Safe and Fast Radial Artery Hemostasis Using Synergistic Strategies: SAFE and FAST Trial

Transradial access (TRA) has been increasingly utilized for cardiac catheterization. Pursuit of faster patient throughput has generated a need for more rapid hemostasis protocols that are safe, effective and affordable. Patients undergoing diagnostic cardiac catheterization using TRA at two tertiary-care centers were randomized to receive the standard of care procedure utilizing 5/6 French hydrophilic introducer sheath, with 50 units/kg of heparin during the procedure and a 2-hour hemostatic compression using a single-balloon device (Group 1), or 25 units/kg of heparin, with 1-hour hemostatic compression using a dual-balloon device capable of simultaneous ipsilateral ulnar artery compression (UC) (Group 2). The primary study endpoint was a composite of radial artery occlusion (RAO), rebound bleeding or hematoma formation. 451 patients were randomized: 224 in Group 1 and 227 in Group 2. A significant reduction in the primary endpoint was observed in Group 2 as compared with Group 1 (4% vs 10.3%, P = 0.01). Patent hemostasis was achieved in 97% of patients in Group 2, compared with 81% in Group 1 P = 0.001), with fewer nursing visits in Group 2 (5.3 ± 0.8 vs 3.1 ± 0.3, P = 0.001). Group 2 patients also achieved successful hemostasis with a significant reduction in duration of compression (mean reduction = 62 minutes, P = 0.001). In conclusion, a strategy of using a lower dose of heparin with UC achieves shorter duration hemostasis after TRA with significantly less rebound bleeding and RAO, as compared with the conventional strategy.