加拿大麦克马斯特大学Jeff S. Healey团队比较了阿哌沙班与阿司匹林治疗亚临床心房颤动患者的疗效与安全性。这一研究成果发表在2023年11月12日出版的《新英格兰医学杂志》上。

亚临床心房颤动持续时间短，无症状，通常只能通过起搏器或除颤器进行长期持续监测才能发现。亚临床房颤与中风风险增加的相关系数为2.5；然而，口服抗凝治疗的疗效并不确定。

研究组对亚临床房颤患者进行了一项持续6分钟至24小时的试验。在双盲、双模拟设计中，患者被随机分配接受阿哌沙班，剂量为5 mg，每日两次（2.5 mg，必要时每日两次）或阿司匹林，剂量为81 mg，每日一次。如果亚临床心房颤动持续超过24小时或出现临床心房颤动，则停止试验药物并开始抗凝治疗。主要疗效结局为中风或全身性栓塞，在意向治疗人群（所有接受随机化的患者）中进行评估；主要安全性结局为大出血，在接受治疗的人群中进行评估（所有接受随机分组并接受至少一剂指定试验药物的患者，在全因永久停止试验药物后5天进行随访）。

共纳入了4012名患者，平均（±SD）年龄为76.8±7.6岁，平均CHA2DS2-VASc评分为3.9±1.1（评分范围从0到9，评分越高表示中风风险越高）；36.1%的患者为女性。平均随访3.5±1.8年后，阿哌沙班组55名患者（每病患-年0.78%）和阿司匹林组86名患者（每病患-年1.24%）发生中风或全身性栓塞（危险比为0.63；P=0.007）。在接受治疗的人群中，阿哌沙班组的大出血率为1.71%，阿司匹林组为0.94%（危险比为1.80；P=0.001）。阿哌沙班组有5名患者和阿司匹林组有8名患者发生致命出血。

研究结果表明，在亚临床心房颤动患者中，阿哌沙班与阿司匹林相比导致中风或全身栓塞的风险更低，但发生大出血的风险更高。

附：英文原文

Title: Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation | NEJM

Author: anonymous

Issue&Volume: 2023-11-12

Abstract:

Background

Subclinical atrial fibrillation is short-lasting and asymptomatic and can usually be detected only by long-term continuous monitoring with pacemakers or defibrillators. Subclinical atrial fibrillation is associated with an increased risk of stroke by a factor of 2.5; however, treatment with oral anticoagulation is of uncertain benefit.

Methods

We conducted a trial involving patients with subclinical atrial fibrillation lasting 6 minutes to 24 hours. Patients were randomly assigned in a double-blind, double-dummy design to receive apixaban at a dose of 5 mg twice daily (2.5 mg twice daily when indicated) or aspirin at a dose of 81 mg daily. The trial medication was discontinued and anticoagulation started if subclinical atrial fibrillation lasting more than 24 hours or clinical atrial fibrillation developed. The primary efficacy outcome, stroke or systemic embolism, was assessed in the intention-to-treat population (all the patients who had undergone randomization); the primary safety outcome, major bleeding, was assessed in the on-treatment population (all the patients who had undergone randomization and received at least one dose of the assigned trial drug, with follow-up censored 5 days after permanent discontinuation of trial medication for any reason).

Results

We included 4012 patients with a mean (±SD) age of 76.8±7.6 years and a mean CHA2DS2-VASc score of 3.9±1.1 (scores range from 0 to 9, with higher scores indicating a higher risk of stroke); 36.1% of the patients were women. After a mean follow-up of 3.5±1.8 years, stroke or systemic embolism occurred in 55 patients in the apixaban group (0.78% per patient-year) and in 86 patients in the aspirin group (1.24% per patient-year) (hazard ratio, 0.63; 95% confidence interval [CI], 0.45 to 0.88; P=0.007). In the on-treatment population, the rate of major bleeding was 1.71% per patient-year in the apixaban group and 0.94% per patient-year in the aspirin group (hazard ratio, 1.80; 95% CI, 1.26 to 2.57; P=0.001). Fatal bleeding occurred in 5 patients in the apixaban group and 8 patients in the aspirin group.

Conclusions

Among patients with subclinical atrial fibrillation, apixaban resulted in a lower risk of stroke or systemic embolism than aspirin but a higher risk of major bleeding.

DOI: 10.1056/NEJMoa2310234

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2310234