Comparison of the Effect of a 6-French Glidesheath Slender and a Conventional Sheath on Distal Radial Artery Occlusion: A Randomized Controlled Trial.

BACKGROUND

There is a lack of randomized clinical trials on whether the 6-French (Fr) Glidesheath Slender (GSS; Terumo, Tokyo, Japan) is superior to the 6-Fr conventional radial sheath (CS) with respect to the early-term incidence of distal radial artery occlusion (dRAO) in patients who have undergone coronary angiography (CAG) and/or percutaneous coronary intervention (PCI) via distal transradial access.

METHODS

This was a prospective, single-centre trial of patients who were randomized to undergo CAG and/or PCI with either a 6-Fr GSS or a 6-Fr CS. The primary end point was the incidence of dRAO at 24 hours postoperatively, evaluated using Doppler ultrasound.

RESULTS

A total of 620 patients were included in the study. The baseline patient and procedural characteristics were similar among the 2 groups. For the primary end point, the incidence of dRAO at 24 hours after the procedure was 1.0% (3/314) in the GSS group and 3.6% (11/306) in the CS group (risk ratio, 0.266; 95% confidence interval, 0.075-0.943; P = 0.027) according to the intention to treat analysis. For the secondary end points, the incidence of proximal radial artery occlusion was 0.3% (1/314) in the GSS group and 2.3% (7/306) in the CS group (P = 0.029). Other secondary end points, including the puncture success rate, procedural outcomes, other puncture-related outcomes, and access-related complications were not significantly different in the 2 groups.

CONCLUSIONS

The use of a thin-walled and hydrophilic coating sheath can reduce the incidence of early-term dRAO in patients who undergo CAG and/or PCI via the distal transradial access.

CLINICAL TRIAL REGISTRATION

NCT05501925.