Randomized Trial of Radial Hemostasis Using Focused vs Balloon Compression Devices.

Background: Radial artery hemostasis devices differ in compression mechanisms, which may influence time to hemostasis and hand perfusion.

Methods: Subjects (n = 52) undergoing transradial diagnostic coronary catheterization or percutaneous coronary intervention (PCI) were randomized 1:1 to either focused compression (VasoStat; Forge Medical) or balloon compression device (TR Band; Terumo Medical) for radial artery hemostasis. Time to complete hemostasis enabling device removal was measured in each subject. Hand perfusion was quantitated using the perfusion index (PI) with oximetry (1) before; (2) during device use; (3) during device use with ulnar artery compression; and (4) following device removal.

Results: Focused compression resulted in a significantly shorter time to complete hemostasis vs balloon compression (208 min [IQR, 115-320 min] vs 242 min [IQR, 120-439 min], respectively; P=.04). This difference was greatest among the subset undergoing PCI, where the VasoStat resulted in a 43-minute reduction until complete hemostasis (P=.04). Baseline PI was similar between the focused and balloon compression groups (4.9 vs 3.9, respectively; P=.09). Focused compression resulted in a similar reduction in median PI from baseline to during device use compared with balloon compression (-27% vs -18%, respectively; P=.26). Both devices decreased PI over 50% from baseline during simultaneous ulnar artery compression (P<.01), and increased PI over 50% from baseline following device removal (P=.02). No radial artery occlusion occurred, and rates of device manipulation and access-site bleeds were low in both groups.

Conclusion: Complete hemostasis was achieved earlier with the VasoStat focused compression device compared with the TR Band balloon compression device. Both devices transiently reduced hand perfusion, particularly during ulnar compression, which increased from baseline following device removal. Larger trials comparing these radial hemostasis devices and outcomes are warranted.