PB2429 EXPERIENCE OF TREATMENT WITH EDOXABAN IN 552 PATIENTS. SUBANALYSIS BASED ON CREATININE CLEARANCE
Authors: A. Garcia Ruiz, P. Romero Garcia, M. Rivas Luque, E. Morente Constantin, G. Salas Camacho, P. Garrido Collado, M. Jurado Chacón
Journal: HemaSphere (2019)

Background: Oral anticoagulation therapy is a well-established treatment for preventing strokes in patients with AF who are at moderate to high risk of stroke, and the non-vitamin K antagonist oral anticoagulants (NOACs) have been recommended as alternatives to warfarin for stroke prevention in patients with non-valvular AF in various treatment guidelines. Therefore, the last Atrial Fibrillation management guidelines recommend that patients determined to be at risk for stroke should receive oral anticoagulants. The FDA considered that in patients with NVAF and a creatinine clearance >95 ml/min, edoxaban should not be used. By contrast the EMA did not perfom this recommendation. On the other hand Hokusai-VTE trials demonstrated that edoxaban was at least as effective as warfarin for the treatment and prevention of venous thromboembolism, but with a lesser risk o bleeding in both cases. Aims: It has been defined as Primary Objective of the study to evaluate the efficacy of Edoxaban in the prevention of stroke and Embolism Systemic and, as a secondary objective, to assess the safety, in function of the major bleeding largest defined according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH). As a secondary objective, the subpopulation of patients with creatinine clearance greater than 95 ml/min is analysed according to the Cockcroft-Gault formula. Methods: This is a descriptive study. We have included a total of 552 patients with Non-valvular Atrial Fibrillation and Deep Vein Thrombosis (DVT). The indication for anticoagulation was Non-valvular Atrial Fibrillation with 536 cases (97.1%) and 16 patients (2,9%) for secondary prevention of Deep Vein Thrombosis. The risk of stroke is assessed according to the scale CHA2DS2-VASc. The mean CHA2DS2-VASc of patients studied was of 3.63 in the total population. The mean of follow-up was 13 month with a range between 1-26 months (median 13 months). In this review 127 patients with creatinine clearance greater than 95 ml/min have been included. The mean CHA2DS2-VASC was 2.76 with a higher risk population percentage (CHA2DS2-VASC greater than or equal to 3) of 53.5%. The mean creatinine clearance value was 118.48 ml/min and the mean follow-up of these patients was 13.57 months. Results: It has not been reported any case of Stroke, Systemic Embolism, or Major Bleeding (according to the criteria of the ISTH) during the follow-up time of the patients treated, both in the main group and in the subpopulation of patients with creatinine clearance above 95 ml/min. Only 3% of patients (17) had complications with Edoxaban, of which 12 had discontinued treatment for this cause. No case of severe or clinically relevant major bleeding has been reported according to the ISTH criteria. During the time of follow-up, twelve cases of death occurred from their base disease or from other causes, but in no case related to Edoxaban. Summary/Conclusion: This is a good sample of 552 patients and more than with a mean of 13 months of follow-up. In the analyzed subpopulation of patients with creatinine clearance greater than 95 ml/min, the good results of Edoxaban are confirmed since they have not presented any stroke recurrence or systemic embolism or major or clinically relevant hemorrhage according to the ISTH criteria. Due to the sample of 127 patients, more studies will be needed to confirm this assertion.