A novel distal radial artery compression device versus elastic bandage compression after coronary angiography or percutaneous coronary intervention via distal transradial access: a prospective randomized controlled trial

Abstract

Distal transradial artery access (dTRA) is increasingly used for coronary interventions because it preserves proximal radial artery patency. However, effective hemostasis at the distal puncture site remains challenging due to the superficial vessel location and limited soft-tissue support. This study evaluated the hemostatic performance, local safety, patient-reported outcomes, and early radial artery patency of a novel distal radial artery compression device compared with conventional elastic bandage compression. In this prospective randomized controlled trial, 148 patients undergoing coronary angiography (CAG) or percutaneous coronary intervention (PCI) via dTRA were randomized (1:1) to device-based or conventional compression. The primary outcome was first-attempt hemostasis success after compression release. Secondary outcomes included total hemostasis duration, operation time, access-site complications, pain, comfort, and ultrasound-assessed radial artery outcomes. First-attempt hemostasis success was achieved in 74 patients (100.0%) in the device group and 70 patients (94.6%) in the elastic bandage group. Compared with elastic bandage compression, the novel device significantly shortened total hemostasis duration and operation time (both P < 0.001). Postoperative hand swelling was significantly less frequent and less severe in the device group (P < 0.001), while bleeding or hematoma formation was descriptively less frequent. No radial artery occlusion was detected by Doppler ultrasound before discharge in either group. Overall repeated-measures analysis showed no significant group effect or group-by-time interaction for pain or comfort scores. The novel dTRA compression device achieved a high first-attempt hemostasis success rate and significantly shortened operation time and total hemostasis duration compared with conventional elastic bandage compression after CAG or PCI via dTRA. The device was associated with less postoperative hand swelling, while bleeding or hematoma formation was infrequent and should be interpreted cautiously. These findings support the short-term feasibility and procedural hemostatic efficiency of the device compared with conventional elastic bandage compression. Further multicenter studies incorporating standardized patent-hemostasis assessment, longer vascular follow-up, and comparisons with currently available dedicated distal radial compression devices are needed. Chinese Clinical Trial Registry, ChiCTR2500105403. Registered 2 July 2025.