Thomas A Meijers1, Adel Aminian2, Marleen van Wely3, Koen Teeuwen4, Thomas Schmitz5, Maurits T Dirksen6, Sudhir Rathore7, René J van der Schaaf8, Paul Knaapen9, Joseph Dens10, Juan F Iglesias11, Pierfrancesco Agostoni12, Vincent Roolvink1, Renicus S Hermanides1, Niels van Royen3, Maarten A H van Leeuwen13. 1. Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands. 2. Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium. 3. Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands. 4. Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands. 5. Department of Cardiology, Elisabeth Krankenhaus, Essen, Germany. 6. Department of Cardiology, Northwest Clinics, Alkmaar, the Netherlands. 7. Department of Cardiology, Frimley Health NHS Foundation Trust, Surrey, United Kingdom. 8. Department of Cardiology, Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands. 9. Department of Cardiology, VU University Medical Center, Amsterdam, the Netherlands. 10. Department of Cardiology, Hospital Oost-Limburg, Genk, Belgium. 11. Department of Cardiology, Geneva University Hospital, Geneva, Switzerland. 12. Department of Cardiology, ZNA Middelheim, Antwerp, the Netherlands. 13. Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands. Electronic address: m.a.h.van.leeuwen@isala.nl.
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 either7-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).
RCT Entities:
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).
Authors: 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; Miguel E Lemmert; Renicus S Hermanides; Niels van Royen; Maarten A H van Leeuwen Journal: J Am Heart Assoc Date: 2022-01-13 Impact factor: 6.106