衰弱对非维生素 K 拮抗剂口服抗凝剂（NOACs）在房颤患者中的疗效和安全性的影响：一项全国性队列研究。

Impact of frailty on the effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation: a nationwide cohort study.

机构信息

Department of Bioanalysis, Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000Ghent, Belgium.

Department of Geriatrics, Ghent University Hospital, C. Heymanslaan 10, 9000Ghent, Belgium.

出版信息

Eur Heart J Qual Care Clin Outcomes. 2024 Jan 12;10(1):55-65. doi: 10.1093/ehjqcco/qcad019.

AIMS

Data on non-vitamin K antagonist oral anticoagulants (NOACs) use in patients with atrial fibrillation (AF) and frailty are scarce. Therefore, the impact of frailty on AF-related outcomes and benefit-risk profiles of NOACs in patients with frailty were investigated.

METHODS AND RESULTS

AF patients initiating anticoagulation between 2013 and 2019 were included using Belgian nationwide data. Frailty was assessed with the Claims-based Frailty Indicator. Among 254 478 anticoagulated AF patients, 71 638 (28.2%) had frailty. Frailty was associated with higher all-cause mortality risks [adjusted hazard ratio (aHR) 1.48, 95% confidence interval (CI) (1.43-1.54)], but not with thromboembolism or bleeding. Among subjects with frailty (78 080 person-years of follow-up), NOACs were associated with lower risks of stroke or systemic embolism (stroke/SE) [aHR 0.77, 95%CI (0.70-0.86)], all-cause mortality [aHR 0.88, 95%CI (0.84-0.92)], and intracranial bleeding [aHR 0.78, 95%CI (0.66-0.91)], a similar major bleeding risk [aHR 1.01, 95%CI (0.93-1.09)], and higher gastrointestinal bleeding risk [aHR 1.19, 95%CI (1.06-1.33)] compared with VKAs. Major bleeding risks were lower with apixaban [aHR 0.84, 95%CI (0.76-0.93)], similar with edoxaban [aHR 0.91, 95%CI (0.73-1.14)], and higher with dabigatran [aHR 1.16, 95%CI (1.03-1.30)] and rivaroxaban [aHR 1.11, 95%CI (1.02-1.21)] compared with VKAs. Apixaban was associated with lower major bleeding risks compared with dabigatran [aHR 0.72, 95%CI (0.65-0.80)], rivaroxaban [aHR 0.78, 95%CI (0.72-0.84)] and edoxaban [aHR 0.74, 95%CI (0.65-0.84)], but mortality risk was higher compared with dabigatran and edoxaban.

CONCLUSION

Frailty was an independent risk factor of death. Non-vitamin K antagonist oral anticoagulants had better benefit-risk profiles than VKAs in patients with frailty, especially apixaban, followed by edoxaban.

目的

关于房颤（AF）和虚弱患者使用非维生素 K 拮抗剂口服抗凝剂（NOACs）的数据很少。因此，研究了虚弱对 AF 相关结局和 NOACs 在虚弱患者中的获益-风险特征的影响。

方法和结果

使用比利时全国性数据纳入了 2013 年至 2019 年期间开始抗凝治疗的 AF 患者。使用基于索赔的虚弱指标评估虚弱。在 254478 例接受抗凝治疗的 AF 患者中，71638 例（28.2%）有虚弱。虚弱与全因死亡率风险增加相关[校正后的危险比（aHR）1.48，95%置信区间（CI）（1.43-1.54）]，但与血栓栓塞或出血无关。在虚弱患者（78080 人年随访）中，NOACs 与卒中或全身性栓塞（卒中/SE）[aHR 0.77，95%CI（0.70-0.86）]、全因死亡率[aHR 0.88，95%CI（0.84-0.92）]和颅内出血[aHR 0.78，95%CI（0.66-0.91）]的风险降低相关，大出血风险相似[aHR 1.01，95%CI（0.93-1.09）]，胃肠道出血风险更高[aHR 1.19，95%CI（1.06-1.33）]与 VKAs 相比。与 VKAs 相比，阿哌沙班的大出血风险较低[aHR 0.84，95%CI（0.76-0.93）]，依度沙班相似[aHR 0.91，95%CI（0.73-1.14）]，达比加群和利伐沙班较高[aHR 1.16，95%CI（1.03-1.30）]和[aHR 1.11，95%CI（1.02-1.21）]。与 VKAs 相比，阿哌沙班与较低的大出血风险相关[aHR 0.72，95%CI（0.65-0.80）]，利伐沙班[aHR 0.78，95%CI（0.72-0.84）]和依度沙班[aHR 0.74，95%CI（0.65-0.84）]，但与达比加群和依度沙班相比，死亡率风险更高。