利伐沙班单药治疗与联合治疗在房颤和稳定型冠心病患者的卒中与出血风险中的比较：AFIRE 试验亚组分析。
Rivaroxaban monotherapy versus combination therapy according to patient risk of stroke and bleeding in atrial fibrillation and stable coronary disease: AFIRE trial subanalysis.
机构信息
Department of Cardiology, National Hospital Organization Kyoto Medical Center, Fushimi-ku, Kyoto, Japan.
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan; National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
出版信息
Am Heart J. 2021 Jun;236:59-68. doi: 10.1016/j.ahj.2021.02.021. Epub 2021 Feb 28.
BACKGROUND
In the AFIRE trial, rivaroxaban monotherapy was noninferior to combination therapy with rivaroxaban and an antiplatelet agent for thromboembolic events or death, and superior for major bleeding in patients with atrial fibrillation (AF) and stable coronary artery disease. Little is known about impacts of stroke and bleeding risks on the efficacy and safety of rivaroxaban monotherapy.
METHODS
In this subanalysis of the AFIRE trial, we assessed the risk of stroke and bleeding by the CHADS, CHADS-VASc, and HAS-BLED scores. The primary efficacy end point was the composite of stroke, systemic embolism, myocardial infarction (MI), unstable angina requiring revascularization, or death from any cause. The primary safety end point was major bleeding defined by the International Society on Thrombosis and Haemostasis.
RESULTS
Rivaroxaban monotherapy significantly reduced the primary efficacy and safety end points with no evidence of differential effects by stroke risk (CHADS, p for interaction = 0.727 for efficacy, 0.395 for safety; CHADS-VASc, p for interaction = 0.740 for efficacy, 0.265 for safety) or bleeding risk (HAS-BLED, p for interaction = 0.581 for efficacy, 0.225 for safety). There was also no evidence of statistical heterogeneity across patient risk categories for other end points; stroke or systemic embolism, ischemic stroke, hemorrhagic stroke, MI, MI or unstable angina, death from any cause, any bleeding, or net adverse clinical events.
CONCLUSIONS
The advantages of rivaroxaban monotherapy compared with those of combination therapy with respect to all prespecified end points, including thromboembolism, bleeding, and mortality were similar across patients with AF and stable coronary artery disease, irrespective of their risk for stroke and bleeding.
CLINICAL TRIAL REGISTRATION
UMIN Clinical Trials Registry number, UMIN000016612, and ClinicalTrials.gov number, NCT02642419.
背景
在 AFIRE 试验中，利伐沙班单药治疗在血栓栓塞事件或死亡方面不劣于利伐沙班联合抗血小板药物治疗，在伴有心房颤动 (AF) 和稳定型冠状动脉疾病的患者中，主要出血方面优于利伐沙班联合抗血小板药物治疗。对于利伐沙班单药治疗的疗效和安全性，卒中风险和出血风险的影响知之甚少。
方法
在 AFIRE 试验的这项亚分析中，我们根据 CHADS、CHADS-VASc 和 HAS-BLED 评分评估了卒中风险和出血风险。主要疗效终点是卒中、全身性栓塞、心肌梗死 (MI)、需要血运重建的不稳定型心绞痛或任何原因导致的死亡的复合终点。主要安全性终点是国际血栓和止血学会定义的大出血。
结果
利伐沙班单药治疗显著降低了主要疗效和安全性终点，且卒中风险（CHADS，疗效的交互 P 值=0.727，安全性的交互 P 值=0.395；CHADS-VASc，疗效的交互 P 值=0.740，安全性的交互 P 值=0.265）或出血风险（HAS-BLED，疗效的交互 P 值=0.581，安全性的交互 P 值=0.225）无差异。对于其他终点，在患者风险类别中也没有证据表明存在统计学异质性；卒中或全身性栓塞、缺血性卒中、出血性卒中、MI、MI 或不稳定型心绞痛、任何原因导致的死亡、任何出血或净不良临床事件。
结论
与联合治疗相比，利伐沙班单药治疗在所有预设终点方面的优势，包括血栓栓塞、出血和死亡率，在伴有 AF 和稳定型冠状动脉疾病的患者中是相似的，无论其卒中风险和出血风险如何。
临床试验注册
UMIN 临床研究注册编号，UMIN000016612，和 ClinicalTrials.gov 编号，NCT02642419。
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