- Radial artery occlusion (RAO) is the most common complication after radial access for coronary procedures; while routine intra-procedural heparin administration is a protective factor, the role of post-procedural anticoagulation has not been established.
- In the RIVARAD study, patients undergoing trans-radial access for coronary procedures were randomized to a week of post-procedural rivaroxaban vs no additional treatment. The primary outcome of interest was 30-day incidence of RAO by ultrasound.
- Patients receiving rivaroxaban experienced a 50% reduction in RAO by ultrasound and a 52% reduction in RAO by palpation compared to the control group. Rivaroxaban use was safe with no increase in overall hemorrhagic complications relative to the control arm.
Radial artery occlusion (RAO) is the most frequent complication of radial access for coronary angiography and ultimately leads to exclusion of that artery for later access. While adequate intra-procedure anticoagulation has been established as a preventative measure, the role of post-procedure anticoagulation has not yet been examined. In a breaking presentation at the 2022 TCT Conference today, Dr. Rania Hammami (Hedi Chaker Hospital, Tunisia) and her team presented their study: “Prevention of Radial Artery Occlusion With Rivaroxaban After Transradial Coronary Procedures,” or the RIVARAD trial.
The RIVARAD study was a prospective, open-label, randomized clinical trial conducted across 5 centers in Tunisia which evaluated the effects of a prophylactic period of rivaroxaban (10mg daily x 7 days) post radial access to prevent RAO. The inclusion criteria comprised adults undergoing radial access for diagnostic coronary angiography or PCI; relevant exclusions included radial artery access failure, local radial complications, thrombolytic therapy within 24 hours, or contraindications to anticoagulation. A total of 538 patients were randomized (after completion of the procedure) to either rivaroxaban or no additional treatment. All patients received an ultrasound examination for RAO at 30 days; patients requiring further angiographic procedures for ACS were then excluded (17 total). The mean age was 60, and 32% of patients were female. 25.7% of patients had prior trans-radial procedures, and 7.29% had known peripheral arterial disease. Separately from the rivaroxaban, 47% of patients received DAPT post procedure, and 41% received only aspirin therapy. 48.7% patients had >1 puncture attempted, and 13.2% had no radial pulse at discharge.
The primary outcome was incidence of RAO by ultrasound at 30 days, and the overall incidence was 10%. Patients receiving rivaroxaban experienced lower rates of RAO (13% vs 6.9%; OR 0.5, 95% CI 0.27-0.91, p= 0.011). Additionally, patients in the rivaroxaban group were less likely to have a non-palpable radial artery pulse at 30 days (12.2% vs 5.8%, p =0.01). With regards to bleeding, 2.3% of patients experienced minor (BARC 1) bleeding, with no severe hemorrhagic complications; there was no significant difference in overall hemorrhagic complications between the two groups. Female sex, current smoking status, and prior trans-radial procedures were found to be positive predictors of RAO; higher heparin dosage was found to be a protective factor.
When discussing the clinical implications of the study at TCT, Dr. Hammami stated: “The RIVARAD study showed the efficacy and safety of rivaroxaban in reducing the rate of RAO after TRA by 50%…this could be a good option to prevent RAO….however, interventional cardiologists must make more effort to respect preventative measures for this complication by implementing the guidelines of best practices of TRA.”