Access-Site Crossover in Patients With Acute Coronary Syndrome Undergoing Invasive Management.


Journal

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

Informations de publication

Date de publication:
22 02 2021
Historique:
received: 05 10 2020
revised: 23 11 2020
accepted: 24 11 2020
entrez: 19 2 2021
pubmed: 20 2 2021
medline: 19 8 2021
Statut: ppublish

Résumé

The aim of this study was to assess the impact of access-site crossover in patients with acute coronary syndrome undergoing invasive management via radial or femoral access. There are limited data on the clinical implications of access-site crossover. In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox)-Access trial, 8,404 patients with acute coronary syndrome were randomized to radial or femoral access. Patients undergoing access-site crossover or successful access site were investigated. Thirty-day coprimary outcomes were a composite of death, myocardial infarction, or stroke (major adverse cardiovascular events [MACE]) and a composite of MACE or Bleeding Academic Research Consortium type 3 or 5 bleeding (net adverse clinical events [NACE]). Access-site crossover occurred in 183 of 4,197 patients (4.4%) in the radial group (mainly to femoral access) and 108 of 4,207 patients (2.6%) in the femoral group (mainly to radial access). In multivariate analysis, the risk for coprimary outcomes was not significantly higher with radial crossover compared with successful radial (MACE: adjusted rate ratio [adjRR]: 1.25; 95% confidence interval [CI]: 0.81 to 1.93; p = 0.32; NACE: adjRR: 1.40; 95% CI: 0.94 to 2.06; p = 0.094) or successful femoral access (MACE: adjRR: 1.17; 95% CI: 0.76 to 1.81; p = 0.47; NACE: adjRR: 1.26; 95% CI: 0.86 to 1.86; p = 0.24). Access site-related Bleeding Academic Research Consortium type 3 or 5 bleeding was higher with radial crossover than successful radial access. Femoral crossover remained associated with higher risks for MACE (adjRR: 1.84; 95% CI: 1.18 to 2.87; p = 0.007) and NACE (adjRR: 1.69; 95% CI: 1.09 to 2.62; p = 0.019) compared with successful femoral access. Results remained consistent after excluding patients with randomized access not attempted. Crossover from radial to femoral access abolishes the bleeding benefit offered by the radial over femoral artery but does not appear to increase the risk for MACE or NACE compared with successful radial or femoral access. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox [MATRIX]; NCT01433627).

Sections du résumé

OBJECTIVES
The aim of this study was to assess the impact of access-site crossover in patients with acute coronary syndrome undergoing invasive management via radial or femoral access.
BACKGROUND
There are limited data on the clinical implications of access-site crossover.
METHODS
In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox)-Access trial, 8,404 patients with acute coronary syndrome were randomized to radial or femoral access. Patients undergoing access-site crossover or successful access site were investigated. Thirty-day coprimary outcomes were a composite of death, myocardial infarction, or stroke (major adverse cardiovascular events [MACE]) and a composite of MACE or Bleeding Academic Research Consortium type 3 or 5 bleeding (net adverse clinical events [NACE]).
RESULTS
Access-site crossover occurred in 183 of 4,197 patients (4.4%) in the radial group (mainly to femoral access) and 108 of 4,207 patients (2.6%) in the femoral group (mainly to radial access). In multivariate analysis, the risk for coprimary outcomes was not significantly higher with radial crossover compared with successful radial (MACE: adjusted rate ratio [adjRR]: 1.25; 95% confidence interval [CI]: 0.81 to 1.93; p = 0.32; NACE: adjRR: 1.40; 95% CI: 0.94 to 2.06; p = 0.094) or successful femoral access (MACE: adjRR: 1.17; 95% CI: 0.76 to 1.81; p = 0.47; NACE: adjRR: 1.26; 95% CI: 0.86 to 1.86; p = 0.24). Access site-related Bleeding Academic Research Consortium type 3 or 5 bleeding was higher with radial crossover than successful radial access. Femoral crossover remained associated with higher risks for MACE (adjRR: 1.84; 95% CI: 1.18 to 2.87; p = 0.007) and NACE (adjRR: 1.69; 95% CI: 1.09 to 2.62; p = 0.019) compared with successful femoral access. Results remained consistent after excluding patients with randomized access not attempted.
CONCLUSIONS
Crossover from radial to femoral access abolishes the bleeding benefit offered by the radial over femoral artery but does not appear to increase the risk for MACE or NACE compared with successful radial or femoral access. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox [MATRIX]; NCT01433627).

