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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.
JACC Cardiovasc Interv. 2014 Jan; 7(1):64-71.JC

Abstract

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).

Authors+Show Affiliations

University Hospital Clinic, IDIBAPS, Cardiology Department, Barcelona, Spain. Electronic address: masabate@clinic.ub.es.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.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

24332423

Citation

Sabaté, Manel, et al. "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." JACC. Cardiovascular Interventions, vol. 7, no. 1, 2014, pp. 64-71.
Sabaté M, Brugaletta S, Cequier A, et al. 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. JACC Cardiovasc Interv. 2014;7(1):64-71.
Sabaté, M., Brugaletta, S., Cequier, A., Iñiguez, A., Serra, A., Hernádez-Antolín, R., Mainar, V., Valgimigli, M., Tespili, M., den Heijer, P., Bethencourt, A., Vázquez, N., Backx, B., & Serruys, P. W. (2014). 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. JACC. Cardiovascular Interventions, 7(1), 64-71. https://doi.org/10.1016/j.jcin.2013.09.006
Sabaté M, et al. 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. JACC Cardiovasc Interv. 2014;7(1):64-71. PubMed PMID: 24332423.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Sabaté,Manel, AU - Brugaletta,Salvatore, AU - Cequier,Angel, AU - Iñiguez,Andrés, AU - Serra,Antonio, AU - Hernádez-Antolín,Rosana, AU - Mainar,Vicente, AU - Valgimigli,Marco, AU - Tespili,Maurizio, AU - den Heijer,Pieter, AU - Bethencourt,Armando, AU - Vázquez,Nicolás, AU - Backx,Bianca, AU - Serruys,Patrick W, Y1 - 2013/12/11/ PY - 2013/08/28/received PY - 2013/09/12/accepted PY - 2013/12/17/entrez PY - 2013/12/18/pubmed PY - 2014/9/30/medline KW - BMS KW - DES KW - EES KW - ST-segment elevation myocardial infarction KW - STEMI KW - bare-metal stent(s) KW - drug-eluting stent(s) KW - everolimus-eluting stent(s) KW - myocardial infarction KW - revascularization KW - stent(s) KW - thrombosis KW - trials SP - 64 EP - 71 JF - JACC. Cardiovascular interventions JO - JACC Cardiovasc Interv VL - 7 IS - 1 N2 - 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). SN - 1876-7605 UR - https://www.unboundmedicine.com/medline/citation/24332423/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1936-8798(13)01537-9 DB - PRIME DP - Unbound Medicine ER -