Rubino Claudia, Blunda Fabiana, Bodega Francesca, Melillo Francesco, Russi Anita, Mattiello Paolo, Salerno Anna, Cera Michela, Margonato Davide, Mazzone Patrizio, Della Bella Paolo, Castiglioni Alessandro, Alfieri Ottavio, DE Bonis Michele, Montorfano Matteo, Filippi Massimo, Tresoldi Moreno, Cappelletti Alberto, Zangrillo Alberto, Margonato Alberto, Godino Cosmo
Unit of Cardiology, Cardio-Thoracic-Vascular Department, IRCCS San Raffaele Hospital, Milan, Italy.
Unit of Information Systems, IRCCS San Raffaele Hospital, Milan, Italy.
Minerva Med. 2023 Apr;114(2):137-147. doi: 10.23736/S0026-4806.21.07432-2. Epub 2021 Jun 28.
Limited real-world data are available regarding the comparison about safety and efficacy of DOACs prescription in very elderly patients (≥85 years) with non-valvular atrial fibrillation (NVAF). Concern about the risk of bleeding with anticoagulation in very older patients still represents an important challenge for clinicians. The aim of this study was to evaluate the different prevalence of major bleeding and thromboembolic events between very elderly NVAF patients (≥85 years) compared to those non very elderly (<85 years).
Single center multidisciplinary registry including NVAF patients treated with DOACs. Primary safety endpoint was 2-year rate of major bleeding. Primary efficacy endpoint was 2-year rate of thromboembolic events. Event-free survival curves among groups were compared using Cox-Mantel Test.
908 NVAF consecutive patients were included, of these, 805 patients were <85 years (89%) and 103 patients were very elderly patients with ≥85 years (11%). Compared to patients <85 years, those very elderly have higher CHA2DS2-VASc Score (P=0.001), higher rate of hypertension (P=0.001), diabetes mellitus (P=0.030), previous bleeding events (P<0.001), previous stroke/TIA/SE (P≤0.001), heart failure (P≤0.001), and lower creatinine clearance (P<0.001). In terms of safety endpoints (overall ISTH-major bleeding) no significative difference between two groups (P=0.952) were observed up to 2-year follow-up. Systemic thromboembolic event (primary efficacy endpoint) was significantly higher in patients with ≥85 years (P=0.027). The incidence of all-cause death was significantly higher in very elderly patients (P<0.001).
This single center registry, showed that the use of DOACs in very elderly NVAF was safe and is a therapeutic option to be pursued for stroke prevention especially for those who are at high risk of ischemic events.
关于在年龄≥85岁的非瓣膜性心房颤动（NVAF）老年患者中使用直接口服抗凝剂（DOACs）的安全性和有效性比较，现有的真实世界数据有限。对于高龄患者抗凝治疗的出血风险担忧仍然是临床医生面临的一项重要挑战。本研究的目的是评估年龄≥85岁的老年NVAF患者与非老年（<85岁）患者相比，主要出血和血栓栓塞事件的不同发生率。
一项单中心多学科登记研究，纳入接受DOACs治疗的NVAF患者。主要安全终点是2年主要出血发生率。主要疗效终点是2年血栓栓塞事件发生率。使用Cox-Mantel检验比较各组间的无事件生存曲线。
共纳入908例连续的NVAF患者，其中805例患者年龄<85岁（89%），103例患者为年龄≥85岁的老年患者（11%）。与年龄<85岁的患者相比，高龄患者的CHA2DS2-VASc评分更高（P=0.001），高血压（P=0.001）、糖尿病（P=0.030）、既往出血事件（P<0.001）、既往卒中/短暂性脑缺血发作/系统性栓塞（P≤0.001）、心力衰竭（P≤0.001）发生率更高，而肌酐清除率更低（P<0.001）。在安全终点方面（总体国际血栓与止血学会（ISTH）定义的主要出血），至2年随访时两组间未观察到显著差异（P=0.952）。年龄≥85岁患者的系统性血栓栓塞事件（主要疗效终点）显著更高（P=0.027）。高龄患者的全因死亡发生率显著更高（P<0.001）。
这项单中心登记研究表明，在高龄NVAF患者中使用DOACs是安全的，并且是预防卒中的一种可采用的治疗选择，尤其是对于那些有缺血事件高风险的患者。
