Objective: Use of vascular closure devices (VCDs) for femoral artery puncture site hemostasis has increased but their safety and efficacy have remained unclear. This study was designed to compare safety and efficacy of Obtura, Angioseal, and Proglide VCD to manual compression (MC) and also between for femoral artery haemostasis. Methods:This was prospective, randomized controlled study where patients were randomly assigned on 1:1:1:1 basis. Primary endpoints were time to hemostasis (TTH) and ambulation time (AT) while secondary endpoints were deployment success, device related adverse events and technical success rate. ANOVA and Tukey HSD was conducted to draw significant difference between individual strategies. P Results: Total of 1,000 patients (250 in each arm) who underwent transfemoral intervention at LPS Institute of Cardiology, Kanpur, India between January 2025 and March 2025 were evaluated. Sheath size, common femoral artery diameter and device size did not differ significantly across all the groups. Mean TTH was shortest for Angioseal (1.30 minutes) followed by Obtura (2.58 minutes), Perclose (3.97 minutes), and MC (17.61 minutes). Similarly, mean AT was shortest for Angio-Seal (123.06 minutes) followed by Perclose ProGlide (162.56 minutes), Obtura (185.42 minutes) and MC (743.23 minutes). Technical success in Angio-Seal, Obtura and Perclose ProGlide were 99.1%, 97.4% and 94.6% respectively. No access site complications (re-bleeding, infection, arteriovenous fistula, and transient access site nerve injury) were noted. There were 2(0.8%), 5(2%), 7(3.2%) and 12(4.8%) cases of haematoma in Angio-Seal, Obtura, Perclose ProGlide and MC arm respectively. There were 2(0.8%), 2(0.8%), and 4(1.6%) case of arterial pseudoaneurysm Obtura, Perclose ProGlide and MC arm respectively while none in Angio-Seal arm. Conclusion- Vascular closure devices showed significantly faster haemostasis and shorter ambulation time compared to manual compression highlighting their clinical efficiency and Angio-Seal was superior safety and efficacy over Obtura and Perclose ProGlide.
Shukla et al. (Wed,) studied this question.