Felice Gragnano1, Mattia Branca2, Enrico Frigoli2, Sergio Leonardi3, Pascal Vranckx4, Dario Di Maio5, Emanuele Monda5, Luigi Fimiani6, Vincenzo Fioretti7, Salvatore Chianese7, Fabrizio Esposito7, Michele Franzese7, Martina Scalise7, Claudio D'Angelo6, Renato Scalise6, Gabriele De Blasi6, Giuseppe Andò6, Giovanni Esposito7, Paolo Calabrò5, Stephan Windecker8, Giovanni Pedrazzini9, Marco Valgimigli10. 1. Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland; Division of Cardiology, Department of Translational Medicine, University of Campania "Luigi Vanvitelli," Caserta, Italy. 2. Clinical Trials Unit, University of Bern, Bern, Switzerland. 3. University of Pavia and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy. 4. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium; Faculty of Medicine and Life Sciences, University of Hasselt, Hasselt, Belgium. 5. Division of Cardiology, Department of Translational Medicine, University of Campania "Luigi Vanvitelli," Caserta, Italy. 6. Unit of Cardiology, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy. 7. Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy. 8. Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. 9. Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland. 10. Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland; Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland. Electronic address: marco.valgimigli@cardiocentro.org.
Abstract
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).
RCT Entities:
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).
Authors: Alexandru Achim; Tímea Szigethy; Dorottya Olajos; Levente Molnár; Roland Papp; György Bárczi; Kornél Kákonyi; István F Édes; Dávid Becker; Béla Merkely; Jef Van den Eynde; Zoltán Ruzsa Journal: Front Cardiovasc Med Date: 2022-05-09