Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan.
Department of Cardiovascular Medicine, Juntendo Tokyo Koto Geriatric Medical Center, Koto-Ku, Tokyo, Japan.
JAMA Cardiol. 2022 Aug 1;7(8):787-794. doi: 10.1001/jamacardio.2022.1561.
Appropriate regimens of antithrombotic therapy for patients with atrial fibrillation (AF) and coronary artery disease (CAD) have not yet been established.
To compare the total number of thrombotic and/or bleeding events between rivaroxaban monotherapy and combined rivaroxaban and antiplatelet therapy in such patients.
DESIGN, SETTING, AND PARTICIPANTS: This was a post hoc secondary analysis of the Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease (AFIRE) open-label, randomized clinical trial. This multicenter analysis was conducted from February 23, 2015, to July 31, 2018. Patients with AF and stable CAD who had undergone percutaneous coronary intervention or coronary artery bypass grafting 1 or more years earlier or who had angiographically confirmed CAD not requiring revascularization were enrolled. Data were analyzed from September 1, 2020, to March 26, 2021.
Rivaroxaban monotherapy or combined rivaroxaban and antiplatelet therapy.
The total incidence of thrombotic, bleeding, and fatal events was compared between the groups. Cox regression analyses were used to estimate the risk of subsequent events in the 2 groups, with the status of thrombotic or bleeding events that had occurred by the time of death used as a time-dependent variable.
A total of 2215 patients (mean [SD] age, 74 [8.2] years; 1751 men [79.1%]) were included in the modified intention-to-treat analysis. The total event rates for the rivaroxaban monotherapy group (1107 [50.0%]) and the combination-therapy group (1108 [50.0%]) were 12.2% (135 of 1107) and 19.2% (213 of 1108), respectively, during a median follow-up of 24.1 (IQR, 17.3-31.5) months. The mortality rate was 3.7% (41 of 1107) in the monotherapy group and 6.6% (73 of 1108) in the combination-therapy group. Rivaroxaban monotherapy was associated with a lower risk of total events compared with combination therapy (hazard ratio, 0.62; 95% CI, 0.48-0.80; P < .001). Monotherapy was an independent factor associated with a lower risk of subsequent events compared with combination therapy. The mortality risk after a bleeding event (monotherapy, 75% [6 of 8]; combination therapy, 62.1% [18 of 29]) was higher than that after a thrombotic event (monotherapy, 25% [2 of 8]; combination therapy, 37.9% [11 of 29]).
Rivaroxaban monotherapy was associated with lower risks of total thrombotic and/or bleeding events than combination therapy in patients with AF and stable CAD. Tapered antithrombotic therapy with a sole anticoagulant should be considered in these patients.
ClinicalTrials.gov Identifier: NCT02642419.
对于患有心房颤动（AF）和冠状动脉疾病（CAD）的患者，尚未确定适当的抗血栓治疗方案。
比较利伐沙班单药治疗与联合利伐沙班和抗血小板治疗在这类患者中的血栓和/或出血事件总发生率。
设计、地点和参与者：这是一项对正在进行的、开放标签、随机临床试验（AFIRE）的事后二次分析。该多中心分析于 2015 年 2 月 23 日至 2018 年 7 月 31 日进行。入选的患者为 AF 合并稳定 CAD，且在 1 年或以上前经皮冠状动脉介入治疗或冠状动脉旁路移植术治疗，或经血管造影证实无需血运重建的 CAD。数据分析于 2020 年 9 月 1 日至 2021 年 3 月 26 日进行。
利伐沙班单药治疗或联合利伐沙班和抗血小板治疗。
比较两组间总的血栓、出血和致死性事件发生率。采用 Cox 回归分析估计两组后续事件的风险，以死亡时已发生的血栓或出血事件状态作为时依变量。
共有 2215 例患者（平均[SD]年龄，74[8.2]岁；1751 例男性[79.1%]）纳入改良意向治疗分析。利伐沙班单药治疗组（1107 例[50.0%]）和联合治疗组（1108 例[50.0%]）的总事件发生率分别为 12.2%（135/1107）和 19.2%（213/1108），中位随访时间为 24.1（IQR，17.3-31.5）个月。单药治疗组死亡率为 3.7%（41/1107），联合治疗组为 6.6%（73/1108）。与联合治疗相比，利伐沙班单药治疗与较低的总事件风险相关（风险比，0.62；95%CI，0.48-0.80；P<0.001）。单药治疗是与联合治疗相比，后续事件风险较低的独立因素。出血事件后（单药治疗组，75%[6/8]；联合治疗组，62.1%[18/29]）的死亡率高于血栓事件后（单药治疗组，25%[2/8]；联合治疗组，37.9%[11/29]）。
对于 AF 和稳定 CAD 患者，与联合治疗相比，利伐沙班单药治疗与较低的总血栓和/或出血事件风险相关。对于这些患者，应考虑采用仅抗凝的抗血栓治疗方案。
ClinicalTrials.gov 标识符：NCT02642419。
