Clinical Research
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

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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)

Key Words

myocardial infarction
revascularization
stent(s)
thrombosis
trials

Abbreviations and Acronyms

BMS
bare-metal stent(s)
DES
drug-eluting stent(s)
EES
everolimus-eluting stent(s)
STEMI
ST-segment elevation myocardial infarction

Cited by (0)

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.