1Universitätsklinikum Schleswig-Holstein Medizinische Klinik II / Kardiologie, Angiologie, Intensivmedizin Lübeck, Deutschland; 2Städtisches Klinikum Dessau Klinik für Innere Medizin II Dessau-Roßlau, Deutschland
Background: Transradial access (TRA) is the recommended approach for coronary procedures considering safety benefits over femoral access with radial artery occlusion (RAO) being the most frequent complication. Although usually not clinically significant, the presence of RAO affects potential future procedures and medical treatments. Distal TRA (dTRA) has been suggested to reduce the risk of postprocedural RAO compared to conventional TRA (cTRA) with, however, inconsistent results in clinical trials.
Objectives: This study aimed to compare the efficacy and safety of dTRA versus cTRA in patients undergoing diagnostic coronary angiography.
Methods: The RAPID trial is a single-center, open-label, 2x2 factorial, randomized study of patients undergoing coronary angiography through a 6-F radial access. The trial was stopped early by the data and safety monitoring board after the second pre-planned interim analysis and inclusion of 600 participants. Patients were randomized to dTRA or cTRA with further stratification according to periprocedural heparin use and preexisting oral anticoagulation. Only patients with sole diagnostic coronary angiography without percutaneous coronary intervention were considered for the main analysis. The primary endpoints were the incidence of RAO assessed by vascular ultrasound and puncture-site related bleedings.
Results: After excluding patients undergoing percutaneous coronary intervention (n=161), the final study population consisted of 222 patients randomized to dTRA and 217 patients to cTRA. Distal TRA was associated with a significantly increased number of puncture attempts (2.4 ± 2.1 versus 1.5 ± 1.1; p<0.001) and failed punctures leading to access site crossover (11.3% versus 4.1%; p=0.005). Consequently, the total procedure time was longer in the dTRA group (25 min versus 20 min; p=0.001) without increasing fluoroscopy time (p=0.187), dose area product (p=0.219), or contrast volume (p=0.681). Patent hemostasis was achieved in 92.6% of patients with cTRA. The rates of RAO (20.3% versus 21.2%, p=0.810) and puncture-site related bleedings (4.1% versus 6.9%; p=0.188) were similar in both groups. These results were consistent in predefined subgroup analyses according to the administration of heparin during the procedure and pre-existing oral anticoagulation.
Conclusions: According to this study, dTRA does not reduce the risk of RAO or bleeding events compared to cTRA.
The “Strategies to maintain Radial Artery Patency following Diagnostic coronary angiography” (RAPID) trial; NCT04301921 and NCT04362020.
Key words: coronary angiography; distal transradial access; radial artery occlusion; bleeding