ANALYSIS OF INTERMEDIATE RESULTS OF A COMPARATIVE MULTICENTER RANDOMIZED TENDERA STUDY INVESTIGATING THE DISTAL RADIATION ACCESS

Abstract

Objective. To prove the safety and efficacy of distal radial artery (DRA) puncture for endovascular interventions versus the traditional forearm radial artery (RA) puncture site by comparing immediate and long-term results. Methods. In 2017, a multicenter, open, randomized (1:1) study TENDERA (Comparison between Traditional Entry Point and Distal Puncture of Radial Artery) was started. During 2 years, 520 patients were included, mean age 63.4±10.0 years. The observation group (DRA puncture) included 271 patients, the comparison group (RA puncture) - 249 patients. The study included both stable patients and those with NSTEMI: the observation group - 39 (14.4%), the comparison group - 34 (13.7%), p=0.809. The primary endpoint is immediate (hospital) or late radial thrombosis. Secondary endpoints are: 1 - composite point, complications from the access artery; 2 - puncture parameters. Results. The average difference in the diameters of the RA and DRA was 0.3 mm and 0.4 mm, in some patients the DRA diameter corresponded to the RA or even exceeded it. The diameter of RA and DRA in men and women significantly differs, 2.65±0.44 mm and 2.36±0.36 mm (p=0.001), 2.31±0.39 mm and 2.13±0.38 mm (p=0.001). Technical success of DRA access requre the number of attempts. 94.1% - the percentage of successful cardiac catheterization performed through the distal radial artery approach, which is significantly less than via RA - 100% (p<0.001). In the observation group, significantly fewer rebleedings and rehemostasis were occured. In the long-term period, there were registered outstandingly more hematomas in the observation group at the time of discharge and after 1 week. Conclusion. Intermediate analysis of the results of the TENDERA study shows that there is no significant difference in the primary endpoint, but the number of complications in the observation group associated with the puncture markedly - hematoma more than 5 cm to the day of discharge and after 7 days. What this paper adds Intermediate results of the first multicenter open randomized (1:1) study devoted to the comparison of distal puncture of the radial artery versus the traditional entry point of puncture of the radial artery on the forearm during the endovascular interventions have been presented. A significant reduction of the number of local complications has been revealed in the group of distal puncture of the radial artery and the absence of differences according to the primary endpoint: early and late radial artery thrombosis.