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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus Arm | Everolimus Eluting Coronary Stent System |
| |
| Non-drug eluting stent Arm | Cobalt chromium balloon-expandable stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus Eluting Coronary Stent System | Drug | Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The EXAMINATION trial population was an all-comers population with ST-elevation myocardial infarction, representative of routine clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore Brugaletta, MD, PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Josep Gómez-Lara, MD, PhD | Hospital Universitari de Bellvitge | Principal Investigator |
| Luis Ortega-Paz, MD, PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Manel Sabaté, MD, PhD | Hospital Clinic of Barcelona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Bolognini | Seriate | Bergamo | 24068 | Italy | ||
| Azienda Ospedaliero Universitaria S. Anna di Ferrara |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22115622 | Background | Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez 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. | |
| 22951305 |
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Will be made available upon request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2018 | Sep 14, 2020 |
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| Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm) | Device | Cobalt chromium balloon-expandable stent (non-drug-eluting stent Arm) implantation |
|
|
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 |
| Ferrara |
| 44100 |
| Italy |
| Erasmus MC, Rotterdam | Rotterdam | 3015 GD | Netherlands |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalonia | 08025 | Spain |
| Hospital Clínic i Provincial de Barcelona | Barcelona | Catalonia | 08036 | Spain |
| Hospital de Bellvitge | Barcelona | Catalonia | 08907 | Spain |
| Complejo Hospitalario U. A Coruña | A Coruña | Galicia | 15006 | Spain |
| Hospital Álvaro Cunqueiro | Vigo | Galicia | 36214 | Spain |
| Hospital Son Dureta | Palma de Mallorca | Mallorca | 07014 | Spain |
| Hospital General de Alicante | Alicante | Valencia | 03010 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Background |
| Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gomez-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. |
| 26520230 | Background | Sabate M, Brugaletta S, Cequier A, Iniguez A, Serra A, Jimenez-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. |
| 17470709 | Background | 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. doi: 10.1161/CIRCULATIONAHA.106.685313. |
| 37506972 | Derived | Verardi FM, Bujak K, Tolomeo P, Gomez-Lara J, Jimenez-Diaz V, Jimenez M, Jimenez-Quevedo P, Diletti R, Bordes P, Campo G, Silvestro A, Maristany J, Flores X, de Miguel-Castro A, Iniguez A, Ielasi A, Tespili M, Lenzen M, Gonzalo N, Tebaldi M, Biscaglia S, Vidal-Cales P, Ortega-Paz L, Romaguera R, Gomez-Hospital JA, Serruys PW, Sabate M, Brugaletta S. Ten-year prognostic impact of target versus non-target vessel failure after STEMI. Insight from the EXAMINATION-EXTEND trial. Rev Esp Cardiol (Engl Ed). 2024 Mar;77(3):215-225. doi: 10.1016/j.rec.2023.07.001. Epub 2023 Jul 26. English, Spanish. |
| 36444863 | Derived | Spione F, Arevalos V, Gabani R, Ortega-Paz L, Gomez-Lara J, Jimenez-Diaz V, Jimenez M, Jimenez-Quevedo P, Diletti R, Pineda J, Campo G, Silvestro A, Maristany J, Flores X, Oyarzabal L, Bastos-Fernandez G, Iniguez A, Serra A, Escaned J, Ielasi A, Tespili M, Lenzen M, Gonzalo N, Bordes P, Tebaldi M, Biscaglia S, Al-Shaibani S, Romaguera R, Gomez-Hospital JA, Rodes-Cabau J, Serruys PW, Sabate M, Brugaletta S. Impact of Diabetes on 10-Year Outcomes Following ST-Segment-Elevation Myocardial Infarction: Insights From the EXAMINATION-EXTEND Trial. J Am Heart Assoc. 2022 Dec 6;11(23):e025885. doi: 10.1161/JAHA.122.025885. Epub 2022 Nov 29. |
| 36008267 | Derived | Gabani R, Spione F, Arevalos V, Grima Sopesens N, Ortega-Paz L, Gomez-Lara J, Jimenez-Diaz V, Jimenez M, Jimenez-Quevedo P, Diletti R, Pineda J, Campo G, Silvestro A, Maristany J, Flores X, Oyarzabal L, Bastos-Fernandez G, Iniguez A, Serra A, Escaned J, Ielasi A, Tespili M, Lenzen M, Gonzalo N, Bordes P, Tebaldi M, Biscaglia S, Al-Shaibani S, Romaguera R, Gomez-Hospital JA, Rodes-Cabau J, Serruys PW, Sabate M, Brugaletta S. Sex Differences in 10-Year Outcomes Following STEMI: A Subanalysis From the EXAMINATION-EXTEND Trial. JACC Cardiovasc Interv. 2022 Oct 10;15(19):1965-1973. doi: 10.1016/j.jcin.2022.07.038. Epub 2022 Aug 22. |
| 33663733 | Derived | Brugaletta S, Gomez-Lara J, Ortega-Paz L, Jimenez-Diaz V, Jimenez M, Jimenez-Quevedo P, Diletti R, Mainar V, Campo G, Silvestro A, Maristany J, Flores X, Oyarzabal L, De Miguel-Castro A, Iniguez A, Serra A, Nombela-Franco L, Ielasi A, Tespili M, Lenzen M, Gonzalo N, Bordes P, Tebaldi M, Biscaglia S, Rodriguez-Arias JJ, Al-Shaibani S, Arevalos V, Romaguera R, Gomez-Hospital JA, Serruys PW, Sabate M. 10-Year Follow-Up of Patients With Everolimus-Eluting Versus Bare-Metal Stents After ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2021 Mar 9;77(9):1165-1178. doi: 10.1016/j.jacc.2020.12.059. |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 12, 2018 | Sep 14, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| D007238 | Infarction |
| D009336 | Necrosis |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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