department of Perpignan Hospital, Perpignan, France.
Commission of Clinical Research and Innovation, Perpignan, France.
Front Med (Lausanne). 2025 Apr 25;12:1570809. doi: 10.3389/fmed.2025.1570809. eCollection 2025.
Patients with atrial fibrillation and a history of intracranial hemorrhage (ICH) face a dilemma when resuming anticoagulation therapy due to the risk of ICH recurrence versus the need for Ischemic stroke (IS) prevention. This study aims to evaluate the safety and efficacy of direct oral anticoagulants (DOAC) compared to no therapy or antiplatelets in these patients.
We conducted a systematic review and meta-analysis following PRISMA 2020 guidelines. Electronic searches were performed in multiple databases (Cochrane, PubMed, Web of Science, Embase, Google Scholar, Scopus) up to March 1, 2024. We included randomized controlled trials (RCTs) and controlled clinical trials (CCTs) involving patients with atrial fibrillation and prior ICH. Studies compared the group with no therapy or antiplatelets (no-DOAC group). Outcomes assessed included mortality, IS, ICH recurrence, and major bleeding events.
Fifteen studies (8,318 patients) met the inclusion criteria, including 2,226 patients in the DOAC group and 5,936 in the no-OAC group. The major cardiovascular ischemic event was significantly lower in the DOAC group [OR = 0.11; CI 95% (0.03, 0.45); = 0.002]. Ischemic stroke was lower in the DOAC group [OR = 0.53, 95% CI (0.39-0.72), < 0.001]. There was no difference in ICH recurrence [OR = 1.25, 95% CI (0.28-5.71), = 0.77] or major bleeding [OR = 0.63, 95% CI (0.23-1.72), = 0.36]. Mortality rates were similar between groups [OR = 0.75, 95% CI (0.50-1.11), = 0.15], while Heterogeneity was low for most outcomes.
DOACs appear to reduce the risk of IS without increasing mortality or major bleeding in patients with atrial fibrillation and prior ICH. However, the risk of ICH recurrence remains uncertain. These findings suggest a potential role for DOACs in this high-risk population, but further RCTs are needed to confirm these results.
Identifier CRD42024587511.
患有心房颤动且有颅内出血（ICH）病史的患者在恢复抗凝治疗时面临两难境地，因为存在ICH复发风险，同时又需要预防缺血性卒中（IS）。本研究旨在评估直接口服抗凝剂（DOAC）与不治疗或抗血小板药物相比，在这些患者中的安全性和有效性。
我们按照PRISMA 2020指南进行了系统评价和荟萃分析。截至2024年3月1日，在多个数据库（Cochrane、PubMed、Web of Science、Embase、Google Scholar、Scopus）中进行了电子检索。我们纳入了涉及心房颤动和既往ICH患者的随机对照试验（RCT）和对照临床试验（CCT）。研究将使用DOAC的组与不治疗或使用抗血小板药物的组（非DOAC组）进行了比较。评估的结局包括死亡率、IS、ICH复发和大出血事件。
15项研究（8318例患者）符合纳入标准，其中DOAC组有2226例患者，非OAC组有5936例患者。DOAC组的主要心血管缺血事件显著更低[比值比（OR）=0.11；95%置信区间（CI）（0.03，0.45）；P=0.002]。DOAC组的缺血性卒中更低[OR=0.53，95%CI（0.39 - 0.72），P<0.001]。ICH复发[OR=1.25，95%CI（0.28 - 5.71），P=0.77]或大出血[OR=0.63，95%CI（0.23 - 1.72），P=0.36]方面无差异。两组死亡率相似[OR=0.75，95%CI（0.50 - 1.11），P=0.15]，而大多数结局的异质性较低。
DOAC似乎可降低心房颤动和既往ICH患者的IS风险，且不增加死亡率或大出血风险。然而，ICH复发风险仍不确定。这些发现表明DOAC在这一高危人群中具有潜在作用，但需要进一步的RCT来证实这些结果。
标识符CRD42024587511
