Ren Yu, Zhu Yanwu, Yan Qiaoyan, Jin Hui, Luo Hua
Department of Pharmacy, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou, Zhejiang, China.
Department of Orthopedic, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou, Zhejiang, China.
Front Pharmacol. 2024 Sep 30;15:1474150. doi: 10.3389/fphar.2024.1474150. eCollection 2024.
Coronary artery bypass grafting (CABG) is essential for treating coronary artery disease, with postoperative aspirin crucial to prevent graft restenosis. However, its gastrointestinal side effects may limit tolerability in some patients. Indobufen presents a potential alternative, but its safety and efficacy need further validation. This study aimed to compare the efficacy and safety of indobufen aspirin in patients' post-CABG.
This retrospective observational study included 39 patients who underwent CABG at two centers from January to December 2023. Patients were retrospectively assigned to two groups based on the antiplatelet therapy they received: the indobufen group (n = 19) and the aspirin group (n = 20). The primary endpoint was a composite of non-fatal myocardial infarction, stroke, and revascularization due to acute coronary syndrome in the intention-to-treat population. Postoperative data on platelet count, hemoglobin, D-dimer, activated partial thromboplastin time (APTT), and hospital stay length were collected. Transfusion rate, bleeding, thrombotic events, and gastrointestinal adverse reactions were compared between the two groups.
Over the 8-to-18-month follow-up period, 5 patients (25%) in the aspirin group reached the primary endpoint, while none in the indobufen group did, a difference that was statistically significant ( = 0.02). Although the rates of non-fatal myocardial infarction, revascularization, stroke, and thrombotic events were higher in the aspirin group, these differences did not reach statistical significance. Importantly, the total bleeding events were markedly lower in the indobufen group (15.79% vs. 55%, = 0.011), with major bleeding events also significantly reduced in the indobufen group (0% vs. 20%, = 0.04). Both groups showed no significant differences were observed in postoperative hospital stay, hemoglobin, and D-dimer levels between the groups. However, the indobufen group demonstrated significantly lower platelet count and APTT. The average daily cost of indobufen was 27.8 times higher than that of aspirin.
Indobufen demonstrates a comparable antiplatelet effect to aspirin and offers significant advantages in reducing gastrointestinal adverse reactions and bleeding risk. It can be considered a preferable alternative for patients who cannot tolerate or have contraindications to aspirin. Further large-scale clinical trials are needed to confirm its potential as the first-choice antiplatelet therapy post-CABG.
冠状动脉旁路移植术(CABG)是治疗冠状动脉疾病的关键手段,术后使用阿司匹林对于预防移植血管再狭窄至关重要。然而,其胃肠道副作用可能会限制部分患者的耐受性。吲哚布芬是一种潜在的替代药物,但其安全性和有效性仍需进一步验证。本研究旨在比较吲哚布芬与阿司匹林在冠状动脉旁路移植术患者中的疗效和安全性。
这项回顾性观察性研究纳入了2023年1月至12月在两个中心接受冠状动脉旁路移植术的39例患者。根据患者接受的抗血小板治疗方法,将患者回顾性地分为两组:吲哚布芬组(n = 19)和阿司匹林组(n = 20)。主要终点是意向性治疗人群中因急性冠状动脉综合征导致的非致命性心肌梗死、中风和血运重建的复合终点。收集术后血小板计数、血红蛋白、D - 二聚体、活化部分凝血活酶时间(APTT)和住院时间的数据。比较两组之间的输血率、出血、血栓形成事件和胃肠道不良反应。
在8至18个月的随访期内,阿司匹林组有5例患者(25%)达到主要终点,而吲哚布芬组无患者达到,差异具有统计学意义(P = 0.02)。虽然阿司匹林组的非致命性心肌梗死、血运重建、中风和血栓形成事件的发生率较高,但这些差异未达到统计学意义。重要的是,吲哚布芬组的总出血事件明显更低(15.79%对55%,P = 0.011),吲哚布芬组的大出血事件也显著减少(0%对20%,P = 0.04)。两组在术后住院时间、血红蛋白和D - 二聚体水平方面均未观察到显著差异。然而,吲哚布芬组的血小板计数和APTT明显更低。吲哚布芬的日均费用比阿司匹林高27.8倍。
吲哚布芬显示出与阿司匹林相当的抗血小板作用,在减少胃肠道不良反应和出血风险方面具有显著优势。对于不能耐受阿司匹林或有阿司匹林禁忌证的患者,可考虑将其作为更优的替代药物。需要进一步的大规模临床试验来证实其作为冠状动脉旁路移植术后首选抗血小板治疗的潜力。