Identifiants

pubmed: 33602431
pii: S1936-8798(20)32377-3
doi: 10.1016/j.jcin.2020.11.042
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT01433627']

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

361-373

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding support and Author Disclosures The MATRIX trial was sponsored by Società Italiana di Cardiologia Invasiva (a nonprofit organization), which received grant support from The Medicines Company and Terumo. This substudy did not receive any direct or indirect funding. Dr. Leonardi has received grants and personal fees from AstraZeneca, Bristol Myers Squibb/Pfizer, and Chiesi; and has received personal fees from Bayer outside the submitted work. Dr. Vranckx has received personal fees from AstraZeneca, Terumo, CSL Behring, Daiichi-Sankyo, and Bayer Health Care outside the submitted work. Dr. Frigoli is affiliated with CTU Bern, University of Bern, which has a staff policy of not accepting honoraria or consultancy fees. However, CTU Bern is involved in the design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. For an up-to-date list of CTU Bern’s conflicts of interest, see http://www.ctu.unibe.ch/research/declaration_of_interest/index_eng.html. Dr. Windecker has received research and educational grants to the institution from Abbott, Amgen, Bristol Myers Squibb, Bayer, Boston Scientific, Biotronik, Cardinal Health, CardioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Johnson & Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed; serves as an unpaid member of the steering and/or executive groups of trials funded by Abbott, Abiomed, Amgen, Bristol Myers Squibb, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Polares, Sinomed, V-Wave, and Xeltis (but has not received personal payments from any pharmaceutical company or device manufacturer); and is a member of the steering and/or executive committee groups of several investigator-initiated trials that receive funding from industry without impact on his personal remuneration. Dr. Valgimigli has received grants and personal fees from Abbott, Terumo, and AstraZeneca; has received personal fees from Chiesi, Bayer, Daiichi-Sankyo, Amgen, Alvimedica, Biosensors, and Idorsia; and has received grants from Medicure outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Auteurs

Felice Gragnano (F)

Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland; Division of Cardiology, Department of Translational Medicine, University of Campania "Luigi Vanvitelli," Caserta, Italy.

Mattia Branca (M)

Clinical Trials Unit, University of Bern, Bern, Switzerland.

Enrico Frigoli (E)

Clinical Trials Unit, University of Bern, Bern, Switzerland.

Sergio Leonardi (S)

University of Pavia and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.

Pascal Vranckx (P)

Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium; Faculty of Medicine and Life Sciences, University of Hasselt, Hasselt, Belgium.

Dario Di Maio (D)

Division of Cardiology, Department of Translational Medicine, University of Campania "Luigi Vanvitelli," Caserta, Italy.

Emanuele Monda (E)

Division of Cardiology, Department of Translational Medicine, University of Campania "Luigi Vanvitelli," Caserta, Italy.

Luigi Fimiani (L)

Unit of Cardiology, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.

Vincenzo Fioretti (V)

Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.

Salvatore Chianese (S)

Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.

Fabrizio Esposito (F)

Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.

Michele Franzese (M)

Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.

Martina Scalise (M)

Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.

Claudio D'Angelo (C)

Unit of Cardiology, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.

Renato Scalise (R)

Unit of Cardiology, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.

Gabriele De Blasi (G)

Unit of Cardiology, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.

Giuseppe Andò (G)

Unit of Cardiology, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.

Giovanni Esposito (G)

Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.

Paolo Calabrò (P)

Division of Cardiology, Department of Translational Medicine, University of Campania "Luigi Vanvitelli," Caserta, Italy.

Stephan Windecker (S)

Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.

Giovanni Pedrazzini (G)

Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.

Marco Valgimigli (M)

Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland; Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland. Electronic address: marco.valgimigli@cardiocentro.org.

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