Randomized Comparison Between Radial and Femoral Large-Bore Access for Complex Percutaneous Coronary Intervention
Thomas A Meijers, Adel Aminian, Marleen van Wely, Koen Teeuwen, Thomas Schmitz, Maurits T Dirksen, Sudhir Rathore, René J van der Schaaf, Paul Knaapen, Joseph Dens, Juan F Iglesias, Pierfrancesco Agostoni, Vincent Roolvink, Renicus S Hermanides, Niels van Royen, Maarten A H van Leeuwen, Thomas A Meijers, Adel Aminian, Marleen van Wely, Koen Teeuwen, Thomas Schmitz, Maurits T Dirksen, Sudhir Rathore, René J van der Schaaf, Paul Knaapen, Joseph Dens, Juan F Iglesias, Pierfrancesco Agostoni, Vincent Roolvink, Renicus S Hermanides, Niels van Royen, Maarten A H van Leeuwen
Abstract
Objectives: The aim of this study was to investigate whether transradial (TR) percutaneous coronary intervention (PCI) is superior to transfemoral (TF) PCI in complex coronary lesions with large-bore guiding catheters with respect to clinically relevant access site-related bleeding or vascular complications.
Background: The femoral artery is currently the most applied access site for PCI of complex coronary lesions, especially when large-bore guiding catheters are required. With downsizing of TR equipment, TR PCI may be increasingly applied in these patients and might be a safer alternative compared with the TF approach.
Methods: An international prospective multicenter trial was conducted, randomizing 388 patients with planned PCI for complex coronary lesions, including chronic total occlusion, left main, heavy calcification, or complex bifurcation, to either 7-F TR access (TRA) or 7-F TF access (TFA). The primary endpoint was defined as access site-related clinically significant bleeding or vascular complications requiring intervention at discharge. The secondary endpoint was procedural success.
Results: The primary endpoint event rate was 3.6% for TRA and 19.1% for TFA (p < 0.001). The crossover rate from radial to femoral access was 3.6% and from femoral to radial access was 2.6% (p = 0.558). The procedural success rate was 89.2% for TFA and 86.0% for TRA (p = 0.285). There was no difference between TFA and TRA with regard to procedural duration, contrast volume, or radiation dose.
Conclusions: In patients undergoing PCI of complex coronary lesions with large-bore access, radial compared with femoral access is associated with a significant reduction in clinically relevant access-site bleeding or vascular complications, without affecting procedural success. (Complex Large-Bore Radial Percutaneous Coronary Intervention [PCI] Trial [Color]; NCT03846752).
Keywords: CTO; complex PCI; large bore; vascular access.
Conflict of interest statement
Funding Support and Author Disclosures Terumo EMEA supported this investigator-initiated study with an unrestricted grant. Drs. van Leeuwen, Aminian, Dens, and Iglesias are consultants for Terumo. Drs. Iglesias and Schmitz have received honoraria and speaker fees from Terumo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed