目前,急性心肌梗死(MI)后接受经皮冠状动脉介入治疗(PCI)的患者的标准治疗包括双联抗血小板治疗(DAPT)以及阿司匹林和一种有效的P2Y12受体抑制剂的联合治疗.然而,阿司匹林的潜在益处部分受到部分患者不耐受的限制.吲哚布芬的安全性和有效性,一种替代阿司匹林的抗血小板药物,PCI术后AMI患者的临床研究尚待彻底.这项回顾性研究是在单个中心进行的,并利用了倾向评分匹配。招募时间为2019年1月至2022年6月,纳入PCI后AMI患者。根据出院处方将参与者分为两组:阿司匹林DAPT组和吲哚布芬DAPT组。主要终点集中在净不良临床事件(NACE),定义为复合结果,包括心脏死亡,MI复发,明确或可能的支架血栓形成(ST),靶病变血运重建(TLR),缺血性卒中和出血学术研究联盟(BARC)标准类型2、3或5.所有患者均接受了一年的随访。本研究共纳入1451例患者,258人被分配到吲哚布芬DAPT组,1193人被分配到阿司匹林DAPT组。在1:1倾向得分匹配之后,每组保留224名患者。在IndobufenDAPT组中,58人(25.9%)在一年内经历了主要终点,与阿司匹林DAPT组52例(23.2%)相比(HR1.128,95%CI0.776-1.639,p=.527).具体来说,在疗效终点(MACCE,20.1%vs.14.7%,HR1.392,95%CI0.893-2.170,p=.146)或安全终点(BARC2,3或5,8.04%与10.30%,HR0.779,p=.427)。这些发现在1、3或6个月时保持一致。此外,与阿司匹林DAPT组相比,吲哚布芬DAPT组的胃肠道症状发生率显着降低(7.1%vs.14.3%,p=.022)。我们的研究表明,吲哚布芬在中国AMI患者PCI术后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的潜在优势,我们建议将其作为不耐受阿司匹林的个体的可行替代方案。
上下文是什么?目前,对于急性心肌梗死后接受经皮冠状动脉介入治疗的患者,标准治疗包括联合使用阿司匹林和强效P2Y12受体抑制剂的双重抗血小板治疗.然而,阿司匹林的潜在益处部分受到部分患者不耐受的限制.吲哚布芬的安全性和有效性,一种替代阿司匹林的抗血小板药物,PCI术后AMI患者的临床研究尚待彻底.什么是新的?虽然美国和欧洲的临床指南都推荐使用吲哚布芬作为不能耐受阿司匹林的患者的替代疗法,关于这个问题的研究有限。我们的研究首次通过比较吲哚布芬和阿司匹林在AMI患者中的疗效和安全性来解决这一差距。我们的研究表明,吲哚布芬在中国AMI患者PCI术后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的潜在优势,我们建议将其作为不耐受阿司匹林的个体的可行替代方案。这些发现可能为进一步探索AMI患者阿司匹林替代品铺平道路。
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, p = .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, p = .146) or the safety endpoint (BARC 2,3 or 5, 8.04% vs. 10.30%, HR 0.779, p = .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%, p = .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.
What is the context? Currently, the standard treatment for patients who have undergone percutaneous coronary intervention following acute myocardial infarction involves dual antiplatelet therapy 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.What is new? While both American and European clinical guidelines recommend the use of indobufen as an alternative treatment for patients who cannot tolerate aspirin, there exists a limited body of research on this subject.Our research is the first to address this gap by comparing the efficacy and safety of indobufen and aspirin in patients with AMI.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.What is the impact? These findings might pave the way for further exploration of alternatives to aspirin in patients with AMI.