Alexander Korotkikh, Avtandil Babunashvili
In this selected single-center population, prolonged low-dose rivaroxaban was associated with a substantial reduction in ultrasound-detected RAO after transradial coronary procedures. These findings support further multicenter placebo-controlled trials but do not justify routine prophylactic use pending additional safety, cost-effectiveness, and comparative-effectiveness data.
BACKGROUND: Transradial access is the preferred approach for coronary angiography and percutaneous coronary intervention; however, radial artery occlusion (RAO) remains the most common vascular complication and may preclude repeat radial access, radiocephalic arteriovenous fistula creation, and use of the radial artery as a coronary bypass conduit. Most preventive strategies target procedural factors, whereas extended pharmacologic prophylaxis remains insufficiently studied.
OBJECTIVE: To evaluate the efficacy of rivaroxaban 2.5 mg twice daily for 3 months in preventing RAO after transradial coronary procedures and to assess bleeding events during follow-up.
METHODS: This prospective, single-center, open-label randomized controlled trial enrolled 300 patients with chronic coronary syndrome undergoing coronary angiography or percutaneous coronary intervention via conventional transradial access. Patients were randomized (1:1) to rivaroxaban 2.5 mg twice daily for 3 months or standard therapy without additional anticoagulation. Duplex ultrasound, performed by a blinded assessor at 7 days, 1 month, and 3 months, evaluated the primary endpoint of complete RAO. Bleeding was classified according to Bleeding Academic Research Consortium criteria. Adjusted associations were assessed using Firth penalized logistic regression.
RESULTS: Rivaroxaban significantly reduced RAO at 7 days (0.7% vs 12.7%; p < 0.001), 1 month (3.3% vs 14.7%; p < 0.001), and 3 months (4.0% vs 13.3%; p = 0.004). At 3 months, the absolute risk reduction was 9.3%, corresponding to a number needed to treat of approximately 11. After adjustment for chronic kidney disease, radial artery diameter, and procedure duration, rivaroxaban remained independently associated with lower RAO (adjusted OR 0.22, 95% CI 0.08-0.61; p = 0.003). No BARC type 3-5 bleeding occurred; four BARC type 1 events were observed.
CONCLUSIONS: In this selected single-center population, prolonged low-dose rivaroxaban was associated with a substantial reduction in ultrasound-detected RAO after transradial coronary procedures. These findings support further multicenter placebo-controlled trials but do not justify routine prophylactic use pending additional safety, cost-effectiveness, and comparative-effectiveness data.