Randomized Comparison Between Radialand Femoral Large-Bore Accessfor Complex Percutaneous Coronary Intervention.

Abstract

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. 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. 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. 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. In patients undergoing PCI of complex coronary lesions with large-bore access, radial compared withfemoral 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).