Author + information
- Received August 28, 2013
- Accepted September 12, 2013
- Published online January 1, 2014.
- Manel Sabaté, MD, PhD∗∗ (, )
- Salvatore Brugaletta, MD, PhD∗,
- Angel Cequier, MD, PhD†,
- Andrés Iñiguez, MD, PhD‡,
- Antonio Serra, MD, PhD§,
- Rosana Hernádez-Antolín, MD, PhD‖,
- Vicente Mainar, MD, PhD¶,
- Marco Valgimigli, MD, PhD#,
- Maurizio Tespili, MD, PhD∗∗,
- Pieter den Heijer, MD, PhD††,
- Armando Bethencourt, MD, PhD‡‡,
- Nicolás Vázquez, MD, PhD§§,
- Bianca Backx, RN‖‖ and
- Patrick W. Serruys, MD, PhD¶¶
- ∗University Hospital Clinic, IDIBAPS, Cardiology Department, Barcelona, Spain
- †University Hospital of Bellvitge, Interventional Cardiology Unit, Barcelona, Spain
- ‡Hospital do Meixoeiro, Interventional Cardiology Unit, Vigo, Spain
- §University Hospital of Sant Pau, Interventional Cardiology Unit, Barcelona, Spain
- ‖University Hospital San Carlos, Interventional Cardiology Unit, Madrid, Spain
- ¶Hospital General of Alicante, Interventional Cardiology Unit, Alicante, Spain
- #University Hospital Ferrara, Interventional Cardiology Unit, Ferrara, Italy
- ∗∗University Hospital Bolognini Seriate, Interventional Cardiology Unit, Bergamo, Italy
- ††Amphia Ziekenhuis, Interventional Cardiology Unit, Breda, the Netherlands
- ‡‡Hospital Son Espases, Interventional Cardiology Unit, Palma de Mallorca, Spain
- §§Hospital Juan Canalejo, Interventional Cardiology Unit, A Coruña, Spain
- ‖‖Erasmus Medical Center, Interventional Cardiology Unit, Rotterdam, the Netherlands
- ¶¶Cardialysis, Rotterdam, the Netherlands
- ↵∗Reprint requests and correspondence:
Dr. Manel Sabaté, Cardiology Department, Thorax Institute, IDIBAPS, University of Barcelona, Hospital Clinic, c/ Villarroel 170, 08036 Barcelona, Spain.
Objectives This study sought to assess the 2-year outcomes of the population included in the EXAMINATION (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction) trial beyond the 1-year prescription period of dual antiplatelet therapy.
Background The EXAMINATION trial compared the performance of everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population.
Methods This was a multicenter, multinational, prospective, randomized, single-blind, controlled trial in patients with STEMI. The primary endpoint, which was the combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularization, and the endpoints target lesion revascularization and stent thrombosis were assessed at 2 years.
Results Between December 31, 2008, and May 15, 2010, 1,498 patients were randomized to receive EES (n = 751) or BMS (n = 747). Compliance with dual antiplatelet regimen was reduced at 2 years to a similar degree (17.3% vs. 17.2%, p = 0.91). At 2 years, the primary endpoint occurred in 108 (14.4%) patients of the EES group and in 129 (17.3%) patients of the BMS group (p = 0.11). Rate of target lesion revascularization was significantly lower in the EES group than in the BMS group (2.9% vs. 5.6%; p = 0.009). Rates of definite and definite or probable stent thrombosis were also significantly reduced in the EES group (0.8% vs. 2.1%; p = 0.03, and 1.3% vs. 2.8%; p = 0.04, respectively).
Conclusions The 2-year follow-up of the EXAMINATION trial confirms the safety and efficacy of the EES compared with BMS in the setting of STEMI. Specifically, both rates of target lesion revascularization and stent thrombosis were reduced in recipients of EES without any signs of late attrition for either of these endpoints. (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction: EXAMINATION Study; NCT00828087)
Dr. Sabaté is a consultant for and has received speaker's fees from Abbott Vascular, Boston Scientific, and Medtronic. Dr. Brugaletta has received speaker's fees from Abbott Vascular and St. Jude Medical. Dr. Valgimigli has received honoraria as a public speaker for Terumo, The Medicines Company, Medtronic, Iroko, Merck & Co., Abbott, Eli Lilly and Company, AstraZeneca, Cordis, CID, and Bayer. Ms. Backx is an employee of Cardialysis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 28, 2013.
- Accepted September 12, 2013.
- American College of Cardiology Foundation