NCT04462315

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,498

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
3 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
Last Updated

September 1, 2022

Status Verified

July 1, 2020

Enrollment Period

5.1 years

First QC Date

July 2, 2020

Last Update Submit

August 29, 2022

Conditions

Myocardial InfarctionST Elevation Myocardial InfarctionInfarctionNecrosisHeart DiseaseCardiovascular DiseasesVascular Diseases

Keywords

Acute myocardial infarctionPrimary Percutaneous Coronary InterventionDrug-Eluting Stent

Outcome Measures

Primary Outcomes (1)

  • Patient-oriented Composite Endpoint (PoCE)

    Rate of composite endpoint of all-cause death, any myocardial infarction, and any revascularization. Defined according to the Academic Research Consortium 1.

    10 years

Secondary Outcomes (5)

  • Device-oriented Composite Endpoint (DoCE)

    10 years

  • Rate of all cause and cardiac mortality

    10 years

  • Rate of recurrent myocardial infarction

    10 years

  • Rate of target lesion revascularization

    10 years

  • Rate of stent thrombosis

    10 years

Study Arms (2)

Everolimus Arm

Everolimus Eluting Coronary Stent System

Drug: Everolimus Eluting Coronary Stent System

Non-drug eluting stent Arm

Cobalt chromium balloon-expandable stent

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

Interventions

Everolimus Eluting Coronary Stent SystemDRUG

Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation

Also known as: N/H
Everolimus Arm
Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm)DEVICE

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

Also known as: N/H
Non-drug eluting stent Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The EXAMINATION trial population was an all-comers population with ST-elevation myocardial infarction, representative of routine clinical practice.

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Azienda Ospedaliera Bolognini

Seriate, Bergamo, 24068, Italy

Location

Azienda Ospedaliero Universitaria S. Anna di Ferrara

Ferrara, 44100, Italy

Location

Erasmus MC, Rotterdam

Rotterdam, 3015 GD, Netherlands

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Hospital de Bellvitge

Barcelona, Catalonia, 08907, Spain

Location

Complejo Hospitalario U. A Coruña

A Coruña, Galicia, 15006, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Galicia, 36214, Spain

Location

Hospital Son Dureta

Palma de Mallorca, Mallorca, 07014, Spain

Location

Hospital General de Alicante

Alicante, Valencia, 03010, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Related Publications (8)

  • 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.

    PMID: 22115622BACKGROUND

  • 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.

    PMID: 22951305BACKGROUND

  • 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.

    PMID: 26520230BACKGROUND

  • 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.

    PMID: 17470709BACKGROUND

  • 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.

    PMID: 37506972DERIVED

  • 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.

    PMID: 36444863DERIVED

  • 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.

    PMID: 36008267DERIVED

  • 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.

    PMID: 33663733DERIVED

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial InfarctionInfarctionNecrosisHeart DiseasesCardiovascular DiseasesVascular Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaIschemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Salvatore Brugaletta, MD, PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

  • Josep Gómez-Lara, MD, PhD

    Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

  • Luis Ortega-Paz, MD, PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

  • Manel Sabaté, MD, PhD

    Hospital Clinic of Barcelona

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 8, 2020

Study Start

May 1, 2015

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

September 1, 2022

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Will be made available upon request.

Locations

ES(8)IT(2)NL(1)