10-Years Follow-up of the EXAMINATION Trial

Completed

• Conditions: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction; Necrosis; Heart Disease; Cardiovascular Diseases; Vascular Diseases
• Interventions: Device: Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm); Drug: Everolimus Eluting Coronary Stent System

• Registration Number: NCT04462315
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2020-07
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1498

Inclusion Criteria

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

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-drug eluting stent Arm	Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm)	Cobalt chromium balloon-expandable stent
Everolimus Arm	Everolimus Eluting Coronary Stent System	Everolimus Eluting Coronary Stent System

Primary Outcome Measures

Name	Time	Method
Patient-oriented Composite Endpoint (PoCE)	10 years	Rate of composite endpoint of all-cause death, any myocardial infarction, and any revascularization. Defined according to the Academic Research Consortium 1.

Secondary Outcome Measures

Name	Time	Method
Rate of all cause and cardiac mortality	10 years	Defined according to the Academic Research Consortium 1.
Rate of target lesion revascularization	10 years	Defined according to the Academic Research Consortium 1.
Rate of stent thrombosis	10 years	Defined according to the Academic Research Consortium 1.
Device-oriented Composite Endpoint (DoCE)	10 years	Rate of composite endpoint of cardiac death, Target vessel myocardial infarction, and Target lesion revascularization. Defined according to the Academic Research Consortium 1.
Rate of recurrent myocardial infarction	10 years	Defined according to the Academic Research Consortium 1.

Trial Locations

Locations (11)

Hospital General de Alicante; 🇪🇸 Alicante, Valencia, Spain

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Cataluña, Spain

Hospital Son Dureta; 🇪🇸 Palma De Mallorca, Mallorca, Spain

Azienda Ospedaliera Bolognini; 🇮🇹 Seriate, Bergamo, Italy

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Erasmus MC, Rotterdam; 🇳🇱 Rotterdam, Netherlands

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Cataluña, Spain

Azienda Ospedaliero Universitaria S. Anna di Ferrara; 🇮🇹 Ferrara, Italy

Complejo Hospitalario U. A Coruña; 🇪🇸 A Coruña, Galicia, Spain

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Galicia, Spain

Hospital de Bellvitge; 🇪🇸 Barcelona, Cataluña, Spain