Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.
Institute for Global Health Sciences, University of California, San Francisco, USA.
Platelets. 2024 Dec;35(1):2364748. doi: 10.1080/09537104.2024.2364748. Epub 2024 Jun 19.
Currently, the standard treatment for patients who have undergone percutaneous coronary intervention (PCI) following acute myocardial infarction (MI) involves dual antiplatelet therapy (DAPT) with a combination of aspirin and a potent P2Y12 receptor inhibitor. However, the potential benefits of aspirin were partially constrained by the intolerance of some patients. The safety and efficacy of indobufen, an alternative antiplatelet agents to aspirin, in patients with AMI after PCI are yet to be thoroughly investigated.This retrospective study was conducted at a single center and utilized propensity score matching. The enrollment spanned from January 2019 to June 2022, incorporating patients with AMI after PCI. The participants were categorized into two groups based on discharged prescriptions: the aspirin DAPT group and the indobufen DAPT group. The primary endpoint focused on net adverse clinical event (NACE), defined as a composite outcome, including cardiac death, recurrence of MI, definite or probable stent thrombosis (ST), target lesion revascularization (TLR), ischemic stroke and Bleeding Academic Research Consortium (BARC) criteria type 2, 3, or 5. All the patients underwent a one-year follow-up period.A total of 1451 patients were enrolled in this study, with 258 assigned to the indobufen DAPT group and 1193 to the aspirin DAPT group. Following 1:1 propensity score matching, 224 patients were retained in each group. In the indobufen DAPT group, 58 individuals (25.9%) experienced the primary endpoint within one year, compared to 52 individuals (23.2%) in the aspirin DAPT group (HR 1.128, 95% CI 0.776-1.639, = .527). Specifically, no significant differences were observed in either the efficacy endpoint (MACCE, 20.1% vs. 14.7%, HR 1.392, 95% CI 0.893-2.170, = .146) or the safety endpoint (BARC 2,3 or 5, 8.04% vs. 10.30%, HR 0.779, = .427). These findings remained consistent at 1, 3, or 6 months. Additionally, the incidence of gastrointestinal symptoms were significantly lower in indobufen DAPT group compared to the aspirin DAPT group (7.1% vs. 14.3%, = .022).Our research reveals that the efficacy and safety of indobufen are comparable to aspirin in Chinese patients with AMI following PCI. Given the potential advantages of indobufen in alleviating gastrointestinal symptoms, we propose it as a viable alternative for individuals intolerant to aspirin.
目前,急性心肌梗死(MI)经皮冠状动脉介入治疗(PCI)后的标准治疗包括双重抗血小板治疗(DAPT),即阿司匹林联合一种强效 P2Y12 受体抑制剂。然而,由于部分患者不耐受阿司匹林,其潜在获益受到了一定限制。吲哚布芬作为阿司匹林的替代抗血小板药物,在 PCI 后 AMI 患者中的安全性和有效性尚未得到充分研究。
本研究为单中心回顾性研究,采用倾向性评分匹配法。纳入 2019 年 1 月至 2022 年 6 月 PCI 后 AMI 患者,根据出院时的处方分为阿司匹林 DAPT 组和吲哚布芬 DAPT 组。主要终点为净不良临床事件(NACE),定义为包括心脏死亡、再发心肌梗死、明确或可能的支架血栓形成(ST)、靶病变血运重建(TLR)、缺血性卒中以及 Bleeding Academic Research Consortium(BARC)标准 2、3 或 5 型的复合结局。所有患者均接受为期 1 年的随访。
共纳入 1451 例患者,其中吲哚布芬 DAPT 组 258 例,阿司匹林 DAPT 组 1193 例。1:1 倾向性评分匹配后,每组各保留 224 例患者。吲哚布芬 DAPT 组 1 年内发生主要终点事件 58 例(25.9%),阿司匹林 DAPT 组 52 例(23.2%)(HR 1.128,95%CI 0.776-1.639, = 0.527)。具体来说,两组在疗效终点(MACCE,20.1%比 14.7%,HR 1.392,95%CI 0.893-2.170, = 0.146)和安全性终点(BARC 2、3 或 5 型,8.04%比 10.30%,HR 0.779, = 0.427)均无显著差异。在 1、3 或 6 个月时,结果仍保持一致。此外,吲哚布芬 DAPT 组胃肠道症状发生率明显低于阿司匹林 DAPT 组(7.1%比 14.3%, = 0.022)。
本研究表明,吲哚布芬在中国 PCI 后 AMI 患者中的疗效和安全性与阿司匹林相当。鉴于吲哚布芬在缓解胃肠道症状方面具有潜在优势,我们建议将其作为不耐受阿司匹林患者的一种可行替代药物。