Sex Differences in 10-Year Outcomes Following STEMI: A Subanalysis From the EXAMINATION-EXTEND Trial.


Journal

JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004

Informations de publication

Date de publication:
10 10 2022
Historique:
received: 19 04 2022
revised: 21 07 2022
accepted: 26 07 2022
pubmed: 26 8 2022
medline: 12 10 2022
entrez: 25 8 2022
Statut: ppublish

Résumé

Short-term outcomes following ST-segment elevation myocardial infarction (STEMI) in women are worse than in men, with a higher mortality rate. It is unknown whether sex plays a role in very long term outcomes. The aim of this study was to assess whether very long term outcomes following STEMI treatment are influenced by sex. EXAMINATION-EXTEND (10-Year Follow-Up of the EXAMINATION Trial) was an investigator-driven 10-year follow-up of the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial, which randomly 1:1 assigned 1,498 patients with STEMI to receive either everolimus-eluting stents or bare-metal stents. The present study was a subanalysis according to sex. The primary endpoint was the composite patient-oriented endpoint (all-cause death, any myocardial infarction, or any revascularization) at 10 years. Secondary endpoints were individual components of the primary endpoint. All endpoints were adjusted for age. Among 1,498 patients with STEMI, 254 (17%) were women. Overall, women were older, with more arterial hypertension and less smoking history than men. At 10 years, no difference was observed between women and men for the patient-oriented composite endpoint (40.6% vs 34.2%; adjusted HR: 1.14; 95% CI: 0.91-1.42; P = 0.259). There was a trend toward higher all-cause death in women vs men (27.6% vs 19.4%; adjusted HR: 1.30; 95% CI: 0.99-1.71; P = 0.063), with no difference in cardiac death or other endpoints. At very long term follow-up, there were no differences in the combined patient-oriented endpoint between women and men, with a trend toward higher all-cause death in women not driven by cardiac death. The present findings underline the need for focused personalized medicine in women after percutaneous revascularization aimed at both cardiovascular and sex-specific risk factor control and targeted treatment. (10-Years Follow-Up of the EXAMINATION Trial [EXAMINAT10N]; NCT04462315).

Sections du résumé

BACKGROUND
Short-term outcomes following ST-segment elevation myocardial infarction (STEMI) in women are worse than in men, with a higher mortality rate. It is unknown whether sex plays a role in very long term outcomes.
OBJECTIVES
The aim of this study was to assess whether very long term outcomes following STEMI treatment are influenced by sex.
METHODS
EXAMINATION-EXTEND (10-Year Follow-Up of the EXAMINATION Trial) was an investigator-driven 10-year follow-up of the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial, which randomly 1:1 assigned 1,498 patients with STEMI to receive either everolimus-eluting stents or bare-metal stents. The present study was a subanalysis according to sex. The primary endpoint was the composite patient-oriented endpoint (all-cause death, any myocardial infarction, or any revascularization) at 10 years. Secondary endpoints were individual components of the primary endpoint. All endpoints were adjusted for age.
RESULTS
Among 1,498 patients with STEMI, 254 (17%) were women. Overall, women were older, with more arterial hypertension and less smoking history than men. At 10 years, no difference was observed between women and men for the patient-oriented composite endpoint (40.6% vs 34.2%; adjusted HR: 1.14; 95% CI: 0.91-1.42; P = 0.259). There was a trend toward higher all-cause death in women vs men (27.6% vs 19.4%; adjusted HR: 1.30; 95% CI: 0.99-1.71; P = 0.063), with no difference in cardiac death or other endpoints.
CONCLUSIONS
At very long term follow-up, there were no differences in the combined patient-oriented endpoint between women and men, with a trend toward higher all-cause death in women not driven by cardiac death. The present findings underline the need for focused personalized medicine in women after percutaneous revascularization aimed at both cardiovascular and sex-specific risk factor control and targeted treatment. (10-Years Follow-Up of the EXAMINATION Trial [EXAMINAT10N]; NCT04462315).

