Cardiovascular Diseases, Heart Disease, Infarction, Myocardial Infarction, Necrosis, ST Elevation Myocardial Infarction, Vascular Diseases
Conditions
Keywords
Acute myocardial infarction, Primary Percutaneous Coronary Intervention, Drug-Eluting Stent
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.
Interventions
Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation
Cobalt chromium balloon-expandable stent (non-drug-eluting stent Arm) implantation
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients who were enrolled in the EXAMINATION trial (NCT00828087).
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 all cause and cardiac mortality | 10 years | Defined according to the Academic Research Consortium 1. |
| Rate of recurrent myocardial infarction | 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. |
Countries
Italy, Netherlands, Spain