TY - JOUR
T1 - 10-Year Follow-Up of Patients With Everolimus-Eluting Versus Bare-Metal Stents After ST-Segment Elevation Myocardial Infarction
AU - Brugaletta, Salvatore
AU - Gomez-Lara, Josep
AU - Ortega-Paz, Luis
AU - Jimenez-Diaz, Victor
AU - Jimenez, Marcelo
AU - Jiménez-Quevedo, Pilar
AU - Diletti, Roberto
AU - Mainar, Vicente
AU - Campo, Gianluca
AU - Silvestro, Antonio
AU - Maristany, Jaume
AU - Flores, Xacobe
AU - Oyarzabal, Loreto
AU - De Miguel-Castro, Antonio
AU - Iñiguez, Andrés
AU - Serra, Antonio
AU - Nombela-Franco, Luis
AU - Ielasi, Alfonso
AU - Tespili, Maurizio
AU - Lenzen, Mattie
AU - Gonzalo, Nieves
AU - Bordes, Pascual
AU - Tebaldi, Matteo
AU - Biscaglia, Simone
AU - Rodriguez-Arias, Juan Jose
AU - Al-Shaibani, Soheil
AU - Arevalos, Victor
AU - Romaguera, Rafael
AU - Gomez-Hospital, Joan Antoni
AU - Serruys, Patrick W.
AU - Sabaté, Manel
N1 - Funding Information:
The EXAMINATION trial was partially funded by an unrestricted grant from Abbott Vascular to the Spanish Heart Foundation (promoter) during the first 5 years of follow-up. The EXAMINATION-EXTEND study was funded by an unrestricted grant from Abbott Vascular to the Spanish Heart Foundation (promoter). Dr. Brugaletta is a consultant for Boston Scientific and iVascular. Dr. Sabaté has receiving consulting and speaker fees from Abbott Vascular and iVascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright: © 2021 American College of Cardiology Foundation
PY - 2021/3/9
Y1 - 2021/3/9
N2 - 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)
AB - 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)
UR - http://www.scopus.com/inward/record.url?scp=85101379776&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2020.12.059
DO - 10.1016/j.jacc.2020.12.059
M3 - Article
C2 - 33663733
AN - SCOPUS:85101379776
SN - 0735-1097
VL - 77
SP - 1165
EP - 1178
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 9
ER -