Concordance Between Randomized Controlled and Real-World Evidence for Distal Radial Access: A Structured Comparison...

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).

To assess whether favorable outcomes observed in randomized trials are consistently reproduced in routine clinical practice.

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.

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.

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.