Lan Yanxian, Chen Jiana, Niu Peiguang, Huang Xinhai, Dong Xiaomin, You Cuifang, Jiang Shuzheng, Zhang Jinhua
Department of Pharmacy, College of Clinical Medicine for Obstetrics and Gynecology and Pediatrics, Fujian Maternity and Child Health Hospital, Fujian Medical University, #18 Daoshan Road, Fuzhou, 350001, China.
Minzu Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.
BMC Geriatr. 2025 Mar 27;25(1):203. doi: 10.1186/s12877-025-05838-4.
Stroke prevention in elderly patients with atrial fibrillation (AF) is challenging and requires a balance between thromboembolic prevention and bleeding. The comparison of novel oral anticoagulants (NOACs) and warfarin in clinical practice in elderly Asian patients has not been well studied. The purpose of this study was to evaluate the efficacy and safety of NOACs versus warfarin in elderly patients with AF in conjunction with data from real-world observational studies.
This was a retrospective multicenter cohort study conducted in 4 centers in China, where patient information and clinical events were collected through an average of 15 months of follow-up and case queries. Clinical outcomes included major bleeding, minor bleeding, total bleeding, thrombosis, and all-cause mortality.
A total of 3450 elderly patients with AF were enrolled. 2656 patients were treated with at least 1 NOAC (dabigatran, rivaroxaban, apixaban, or edoxaban), and 794 patients were treated with warfarin. After correcting for confounders, NOACs significantly reduced the risk of minor bleeding [OR 0.70 (95% CL, 0.49-1.01),P = 0.049] and all-cause mortality [OR 0.57( 95% CI, 0.44-0.75),P < 0.001] compared with warfarin, however, major bleeding events [OR 1.51 (95% CL, 0.98-2.42),P = 0.075] and thrombotic events [OR 0.79 (95% CL, 0.57-1.13),P = 0.187] were not significantly different. There was no heterogeneity between clinical outcomes of NOACs and warfarin in subgroup analyses of age (65-74, 75-84, ≥ 85 years), sex (male, female), BMI (≥ 25, < 25), comorbidities (including hypertension, diabetes and no hypertension, no diabetes), except in female subgroup, where NOACs significantly reduced the risk of minor bleeding [OR 0.56 (95% CL, 0.34-0.91),P = 0.018] and increased the risk of major bleeding [OR 2.28 (95% CL, 1.12-5.14),P = 0.032] compared with warfarin.
Compared with warfarin, NOACs significantly reduced the risk of minor bleeding, all-cause mortality, and there were no statistically significant differences in major bleeding or thrombotic events. NOACs were not more effective than warfarin in thrombotic and bleeding events, regardless of the subgroup analyses on age, male, BMI and comorbid hypertension and diabetes.
老年心房颤动（AF）患者的卒中预防具有挑战性，需要在预防血栓栓塞和出血之间取得平衡。新型口服抗凝药（NOACs）与华法林在老年亚洲患者临床实践中的比较尚未得到充分研究。本研究的目的是结合真实世界观察性研究数据，评估NOACs与华法林在老年AF患者中的疗效和安全性。
这是一项在中国4个中心进行的回顾性多中心队列研究，通过平均15个月的随访和病例查询收集患者信息和临床事件。临床结局包括大出血、小出血、总出血、血栓形成和全因死亡率。
共纳入3450例老年AF患者。2656例患者接受了至少1种NOAC（达比加群、利伐沙班、阿哌沙班或依度沙班）治疗，794例患者接受了华法林治疗。校正混杂因素后，与华法林相比，NOACs显著降低了小出血风险[比值比（OR）0.70（95%可信区间，0.49-1.01），P = 0.049]和全因死亡率[OR 0.57（95%CI，0.44-0.75），P < 0.001]，然而，大出血事件[OR 1.51（95%CL，0.98-2.42），P = 0.075]和血栓形成事件[OR 0.79（95%CL，0.57-1.13），P = 0.187]无显著差异。在年龄（65-74岁、75-84岁、≥85岁）、性别（男性、女性）、体重指数（BMI）（≥25、<25）、合并症（包括高血压、糖尿病和无高血压、无糖尿病）的亚组分析中，NOACs和华法林的临床结局无异质性，但在女性亚组中，与华法林相比，NOACs显著降低了小出血风险[OR 0.56（95%CL，0.34-0.91），P = 0.018]，并增加了大出血风险[OR 2.28（95%CL，1.12-5.14），P = 0.032]。
与华法林相比，NOACs显著降低了小出血风险和全因死亡率，在大出血或血栓形成事件方面无统计学显著差异。无论在年龄、性别、BMI以及合并高血压和糖尿病方面进行亚组分析，NOACs在血栓形成和出血事件方面并不比华法林更有效。
