Comparison of Three TR Band Deflation Protocols Following Radial Coronary Procedures: A Prospective Randomized Trial

BACKGROUND: Radial artery hemostasis can be achieved through a variety of methods after the excision of the sheath. The risk of radial artery blockage presents a challenge linked to the radial approach, potentially limiting its future application. The patent hemostasis method effectively achieves hemostasis while maintaining the patency of the radial artery, thereby reducing the likelihood of radial artery occlusion. AIMS: The aim of this study was to compare three TR band deflation protocols (early initiation with long intervals, delayed initiation with short intervals, and routine protocol) to determine the optimum approach for TR band deflation following radial coronary procedures. METHODS: A randomized controlled trial was performed at King Abdullah Medical City, including 207 cardiac patients undergoing trans-radial coronary procedures. The TR band was utilized with the patented hemostasis technique, wherein 2 mL of air was injected following the detection of the radial pulse on pulse oximetry after complete occlusion with 16 mL of air. Patients were randomized using electronic randomization in a 1:1:1 ratio into three groups. Total time for TR band removal, bleeding complications, and radial artery occlusions' occurrence were measured through one tool developed by the researcher. This study was conducted in accordance with the CONSORT guidelines. RESULTS: A total of 207 patients were recruited. Protocols A, B, and C had significantly different mean percentages of total TR band removal time (194.1 ± 38.15, 200.1 ± 27.2, and 152.9 ± 59.4, p = 0.000). The three groups had similar bleeding rates (11.8%, 15.9%, and 22.9%; p = 0.2). The study indicated that 10.3% of patients in protocol A, 7.2% in protocol B, and 22.9% in protocol C reported bleeding during the first hour from starting the protocol, with a significant difference (p = 0.01). In the second hour, 1.4% of protocol B patients had small hematomas (< 5 cm). No incidence of radial artery occlusion was observed in any group. CONCLUSION: The early protocol appears to be the most effective in reducing the incidence of bleeding complications, while the routine protocol offers a faster approach but is associated with earlier bleeding complications.