P3311A randomized comparison of frequency of radial artery occlusion and radial artery spasm associated with TRI Using 6.5-Fr Sheathless Guide Catheter vs. 6.0-Fr Glidesheath Slender

Abstract

Background: Transradial coronary intervention (TRI) had reduced vascular complications compared with transfemoral approach, however there is concern of radial artery occlusion (RAO) and radial artery spasm (RAS). Both a 6.5‐Fr sheathless hydrophilic‐coating guide catheter (SH‐GC) and a 6.0‐Fr Glidesheath Slender (GSS) were developed as less traumatic system for TRI. However a comparative investigation has not been reported. Purpose: We compared the incidence of RAO and RAS associated with TRI using a 6.5‐Fr SH‐GC vs. a 6.0‐Fr GSS. Methods: This trial is an open‐label randomized study to compare the frequency of complications in radial arteries between patients received TRI using 6.5‐Fr SH‐GC vs. 6.0‐Fr GSS in our hospital. The primary endpoint was a composite of RAO evaluated by ultrasound 1 month after TRI and symptomatic RAS. The secondary endpoints were acute procedural success, the onset of major adverse cardiac events (MACE) and procedure times. Results: From January 2015 to June 2016, we analysed consecutive 600 patients with stable coronary disease who underwent elective TRI using the 6.5‐Fr SH‐GC (SH‐GC group, n=300) or the 6.0‐Fr GSS (GSS group, n=300) in our hospital. Baseline and procedural characteristics were similar between the groups. However, the ratio of sheath/artery diameter (S/RA ratio) was significantly smaller in the SH‐GC group (1.02±0.23 vs. 1.17±0.27, p<0.001), because the external diameter of the 6.5‐Fr SH‐GC (2.16 mm) is smaller than one of 6.0‐Fr GSS (2.46 mm). The rate of procedural failure (2.7% vs. 1.0%, p=0.121) and the rate of crossover to the other systems (1.7% vs. 0.7%, p=0.246) more frequent in the SH‐GC group respectively, but the differences were not significant. The incidence rates of MACE (1.3% vs. 1.3%, p=1.000) and procedure times (46.6±20.8 vs. 44.9±20.1 minutes, p=0.322) were also similar in both groups. The composite of RAO and RAS was significantly less frequent with the 6.5‐Fr SH‐GC (0.3%) than with the 6.0‐Fr GSS (3.0%, p=0.011). Multivariate analysis revealed that a large S/RA ratio (p<0.001) and use of carvedilol (p=0.029) were independently associated with RAO and RAS. Conclusions: The 6.5‐Fr SH‐GC is a promising alternative to conventional TRI and is associated with less frequent occurrence of RAO and RAS than the 6.0‐Fr GSS (UMIN000019739).