Traditional Versus Distal Radial Access for Coronary Diagnostic and Revascularization Procedures: Final Results of the TENDERA Multicenter, Randomized Controlled Study

• Published in: Catheterization and cardiovascular interventions 2024-10
• Main Authors: Babunashvili, Avtandil M, Pancholy, Samir, Zulkarnaev, Aleksei B, Kaledin, Alexander L, Kochanov, Igor N, Korotkih, Alexander V, Kartashov, Dmitriy S, Babunashvili, Mikhail A
• Format: Article
• Language: English
• ISSN: 1522-1946; 1522-726X; 1522-726X
• DOI: 10.1002/ccd.31271

Traditional transradial access (TRA) is widely used for coronary and non-coronary interventions with significant improvements in procedural outcomes; however, it is associated with RAO that precludes repeat use of the same artery for possible future TRI and other purposes. Distal radial access (DRA) has been proposed as an effective alternative to decrease RAO rates. Published literature describing the RAO rate after DRA versus TRA from various RCT and clinical registries has shown conflicting results. This study compared the forearm radial artery occlusion (RAO) rate assessed by Doppler ultrasound between distal and conventional radial access at 1-year follow-up after the initial procedure. TENDERA was a multicenter, randomized controlled study comparing DRA versus TRA for coronary diagnostic and interventional procedures using 5 or 6F hydrophilic-coated sheaths. The primary endpoint was forearm RAO at 12 months after radial access. The secondary endpoints included puncture time, sheath insertion and total procedure time, radiation dose, and vascular access site-related complications. Eight hundred and fifty patients were randomized to either TRA (n = 418) and DRA (n = 432) groups. In the intention-to-treat analysis, the rate of forearm RAO at 12 months was observed in 39 patients (4.6%) and was significantly reduced in the DRA group compared with the TRA group (2.5% vs. 6.7%, RR 2.59 [95% CI 1.29-5.59], p = 0.010). Analysis in per protocol population has shown consistent results with forearm RAO rate 2.8% in the DRA group versus 6.5% in the TRA group (p = 0.008). The crossover rate was higher (4.6% vs. 1%, p = 0.013) and median hemostasis time was shorter (156.5 min vs. 180 min, p  5 cm occurred less frequently in the DRA group compared with the TRA group (3.2% vs. 20.5%, p