Ultrahigh Resolution Ultrasound Characterization of Access Site Trauma and Intimal Hyperplasia following use of a 7F sheathless Guide vs. 6F Sheath/Guide Combination for Transradial Artery PCI: Results of The PRAGMATIC Trial ☆

Background There exist limited data on the relative degree of acute injury and late healing of the radial artery after transradial artery (TRA) percutaneous coronary intervention (PCI) with a 7F sheathless guide catheter compared with a 6F sheath/guide combination. We used ultrahigh-resolution (55 MHz) vascular ultrasound to compare intimal-medial thickening (IMT) and early and late radial artery (RA) injury resulting from a sheathless 7F guide catheter versus a 6F sheath/guide combination for TRA-PCI. Methods Forty-one consecutive consenting patients undergoing elective nonemergent TRA-PCI at a single institution from June 2016 to December 2016 were included. Patients were randomized (stratified by sex) to undergo TRA-PCI using a 7F sheathless guide catheter versus a 6F sheath/6F guide combination. Ultrahigh-resolution vascular ultrasound (55 MHz) of the RA access site was performed at 24 hours and 90 days post–TRA-PCI. The primary outcome of the study was a noninferiority comparison of radial artery IMT thickness at 90 days. PCI success rates, fluoroscopy times, number of guides used, and crossover rates to a femoral approach were also compared. Results Baseline characteristics were similar between groups. Radial arterial IMT (mm) was similar between the 7F sheathless and 6F sheath/guide groups at 24 hours (0.27 vs 0.29, respectively; P  = .43) and at 90 days (0.35 vs 0.34, respectively; P  = .96). The P value for the noninferiority testing of a 0.07-mm limit was .002. Limited access site intimal tears were relatively common in both groups at 24 hours (4 vs 5, P  = .53) but often healed by 90 days. Radial artery occlusion was infrequent at 90 days (2 vs 1, P  = .10), and no frank dissections were noted. PCI success rates (100% vs 95%, P  = .59), fluoroscopy times (16 vs 12 minutes, P  = .17), number of guides used (1.1 vs 1.2, P  = .48), and femoral crossover rates (0% vs 0%) were similar between the 2 respective groups. Conclusions A 7F sheathless approach to TRA-PCI results in no more IMT and early or late RA trauma than a standard 6F sheath/guide combination, rendering the 7F sheathless technique an attractive option for complex TRA-PCI.