10-Years Follow-up of the EXAMINATION Trial

Study Overview
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Everolimus Eluting Coronary Stent System
* Device: Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were enrolled in the EXAMINATION trial (NCT00828087). Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Everolimus Arm<br>Everolimus Eluting Coronary Stent System | Drug: Everolimus Eluting Coronary Stent System<br>* Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation<br>* Other names: N/H;|
| Non-drug eluting stent Arm<br>Cobalt chromium balloon-expandable stent | Device: Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm)<br>* Cobalt chromium balloon-expandable stent (non-drug-eluting stent Arm) implantation<br>* Other names: N/H;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute myocardial infarction, Primary Percutaneous Coronary Intervention, Drug-Eluting Stent