Healey JS, Eikelboom J, Douketis J, Wallentin L, Oldgren J, Yang S, et al.
Circulation. 2012;126(3):343-348
Background:
Dabigatran reduces ischemic stroke in comparison with warfarin; however, given the lack of antidote, there is concern that it might increase bleeding when surgery or invasive procedures are required.
Methods and results:
The current analysis was undertaken to compare the periprocedural bleeding risk of patients in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial treated with dabigatran and warfarin. Bleeding rates were evaluated from 7 days before until 30 days after invasive procedures, considering only the first procedure for each patient. A total of 4591 patients underwent at least 1 invasive procedure: 24.7% of patients received dabigatran 110 mg, 25.4% received dabigatran 150 mg, and 25.9% received warfarin, P=0.34. Procedures included: pacemaker/defibrillator insertion (10.3%), dental procedures (10.0%), diagnostic procedures (10.0%), cataract removal (9.3%), colonoscopy (8.6%), and joint replacement (6.2%). Among patients assigned to either dabigatran dose, the last dose of study drug was given 49 (35-85) hours before the procedure on comparison with 114 (87-144) hours in patients receiving warfarin, P<0.001. There was no significant difference in the rates of periprocedural major bleeding between patients receiving dabigatran 110 mg (3.8%) or dabigatran 150 mg (5.1%) or warfarin (4.6%); dabigatran 110 mg versus warfarin: relative risk, 0.83; 95% CI, 0.59 to 1.17; P=0.28; dabigatran 150 mg versuswarfarin: relative risk, 1.09; 95% CI, 0.80 to 1.49; P=0.58. Among patients having urgent surgery, major bleeding occurred in 17.8% with dabigatran 110 mg, 17.7% with dabigatran 150 mg, and 21.6% with warfarin: dabigatran 110 mg; relative risk, 0.82; 95% CI, 0.48 to 1.41; P=0.47; dabigatran 150 mg: relative risk, 0.82; 95% CI, 0.50 to 1.35; P=0.44.
Conclusions:
Dabigatran and warfarin were associated with similar rates of periprocedural bleeding, including patients having urgent surgery. Dabigatran facilitated a shorter interruption of oral anticoagulation.
Comentario del Dr. Fernando Arribas
Es un subanálisis post-hoc de la incidencia de sangrados periprocedimiento dentro de la población del estudio RE-LY. Se incluyeron los 4591 pacientes en los que se les suspendió la anticoagulación temporalmente con motivo de un procedimiento quirúrgico o invasivo y se comparó la incidencia de sangrado en cada uno de los tres grupos de tratamiento. La suspensión del tratamiento anticoagulante se realizó de acuerdo con las recomendaciones actuales.
No se encontraron diferencias significativas en cuanto a la incidencia de sangrado mayor, otros tipos de sangrado o eventos tromboembólicos en ninguno de los tres grupos. Como hallazgo más relevante, el estudio mostró que la cirugía pudo realizarse dentro de las primeras 48 horas tras la retirada del tratamiento anticoagulante en un porcentaje mayor de pacientes de los grupos tratados con dabigatrán. Estos hallazgos se explican porque la vida media del fármaco es más corta y la normalización del efecto anticoagulante una vez suspendido el tratamiento es más rápida. Sin embargo, no se objetivó ninguna repercusión clínica en este estudio.
