Concordance Between Randomized Controlled and Real-World Evidence for Distal Radial Access: A Structured Comparison of the DISCO RADIAL Trial and KODRA Study.

BACKGROUND: Distal radial access (DRA) has emerged as an alternative to conventional transradial access (TRA) for percutaneous coronary procedures, with potential advantages for reducing radial artery occlusion (RAO). AIM: To assess whether favorable outcomes observed in randomized trials are consistently reproduced in routine clinical practice. METHODS: A structured comparative analysis was performed between the largest randomized controlled trial of DRA (DISCO RADIAL; 650 patients, 16 centers, strict selection criteria, experienced operators) and the largest real-world DRA registry (KODRA; 4977 consecutive patients, 14 centers, broader inclusion criteria, heterogeneous operator experience). Access-related outcomes were summarized using inverse variance-weighted estimates and analyzed using random-effects models to assess agreement across clinical settings, with absolute differences as the primary measure. Heterogeneity (I2) was reported descriptively. RESULTS: Despite marked differences in study design, patient populations (body surface area 2.0 vs. 1.7 m2), and operator experience (100% vs. 70% with ≥ 100 DRA cases), concordance was remarkable. RAO at discharge was 0.18% (95% CI 0.07%-0.29%, I2 = 0%). Overall crossover occurred in 6.8% (95% CI 6.1%-7.4%, I2 = 0%), with same-side conventional TRA as predominant bailout (4.3%). Femoral access was required in only 1.3% of cases. No serious bleeding events occurred in either study. Minor bleeding and hematoma showed considerable heterogeneity (I2 = 80%-98%), likely reflecting differences in surveillance and practice patterns. Sensitivity analyses confirmed the stability of crossover and RAO estimates. CONCLUSIONS: DRA demonstrates very low RAO rates, high procedural success, and favorable safety, with consistent performance across controlled and real-world settings, supporting its feasibility in routine clinical practice.