非瓣膜性心房颤动且胃肠道出血高危风险患者的口服抗凝剂的比较安全性和有效性：一项全国性法国队列研究。
Comparative safety and effectiveness of oral anticoagulants in patients with non-valvular atrial fibrillation and high risk of gastrointestinal bleeding: A nationwide French cohort study.
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.
Department of Clinical Medicine, Danish Center for Health Services Research, Aalborg University, Aalborg, Denmark.
出版信息
PLoS One. 2024 Nov 15;19(11):e0310322. doi: 10.1371/journal.pone.0310322. eCollection 2024.
BACKGROUND
This observational study compared effectiveness and safety of direct oral anticoagulants (DOACs; apixaban, rivaroxaban, dabigatran) or vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) at high risk for gastrointestinal bleeding (GIB).
METHODS
Anticoagulant-naïve adults with NVAF with ≥1 GIB risk factor, initiating anticoagulant treatment January 2016-December 2019, and covered by the French national health data system were eligible. Outcomes included major bleeding (MB) and stroke/systemic embolism (SE). Patient characteristics were balanced using propensity score matching.
RESULTS
A total of 314,184 patients were identified with 162,150 (51.5%) in the apixaban cohort, 88,427 (28.1%) in the rivaroxaban cohort, 16,465 (5.2%) in the dabigatran cohort, and 47,142 (15.0%) in the VKA cohort (mean age 79.0 years, standard deviation 10.5; 51.0% female). A total of 45,124 apixaban-VKAs, 38,737 rivaroxaban-VKAs, 16,415 dabigatran-VKAs, 88,414 apixaban-rivaroxaban, 16,464 apixaban-dabigatran, and 16,459 rivaroxaban-dabigatran pairs were retained after propensity score matching. Apixaban had lower risk of MB versus dabigatran (hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.63-0.83) and rivaroxaban (HR, 0.63; 95% CI, 0.59-0.66). Apixaban had lower risk of GIB versus dabigatran (HR, 0.46; 95% CI, 0.37-0.56) and rivaroxaban (HR, 0.54; 95% CI, 0.49-0.59). Risk of GIB was similar with dabigatran versus rivaroxaban (HR, 1.05; 95% CI, 0.89-1.24). Apixaban had lower risk of stroke/SE versus rivaroxaban (HR, 0.90; 95% CI, 0.84-0.96), while risk was similar versus dabigatran (HR, 1.1; 95% CI, 0.9-1.3). All DOACs had lower risk of MB and stroke/SE versus VKAs (p<0.001 for all).
CONCLUSIONS
DOACs had improved safety and effectiveness from bleeding and stroke/SE, respectively, versus VKAs among patients with NVAF at high risk for GIB. Apixaban was associated with lower MB and GIB risk versus other DOACs. For stroke/SE, apixaban was associated with reduced risk versus rivaroxaban and similar risk versus dabigatran.
背景
本观察性研究比较了非瓣膜性心房颤动（NVAF）患者中胃肠道出血（GIB）高危患者使用直接口服抗凝剂（DOAC；阿哌沙班、利伐沙班、达比加群）或维生素 K 拮抗剂（VKA）的疗效和安全性。
方法
2016 年 1 月至 2019 年 12 月，纳入抗凝治疗初治、伴有≥1 项 GIB 风险因素且覆盖法国国家健康数据系统的 NVAF 成年患者。主要终点为大出血（MB）和卒中/全身性栓塞（SE）。采用倾向评分匹配平衡患者特征。
结果
共纳入 314184 例患者，其中阿哌沙班组 162150 例（51.5%），利伐沙班组 88427 例（28.1%），达比加群组 16465 例（5.2%），VKA 组 47142 例（15.0%）。平均年龄 79.0 岁，标准差 10.5 岁；51.0%为女性。经倾向评分匹配后，共保留 45124 例阿哌沙班-VKA、38737 例利伐沙班-VKA、16415 例达比加群-VKA、88414 例阿哌沙班-利伐沙班、16464 例阿哌沙班-达比加群和 16459 例利伐沙班-达比加群。与达比加群相比，阿哌沙班发生 MB 的风险较低（风险比 [HR]，0.72；95%置信区间 [CI]，0.63-0.83）和利伐沙班（HR，0.63；95%CI，0.59-0.66）。与达比加群和利伐沙班相比，阿哌沙班发生 GIB 的风险较低（HR，0.46；95%CI，0.37-0.56）。达比加群和利伐沙班发生 GIB 的风险相似（HR，1.05；95%CI，0.89-1.24）。与利伐沙班相比，阿哌沙班发生 SE 的风险较低（HR，0.90；95%CI，0.84-0.96），而与达比加群相比风险相似（HR，1.1；95%CI，0.9-1.3）。与 VKA 相比，所有 DOAC 均降低了 MB 和 SE 的风险（所有 P<0.001）。
结论
对于 GIB 高危 NVAF 患者，与 VKA 相比，DOAC 在出血和卒中/SE 方面具有更好的安全性和疗效。与其他 DOAC 相比，阿哌沙班发生 MB 和 GIB 的风险较低。对于 SE，阿哌沙班与利伐沙班相比风险降低，与达比加群相比风险相似。
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