Background We investigated outcomes in patients with intracerebral haemorrhage (ICH) according to prior anticoagulation treatment with Vitamin K antagonists (VKAs), direct oral anticoagulants (DOACs) or no anticoagulation. Methods This is an individual patient data study combining two prospective national stroke registries from Switzerland and Norway (2013–2019). We included all consecutive patients with ICH from both registries. The main outcomes were favourable functional outcome (modified Rankin Scale 0–2) and mortality at 3 months. Results Among 11 349 patients with ICH (mean age 73.6 years; 47.6% women), 1491 (13.1%) were taking VKAs and 1205 (10.6%) DOACs (95.2% factor Xa inhibitors). The median percentage of patients on prior anticoagulation was 23.7 (IQR 22.6–25.1) with VKAs decreasing (from 18.3% to 7.6%) and DOACs increasing (from 3.0% to 18.0%) over time. Prior VKA therapy (n=209 (22.3%); adjusted ORs (aOR), 0.64; 95% CI, 0.49 to 0.84) and prior DOAC therapy (n=184 (25.7%); aOR, 0.64; 95% CI, 0.47 to 0.87) were independently associated with lower odds of favourable outcome compared with patients without anticoagulation (n=2037 (38.8%)). Prior VKA therapy (n=720 (49.4%); aOR, 1.71; 95% CI, 1.41 to 2.08) and prior DOAC therapy (n=460 (39.7%); aOR, 1.28; 95% CI, 1.02 to 1.60) were independently associated with higher odds of mortality compared with patients without anticoagulation (n=2512 (30.2%)). Conclusions The spectrum of anticoagulation-associated ICH changed over time. Compared with patients without prior anticoagulation, prior VKA treatment and prior DOAC treatment were independently associated with lower odds of favourable outcome and higher odds of mortality at 3 months. Specific reversal agents unavailable during the study period might improve outcomes of DOAC-associated ICH in the future. Data are available upon reasonable request. Anonymized data may be obtained upon reasonable request from any qualified investigator and after clearance by the local ethics committee and the steering committees from the Swiss and Norwegian Stroke Registries.

中文翻译：

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服用不同类型口服抗凝剂的患者的脑出血：来自两个国家卒中登记处的个体患者数据汇总分析

背景 我们根据既往接受维生素 K 拮抗剂 (VKA)、直接口服抗凝剂 (DOAC) 或不抗凝治疗的脑出血 (ICH) 患者的结果进行了调查。方法 这是一项个体患者数据研究，结合了瑞士和挪威的两个前瞻性国家卒中登记处（2013-2019 年）。我们纳入了来自两个登记处的所有连续 ICH 患者。主要结局是良好的功能结局（改良Rankin量表0-2）和3个月时的死亡率。结果 在 11 349 名 ICH 患者（平均年龄 73.6 岁；47.6% 为女性）中，1491 名（13.1%）正在服用 VKA，1205 名（10.6%）正在服用 DOAC（95.2% 服用 Xa 因子抑制剂）。既往接受抗凝治疗的患者中位百分比为 23.7 (IQR 22.6–25.1)，随着时间的推移，VKA 逐渐减少（从 18.3% 降至 7.6%），DOAC 逐渐增加（从 3.0% 升至 18.0%）。既往 VKA 治疗 (n=209 (22.3%)；调整后 OR (aOR)，0.64；95% CI，0.49 至 0.84）和既往 DOAC 治疗 (n=184 (25.7%)；aOR，0.64；95% CI，0.47与未接受抗凝治疗的患者相比 (n=2037 (38.8%)) 与较低的有利结果几率独立相关。既往 VKA 治疗（n=720 (49.4%)；aOR，1.71；95% CI，1.41 至 2.08）和既往 DOAC 治疗（n=460 (39.7%)；aOR，1.28；95% CI，1.02 至 1.60）的比较与未接受抗凝治疗的患者相比，与较高的死亡率独立相关（n=2512（30.2%））。结论 抗凝相关的 ICH 谱随时间而变化。与既往未接受抗凝治疗的患者相比，既往接受过 VKA 治疗和既往接受过 DOAC 治疗的患者 3 个月时良好结局的几率较低，死亡率较高，独立相关。研究期间无法使用的特定逆转剂可能会改善未来 DOAC 相关 ICH 的结果。数据可根据合理要求提供。根据任何合格调查人员的合理要求，并经过当地伦理委员会以及瑞士和挪威卒中登记处指导委员会的批准后，可以获取匿名数据。