Kaikita Koichi, Uchiyama Shinichiro, Atarashi Hirotsugu, Inoue Hiroshi, Kitazono Takanari, Yamashita Takeshi, Shimizu Wataru, Ikeda Takanori, Kamouchi Masahiro, Fukuda Koji, Origasa Hideki, Shimokawa Hiroaki
Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki.
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University.
J Atheroscler Thromb. 2025 Feb 1;32(2):176-187. doi: 10.5551/jat.64681. Epub 2024 Sep 28.
In this subanalysis of the EXPAND study, we evaluated the risks and benefits of rivaroxaban plus antiplatelet therapy (APT) for patients with non-valvular atrial fibrillation (NVAF) complicated by stable coronary artery disease (CAD), ischemic stroke, or peripheral artery disease (PAD).
From the EXPAND study population (n=7,141), patients with NVAF complicated by stable CAD (n=886), ischemic stroke (n=1,231), or PAD (n=160) were included. Patients complicated by any of them were set as ALL (n=2,030). Patients were all treated with rivaroxaban (10 or 15 mg/day) with (+) or without (-) APT. Efficacy outcomes were symptomatic stroke＋systemic embolism (SE), symptomatic stroke＋SE＋myocardial infarction＋cardiovascular death, and all-cause death. Safety outcomes included major and any bleeding. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated for differences between the APT(+) and APT(-) groups.
There were no significant differences in the efficacy outcomes between the APT(+) and APT(-) groups in the ALL cohort or in the CAD and STROKE sub-cohorts. In the PAD subcohort, the HR [95% CI] for all-cause death in the APT(+) group increased (4.43 [1.05-18.71]; p=0.043). In the APT(+) group, the HR [95% CI] for any bleeding increased in the ALL cohort (1.28 [1.01-1.62]; p=0.044) and STROKE subcohort (1.42 [1.01-2.01]; p=0.047), and for major bleeding in the CAD subcohort (2.00 [1.01-3.93]; p=0.046).
Rivaroxaban with APT did not reduce ischemic outcomes in patients with stable CAD or ischemic stroke; however, it did increase the risk of bleeding in patients with stable CAD or ischemic stroke.
在这项EXPAND研究的亚组分析中，我们评估了利伐沙班联合抗血小板治疗（APT）对合并稳定型冠状动脉疾病（CAD）、缺血性卒中或外周动脉疾病（PAD）的非瓣膜性心房颤动（NVAF）患者的风险和获益。
从EXPAND研究人群（n = 7141）中，纳入合并稳定型CAD（n = 886）、缺血性卒中（n = 1231）或PAD（n = 160）的NVAF患者。合并其中任何一种疾病的患者被归为ALL组（n = 2030）。所有患者均接受利伐沙班（10或15 mg/天）治疗，部分患者（+）联合APT，部分患者（-）不联合APT。疗效指标包括有症状性卒中＋全身性栓塞（SE）、有症状性卒中＋SE＋心肌梗死＋心血管死亡以及全因死亡。安全性指标包括大出血和任何出血事件。计算APT（+）组和APT（-）组之间差异的风险比（HR）和95%置信区间（CI）。
在ALL队列以及CAD和卒中亚组中，APT（+）组和APT（-）组的疗效指标无显著差异。在PAD亚组中，APT（+）组全因死亡的HR [95%CI]升高（4.43 [1.05 - 18.71]；p = 0.043）。在APT（+）组中，ALL队列（1.28 [1.01 - 1.62]；p = 0.044）和卒中亚组（1.42 [1.01 - 2.01]；p = 0.047）中任何出血的HR [95%CI]升高，CAD亚组中大出血的HR [95%CI]升高（2.00 [1.01 - 3.93]；p = 0.046）。
利伐沙班联合APT并未降低稳定型CAD或缺血性卒中患者的缺血性事件发生率；然而，它确实增加了稳定型CAD或缺血性卒中患者的出血风险。
