RESUMEN
The aim of this study was to assess the immediate and medium-term (3 months) results of the safety and efficacy of distal radial access (DRA) in coronary interventions compared with conventional transradial radial access (TRA). TRA is the recommended access for coronary procedures because of increased safety: fewer local complications, large and small bleeding. Recently, DRA has emerged as a promising alternative access to minimize radial artery occlusion (RAO) risk, as well as other complications. A large-scale, international, randomized trial comparing medium-term results with TRA and DRA is lacking. An analysis of 776 patients of the prospective randomized TENDERA trial was carried out: the distal artery access group (DRA) - 391, the transradial access group (TRA) - 385. Statistically more often the crossover access was in the DRA group (5.1% and 0.8%, P < 0.001). The primary endpoint was early or late thrombosis/occlusion of the radial artery (RA). Secondary endpoints: (1) composite complications from access vessels; (2) access parameters. Statistically significant differences were obtained for the primary endpoint: DRA 2.7% (nâ¯=â¯10), TRA 6.8% (nâ¯=â¯26), Pâ¯=â¯0.008. Occlusion of the distal radial artery (DRAt), with patent RA: DRA 1.3% (nâ¯=â¯5), TRA 0 (0), Pâ¯=â¯0.023. At the secondary composite endpoint, statistically significant differences were obtained for the following groups of complications: BARC type I bleeding (DRA: 3.8% (nâ¯=â¯14), TRA: 21.7% (nâ¯=â¯83), P < 0.001); hematoma larger than 5 cm on day 1 (DRA: 10% [nâ¯=â¯37], TRA: 25.9% [nâ¯=â¯98], P < 0.001); hematoma larger than 5 cm on day 7 (DRA: 12.4% [nâ¯=â¯45], TRA: 34.6% [nâ¯=â¯132], P < 0.001). Of the access parameters, the following statistically significantly differed: puncture time DRA 19.0 (8.0; 50), TRA 13.5 (5.0; 29), P < 0.001; insertion of introducer DRA 42.0 (26.0; 84.0), TRA 35.0 (23.0; 55.0), P < 0.001, access artery hemostasis duration (min.) DRA 180.0 (120.0; 480.0), TRA 155.0 (115.0; 195.0), P < 0.001. The duration of the procedure and fluoroscopy, radiation dose, RA spasm in both groups had no statistically significant differences. In the TENDERA trail, DRA demonstrated efficacy and safety in interventional coronary interventions compared with TRA in the medium-term follow-up period: a statistically significant lower incidence of RA occlusion and local complications.