OBJECTIVE: To compare the effects of elastic bandage compression with the specific hemostasis devices in patients undergoing transradial coronary intervention. METHODS: A total of 3000 consecutive patients were randomized to 3 groups and 2910 patients completed the study, 963 patients inelastic bandage group (ER), 976 in T band group (TB) and 971 in balloon group (TR). In-hospital vascular related complication was the primary study endpoint. The secondary endpoints included: risk factors of complications, compression time, fibroplasia conditions and the comfort feeling of patients. RESULTS: The overall incidence of vascular related complication in 3 groups was similar (P = 0.262). Female, low body weight, prolongation of procedure and multi-punctures were identified as the independent risk factors for complications. Moreover, the compression time and the fibroplasia condition in TB and TR group were superior to those in the ER group. Comfortable feeling of the patients was better in TR and TB group than in ER group (P < 0.001). CONCLUSIONS: Both conventional bandage device and specific radial device are feasible and associated with low incidence of vascular complication. However, the specific radial device has significant advantage over bandage strategy in compression time and quality of life.
RCT Entities:
OBJECTIVE: To compare the effects of elastic bandage compression with the specific hemostasis devices in patients undergoing transradial coronary intervention. METHODS: A total of 3000 consecutive patients were randomized to 3 groups and 2910 patients completed the study, 963 patients in elastic bandage group (ER), 976 in T band group (TB) and 971 in balloon group (TR). In-hospital vascular related complication was the primary study endpoint. The secondary endpoints included: risk factors of complications, compression time, fibroplasia conditions and the comfort feeling of patients. RESULTS: The overall incidence of vascular related complication in 3 groups was similar (P = 0.262). Female, low body weight, prolongation of procedure and multi-punctures were identified as the independent risk factors for complications. Moreover, the compression time and the fibroplasia condition in TB and TR group were superior to those in the ER group. Comfortable feeling of the patients was better in TR and TB group than in ER group (P < 0.001). CONCLUSIONS: Both conventional bandage device and specific radial device are feasible and associated with low incidence of vascular complication. However, the specific radial device has significant advantage over bandage strategy in compression time and quality of life.