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Two HEmostasis Methods After TransradIal Catheterization: THEMATIC Randomized Clinical Trial
Dos Santos SM, Wainstein RV, Valle FH, Correa CL, Aliti GB, Ruschel KB, Goncalves SC, Wainstein MV, Rabelo-Silva ER
The Journal of cardiovascular nursing. 2020
Abstract
OBJECTIVE The aim of this study was to compare the effect of 2 hemostasis devices on the incidence of radial artery occlusion (RAO) after transradial cardiac catheterization. BACKGROUND Radial artery occlusion is the most prevalent ischemic complication after radial artery catheterization. There is still no predictive pattern of vessel patency assessment, and the comparative effectiveness of different hemostasis techniques has yet to be established. METHODS This study used a randomized clinical trial of adult patients undergoing transradial cardiac catheterization. Participants were randomized into an intervention group (hemostasis with the TR Band device) and a control group (hemostasis with a conventional pressure dressing). The primary end point was the incidence of RAO (at discharge and at 30 days post catheterization). RESULTS Among the 600 patients included (301 in the intervention group and 299 controls), immediate RAO occurred in 24 (8%) in the TR Band group and 19 (6%) in the pressure-dressing group; at 30 days, RAO was present in 5 patients (5%) in the TR Band group and 7 (6%) in the pressure-dressing group. On multivariate analysis, peripheral vascular disease was the only independent predictor of RAO at discharge and at 30 days. CONCLUSIONS The incidence of RAO was similar in patients who received hemostasis with a TR Band versus a pressure dressing after transradial cardiac catheterization.