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10-Years Follow-up of the EXAMINATION Trial

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04462315
Acronym
EXAMINAT10N
Enrollment
1498
Registered
2020-07-08
Start date
2015-05-01
Completion date
2020-05-31
Last updated
2022-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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

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

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None.

Design outcomes

Primary

MeasureTime frameDescription
Patient-oriented Composite Endpoint (PoCE)10 yearsRate of composite endpoint of all-cause death, any myocardial infarction, and any revascularization. Defined according to the Academic Research Consortium 1.

Secondary

MeasureTime frameDescription
Device-oriented Composite Endpoint (DoCE)10 yearsRate 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 mortality10 yearsDefined according to the Academic Research Consortium 1.
Rate of recurrent myocardial infarction10 yearsDefined according to the Academic Research Consortium 1.
Rate of target lesion revascularization10 yearsDefined according to the Academic Research Consortium 1.
Rate of stent thrombosis10 yearsDefined according to the Academic Research Consortium 1.

Countries

Italy, Netherlands, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026