Volumen: 18 # Number : 3
Publication Date : Septiembre - Diciembre Year: 2014
Dabigratan Etexilate: Institutional Experience
Authors: Otero V, Freue J, Schutz N, Penchasky D, Viñuales E
Abstract: During the last couple of years, new anticoagulant drugs
have been developed that target key coagulation factors,
such as factors Xa and IIa (thrombin): Rivaroxaban,
Apixaban and Dabigatran Etexilate (DE).
Objectives: To evaluate patients from the health care insurance
of the Italian Hospital in Buenos Aires treated
with DE for any cause from january 2010 to december
2012.
Materials and Methods: Retrospective observational
study including 206 patients.
Results: The number of patients treated with DE for
DVT prophylaxis after orthopedic surgery was 140
patients; including 43 patients with total hip replacement
(RTC); and 97 total knee replacement (RTR). The number
of patients treated for atrial fibrillation was 66; including
5 patient with valvular atrial fibrillation,
The median age of the patients was 75 years (27-92),
71% were females, 18,35% (38 patients) received concomitant
antiplatelet drugs.and 14% (29 patients) were
under treatment with drugs interacting with Glycoprotein
P (GpP). The median basal creatinine (Cr) was 0,79mg/
dl (0,40- 2,82). During treatment with DE, 7,2% patients
reported bleeds: 5 gastrointestinal haemorrhages and 3
epistaxis. There was one major bleeding and none intracranial
bleeds. There was no association between bleeding
and renal failure or concomitant antiplatelet therapy. Only 38 patients were monitored with coagulation assays
during treatment with DE; of them 47% had abnormal
laboratory values.
In the subgroup of patients with atrial fibrillation, the median
age was 78 years (27-92); 61% were females; the
median CHA2DS2VASc 3,17 and HASBLED 2,52. The
incidence of bleeds was 16,41% with a median age in this
population of 85 years; 4 patients had ischaemic stroke.
In the subgroup of patients treated for DVT prophylaxis,
the median time of treatment with DE was 15 days for
RTR and 30.7 days for RTC. The incidence of adverse
events was 2,8% for bleeds and thromboembolic events.
Conclusion: The incidence of hemorrhagic and thrombotic
events in patients treated with DE as prophylaxis
after orthopedic surgery was similar to the reported incidence
with heparin. Patients treated with DE for atrial
fibrillation had a higher rate of hemorrhagic events compared
to the RE-LY trial. This suggests that we should
improve patient selection and treatment monitoring in the
clinical practice outside clinical trials.
Key words: Dabigatran
Atrial Fibrillation
Anticoagulation
Thromboprophylaxis
Bleeds
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