Ultrahigh-resolution ultrasound characterization of access site trauma and intimal hyperplasia following use of a 7F sheathless guide versus 6F sheath/guide combination for transradial artery PCI: Results of the PRAGMATIC trial.

ABSTRACT

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 (55MHz) of the RA access site was performed at 24hours and 90days post-TRA-PCI. The primary outcome of the study was a noninferiority comparison of radial artery IMT thickness at 90days. 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 24hours (0.27 vs 0.29, respectively; P=.43) and at 90days (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 24hours (4 vs 5, P=.53) but often healed by 90days. Radial artery occlusion was infrequent at 90days (2 vs 1, P=.10), and no frank dissections were noted. PCI success rates (100% vs 95%, P=.59), fluoroscopy times (16 vs 12minutes, 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.