Balloon pressure monitoring for radial artery hemostasis: interim RCT analysis

Background Radial artery occlusion (RAO), occurring in up to 33% of cases, restricts reaccess following transradial angiography. Traditional hemostasis methods, reliant on manual volume adjustments (e.g., initial 18 mL inflation), suffer from inconsistent pressure control and operator dependency. This interim analysis of a large randomized controlled trial (RCT; planned N = 818, interim n = 390) evaluates the efficacy and efficiency of balloon pressure monitoring (±2 mmHg precision), which standardizes compression via real-time manometry, compared to conventional volume-guided approaches. Purpose The study aimed to: (1) compare 24-hour RAO rates between balloon pressure monitoring and traditional methods; (2) assess operational efficiency (time and personnel requirements); and (3) identify predictors of bleeding and RAO. 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, and diabetes doubled bleeding odds, 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.