Danbee Kang, Ki Hong Choi, Hyejeong Park, Jihye Heo, Taek Kyu Park, Joo Myung Lee, Juhee Cho, Jeong Hoon Yang, Young Bin Song, Seung-Hyuk Choi, Hyeon-Cheol Gwon, Joo-Yong Hahn
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Patients were matched using a large-scale propensity score (PS) algorithm according to the co-prescription of PPIs. The primary efficacy endpoint was major gastrointestinal bleeding requiring transfusion with hospitalisation within 1 year. The primary safety endpoint was major adverse cardiac and cerebrovascular events (MACCE), a composite of cardiovascular death, spontaneous myocardial infarction, repeat revascularisation and ischaemic stroke within 1 year.</p><p><strong>Results: </strong>Among the total population, 30.0% of patients (n=35,566) received PPIs with DAPT after PCI for AMI. After PS matching, 35,560 pairs were generated. Compared to patients without PPIs, those on PPIs were associated with a significantly lower 1-year risk of major gastrointestinal bleeding (0.7% vs 0.4%, hazard ratio [HR] 0.59, 95% confidence interval [CI]: 0.48-0.73). The 1-year risk of MACCE did not differ significantly between the groups with or without PPIs (13.4% vs 13.1%, HR 0.98, 95% CI: 0.94-1.02). The beneficial effects of PPIs on gastrointestinal bleeding, without increased risk of cardiovascular events, were observed consistently, regardless of P2Y<sub>12</sub> inhibitor type, PPI type, or individual bleeding risk.</p><p><strong>Conclusions: </strong>In real-world data from a large study of East Asian patients with AMI undergoing PCI and maintaining DAPT, PPI use significantly reduced the risk of major gastrointestinal bleeding without increasing ischaemic events, irrespective of bleeding risk or type of P2Y<sub>12</sub> inhibitor. 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引用次数: 0
摘要
背景:对于双重抗血小板治疗(DAPT)患者常规使用质子泵抑制剂(PPIs),欧洲和美国的指南建议存在差异。目的:本研究旨在探讨急性心肌梗死(AMI)患者行经皮冠状动脉介入治疗(PCI)时,PPIs与DAPT合用与胃肠道出血及缺血事件发生的关系。方法:使用韩国全国索赔数据库进行搜索,以确定AMI患者接受PCI与DAPT。使用大规模倾向评分(PS)算法根据PPIs的共同处方对患者进行匹配。主要疗效终点为1年内住院需要输血的消化道大出血。主要安全性终点是主要心脑血管不良事件(MACCE),即1年内心血管死亡、自发性心肌梗死、重复血运重建和缺血性卒中的复合指标。结果:在总人口中,30.0%的患者(n=35,566)在AMI PCI术后接受了PPIs和DAPT。PS匹配后,共生成35560对。与未服用PPIs的患者相比,服用PPIs的患者1年内发生胃肠大出血的风险显著降低(0.7% vs 0.4%,风险比[HR] 0.59, 95%可信区间[CI]: 0.48-0.73)。1年MACCE风险在有或没有PPIs组之间没有显著差异(13.4% vs 13.1%, HR 0.98, 95% CI: 0.94-1.02)。无论P2Y12抑制剂类型、PPI类型或个体出血风险如何,PPIs对胃肠道出血的有益作用都是一致的,且没有增加心血管事件的风险。结论:在一项东亚AMI患者接受PCI并维持DAPT的大型研究中,PPI的使用显著降低了主要胃肠道出血的风险,而不增加缺血事件,与出血风险或P2Y12抑制剂的类型无关。(ClinicalTrials.gov: NCT06241833)。
Effects of proton pump inhibitors on gastrointestinal bleeding and cardiovascular outcomes in myocardial infarction patients treated with DAPT.
Background: A discrepancy exists between the European and American guideline recommendations for the routine use of proton pump inhibitors (PPIs) in patients treated with dual antiplatelet therapy (DAPT).
Aims: This study aimed to determine the association between the co-prescription of PPIs and DAPT and the occurrence of gastrointestinal bleeding and ischaemic events in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI).
Methods: A search was conducted using a nationwide Korean claims database to identify patients with AMI undergoing PCI with DAPT. Patients were matched using a large-scale propensity score (PS) algorithm according to the co-prescription of PPIs. The primary efficacy endpoint was major gastrointestinal bleeding requiring transfusion with hospitalisation within 1 year. The primary safety endpoint was major adverse cardiac and cerebrovascular events (MACCE), a composite of cardiovascular death, spontaneous myocardial infarction, repeat revascularisation and ischaemic stroke within 1 year.
Results: Among the total population, 30.0% of patients (n=35,566) received PPIs with DAPT after PCI for AMI. After PS matching, 35,560 pairs were generated. Compared to patients without PPIs, those on PPIs were associated with a significantly lower 1-year risk of major gastrointestinal bleeding (0.7% vs 0.4%, hazard ratio [HR] 0.59, 95% confidence interval [CI]: 0.48-0.73). The 1-year risk of MACCE did not differ significantly between the groups with or without PPIs (13.4% vs 13.1%, HR 0.98, 95% CI: 0.94-1.02). The beneficial effects of PPIs on gastrointestinal bleeding, without increased risk of cardiovascular events, were observed consistently, regardless of P2Y12 inhibitor type, PPI type, or individual bleeding risk.
Conclusions: In real-world data from a large study of East Asian patients with AMI undergoing PCI and maintaining DAPT, PPI use significantly reduced the risk of major gastrointestinal bleeding without increasing ischaemic events, irrespective of bleeding risk or type of P2Y12 inhibitor. (ClinicalTrials.gov: NCT06241833).
期刊介绍:
EuroIntervention Journal is an international, English language, peer-reviewed journal whose aim is to create a community of high quality research and education in the field of percutaneous and surgical cardiovascular interventions.