Paradies Valeria, Van Mieghem Nicolas M, Oemrawsingh Rohit M, Richardt Gert, Esposito Giovanni, Campo Gianluca, Burzotta Francesco, Canova Paolo, Linke Axel, Porto Italo, Trabattoni Daniela, Teeuwen Koen, Adriaenssens Tom, Kala Petr, Stankovic Goran, Vliet Ria van, Giacoppo Daniele, Daemen Joost, Smits Pieter C
Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands.
Department of Cardiology, Cardiovascular Institute, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
EuroIntervention. 2025 May 16;21(10):571-580. doi: 10.4244/EIJ-D-24-00829.
Monotherapy with a potent P2Y receptor antagonist after 1 month of dual antiplatelet therapy (DAPT) may reduce bleeding in the absence of increased ischaemic events compared to 12-month DAPT in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). PCI guidance with optical coherence tomography (OCT) may enhance stent expansion. COMPARE STEMI ONE is an international, multicentre, open-label, randomised controlled trial. In 1,656 ST-segment elevation myocardial infarction (STEMI) patients, prasugrel monotherapy after 1 month of DAPT, as compared to standard 12-month prasugrel-based DAPT, will be tested for non-inferiority for the primary composite endpoint of net adverse clinical events - defined as all-cause death, myocardial infarction, stroke, or Bleeding Academic Research Consortium Type 3 or 5 bleeding events - at 11 months after randomisation. Furthermore, an ancillary substudy will test the superiority of OCT-guided versus angiography-guided staged complete revascularisation in achieving a larger minimal stent area (MSA) in non-culprit lesions during staged procedures. COMPARE STEMI ONE is the first randomised controlled trial assessing an abbreviated 1-month DAPT regimen followed by prasugrel monotherapy in the context of STEMI. The trial will also study the value of OCT-guided PCI in terms of the MSA of non-culprit lesions and may elucidate potential synergies between intravascular imaging-guided PCI and abbreviated DAPT regimens. (ClinicalTrials.gov: NCT05491200).
在接受经皮冠状动脉介入治疗（PCI）的急性冠状动脉综合征患者中，与12个月的双联抗血小板治疗（DAPT）相比，在1个月的DAPT后使用强效P2Y受体拮抗剂进行单药治疗，可能在不增加缺血事件的情况下减少出血。光学相干断层扫描（OCT）指导的PCI可能会增强支架扩张。COMPARE STEMI ONE是一项国际多中心、开放标签的随机对照试验。在1656例ST段抬高型心肌梗死（STEMI）患者中，将对1个月DAPT后的普拉格雷单药治疗与标准的基于普拉格雷的12个月DAPT进行比较，以检验随机分组后11个月时净不良临床事件的主要复合终点（定义为全因死亡、心肌梗死、中风或出血学术研究联盟3型或5型出血事件）的非劣效性。此外，一项辅助亚研究将检验在分期手术中，OCT指导与血管造影指导的分期完全血运重建在非罪犯病变中实现更大最小支架面积（MSA）方面的优越性。COMPARE STEMI ONE是第一项评估在STEMI背景下采用1个月简短DAPT方案后再进行普拉格雷单药治疗的随机对照试验。该试验还将研究OCT指导的PCI在非罪犯病变MSA方面的价值，并可能阐明血管内成像指导的PCI与简短DAPT方案之间的潜在协同作用。（ClinicalTrials.gov：NCT05491200）
