10-Years Follow-up of the EXAMINATION Trial

Cardiovascular Diseases Clinical Trial

— EXAMINAT10N  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04462315
• Other study ID #: HCB/2018/0906
• Status: Completed
• Start date: May 1, 2015
• Est. completion date: May 31, 2020

Study information

• Verified date: July 2020
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1498
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Everolimus Eluting Coronary Stent System
Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation

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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria S. Anna di Ferrara	Ferrara
Italy	Azienda Ospedaliera Bolognini	Seriate	Bergamo
Netherlands	Erasmus MC, Rotterdam	Rotterdam
Spain	Complejo Hospitalario U. A Coruña	A Coruña	Galicia
Spain	Hospital General de Alicante	Alicante	Valencia
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona	Cataluña
Spain	Hospital de Bellvitge	Barcelona	Cataluña
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Cataluña
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Son Dureta	Palma De Mallorca	Mallorca
Spain	Hospital Álvaro Cunqueiro	Vigo	Galicia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Countries where clinical trial is conducted

Italy,  Netherlands,  Spain, 

References & Publications (4)

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. — View Citation

Sabaté M, Brugaletta S, Cequier A, Iñiguez A, Serra A, Jiménez-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. — View Citation

Sabaté M, Cequier A, Iñiguez A, Serra A, Hernández-Antolín R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vázquez 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. — View Citation

Sabate M, Cequier A, Iñiguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gómez-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rate of all cause and cardiac mortality	Defined according to the Academic Research Consortium 1.	10 years
Secondary	Rate of recurrent myocardial infarction	Defined according to the Academic Research Consortium 1.	10 years
Secondary	Rate of target lesion revascularization	Defined according to the Academic Research Consortium 1.	10 years
Secondary	Rate of stent thrombosis	Defined according to the Academic Research Consortium 1.	10 years