Identifiants

pubmed: 36008267
pii: S1936-8798(22)01486-8
doi: 10.1016/j.jcin.2022.07.038
pii:
doi:

Substances chimiques

Everolimus 9HW64Q8G6G
Sirolimus W36ZG6FT64

Banques de données

ClinicalTrials.gov
['NCT04462315']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1965-1973

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures This study was an investigator-driven clinical trial conducted by the Hospital Clinic of Barcelona. The EXAMINATION-EXTEND study was funded by an unrestricted grant from Abbott Vascular to the Spanish Heart Foundation (promoter). The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Auteurs

Rami Gabani (R)

Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.

Francesco Spione (F)

Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain; Department of Advanced Biomedical Sciences, University of Naples, Federico II, Naples, Italy.

Victor Arevalos (V)

Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.

Nadine Grima Sopesens (N)

Faculty of Medicine, University of Barcelona, Barcelona, Spain.

Luis Ortega-Paz (L)

Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain; Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, USA.

Josep Gomez-Lara (J)

Hospital Universitari de Bellvitge, Institut d'Investigació Biomedica de Bellvitge, L'Hospitalet de Llobregat, Spain.

Victor Jimenez-Diaz (V)

Hospital Alvaro Cunqueiro, Vigo, Spain; Cardiovascular Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain.

Marcelo Jimenez (M)

University Hospital of Sant Pau, Barcelona, Spain.

Pilar Jiménez-Quevedo (P)

University Hospital San Carlos, Madrid, Spain.

Roberto Diletti (R)

Thoraxcenter, Rotterdam, the Netherlands.

Javier Pineda (J)

Hospital General of Alicante, Alicante, Spain.

Gianluca Campo (G)

Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Cona, Italy.

Antonio Silvestro (A)

University Hospital Bolognini Seriate, Bergamo, Italy.

Jaume Maristany (J)

Hospital Son Dureta, Palma de Mallorca, Spain.

Xacobe Flores (X)

Hospital Universitario, A Coruña, Spain.

Loreto Oyarzabal (L)

Hospital Universitari de Bellvitge, Institut d'Investigació Biomedica de Bellvitge, L'Hospitalet de Llobregat, Spain.

Guillermo Bastos-Fernandez (G)

Hospital Alvaro Cunqueiro, Vigo, Spain; Cardiovascular Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain.

Andrés Iñiguez (A)

Hospital Alvaro Cunqueiro, Vigo, Spain; Cardiovascular Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain.

Antonio Serra (A)

University Hospital of Sant Pau, Barcelona, Spain.

Javier Escaned (J)

University Hospital San Carlos, Madrid, Spain.

Alfonso Ielasi (A)

University Hospital Bolognini Seriate, Bergamo, Italy.

Maurizio Tespili (M)

University Hospital Bolognini Seriate, Bergamo, Italy.

Mattie Lenzen (M)

Thoraxcenter, Rotterdam, the Netherlands.

Nieves Gonzalo (N)

University Hospital San Carlos, Madrid, Spain.

Pascual Bordes (P)

Hospital General of Alicante, Alicante, Spain.

Matteo Tebaldi (M)

Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Cona, Italy.

Simone Biscaglia (S)

Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Cona, Italy.

Soheil Al-Shaibani (S)

Thoraxcenter, Rotterdam, the Netherlands.

Rafael Romaguera (R)

Hospital Universitari de Bellvitge, Institut d'Investigació Biomedica de Bellvitge, L'Hospitalet de Llobregat, Spain.

Joan Antoni Gomez-Hospital (JA)

Hospital Universitari de Bellvitge, Institut d'Investigació Biomedica de Bellvitge, L'Hospitalet de Llobregat, Spain.

Josep Rodes-Cabau (J)

Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.

Patrick W Serruys (PW)

International Center of Circulatory Health, Imperial College London, London, United Kingdom; Department of Cardiology, National University of Ireland, Galway, Ireland.

Manel Sabaté (M)

Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain; CIBER-CV, Instituto de Salud Carlos III, Madrid, Spain.

Salvatore Brugaletta (S)

Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain. Electronic address: sabrugaletta@gmail.com.

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