RESUMO
OBJECTIVE: This study aimed to investigate the hemostatic efficacy of a novel femoral artery compression device in patients undergoing an interventional procedure through femoral artery puncture. MATERIAL AND METHODS: Patients enrolled in this trial were randomly assigned 1:1 to the novel femoral artery compression device (NFACD) or the manual compression (MC) group. The primary endpoints were time to hemostasis (TTH), time to ambulation (TTA), any other complications, such as the occurrence of hematoma, bleeding, pseudoaneurysm and arteriovenous fistula at the puncture site, and time to hospital discharge. RESULTS: A total of 617 patients were included in this study (NFACD, n = 308 versus MC, n = 309) from May 2017 to September 2019, and the baseline characteristics of the groups were similar. We found that the TTH and TTA were significantly shorter in the NFACD group than in the MC group (4.4 ± 11.6 min vs. 20.1 ± 22.5 min; p < 0.001; 8.9 ± 14.2 h vs. 16.3 ± 27.5 h; p = 0.002). There were few other complications in either group. In addition, there was no significant difference in time to hospital discharge between the NFACD group and the MC group. CONCLUSION: The novel femoral artery compression device is effective in achieving hemostasis in patients undergoing femoral artery puncture and is associated with a marked shortening of the TTH and TTA.