Hydrophilic-coated sheaths increase the success rate of transradial coronary procedures and reduce patient discomfort but do not reduce the occlusion rate: randomized single-blind comparison of coated vs. non-coated sheaths

Abstract

To examine the effect of hydrophilic-coated Vs. non-coated sheaths for coronary angiography by transradial access and to determine whether the rate of post-procedural vascular occlusion can be reduced if different sheath diameters are used in accordance with vessel diameters. Main complications of the transradial access include spasms, discomfort and occlusion of the radial artery (RA). Coated sheaths have been demonstrated to reduce spasms and discomfort but have not been previously investigated for their potential effect on the occlusion rate. A total of 200 consecutive patients were randomized into four groups of 50 patients each. Two study groups were examined with hydrophilic-coated sheaths featuring a caliber of five or six French depending on RA diameters as determined by ultrasound. Two control groups were examined with traditional non-coated sheaths. RA occlusion was the primary endpoint of the study. Secondary endpoints included RA alterations as determined by ultrasound after 4 weeks. Pain intensities during sheath withdrawal were rated on a visual analog scale. Post-procedural occlusion was diagnosed in nine patients of both study groups (9%) and in six patients of both control groups (6%). This difference was not statistically significant (P = 0.42). The same was true of the secondary endpoints (3% Vs. 9%; P = 0.74). However, the pain intensity scores obtained immediately after sheath withdrawal were significantly lower in the patients treated with coated sheaths (1.4 Vs. 2.7; P < 0.0001). Hydrophilic-coated sheaths for transradial access will reduce patient discomfort but do not involve fewer cases of occlusion than traditional non-coated sheaths.