Prevention of radial artery occlusion with rivaroxaban after interventional coronary interventions using transradial access: Results of a single-center randomized clinical trial.
Abstract
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.