10-Year Follow-Up of Patients With Everolimus-Eluting Versus Bare-Metal Stents After ST-Segment Elevation Myocardial Infarction

BACKGROUND Outcomes data for a durable-polymer everolimus-eluting stent (EES) at extended long-term follow-up in patients with ST-segment elevation myocardial infarction (STEMI) are unknown. OBJECTIVES The aim of this study was to assess the 10-year outcomes of patients enrolled in the EXAMINATION (...

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Detalhes bibliográficos
Autores: 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
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Recursos:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
Repositorio:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
OAI Identifier:oai:isabial.fundanetsuite.com:p7759
Acesso em linha:https://isabial.portalinvestigacion.com/publicaciones7759
https://reader.elsevier.com/reader/sd/pii/S073510972100019X?token=B817C7680CED0EB28E0166E6E73085D481A827E137273A2711A9A0F683EC2ED080503FCDAF41E2E6E2618AB78853EFD5&originRegion=eu-west-1&originCreation=20220321130838
Access Level:acceso abierto
Palavra-chave:everolimus
randomized controlled trial
stent
stent thrombosis
ST-segment elevation myocardial infarction
Descrição
Resumo:BACKGROUND Outcomes data for a durable-polymer everolimus-eluting stent (EES) at extended long-term follow-up in patients with ST-segment elevation myocardial infarction (STEMI) are unknown. OBJECTIVES The aim of this study was to assess the 10-year outcomes of patients enrolled in the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial. METHODS The EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION Trial) study is an investigator-driven 10-year follow-up of the EXAMINATION trial, which randomly assigned 1,498 patients with STEMI in a 1:1 ratio to receive either EES (n = 751) or bare-metal stents (n = 747). The primary endpoint was a patient-oriented composite endpoint of all-cause death, any myocardial infarction, or any revascularization. Secondary endpoints included a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, or target lesion revascularization; the individual components of the combined endpoints; and stent thrombosis. RESULTS Complete 10-year clinical follow-up was obtained in 94.5% of the EES group and 95.9% of the bare-metal stent group. Rates of the patient-oriented composite endpoint and device-oriented composite endpoint were significantly reduced in the EES group (32.4% vs. 38.0% [hazard ratio: 0.81; 95% confidence interval: 0.68 to 0.96; p = 0.013] and 13.6% vs. 18.4% [hazard ratio: 0.72; 95% confidence interval: 0.55 to 0.93; p = 0.012], respectively), driven mainly by target lesion revascularization (5.7% vs. 8.8%; p = 0.018). The rate of definite stent thrombosis was similar in both groups (2.2% vs. 2.5%; p = 0.590). No differences were found between the groups in terms of target lesion revascularization (1.4% vs. 1.3%; p = 0.963) and definite or probable stent thrombosis (0.6% vs. 0.4%; p = 0.703) between 5 and 10 years. CONCLUSIONS At 10-year follow-up, EES demonstrated confirmed superiority in combined patient- and device-oriented composite endpoints compared with bare-metal stents in patients with STEMI requiring primary percutaneous coronary intervention. Between 5- and 10-year follow-up, a low incidence of adverse cardiovascular events related to device failure was found in both groups. (10-Years Follow-Up of the EXAMINATION Trial; NCT04462315) (c) 2021 by the American College of Cardiology Foundation.