Hydrophilic coating aids radial sheath withdrawal and reduces patient discomfort following transradial coronary intervention: a randomized double-blind comparison of coated and uncoated sheaths.

Radial artery spasm may cause severe discomfort during radial artery sheath removal. A hydrophilic-coated sheath may reduce the force required to remove a radial sheath. This force may be quantified using an automatic pullback device (APD). The objective of this study was to assess if a hydrophilic coating reduces the required force and discomfort associated with removal of a radial sheath following transradial coronary intervention. Ninety patients undergoing percutaneous coronary intervention via the radial artery were randomly assigned to two groups receiving either coated or uncoated introducer sheaths. Radifocus Introducer II (Terumo) 25 cm, 6 Fr radial sheaths and sheaths that were identical apart from the presence of the coating were used in all patients. The APD was used for sheath removal at the end of the procedure. Three patients (7%) in the coated group experienced discomfort during automatic sheath removal, compared to 12 patients (27%) in the uncoated group (P = 0.02). The maximum pullback force (MPF) was significantly lower in the coated compared to the uncoated group (0.24 +/- 0.31 vs. 0.44 +/- 0.33 kg; P = 0.003). Similarly, the mean pullback force was significantly lower in the coated group (0.14 +/- 0.23 vs. 0.32 +/- 0.24 kg; P < 0.001). Only one patient (2%) in each group had an MPF greater than 1.0 kg together with clinical evidence of radial artery spasm. Removal of the coated Terumo Radifocus sheath requires less force than an identical uncoated sheath. The coated sheath was also associated with less discomfort for the patient. Copyright 2003 Wiley-Liss, Inc.

RCT Entities:   Population Interventions Outcomes