Prevention of radial artery occlusion with Rivaroxaban after transradial coronary interventions: results of a single-center randomized clinical trial

Abstract

The transradial approach is the gold standard for coronary interventions, however, radial artery occlusion (RAO) remains a frequent complication limiting the possibility of repeated use of the vessel. Despite all existing methods for RAO prevention, they are all aimed at influencing the radial artery (RA) during or immediately after the procedure. Aim: To evaluate the efficacy and safety of RAO prevention with Rivaroxaban 2.5 mg twice daily for 3 months in patients after coronary interventions performed via the transradial approach (TRA). Material and Methods. A single-center randomized controlled trial was conducted (n = 300). Patients were randomly assigned (1:1) to one of two groups: those receiving Rivaroxaban 2.5 mg twice daily for 3 months after transradial endovascular coronary intervention (Rivaroxaban group – Group I), and those receiving standard treatment (control group – Group II). The primary endpoint was the incidence of RAO at day 7 after puncture, as well as at 1 and 3 months; assessed by ultrasound Doppler control. Secondary endpoints were hemorrhagic complications according to the BARC classification. Results. The administration of Rivaroxaban led to a significant reduction in RAO incidence at all follow-up time points: day 7 – 0.7% vs. 12.7%, p < 0.001; OR = 0.046 (95% CI: 0.006–0.35); 1 month – 3.3% vs. 14.7%, p < 0.001; OR = 0.20 (95% CI: 0.07–0.54); 3 months – 4.0% vs. 13.3%, p = 0.004; OR = 0.27 (95% CI: 0.10–0.72). No cases of severe bleeding BARC type 3–5 were observed in either group. The number of minor bleeding events (BARC 1) in the entire sample was 1.3%, with no statistically significant difference between the groups: 1.0% vs. 0.33%, p = 0.624; OR = 3.04 (95% CI: 0.31–29.6). Conclusions. The administration of Rivaroxaban 2.5 mg twice daily for 3 months can be considered an effective and safe method for RAO prevention in patients after elective coronary interventions performed via the transradial approach.