Rationale and design of the EXAMINATION trial: a randomised comparison between everolimus-eluting stents and cobalt-chromium bare-metal stents in ST-elevation myocardial infarction
Manel Sabaté, Angel Cequier, Andrés Iñiguez, Antonio Serra, Rosana Hernández-Antolín, Vicente Mainar, Marco Valgimigli, Maurizio Tespili, Pieter den Heijer, Armando Bethencourt, Nicolás Vázquez, Salvatore Brugaletta, Bianca Backx, Patrick Serruys, Manel Sabaté, Angel Cequier, Andrés Iñiguez, Antonio Serra, Rosana Hernández-Antolín, Vicente Mainar, Marco Valgimigli, Maurizio Tespili, Pieter den Heijer, Armando Bethencourt, Nicolás Vázquez, Salvatore Brugaletta, Bianca Backx, Patrick Serruys
Abstract
Aims: To assess the performance of the everolimus-eluting stent (EES) versus cobalt chromium bare-metal stent (BMS) in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI). The implantation of a drug-eluting stent in the setting of an acute myocardial infarction is still controversial. In several registries this clinical scenario has been associated with the development of stent thrombosis. The EES has demonstrated to reduce the stent thrombosis rate as compared to paclitaxel-eluting stent in randomised controlled trials, mainly performed in patients in stable clinical conditions. There are however few data regarding the effectiveness of EES in the context of STEMI.
Methods and results: This is an investigator-driven, prospective, multicentre, multinational, randomised, single blind, two-arm, controlled trial (ClinicalTrials.gov number: NCT00828087). This trial, with an all comer design, randomises approximately 1,500 patients 1:1 to EES or BMS. Overall, any patient presenting with STEMI up to 48 hours who requires emergent percutaneous coronary intervention can be included. The primary endpoint is the patient-oriented combined endpoint of all-cause death, any myocardial infarction and any revascularisation at 1-year according to the Academic Research Consortium. Clinical follow-up will be scheduled at 30 days, six months, one year and yearly up to five years. No angiographic follow-up is mandated per protocol.
Conclusions: This trial with broad inclusion and few exclusion criteria will shed light on the performance of the second generation EES in the complex scenario of STEMI.
Source: PubMed