Comparing Two Distal Radial Hemostatic Devices for Radial Artery Patency Post-TACE: A Randomized Trial

Purpose

To compare the patency outcomes and safety profile between the modified TR Band and the PreludeSYNC DISTAL (PSD) for hemostasis following distal transradial access (dTRA) for transarterial chemoembolization (TACE).

Methods

This prospective randomized trial enrolled 104 participants undergoing TACE via dTRA (143 procedures, all performed using a 4-Fr catheter. Participants achieved hemostasis with either the modified TR Band (n = 74) or PSD (n = 69). The primary endpoint was the incidence of radial artery occlusion (RAO) assessed by Doppler ultrasonography at 4 h, 24 h, and > 1 week. Outcome assessors were blinded. Secondary endpoints included hemostatic performance and complications.

Results

No complete RAO occurred in either group (0/143). Partial RAO (mural thrombus with preserved flow) peaked at 4 h (TR Band: 28.4% vs. PSD: 18.8%; risk difference 9.5%, 95% CI -4.3 to 23.3%, p  = 0.181) and declined to 4.1% vs. 2.9% by final follow-up ( p  = 1.000), representing a spontaneous resolution rate of 85.3%. Generalized estimating equations showed no significant difference in overall incidence. The TR Band group had a numerically higher rate of delayed hemostasis (> 4 h) compared with PSD (5.4% vs. 0.0%, p  = 0.121). Complication rates (hematoma, pseudoaneurysm) did not differ significantly.

Conclusion

The modified TR Band and PSD demonstrated comparable rates of partial radial artery occlusion and access-site complications following dTRA for TACE.

Graphical Abstract