Trial reportCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2024
Traditional Versus Distal Radial Access for Coronary Diagnostic and Revascularization Procedures: Final Results of the TENDERA Multicenter, Randomized Controlled Study.
Trial report in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized Controlled Trial Comparison Between Traditional ENtry Point and Distal puncturE of RAdial Artery (TENDERA Trial)
COmparison of the HaNd DysFunction in Coronary Diagnosis and INtervention Via Distal vs Conventional Radial AccEss: Randomized Controlled Trial (CONFINE)
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Hand Dysfunction After Intervention via Distal Versus Conventional Transradial Access: A Meta-Analysis of Randomized Trials.Clinical cardiology · 2026Pooled it
- Distal radial access to prevent radial artery occlusion for STEMI patients (RAPID III): a randomized controlled trial.BMC medicine · 2025Trial
- Optimizing distal radial access: clinical and anatomical predictors of failure from the multicenter DISTAL registry.Coronary artery disease · 2026Article
- The efficacy and safety of percutaneous coronary intervention via distal transradial access in the treatment of coronary heart disease patients.Pakistan journal of medical sciences · 2025Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTraditional 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.
objectivesThis 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.
methodsTENDERA 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.
resultsEight 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 < 0.001) with DRA. Overall bleeding (BARC 1-2) and postprocedure hematoma > 5 cm occurred less frequently in the DRA group compared with the TRA group (3.2% vs. 20.5%, p < 0.001% and 9.0% vs. 27.0%, p < 0.001, respectively). No significant differences were observed in total procedure time and radiation dose between groups.
conclusionsDRA for coronary diagnostic and interventional procedures is associated with reduced forearm RAO rate and shorter hemostasis time, but a longer sheath insertion time and higher crossover rate compared with TRA.
trial registrationClinicalTrials.gov: NCT04211584.
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