Chiou Wei-Ru, Huang Chun-Che, Lin Po-Lin, Chuang Jen-Yu, Liu Lawrence Yu-Min, Su Min-I, Liao Feng-Ching, Chen Chun-Yen, Kuo Jen-Yuan, Tsai Cheng-Ting, Wu Yih-Jer, Lee Ying-Hsiang
Division of Cardiology, Taitung MacKay Memorial Hospital, Taitung, Taiwan.
Department of Medicine, Mackay Medical College, New Taipei, Taiwan.
Am J Cardiovasc Drugs. 2021 Jul;21(4):459-469. doi: 10.1007/s40256-020-00454-6. Epub 2020 Dec 28.
Rivaroxaban reduces the risk of thromboembolism in atrial fibrillation (AF) patients, who often also receive antiarrhythmic drugs (AADs) to maintain sinus rhythm. Current guidelines contraindicate concomitant use of rivaroxaban with the popular AAD dronedarone, despite little data demonstrating interactions with AADs. This study investigates the outcomes of concomitant rivaroxaban and AAD drug use in a real-world cohort.
This retrospective study included 1777 non-permanent AF patients taking rivaroxaban for ≥ 1 month between 2011 and 2016 from a multicenter cohort in Taiwan, and compared concomitant AAD use against clinical outcome endpoints for safety, effectiveness, and major adverse cardiac events (MACE). Multivariate Cox proportional hazard analyses were used to evaluate the association between concomitant AAD use and outcomes.
Patients were divided into rivaroxaban alone (n = 1205) and with concomitant amiodarone (n = 177), dronedarone (n = 231), or propafenone (n = 164) groups. The proportion of patients using rivaroxaban 10 mg was highest in the concomitant dronedarone group: rivaroxaban alone, 53.6%; with amiodarone, 57.6%; with dronedarone, 77.1%; and with propafenone, 46.3% (p < 0.001). The cumulative incidences of safety (p = 0.892), effectiveness (p = 0.336), and MACE (p = 0.674) were similar between the four groups; however, there were significantly fewer new systemic thromboembolisms in the dronedarone group: rivaroxaban alone, 2.5%; with amiodarone, 0.6%; with dronedarone, 0%; and with propafenone, 1.2% (p = 0.029). The all-cause death rate was also lowest in the dronedarone group: rivaroxaban alone, 9.0%; with amiodarone, 9.6%; with dronedarone, 3.0%; and with propafenone: 6.1% (p = 0.013). After covariate adjustment, there were no differences in the safety, effectiveness, and MACE endpoints between patients receiving or not receiving AADs.
Concomitant use of rivaroxaban with AADs appears to be well tolerated, warranting further investigation into the apparent benefits of a reduced dose of rivaroxaban combined with dronedarone.
利伐沙班可降低心房颤动（AF）患者发生血栓栓塞的风险，这类患者通常也会使用抗心律失常药物（AADs）来维持窦性心律。尽管几乎没有数据表明利伐沙班与AADs之间存在相互作用，但当前指南仍禁止利伐沙班与常用的AADs决奈达隆联合使用。本研究调查了在真实世界队列中利伐沙班与AADs联合使用的结果。
这项回顾性研究纳入了2011年至2016年间来自台湾一个多中心队列的1777例服用利伐沙班≥1个月的非永久性AF患者，比较了联合使用AADs与临床结局终点在安全性、有效性和主要不良心脏事件（MACE）方面的情况。采用多变量Cox比例风险分析来评估联合使用AADs与结局之间的关联。
患者被分为单独使用利伐沙班组（n = 1205）以及联合使用胺碘酮组（n = 177）、决奈达隆组（n = 231）或普罗帕酮组（n = 164）。联合决奈达隆组使用10 mg利伐沙班的患者比例最高：单独使用利伐沙班组为53.6%；联合胺碘酮组为57.6%；联合决奈达隆组为77.1%；联合普罗帕酮组为46.3%（p < 0.001）。四组之间安全性（p = 0.892）、有效性（p = 0.336）和MACE（p = 0.674）的累积发生率相似；然而，决奈达隆组新发生的系统性血栓栓塞明显更少：单独使用利伐沙班组为2.5%；联合胺碘酮组为0.6%；联合决奈达隆组为0%；联合普罗帕酮组为1.2%（p = 0.029）。决奈达隆组的全因死亡率也最低：单独使用利伐沙班组为9.0%；联合胺碘酮组为9.6%；联合决奈达隆组为3.0%；联合普罗帕酮组为6.1%（p = 0.013）。在进行协变量调整后，接受或未接受AADs的患者在安全性、有效性和MACE终点方面没有差异。
利伐沙班与AADs联合使用似乎耐受性良好，有必要进一步研究降低剂量的利伐沙班与决奈达隆联合使用的明显益处。
