口服抗凝剂在非瓣膜性心房颤动且有高胃肠道出血风险关键亚组患者中的比较安全性和有效性：一项基于法国国家卫生数据系统（SNDS）的队列研究
Comparative safety and effectiveness of oral anticoagulants in key subgroups of patients with non-valvular atrial fibrillation and at high risk of gastrointestinal bleeding: A cohort study based on the French National Health Data System (SNDS).
作者信息
Lip Gregory Y H, Benamouzig Robert, Martin Anne-Céline, Pesce Giancarlo, Gusto Gaelle, Quignot Nadia, Khachatryan Artak, Dai Feng, Sedjelmaci Fouad, Chaves Jose, Subash Rupesh, Mokgokong Ruth
机构信息
Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom.
Danish Center for Health Services Research, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
出版信息
PLoS One. 2025 Jan 22;20(1):e0317895. doi: 10.1371/journal.pone.0317895. eCollection 2025.
BACKGROUND
Risk factors and comorbidities can complicate management of non-valvular atrial fibrillation. We describe and compare real-world safety and effectiveness of direct oral anticoagulants (DOACs; apixaban, rivaroxaban, dabigatran) and vitamin K antagonists (VKAs) in subgroups of patients with non-valvular atrial fibrillation at high risk for gastrointestinal (GI) bleeding, utilizing data from a national quasi-exhaustive French database.
METHODS
Anticoagulant-naïve adults with non-valvular atrial fibrillation with ≥1 gastrointestinal bleeding risk factor, initiating anticoagulant treatment January 2016-December 2019, and covered by the French national health data system were eligible. The following subgroups were evaluated: patients age ≥75 years, receiving concomitant medications, HAS-BLED score ≥3, and chronic kidney disease stage 3-4. Outcomes included major bleeding and stroke/systemic embolism. Patient characteristics were balanced using propensity score matching.
RESULTS
A total of 314,184 patients were identified; characteristics were similar for propensity score-matched subgroups in VKA/DOAC and DOAC/DOAC comparisons. DOACs showed lower risk of major bleeding versus VKAs in all subgroups evaluated (p<0.0001 for all). Apixaban showed lower risk of major bleeding and gastrointestinal bleeding versus rivaroxaban in all subgroups (p≤0.05 for all) and versus dabigatran in elderly patients, patients with HAS-BLED score ≥3, and those receiving concomitant medications (p<0.05 for all). Stroke/systemic embolism risk was lower with apixaban versus rivaroxaban in elderly patients, those with HAS-BLED ≥3, and those receiving concomitant medications; risks were similar for other comparisons.
CONCLUSIONS
DOACs were associated with improved safety and effectiveness when compared to VKAs among subgroups of non-valvular atrial fibrillation patients at high risk of gastrointestinal bleeding. Apixaban was associated with lower risks of major bleeding, gastrointestinal bleeding, and stroke/systemic embolism versus rivaroxaban as well as lower risk of major bleeding, gastrointestinal bleeding bleed and similar risk of stroke/systemic embolism versus dabigatran among several of these patient subgroups.
背景
危险因素和合并症会使非瓣膜性心房颤动的管理复杂化。我们利用法国一个全国性的近乎详尽的数据库中的数据，描述并比较直接口服抗凝剂（DOACs；阿哌沙班、利伐沙班、达比加群）和维生素K拮抗剂（VKAs）在非瓣膜性心房颤动且有胃肠道（GI）出血高风险的患者亚组中的真实世界安全性和有效性。
方法
2016年1月至2019年12月开始抗凝治疗、未接受过抗凝治疗且有≥1个胃肠道出血危险因素的非瓣膜性心房颤动成年患者，且纳入法国国家卫生数据系统者符合条件。评估了以下亚组：年龄≥75岁的患者、接受联合用药的患者、HAS - BLED评分≥3的患者以及慢性肾脏病3 - 4期的患者。结局包括大出血和卒中/全身性栓塞。使用倾向评分匹配使患者特征达到平衡。
结果
共识别出314,184例患者；在VKA/DOAC和DOAC/DOAC比较中，倾向评分匹配的亚组特征相似。在所有评估的亚组中，DOACs与VKAs相比大出血风险更低（所有比较p<0.0001）。在所有亚组中，阿哌沙班与利伐沙班相比大出血和胃肠道出血风险更低（所有比较p≤0.05），在老年患者、HAS - BLED评分≥3的患者以及接受联合用药的患者中，与达比加群相比大出血风险更低（所有比较p<0.05）。在老年患者、HAS - BLED≥3的患者以及接受联合用药的患者中，阿哌沙班与利伐沙班相比卒中/全身性栓塞风险更低；其他比较的风险相似。
结论
在有胃肠道出血高风险的非瓣膜性心房颤动患者亚组中，与VKAs相比，DOACs的安全性和有效性更佳。在这些患者亚组中的几个亚组中，与利伐沙班相比，阿哌沙班大出血、胃肠道出血和卒中/全身性栓塞风险更低，与达比加群相比，大出血、胃肠道出血风险更低且卒中/全身性栓塞风险相似。
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