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 AusielloDennis 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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)36-50
Number of pages15
JournalJACC: Cardiovascular Interventions
Volume11
Issue number1
DOIs
Publication statusPublished - Jan 8 2018

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Acute Coronary Syndrome
Thigh
Hemorrhage
Stroke
Myocardial Infarction
Cause of Death
Safety
Research

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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. / Gargiulo, Giuseppe; Ariotti, Sara; Vranckx, Pascal; Leonardi, Sergio; Frigoli, Enrico; Ciociano, Nestor; Tumscitz, Carlo; Tomassini, Francesco; Calabrò, Paolo; Garducci, Stefano; Crimi, Gabriele; Andò, Giuseppe; Ferrario, Maurizio; Limbruno, Ugo; Cortese, Bernardo; Sganzerla, Paolo; Lupi, Alessandro; Russo, Filippo; Garbo, Roberto; Ausiello, Arturo; Zavalloni, Dennis; Sardella, Gennaro; Esposito, Giovanni; Santarelli, Andrea; Tresoldi, Simone; Nazzaro, Marco Stefano; Zingarelli, Antonio; Petronio, Anna Sonia; Windecker, Stephan; da Costa, Bruno R; Valgimigli, Marco.

In: JACC: Cardiovascular Interventions, Vol. 11, No. 1, 08.01.2018, p. 36-50.

Research output: Contribution to journalArticle

Gargiulo, G, Ariotti, S, Vranckx, P, Leonardi, S, Frigoli, E, Ciociano, N, Tumscitz, C, Tomassini, F, Calabrò, P, Garducci, S, Crimi, G, Andò, G, Ferrario, M, Limbruno, U, Cortese, B, Sganzerla, P, Lupi, A, Russo, F, Garbo, R, Ausiello, A, Zavalloni, D, Sardella, G, Esposito, G, Santarelli, A, Tresoldi, S, Nazzaro, MS, Zingarelli, A, Petronio, AS, Windecker, S, da Costa, BR & Valgimigli, M 2018, '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', JACC: Cardiovascular Interventions, vol. 11, no. 1, pp. 36-50. https://doi.org/10.1016/j.jcin.2017.09.014
Gargiulo, Giuseppe ; Ariotti, Sara ; Vranckx, Pascal ; Leonardi, Sergio ; Frigoli, Enrico ; Ciociano, Nestor ; Tumscitz, Carlo ; Tomassini, Francesco ; Calabrò, Paolo ; Garducci, Stefano ; Crimi, Gabriele ; Andò, Giuseppe ; Ferrario, Maurizio ; Limbruno, Ugo ; Cortese, Bernardo ; Sganzerla, Paolo ; Lupi, Alessandro ; Russo, Filippo ; Garbo, Roberto ; Ausiello, Arturo ; Zavalloni, Dennis ; Sardella, Gennaro ; Esposito, Giovanni ; Santarelli, Andrea ; Tresoldi, Simone ; Nazzaro, Marco Stefano ; Zingarelli, Antonio ; Petronio, Anna Sonia ; Windecker, Stephan ; da Costa, Bruno R ; Valgimigli, Marco. / 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. In: JACC: Cardiovascular Interventions. 2018 ; Vol. 11, No. 1. pp. 36-50.
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title = "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",
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.",
author = "Giuseppe Gargiulo and Sara Ariotti and Pascal Vranckx and Sergio Leonardi and Enrico Frigoli and Nestor Ciociano and Carlo Tumscitz and Francesco Tomassini and Paolo Calabr{\`o} and Stefano Garducci and Gabriele Crimi and Giuseppe And{\`o} and Maurizio Ferrario and Ugo Limbruno and Bernardo Cortese and Paolo Sganzerla and Alessandro Lupi and Filippo Russo and Roberto Garbo and Arturo Ausiello and Dennis Zavalloni and Gennaro Sardella and Giovanni Esposito and Andrea Santarelli and Simone Tresoldi and Nazzaro, {Marco Stefano} and Antonio Zingarelli and Petronio, {Anna Sonia} and Stephan Windecker and {da Costa}, {Bruno R} and Marco Valgimigli",
note = "Copyright {\circledC} 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.",
year = "2018",
month = "1",
day = "8",
doi = "10.1016/j.jcin.2017.09.014",
language = "English",
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pages = "36--50",
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TY - JOUR

T1 - Impact of Sex on Comparative Outcomes of Radial Versus Femoral Access in Patients With Acute Coronary Syndromes Undergoing Invasive Management

T2 - Data From the Randomized MATRIX-Access Trial

AU - Gargiulo, Giuseppe

AU - Ariotti, Sara

AU - Vranckx, Pascal

AU - Leonardi, Sergio

AU - Frigoli, Enrico

AU - Ciociano, Nestor

AU - Tumscitz, Carlo

AU - Tomassini, Francesco

AU - Calabrò, Paolo

AU - Garducci, Stefano

AU - Crimi, Gabriele

AU - Andò, Giuseppe

AU - Ferrario, Maurizio

AU - Limbruno, Ugo

AU - Cortese, Bernardo

AU - Sganzerla, Paolo

AU - Lupi, Alessandro

AU - Russo, Filippo

AU - Garbo, Roberto

AU - Ausiello, Arturo

AU - Zavalloni, Dennis

AU - Sardella, Gennaro

AU - Esposito, Giovanni

AU - Santarelli, Andrea

AU - Tresoldi, Simone

AU - Nazzaro, Marco Stefano

AU - Zingarelli, Antonio

AU - Petronio, Anna Sonia

AU - Windecker, Stephan

AU - da Costa, Bruno R

AU - Valgimigli, Marco

N1 - Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

PY - 2018/1/8

Y1 - 2018/1/8

N2 - 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.

AB - 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.

U2 - 10.1016/j.jcin.2017.09.014

DO - 10.1016/j.jcin.2017.09.014

M3 - Article

C2 - 29301646

VL - 11

SP - 36

EP - 50

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

SN - 1936-8798

IS - 1

ER -