P756TransRadial versus transulnar artery approach for elective invasive percutaneous coronary interventions - Randomized feasibility and safety trial with ultrasonographic outcome

Abstract

Background: Transradial access (TRA) for coronary angiography (CAG) in percutaneous coronary intervention (PCI) has been shown to be superior to the transfemoral access (TFA) in patients with acute coronary syndromes (ACS) and elective procedures. Purpose: The aim of this study was to compare efficacy and safety of TRA vs TUA in patients scheduled for CAG. Methods: The study was prospective, single center, randomized trial. Between 2013 and 2016, 200 patients were randomized to TRA or TUA group. Ultrasonography was performed before CAG and after procedure (during haemostasis, within 24 hours, 1 and 6 months). CAG was performed by certified interventional cardiologists. The primary endpoint was efficacy defined as a success in CAG without cross-over (CO) of vascular access. The secondary endpoint was safety assessed with number of vascular complications (total occlusion, haematoma). Results: Among 200 patients, 13 (6.5%) were lost to follow-up, leaving 187 patients, with 94 assigned to TRA and 93 to TUA with evaluable data for 6-month follow-up. CAG was done in all study patients (n=200) and ad hoc PCI was done in 37 (37%) patients in TRA and 36 (36%) in TUA group. There were not significant differences in clinical characteristics between both groups (TRA group: 41 men, mean age 66.0±8.8; TUA group: 52 men, mean age 66.3±10.7). In the TRA group, CO was required in 5 (5%) cases, in the TUA group in 25 (25%) cases (p<0.0001). The CO frequency was dependent on the operator experience. The incidence of CO by operator 1 (expert TRA and TUA) was 9.2%, operator 2 (expert TRA and TUA) was 10%, operator 3 (beginner TUA) was 24%. After exclusion operator 3 group, the efficacy of both approaches was similar (p = NS). In multivariate regression analysis, independent factors for CAG success in TUA were: diameter of ulnar artery (UA) [OR 10,7 (1,892 - 60,413) 95% CI]; depth of UA [OR 1,34 (1,03-1,732) 95% CI]; operator experience 1 vs 3 [OR 8,8 (2,25- 34,41) 95% CI]. There were no statistically significant differences between TRA and TUA in vascular access safety. Conclusions: In patients undergoing CAG, TUA occurred a feasible and safe route for the procedure but its efficacy was significantly lower as compared with TRA. After exclusion of the operator beginner TUA group efficacy of TRA and TUA was similar. Operator experience significantly impacted the efficacy of TUA. (Table Presented).