Similar Bleeding and Thrombotic Complication Rates Between Dabigatran and Rivaroxaban

SAN FRANCISCO, CA—At ACC.13, the American College of Cardiology’s 62nd Annual Scientific Session, Anil Rajendra, MD, from the Medical University of South Carolina, in Charleston, SC, presented data showing similar bleeding and thrombotic complication rates at the time of atrial fibrillation ablation (AFA) in patients anticoagulated with dabigatran and rivaroxaban. Dr. Rajendra and colleagues determined that rivaroxaban has an acceptable safety profile for AFA.

In patients experiencing anti-arrhythmic drug-refractory atrial fibrillation, AFA has been shown to be the mainstay of treatment. Increased use of newly approved oral anticoagulants requires the evaluation of appropriate peri-operative strategies at the time of AFA. Mixed results regarding the safety profile of peri-operative dabigatran and AFA have already been reported, but little is known regarding the safety and efficacy of peri-procedure rivaroxaban with AFA.

Dr. Rajendra and colleagues performed an analysis on 155 dabigatran and 75 rivaroxaban patients undergoing AFA at MUSC from January–September 2012 anticoagulated with dabigatran or rivaroxaban. WACA was performed in patients with persistent or without paroxysmal linear lesions. Anticoagulants were discontinued within 24 hours prior to the procedure and restarted within 24 hours of procedure completion. Anticoagulants were withheld for 24–72 hours after the case, in patients experiencing major bleeding complications. Patients enrolled in this study were followed for up to 30 days.

Major bleeding was defined as pericardial tamponade, vascular hematoma, or other bleeding requiring transfusion. Minor bleeding was defined as a moderate to large pericardial effusion without tamponade, minor hematoma, or other bleeding events that did not require transfusion.

Major bleeding complications (tamponade) occurred in 2/155 (1.3%) with dabigatran and 1/75 (1.3%) with rivaroxaban (P=1). Minor bleeding complications (>2cm effusion) occurred in 1/155 (0.7%) with dabigatran and 1/75 (1.3%) with rivaroxaban (P=1). Patients treated with either dabigatran or rivaroxaban did not experience any thrombotic events or major vascular injuries.

Dr. Rajendra concluded that similar bleeding and thrombotic complication rates were observed at the time of AFA with dabigatran and rivaroxaban. “Dabigatran and rivaroxaban appears to have an acceptable safety profile in comparison to traditional anticoagulants,” as stated by Dr. Rajendra.