10-Years Follow-up of the EXAMINATION Trial

NCT ID: NCT04462315

Last Updated: 2022-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1498 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-01

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction ST Elevation Myocardial Infarction Infarction Necrosis Heart Disease Cardiovascular Diseases Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Everolimus Arm

Everolimus Eluting Coronary Stent System

Everolimus Eluting Coronary Stent System

Intervention Type DRUG

Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation

Non-drug eluting stent Arm

Cobalt chromium balloon-expandable stent

Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm)

Intervention Type DEVICE

Cobalt chromium balloon-expandable stent (non-drug-eluting stent Arm) implantation

Interventions

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Everolimus Eluting Coronary Stent System

Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation

Intervention Type DRUG

Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm)

Cobalt chromium balloon-expandable stent (non-drug-eluting stent Arm) implantation

Intervention Type DEVICE

Other Intervention Names

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N/H N/H

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Salvatore Brugaletta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Josep Gómez-Lara, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge

Luis Ortega-Paz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Manel Sabaté, MD, PhD

Role: STUDY_CHAIR

Hospital Clinic of Barcelona

Locations

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Azienda Ospedaliera Bolognini

Seriate, Bergamo, Italy

Site Status

Azienda Ospedaliero Universitaria S. Anna di Ferrara

Ferrara, , Italy

Site Status

Erasmus MC, Rotterdam

Rotterdam, , Netherlands

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Site Status

Hospital Clínic i Provincial de Barcelona

Barcelona, Catalonia, Spain

Site Status

Hospital de Bellvitge

Barcelona, Catalonia, Spain

Site Status

Complejo Hospitalario U. A Coruña

A Coruña, Galicia, Spain

Site Status

Hospital Álvaro Cunqueiro

Vigo, Galicia, Spain

Site Status

Hospital Son Dureta

Palma de Mallorca, Mallorca, Spain

Site Status

Hospital General de Alicante

Alicante, Valencia, Spain

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Countries

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Italy Netherlands Spain

References

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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.

Reference Type BACKGROUND
PMID: 22115622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22951305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26520230 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17470709 (View on PubMed)

Verardi FM, Bujak K, Tolomeo P, Gomez-Lara J, Jimenez-Diaz V, Jimenez M, Jimenez-Quevedo P, Diletti R, Bordes P, Campo G, Silvestro A, Maristany J, Flores X, de Miguel-Castro A, Iniguez A, Ielasi A, Tespili M, Lenzen M, Gonzalo N, Tebaldi M, Biscaglia S, Vidal-Cales P, Ortega-Paz L, Romaguera R, Gomez-Hospital JA, Serruys PW, Sabate M, Brugaletta S. Ten-year prognostic impact of target versus non-target vessel failure after STEMI. Insight from the EXAMINATION-EXTEND trial. Rev Esp Cardiol (Engl Ed). 2024 Mar;77(3):215-225. doi: 10.1016/j.rec.2023.07.001. Epub 2023 Jul 26. English, Spanish.

Reference Type DERIVED
PMID: 37506972 (View on PubMed)

Spione F, Arevalos V, Gabani R, 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. Impact of Diabetes on 10-Year Outcomes Following ST-Segment-Elevation Myocardial Infarction: Insights From the EXAMINATION-EXTEND Trial. J Am Heart Assoc. 2022 Dec 6;11(23):e025885. doi: 10.1161/JAHA.122.025885. Epub 2022 Nov 29.

Reference Type DERIVED
PMID: 36444863 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36008267 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33663733 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HCB/2018/0906

Identifier Type: -

Identifier Source: org_study_id

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