Shurrab Mohammed, Austin Peter C, Jackevicius Cynthia A, Tu Karen, Qiu Feng, Haldenby Olivia, Davies Steven, Lopes Renato D, Baykaner Tina, Johnson Linda S, Healey Jeff S, Ko Dennis T
Cardiology Department, Health Sciences North, Northern Ontario School of Medicine University, Sudbury, Ontario, Canada; Health Sciences North Research Institute, Sudbury, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; ICES, Toronto and North, Ontario, Canada; Division of Cardiology, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; ICES, Toronto and North, Ontario, Canada.
Heart Rhythm. 2025 Apr;22(4):961-970. doi: 10.1016/j.hrthm.2024.08.033. Epub 2024 Aug 21.
Despite many atrial fibrillation (AF) patients being at risk of bleeding, very limited data are available on bleeding rates of different direct oral anticoagulants based on the spectrum of bleeding risk.
We aimed to compare the risk of major bleeding and thromboembolic events with apixaban vs rivaroxaban for AF patients stratified by bleeding risk.
We conducted a population-based, retrospective cohort study of all adult patients (66 years or older) with AF in Ontario, Canada, who were treated with apixaban or rivaroxaban between April 1, 2011, and March 31, 2020. Bleeding risk was estimated by the HAS-BLED score, with high bleeding risk defined as a score of ≥3. The primary safety outcome was major bleeding, and the primary efficacy outcome was thromboembolic events. Comparisons were adjusted for baseline comorbidities by inverse probability of treatment weighting.
This study included 18,156 AF patients with high bleeding risk and 55,186 AF patients with low bleeding risk. Apixaban use was more common in patients with high bleeding risk; 63% of high-risk patients used apixaban compared with 56% of low-risk patients. Apixaban users had lower rates of major bleeding in high-risk patients (2.9% vs 4.2% per year; hazard ratio [HR], 0.69; 95% CI, 0.58-0.81) and in low-risk patients (1.8% vs 2.9% per year; HR, 0.63; 95% CI, 0.56-0.70) compared with rivaroxaban. There were no differences in rates of thromboembolic events, 3.1% vs 3.0% per year (HR, 1.02; 95% CI, 0.86-1.22) in high-risk patients and 1.9% vs 1.9% per year (HR, 1.00; 95% CI, 0.89-1.14) in low-risk patients.
In older AF patients with high or low bleeding risk, treatment with apixaban was associated with lower rates of major bleeding with no difference in risk for thromboembolic events compared with rivaroxaban.
尽管许多心房颤动（AF）患者有出血风险，但基于出血风险谱，关于不同直接口服抗凝剂出血率的数据非常有限。
我们旨在比较阿哌沙班与利伐沙班在按出血风险分层的AF患者中发生大出血和血栓栓塞事件的风险。
我们对加拿大安大略省所有年龄在66岁及以上、在2011年4月1日至2020年3月31日期间接受阿哌沙班或利伐沙班治疗的成年AF患者进行了一项基于人群的回顾性队列研究。通过HAS - BLED评分评估出血风险，高出血风险定义为评分≥3分。主要安全结局是大出血，主要疗效结局是血栓栓塞事件。通过治疗权重的逆概率对基线合并症进行调整后进行比较。
本研究纳入了18156例高出血风险的AF患者和55186例低出血风险的AF患者。阿哌沙班在高出血风险患者中使用更为普遍；63% 的高风险患者使用阿哌沙班，而低风险患者中这一比例为56%。与利伐沙班相比，阿哌沙班使用者在高风险患者中的大出血发生率较低（每年2.9% 对4.2%；风险比[HR]，0.69；95% 置信区间[CI]，0.58 - 0.81），在低风险患者中也是如此（每年1.8% 对2.9%；HR，0.63；95% CI，0.56 - 0.70）。血栓栓塞事件发生率无差异，高风险患者中每年为3.1% 对3.0%（HR，1.02；95% CI，0.86 - 1.22），低风险患者中每年为1.9% 对1.9%（HR，1.00；95% CI，0.89 - 1.14）。
在出血风险高或低的老年AF患者中，与利伐沙班相比阿哌沙班治疗与大出血发生率较低相关，血栓栓塞事件风险无差异。
