Impact of Sex on Comparative Outcomes of Radial Versus Femoral Access in Patients With Acute Coronary Syndromes Undergoing Invasive Management: Data From the Randomized MATRIX-Access Trial
Giuseppe Gargiulo, Sara Ariotti, Pascal Vranckx, Sergio Leonardi, Enrico Frigoli, Nestor Ciociano, Carlo Tumscitz, Francesco Tomassini, Paolo Calabrò, Stefano Garducci, Gabriele Crimi, Giuseppe Andò, Maurizio Ferrario, Ugo Limbruno, Bernardo Cortese, Paolo Sganzerla, Alessandro Lupi, Filippo Russo, Roberto Garbo, Arturo Ausiello, Dennis Zavalloni, Gennaro Sardella, Giovanni Esposito, Andrea Santarelli, Simone Tresoldi, Marco Stefano Nazzaro, Antonio Zingarelli, Anna Sonia Petronio, Stephan Windecker, Bruno R da Costa, Marco Valgimigli, Giuseppe Gargiulo, Sara Ariotti, Pascal Vranckx, Sergio Leonardi, Enrico Frigoli, Nestor Ciociano, Carlo Tumscitz, Francesco Tomassini, Paolo Calabrò, Stefano Garducci, Gabriele Crimi, Giuseppe Andò, Maurizio Ferrario, Ugo Limbruno, Bernardo Cortese, Paolo Sganzerla, Alessandro Lupi, Filippo Russo, Roberto Garbo, Arturo Ausiello, Dennis Zavalloni, Gennaro Sardella, Giovanni Esposito, Andrea Santarelli, Simone Tresoldi, Marco Stefano Nazzaro, Antonio Zingarelli, Anna Sonia Petronio, Stephan Windecker, Bruno R da Costa, Marco Valgimigli
Abstract
Objectives: This study sought to assess whether transradial access (TRA) compared with transfemoral access (TFA) is associated with consistent outcomes in male and female patients with acute coronary syndrome undergoing invasive management.
Background: There are limited and contrasting data about sex disparities for the safety and efficacy of TRA versus TFA for coronary intervention.
Methods: In the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) program, 8,404 patients were randomized to TRA or TFA. The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACCE or major bleeding.
Results: Among 8,404 patients, 2,232 (26.6%) were women and 6,172 (73.4%) were men. MACCE and NACE were not significantly different between men and women after adjustment, but women had higher risk of access site bleeding (male vs. female rate ratio [RR]: 0.64; p = 0.0016), severe bleeding (RR: 0.17; p = 0.0012), and transfusion (RR: 0.56; p = 0.0089). When comparing radial versus femoral, there was no significant interaction for MACCE and NACE stratified by sex (pint = 0.15 and 0.18, respectively), although for both coprimary endpoints the benefit with TRA was relatively greater in women (RR: 0.73; p = 0.019; and RR: 0.73; p = 0.012, respectively). Similarly, there was no significant interaction between male and female patients for the individual endpoints of all-cause death (pint = 0.79), myocardial infarction (pint = 0.25), stroke (pint = 0.18), and Bleeding Academic Research Consortium type 3 or 5 (pint = 0.45).
Conclusions: Women showed a higher risk of severe bleeding and access site complications, and radial access was an effective method to reduce these complications as well as composite ischemic and ischemic or bleeding endpoints.
Trial registration: ClinicalTrials.gov NCT01433627.
Keywords: MATRIX; acute coronary syndrome(s); female; femoral access; male; radial access.
Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed