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Concordance Between Randomized Controlled and Real-World Evidence for Distal Radial Access: A Structured Comparison
Gregory A Sgueglia1, Adel Aminian2, Yongcheol Kim3
1Division of Cardiology, Sant'Eugenio Hospital, Rome, Italy.
Insights
Distal radial access (DRA) shows very low rates of radial artery occlusion (RAO) and high success in percutaneous coronary procedures. These positive outcomes are consistent in both controlled trials and real-world practice, supporting its routine use.
Area of Science:
- Cardiovascular Interventions
- Vascular Access Techniques
- Interventional Cardiology
Background:
- Distal radial access (DRA) is an alternative to conventional transradial access (TRA).
- DRA may offer advantages in reducing radial artery occlusion (RAO).
Purpose of the Study:
- To evaluate if favorable outcomes from DRA randomized trials are replicated in routine clinical practice.
- To compare DRA outcomes against conventional TRA in a real-world setting.
Main Methods:
- Comparative analysis of the largest DRA randomized controlled trial (DISCO RADIAL) and the largest real-world DRA registry (KODRA).
- Analysis included 650 patients in the trial and 4977 consecutive patients in the registry.
- Outcomes were assessed using inverse variance-weighted estimates and random-effects models.
Main Results:
- DRA demonstrated a very low RAO rate of 0.18% across both settings.
- Overall crossover to other access sites occurred in 6.8%, with femoral access needed in only 1.3%.
- No serious bleeding events were reported; minor bleeding and hematoma showed heterogeneity.
Conclusions:
- Distal radial access (DRA) is safe and effective for percutaneous coronary procedures.
- Consistent performance in controlled and real-world settings supports DRA's feasibility for routine clinical practice.
- DRA offers a low rate of radial artery occlusion and high procedural success.
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.