Balloon pressure monitoring for radial artery hemostasis: design and basic principles of a single-center, prospective, randomized controlled trial

Background Radial artery occlusion (RAO) remains a common complication of transradial coronary angiography, with incidence varying between 1% and 10%. Traditional hemostasis methods require repeated use of photoplethysmography to assess blood flow and frequent manual adjustments of hemostatic pressure with successful rate around 50% to 80%. Present study aimed to test the hypothesis that a novel balloon pressure monitoring strategy (Figure 1) might be an easy to operate and more efficient option to achieve higher success rate of radial artery patency hemostasis after transradial coronary angiography. Purpose This single-center, prospective, randomized controlled trial aimed to evaluate the effectiveness of balloon pressure monitoring in radial artery patency hemostasis. A total of 818 patients undergoing coronary angiography will be enrolled and randomized into two groups at 1:1 ratio: balloon pressure monitoring and traditional hemostasis. The primary endpoint is the 24-hour RAO incidence; secondary endpoints include vascular/bleeding complication rates and hemostasis convenience. Methods A single-center RCT enrolled 390 patients (of a planned 818) undergoing transradial coronary angiography. Participants were randomized into two groups: the balloon group received phased decompression (initial 260 mmHg, adjusted based on bleeding), while the control group underwent volume-guided hemostasis. Primary outcomes included 24-hour RAO incidence (ultrasound-confirmed), and secondary outcomes encompassed bleeding complications, hemostasis time, and personnel utilization. Statistical analyses adhered to intention-to-treat principles, employing chi-square tests, Mann-Whitney U tests, and multivariate logistic regression. Results Baseline demographics were balanced between groups (all p> 0.05). RAO incidence was 2.1% (4/195) in the balloon group versus 1.5% (3/195) in controls (OR = 1.333, 95% CI: 0.302–5.879; p>0.05). Balloon monitoring significantly reduced median hemostasis time (98 vs. 180 seconds ; p< 0.001) and operator requirements (1 vs.2 personnel). Multivariate analysis revealed shorter compression time (OR = 0.962, p< 0.001) and diabetes (OR = 2.1, p= 0.032) as independent predictors of bleeding, while no predictors for RAO emerged. Pressure data indicated a median of 170 mmHg (range: 120–260) in non-occluded cases. Conclusions Interim findings demonstrate that balloon pressure monitoring achieves RAO prevention comparable to traditional methods, while significantly improving efficiency. Individualized pressure titration may optimize hemostasis-patency balance. Shorter compression time reduced bleeding risk, highlighting the need for tailored protocols. Final data from 818 participants will validate long-term efficacy and refine pressure guidance strategies. These results support scalable adoption in resource-limited settings.