Early Stepwise versus Standard TR Band Deflation after Transradial Coronary Angiography: A Randomized Comparative Trial

Abstract

Objectives: This study aimed to compare the effectiveness and safety of the standard manufacturer-recommended TR Band deflation protocol with an earlier stepwise (Light) deflation protocol in preventing radial artery occlusion (RAO) following transradial diagnostic coronary angiography. Methodology: A prospective two-center randomized comparative trial was conducted between August 2024 and January 2025 at two tertiary cardiac centers in Sindh, Pakistan. Adult patients undergoing diagnostic coronary angiography through transradial access were randomly assigned in a 1:1 ratio to either the standard TR Band deflation protocol or the Light protocol. The primary outcome was radial artery occlusion assessed 24 hours after the procedure using clinical examination, reverse Barbeau testing, and Doppler ultrasonography. Secondary outcomes included immediate RAO, bleeding complications, hematoma formation, hemostasis time, TR Band reinflation, patient discomfort, and 30-day follow-up outcomes. Results: A total of 270 patients were randomized, including 129 allocated to the standard protocol and 141 to the Light protocol. Overall, 24-hour RAO occurred in 15 patients (5.6%). The incidence of RAO was significantly lower in the Light protocol group compared with the standard protocol group (1.4% vs. 10.1%; p<0.001), corresponding to an absolute risk reduction of 8.7% and a relative risk of 0.14 (95% CI: 0.03–0.56). Minor bleeding occurred more frequently in the Light protocol group (31.9% vs. 19.4%; p=0.024), whereas no major bleeding events were observed in either group. Hematoma formation was less frequent in the Light protocol group, and median time to hemostasis was significantly shorter (2.25 vs. 3.08 hours; p<0.001). No rehospitalizations due to bleeding or RAO occurred during the 30-day follow-up period. Conclusion: The early stepwise (Light) TR Band deflation protocol significantly reduced the incidence of radial artery occlusion while shortening hemostasis time compared with the conventional manufacturer-recommended protocol. Although minor bleeding occurred more frequently, all events were clinically manageable without major bleeding, vascular intervention, or rehospitalization.