Clinical Electrophysiology -> Atrial Fibrillation & Atrial Flutter: -> Pharmacology (Antiarrhythmic drugs and anticoagulants) D-PO02 - Poster Session II (ID 47) Poster

D-PO02-231 - Left Atrial Appendage Thrombus Resolution With Dabigatran Versus Vitamin-k-antagonist. The Re-lated Af Study - A Prospective Randomized Open, Blinded End-point Study (ID 1071)

Abstract

Background: Left atrial appendage (LAA) thrombus formation may occur as a consequence of atrial fibrillation (AF).
Objective: We conducted the first multicenter prospective randomized study that compared Phenprocoumon with Dabigatran for LAA thrombus resolution.
Methods: This study aimed to include a total of 110 patients with AF and a recently new diagnosed LAA thrombus in 12 German centers. After incidental finding of LAA thrombus in transesophageal echocardiography (TEE), randomization was performed. Randomization was performed to either Phenprocoumon or Dabigatran with 150mg bid. Treatment effects were determined by repeated TEE after 21, 28 and 42 days, respectively. Primary endpoint was time to LAA thrombus resolution, secondary endpoint was complete thrombus resolution after 6 weeks of treatment
Results: We report the first preliminary results of the study. A total number of 64 patients were finally randomized, 31 patients to the treatment with Dabigatran and 33 to Phenprocoumon. The median time to thrombus resolution was 42 days [95% CI 23-65] in the Dabigatran treatment group and 24 days [95% CI 23-n.a.] in the Phenprocoumon group. This difference did not reach statistical significance (p=0.403, figure 1). At study end (after 6 weeks), thrombus resolution was observed in 50% of patients in the Dabigatran group and 52% in the Phenprocoumon group (p=0.882). More adverse events occurred in the Phenprocoumon than in the Dabigatran group (0.84 vers. 0.40 per patient).
Conclusion: The RE-LATED AF study did not show any statistical difference in efficacy but a higher adverse event rate in the VKA treatment arm.
Collapse