The EXAMINATION trial (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction): 2-year results from a multicenter randomized controlled trial.
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).
['Sabaté|Manel|M|', 'Brugaletta|Salvatore|S|', 'Cequier|Angel|A|', 'Iñiguez|Andrés|A|', 'Serra|Antonio|A|', 'Hernádez-Antolín|Rosana|R|', 'Mainar|Vicente|V|', 'Valgimigli|Marco|M|', 'Tespili|Maurizio|M|', 'den Heijer|Pieter|P|', 'Bethencourt|Armando|A|', 'Vázquez|Nicolás|N|', 'Backx|Bianca|B|', 'Serruys|Patrick W|PW|']
D000368:Aged D002317:Cardiovascular Agents D003328:Coronary Thrombosis D004334:Drug Administration Schedule D004359:Drug Therapy, Combination D054855:Drug-Eluting Stents D005060:Europe D000068338:Everolimus D005260:Female D006801:Humans D008297:Male D008875:Middle Aged D009203:Myocardial Infarction D062645:Percutaneous Coronary Intervention D010975:Platelet Aggregation Inhibitors D011446:Prospective Studies D011474:Prosthesis Design D012008:Recurrence D016037:Single-Blind Method D020123:Sirolimus D013997:Time Factors D016896:Treatment Outcome
trials ST-segment elevation myocardial infarction myocardial infarction EES BMS STEMI revascularization thrombosis DES bare-metal stent(s) drug-eluting stent(s) everolimus-eluting stent(s) stent(s)