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Rationale and design of amphilimus sirolimus‐eluting stents versus zotarolimus‐eluting stents in all‐comers requiring percutaneous coronary intervention (ReCre8): A multicenter randomized clinical trial

2017; Wiley; Volume: 91; Issue: 3 Linguagem: Inglês

10.1002/ccd.27142

1522-726X

Rik Rozemeijer, Mèra Stein, Peter Frambach, Michiel Voskuil, Adriaan O. Kraaijeveld, Ramón Rodríguez‐Olivares, Leo Timmers, Bruno Pereira, Saskia Z.H. Rittersma, Pierfrancesco Agostoni, Pieter A. Doevendans, Pieter R. Stella,

Cardiac Valve Diseases and Treatments

Abstract Background Amphilimus sirolimus‐eluting stents (A‐SES) represent a novel elution technology in the current era of drug‐eluting stents with promising results in patients with diabetes mellitus. At present no large trial has been designed to evaluate clinical outcomes of A‐SES as compared to new‐generation drug‐eluting stents in unselected patients. Accordingly, we designed this trial to evaluate clinical noninferiority of A‐SES as compared with zotarolimus‐eluting stents (ZES) in a real‐world, all‐comers setting. Study design ReCre8 is a prospective multicenter randomized clinical trial evaluating the clinical outcomes of A‐SES as compared with ZES in all‐comers requiring percutaneous coronary intervention. Patients are randomized 1:1 to receive either A‐SES or ZES. On‐site block‐randomization is stratified by diabetes mellitus, and troponin status to perform prespecified subanalyses. Patients receive 1‐month of dual antiplatelet therapy (DAPT) when troponin‐negative, or 12‐months of DAPT when troponin‐positive. The primary endpoint is target‐lesion failure at 1‐year follow‐up. A total of 1,532 patients will be enrolled to demonstrate clinical noninferiority of A‐SES with at least 80% power, a noninferiority margin of 3.5% and a type‐I‐error of 0.05. Conclusions ReCre8 (NCT02328898) is the first randomized multicenter trial with a head‐to‐head comparison of A‐SES as compared with ZES to investigate the clinical safety and efficacy of these new‐generation DES in a real‐world, all‐comers population.