Lu Min, Li Jiaqi, Ni Huanyu, Qiao Tong, Wang Baoyan
Changshu No.2 People's Hospital, Affiliated Changshu Hospital of Nantong University, Changshu, Jiangsu, China.
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu, China.
Front Pharmacol. 2025 Jan 13;15:1485380. doi: 10.3389/fphar.2024.1485380. eCollection 2024.
To evaluate the efficacy and safety of clopidogrel-rivaroxaban combination compared to aspirin-rivaroxaban combination in patients with symptomatic peripheral artery disease (PAD).
Consecutive patients with symptomatic PAD patients were analyzed from January, 2018 to June, 2022 at Nanjing Drum Tower Hospital. Patients were divided into two groups based on the antithrombotic therapy. The primary efficacy outcome was a composite of major adverse cardiovascular events (MACE) and major adverse limb events (MALE), and the primary safety outcome was major bleeding. Patients were followed until the first occurrence of any outcomes or the study end date (30 June 2024).
A total of 695 patients were enrolled into this study. The clopidogrel-rivaroxaban combination significantly reduced the risk of composite outcome (HR: 0.59, 95%CI: 0.41-0.83) without increasing the risk of major bleeding (HR: 0.68, 95%CI: 0.27-1.69). When analyzed separately, clopidogrel-rivaroxaban combination was associated with a reduced risk of MALE (HR: 0.61, 95%CI: 0.41-0.91), although no significant differences were observed in terms of MACE (HR: 0.64, 95%CI: 0.34-1.20) or all bleeding events (HR: 1.00, 95%CI: 0.52-1.93). In the subgroup analysis, there were no significant interactions between the treatment groups and the subgroups of age, diabetes, lesion sites, Rutherford classifications and renal function for composite outcome, MACE and MALE.
The clopidogrel-rivaroxaban combination in PAD patients may offer enhanced cardiovascular protection without increasing the risk of bleeding complications. These findings suggested that clopidogrel could be a superior alternative to aspirin in dual antithrombotic therapy for PAD management.
评估在有症状的外周动脉疾病(PAD)患者中,氯吡格雷-利伐沙班联合用药相较于阿司匹林-利伐沙班联合用药的疗效和安全性。
对2018年1月至2022年6月期间在南京鼓楼医院连续收治的有症状PAD患者进行分析。根据抗血栓治疗方法将患者分为两组。主要疗效结局为主要不良心血管事件(MACE)和主要不良肢体事件(MALE)的复合结局,主要安全结局为大出血。对患者进行随访,直至首次出现任何结局或研究结束日期(2024年6月30日)。
本研究共纳入695例患者。氯吡格雷-利伐沙班联合用药显著降低了复合结局的风险(HR:0.59,95%CI:0.41-0.83),且未增加大出血风险(HR:0.68,95%CI:0.27-1.69)。单独分析时,氯吡格雷-利伐沙班联合用药与MALE风险降低相关(HR:0.61,95%CI:0.41-0.91),尽管在MACE(HR:0.64,95%CI:0.34-1.20)或所有出血事件方面未观察到显著差异(HR:1.00,95%CI:0.52-1.93)。在亚组分析中,治疗组与年龄、糖尿病、病变部位、卢瑟福分级和肾功能亚组之间在复合结局、MACE和MALE方面均无显著交互作用。
PAD患者使用氯吡格雷-利伐沙班联合用药可能在不增加出血并发症风险的情况下提供更强的心血管保护。这些发现表明,在PAD管理的双重抗血栓治疗中,氯吡格雷可能是阿司匹林的更好替代品。