Department of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan.
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan; National Cerebral and Cardiovascular Center, Suita, Japan.
JACC Cardiovasc Interv. 2021 Nov 8;14(21):2330-2340. doi: 10.1016/j.jcin.2021.07.045.
The aim of this AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial subgroup analysis was to examine rivaroxaban monotherapy benefits and their relation to the time between stenting and enrollment among patients after coronary stenting.
Of 2,215 patients with atrial fibrillation and stable coronary artery disease in the AFIRE trial, rivaroxaban monotherapy was noninferior to rivaroxaban plus antiplatelet therapy (combination therapy) in terms of efficacy and superior for safety endpoints. However, thrombotic risk after antiplatelet therapy cessation remained a concern among 1,444 patients who had undergone coronary stenting >1 year before enrollment.
The benefits of rivaroxaban monotherapy in coronary stenting subgroups were assessed for efficacy (a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death of any cause), safety (major bleeding defined according to International Society on Thrombosis and Haemostasis criteria), ischemic endpoints, net adverse clinical event, and time between stenting and enrollment.
Efficacy and safety endpoints for monotherapy were superior to combination therapy, with HRs of 0.70 for efficacy (95% CI: 0.50-0.98; P = 0.036) and 0.55 for safety (95% CI: 0.33-0.92; P = 0.019). For ischemic endpoints, the HR was 0.82 (95% CI: 0.58-1.15; P = 0.240). The HR became smaller with longer time between stenting and enrollment (efficacy, P for interaction = 0.158; safety, P = 0.097).
In patients with atrial fibrillation after coronary stenting, the benefits of rivaroxaban monotherapy for efficacy and safety endpoints were consistent with those in the whole AFIRE trial population. The benefits became apparent with longer time between stenting and enrollment. (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study [AFIRE]; UMIN000016612, NCT02642419).
本项 AFIRE（稳定型冠状动脉疾病合并房颤患者应用利伐沙班）试验亚组分析的目的在于评估利伐沙班单药治疗的获益及其与接受经皮冠状动脉介入治疗（PCI）后患者的支架置入时间之间的关系。
在 AFIRE 试验的 2215 例合并房颤和稳定型冠状动脉疾病的患者中，与利伐沙班联合抗血小板治疗（联合治疗）相比，利伐沙班单药治疗在疗效方面不劣效，且安全性终点更优。然而，在 1444 例 PCI ＞1 年前入组的患者中，抗血小板治疗停药后的血栓形成风险仍然令人担忧。
评估利伐沙班单药治疗在 PCI 亚组中的获益情况，包括疗效（卒中和全身性栓塞、心肌梗死、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）、安全性（根据国际血栓与止血学会标准定义的大出血）、缺血性终点、净不良临床事件和支架置入与入组之间的时间。
单药治疗的疗效和安全性终点优于联合治疗，疗效的 HR 为 0.70（95%CI：0.50-0.98；P=0.036），安全性的 HR 为 0.55（95%CI：0.33-0.92；P=0.019）。对于缺血性终点，HR 为 0.82（95%CI：0.58-1.15；P=0.240）。支架置入与入组之间的时间越长，HR 越小（疗效，P 交互=0.158；安全性，P=0.097）。
在接受 PCI 后的房颤患者中，利伐沙班单药治疗在疗效和安全性终点的获益与 AFIRE 试验总体人群一致。支架置入与入组之间的时间越长，获益越明显。（稳定型冠状动脉疾病合并房颤患者应用利伐沙班研究[AFIRE]；UMIN000016612，NCT02642419）。
