Atreja Nipun, Dubey Anandkumar, Kang Amiee, Jiang Jenny, Hagan Melissa, Michael-Asalu Abimbola, Cheng Dong, Deitelzweig Steven
Bristol Myers Squibb, Lawrenceville, NJ, USA.
STATinMED LLC, Dallas, TX, USA.
Adv Ther. 2025 Mar;42(3):1462-1483. doi: 10.1007/s12325-024-03099-y. Epub 2025 Jan 30.
Atrial fibrillation (AF), a common heart rhythm abnormality, is linked to a higher risk of stroke. Traditionally, warfarin has been the primary anticoagulation treatment for reducing the stroke risk. The new standard of treatment by direct oral anticoagulants (DOACs) offers greater benefits including improved efficacy and fewer adverse effects with reduced monitoring. This study aims to evaluate the risk of stroke/systemic embolism (SE) and major bleeding (MB) among patients with AF who switched from warfarin to DOACs.
This study utilized Medicare data to conduct a retrospective analysis of patients with non-valvular atrial fibrillation (NVAF) who switched from warfarin to DOACs between January 1, 2012, and December 31, 2019. Patients with NVAF aged 65 and older who switched from warfarin and had continuous health plan enrollment were included. Descriptive statistics, propensity score matching (PSM), and Cox proportional hazard (PH) models were utilized to compare the outcomes and assess risks of SE and MB across the DOAC cohorts.
Among 1,843,495 patients with NVAF on warfarin, 171,700 switched to DOACs within 90 days of discontinuation (apixaban: 90,850; rivaroxaban: 67,698; dabigatran: 12,900). The mean follow-up period across DOAC cohorts ranged from 552 to 628 days. After PSM, apixaban showed significantly lower rates of stroke/SE compared to dabigatran (2.99% vs. 3.98%, p < 0.0001) and rivaroxaban (3.08% vs. 3.80%, p < 0.0001). MB rates were also lower with apixaban versus dabigatran (4.29% vs. 5.57%, p < 0.0001) and rivaroxaban (4.07% vs. 6.35%, p < 0.0001). Cox PH models confirmed these findings, with apixaban demonstrating lower risks of stroke/SE [hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.72-0.96 vs. dabigatran; HR 0.91, 95% CI 0.85-0.96 vs. rivaroxaban] and MB (HR 0.79, 95% CI 0.71-0.89 vs. dabigatran; HR 0.68, 95% CI 0.65-0.72 vs. rivaroxaban).
The risk of stroke/SE and MB varies significantly among patients with NVAF switching from warfarin to different DOACs, with apixaban presenting the lowest risk compared to dabigatran and rivaroxaban.
心房颤动(AF)是一种常见的心律失常,与中风风险较高相关。传统上,华法林一直是降低中风风险的主要抗凝治疗药物。直接口服抗凝剂(DOACs)的新治疗标准具有更大的益处,包括疗效提高、副作用减少以及监测需求降低。本研究旨在评估从华法林转换为DOACs的房颤患者发生中风/全身性栓塞(SE)和大出血(MB)的风险。
本研究利用医疗保险数据,对2012年1月1日至2019年12月31日期间从华法林转换为DOACs的非瓣膜性心房颤动(NVAF)患者进行回顾性分析。纳入年龄在65岁及以上、从华法林转换且持续参加健康计划的NVAF患者。采用描述性统计、倾向评分匹配(PSM)和Cox比例风险(PH)模型来比较结果,并评估各DOAC队列中SE和MB的风险。
在1,843,495名服用华法林的NVAF患者中,171,700人在停药后90天内转换为DOACs(阿哌沙班:90,850人;利伐沙班:67,698人;达比加群:12,900人)。各DOAC队列的平均随访期为552至628天。PSM后,与达比加群(2.99%对3.98%,p<0.0001)和利伐沙班(3.08%对3.80%,p<0.0001)相比,阿哌沙班的中风/SE发生率显著较低。与达比加群(4.29%对5.57%,p<0.0001)和利伐沙班(4.07%对6.35%,p<0.0001)相比,阿哌沙班的MB发生率也较低。Cox PH模型证实了这些发现,阿哌沙班的中风/SE风险较低[风险比(HR)0.83,95%置信区间(CI)0.72 - 0.96对比达比加群;HR 0.91,95%CI 0.85 - 0.96对比利伐沙班],MB风险也较低(HR 0.79,95%CI 0.71 - 0.89对比达比加群;HR 0.68,95%CI 0.65 - 0.72对比利伐沙班)。
从华法林转换为不同DOACs的NVAF患者中,中风/SE和MB的风险存在显著差异,与达比加群和利伐沙班相比,阿哌沙班的风险最低。