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

Salvatore Brugaletta*, Josep Gomez-Lara, Luis Ortega-Paz, Victor Jimenez-Diaz, Marcelo Jimenez, Pilar Jiménez-Quevedo, Roberto Diletti, Vicente Mainar, Gianluca Campo, Antonio Silvestro, Jaume Maristany, Xacobe Flores, Loreto Oyarzabal, Antonio De Miguel-Castro, Andrés Iñiguez, Antonio Serra, Luis Nombela-Franco, Alfonso Ielasi, Maurizio Tespili, Mattie LenzenNieves Gonzalo, Pascual Bordes, Matteo Tebaldi, Simone Biscaglia, Juan Jose Rodriguez-Arias, Soheil Al-Shaibani, Victor Arevalos, Rafael Romaguera, Joan Antoni Gomez-Hospital, Patrick W. Serruys, Manel Sabaté

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

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)

Original languageEnglish
Pages (from-to)1165-1178
Number of pages14
JournalJournal of the American College of Cardiology
Volume77
Issue number9
DOIs
Publication statusPublished - 9 Mar 2021

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