Journal Article

Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial

den Heijer, Peter, Vazquez, Nicolás, Serra, Antonio, Backx, Bianca, Mainar, Vicente, van Es, Gerrit Anne, Iñiguez, Andrés, Jiménez-Quevedo, Pilar, Campo, Gianluca, Bethencourt, Armando, Tespili, Maurizio, Brugaletta, Salvatore, Cequier, Angel, Sabaté, Manel, Valgimigli, Marco, Serruys, Patrick W

2016

Overview

Data for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial. In the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1:1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087. 1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0·80, 95% CI 0·65–0·98; p=0·033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0·72, 0·52–0·10; p=0·047). Our findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction. Spanish Heart Foundation.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Aged / Cause of Death / Clinical outcomes / Drug-Eluting Stents / Endpoint Determination / Europe - epidemiology / Everolimus - administration & dosage / Female / Follow-Up Studies / Heart attacks / Humans / Internal Medicine / Kaplan-Meier Estimate / Male / Metals / Mortality / Myocardial infarction / Myocardial Infarction - epidemiology / Myocardial Infarction - therapy / Myocardial Revascularization - statistics & numerical data / Patient Outcome Assessment / Patients / Polymers / Prospective Studies / Single-Blind Method / Stents / Thrombosis / Thrombosis - epidemiology