Jorge Sanz-Sánchez, Sandra Santos Martínez, Eva Rumiz González, Juan Francisco Oteo Domínguez, David Tejada Ponce, Antonio Gómez Menchero, Guillermo Sánchez Elvira, Georgina Fuertes Ferre, Fernando Rivero Crespo, Antonela Lukic Otanovic, José Díaz Fernández, Eladio Galindo Fernández, Cristóbal Urbano Carrillo, Neus Salvatella Giralt, Mauricio Torres Sánchez, Arturo García Touchard, Borja Ibáñez Cabeza, Giulio Stefanini, Fernando Alfonso Manterola, Héctor García García, Ignacio J Amat-Santos
{"title":"Reduced stent strategy versus conventional percutaneous coronary revascularization in patients presenting with STEMI: the COPERNICAN trial.","authors":"Jorge Sanz-Sánchez, Sandra Santos Martínez, Eva Rumiz González, Juan Francisco Oteo Domínguez, David Tejada Ponce, Antonio Gómez Menchero, Guillermo Sánchez Elvira, Georgina Fuertes Ferre, Fernando Rivero Crespo, Antonela Lukic Otanovic, José Díaz Fernández, Eladio Galindo Fernández, Cristóbal Urbano Carrillo, Neus Salvatella Giralt, Mauricio Torres Sánchez, Arturo García Touchard, Borja Ibáñez Cabeza, Giulio Stefanini, Fernando Alfonso Manterola, Héctor García García, Ignacio J Amat-Santos","doi":"10.1016/j.rec.2025.05.005","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction and objectives: </strong>Primary percutaneous coronary intervention (PCI) with drug-eluting stent implantation (DES) is the standard of treatment in patients presenting with ST-segment elevation myocardial infarction (STEMI). However, target lesion failure can occur due to stent underexpansion, malapposition, hypersensitivity, fracture, and neoatherosclerosis. Drug-coated balloons (DCB) represent a potential alternative supported by the concept of \"leaving nothing behind.\" The aim is to compare a reduced stent strategy based on DCB- with DES-PCI in patients presenting with STEMI.</p><p><strong>Methods: </strong>Prospective, pragmatic, multicenter, noninferiority, randomized clinical trial.</p><p><strong>Results: </strong>A total of 1 272 patients presenting with STEMI will be randomized to any paclitaxel-DCB vs any sirolimus-DES (both with CE approval) for all culprit and nonculprit lesions during PCI. The primary endpoint will be target-lesion failure: cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization at 12-month follow-up. An independent clinical events committee masked to treatment allocation will adjudicate all suspected events. Clinical follow-up will be performed after 1 month (30 days ± 5 days) and 1 year (365 days ± 30 days). An extended follow-up at 3, 5, and 10 years is planned..</p><p><strong>Conclusions: </strong>The COPERNICAN trial will be the first randomized study comparing clinical outcomes of DCB vs DES in STEMI patients.</p><p><strong>Clinicaltrials: </strong>gov: NCT06353594.</p>","PeriodicalId":38430,"journal":{"name":"Revista española de cardiología (English ed.)","volume":" ","pages":""},"PeriodicalIF":7.2000,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Revista española de cardiología (English ed.)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.rec.2025.05.005","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction and objectives: Primary percutaneous coronary intervention (PCI) with drug-eluting stent implantation (DES) is the standard of treatment in patients presenting with ST-segment elevation myocardial infarction (STEMI). However, target lesion failure can occur due to stent underexpansion, malapposition, hypersensitivity, fracture, and neoatherosclerosis. Drug-coated balloons (DCB) represent a potential alternative supported by the concept of "leaving nothing behind." The aim is to compare a reduced stent strategy based on DCB- with DES-PCI in patients presenting with STEMI.
Results: A total of 1 272 patients presenting with STEMI will be randomized to any paclitaxel-DCB vs any sirolimus-DES (both with CE approval) for all culprit and nonculprit lesions during PCI. The primary endpoint will be target-lesion failure: cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization at 12-month follow-up. An independent clinical events committee masked to treatment allocation will adjudicate all suspected events. Clinical follow-up will be performed after 1 month (30 days ± 5 days) and 1 year (365 days ± 30 days). An extended follow-up at 3, 5, and 10 years is planned..
Conclusions: The COPERNICAN trial will be the first randomized study comparing clinical outcomes of DCB vs DES in STEMI patients.
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