Clinical trial NCT04462315: 10-Years Follow-up of the EXAMINATION Trial
Official title: Ten-year Follow-up of the Clinical Evaluation of Everolimus-Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction: EXAMINATION-EXTEND Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Necrosis
Heart Disease
Cardiovascular Diseases
Vascular Diseases
Keywords: Acute myocardial infarction
Primary Percutaneous Coronary Intervention
Drug-Eluting Stent
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 1498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The EXAMINATION trial population was an all-comers population with ST-elevation myocardial infarction, representative of routine clinical practice.

Brief summary: The EXAMINATION trial was a superiority trial that compared everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population. The patient-oriented endpoint was not superior at 1-year, but it was at 5-year. However, very-long term follow-up is unknown. The study had an independent Clinical event Committee (CEC). All events were adjudicated by an independent clinical committee, according to the Academic Research Consortium 1.


Eligibility criteria: Inclusion Criteria:

* Patients who were enrolled in the EXAMINATION trial (NCT00828087).

Exclusion Criteria:

* None.

Primary outcomes:
measure: Patient-oriented Composite Endpoint (PoCE)
timeFrame: 10 years
Secondary outcomes:
measure: Device-oriented Composite Endpoint (DoCE)
timeFrame: 10 years
measure: Rate of all cause and cardiac mortality
timeFrame: 10 years
measure: Rate of recurrent myocardial infarction
timeFrame: 10 years
measure: Rate of target lesion revascularization
timeFrame: 10 years
measure: Rate of stent thrombosis
timeFrame: 10 years
Other outcomes:
Locations:
city: Seriate
country: Italy
facility: Azienda Ospedaliera Bolognini
state: Bergamo
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria S. Anna di Ferrara
city: Rotterdam
country: Netherlands
facility: Erasmus MC, Rotterdam
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
state: Cataluña
city: A Coruña
country: Spain
facility: Complejo Hospitalario U. A Coruña
state: Galicia
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Galicia
city: Palma De Mallorca
country: Spain
facility: Hospital Son Dureta
state: Mallorca
city: Alicante
country: Spain
facility: Hospital General de Alicante
state: Valencia
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Salvatore Brugaletta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari de Bellvitge
name: Josep Gómez-Lara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Luis Ortega-Paz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Manel Sabaté, MD, PhD
role: STUDY_CHAIR
References:
citation: Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Brugaletta S, Backx B, Serruys P. 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. EuroIntervention. 2011 Dec;7(8):977-84. doi: 10.4244/EIJV7I8A154.
citation: Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gomez-Hospital JA, Baz JA, Martin-Yuste V, van Geuns RJ, Alfonso F, Bordes P, Tebaldi M, Masotti M, Silvestro A, Backx B, Brugaletta S, van Es GA, Serruys PW. Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet. 2012 Oct 27;380(9852):1482-90. doi: 10.1016/S0140-6736(12)61223-9. Epub 2012 Sep 3.
citation: Sabate M, Brugaletta S, Cequier A, Iniguez A, Serra A, Jimenez-Quevedo P, Mainar V, Campo G, Tespili M, den Heijer P, Bethencourt A, Vazquez N, van Es GA, Backx B, Valgimigli M, Serruys PW. Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial. Lancet. 2016 Jan 23;387(10016):357-366. doi: 10.1016/S0140-6736(15)00548-6. Epub 2015 Oct 29.
citation: Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.
citation: Gabani R, Spione F, Arevalos V, Grima Sopesens N, Ortega-Paz L, Gomez-Lara J, Jimenez-Diaz V, Jimenez M, Jimenez-Quevedo P, Diletti R, Pineda J, Campo G, Silvestro A, Maristany J, Flores X, Oyarzabal L, Bastos-Fernandez G, Iniguez A, Serra A, Escaned J, Ielasi A, Tespili M, Lenzen M, Gonzalo N, Bordes P, Tebaldi M, Biscaglia S, Al-Shaibani S, Romaguera R, Gomez-Hospital JA, Rodes-Cabau J, Serruys PW, Sabate M, Brugaletta S. Sex Differences in 10-Year Outcomes Following STEMI: A Subanalysis From the EXAMINATION-EXTEND Trial. JACC Cardiovasc Interv. 2022 Oct 10;15(19):1965-1973. doi: 10.1016/j.jcin.2022.07.038. Epub 2022 Aug 22.
citation: Brugaletta S, Gomez-Lara J, Ortega-Paz L, Jimenez-Diaz V, Jimenez M, Jimenez-Quevedo P, Diletti R, Mainar V, Campo G, Silvestro A, Maristany J, Flores X, Oyarzabal L, De Miguel-Castro A, Iniguez A, Serra A, Nombela-Franco L, Ielasi A, Tespili M, Lenzen M, Gonzalo N, Bordes P, Tebaldi M, Biscaglia S, Rodriguez-Arias JJ, Al-Shaibani S, Arevalos V, Romaguera R, Gomez-Hospital JA, Serruys PW, Sabate M. 10-Year Follow-Up of Patients With Everolimus-Eluting Versus Bare-Metal Stents After ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2021 Mar 9;77(9):1165-1178. doi: 10.1016/j.jacc.2020.12.059.