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Duraes AR, Roriz PD, Bulhoes FV, et al. Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively: protocol. JMIR Res Protoc. 2014;3(2):e21doi: 10.2196/resprot.3014.
Duraes, A. R., Roriz, P. D., Bulhoes, F. V., Nunes, B. D., Muniz, J. Q., Neto, I. N., Fernandes, A. M., Reis, F. J., Camara, E. J., Junior, E. D., Segundo, D. T. s., Silva, F. P., & Aras, R. (2014). Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively: protocol. JMIR research protocols, 3(2), e21. https://doi.org/10.2196/resprot.3014
Duraes, Andre Rodrigues, et al. "Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively: protocol." JMIR research protocols vol. 3,2 (2014): e21. doi: https://doi.org/10.2196/resprot.3014
Duraes AR, Roriz PD, Bulhoes FV, Nunes BD, Muniz JQ, Neto IN, Fernandes AM, Reis FJ, Camara EJ, Junior ED, Segundo DTs, Silva FP, Aras R. Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively: protocol. JMIR Res Protoc. 2014 Apr 01;3(2):e21. doi: 10.2196/resprot.3014. PMID: 24691436; PMCID: PMC4004148.
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JMIR Res Protoc. 2014 Apr 01;3(2):e21. doi: 10.2196/resprot.3014.

Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively: protocol.

JMIR research protocols

Andre Rodrigues Duraes, Pollianna Ds Roriz, Fabio V Bulhoes, Bianca DA Nunes, Juliana Qv Muniz, Italvar Ndcr Neto, Andre Ms Fernandes, Francisco Jfbd Reis, Edmundo Jn Camara, Erenaldo Dsr Junior, Deusdeth Ts Segundo, Felipe Pinho E Albuquerque Silva, Roque Aras

Affiliations

  1. Hospital Ana Nery, Serviço de Cardiologia, Universidade do Estado da Bahia, Salvador, Brazil. [email protected].

PMID: 24691436 PMCID: PMC4004148 DOI: 10.2196/resprot.3014

Abstract

BACKGROUND: Warfarin and similar vitamin K antagonists have been the standard therapy for patients with mechanical or biological valve prosthesis and atrial fibrillation (AF). Even with the appropriate use of therapy, some studies have reported that there is a high incidence of thromboembolic events, 1%-4% per year. Furthermore, a bleeding risk is significant, ranging from 2% to 9% per year, according to some studies.

OBJECTIVE: The objective of our study was to examine the effect of dabigatran etexilate versus dose-adjusted warfarin for the prevention of intracardiac thrombus in persistent or permanent AF at least 3 months after aortic and/or mitral bioprosthesis replacement.

METHODS: Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively (DAWA) is a phase 2, prospective, open label, randomized exploratory pilot study. The main variable to be observed in this study is intracardiac thrombus. From August 2013 to April 2015, 100 patients, at least 3 months after aortic and/or mitral bioprosthesis replacement and permanent or persistent AF postoperatively, who match eligibility criteria will be selected from Ana Nery Hospital in Salvador-Bahia with a follow-up of three months. Patients were randomly assigned in a 1:1 ratio to receive either dabigatran etexilate or warfarin.

RESULTS: Although the present study has no statistic power to proof non-inferiority, it is expected that the dabigatran etexilate group will be protected as well as the warfarin group from intracardiac thrombus, without increasing the bleeding rates, since we are using safer doses (110 mg bid). The lack of necessity of monitoring INR is also another factor that contributes to a better adherence to the new drug and it can make all the difference in the manner of doing anticoagulation for patients with similar clinical characteristics.

CONCLUSIONS: The study is in the recruitment phase. It is possible that dabigatran etexilate is as effective as warfarin in preventing the emergence of intracardiac thrombus in patients with AF and mitral and/or aortic bioprosthesis.

TRIAL REGISTRATION: Clinicaltrials.gov NCT01868243; http://clinicaltrials.gov/ct2/show/NCT01868243 (Archived by WebCite at http://www.webcitation/6OABiuasd).

Keywords: anticoagulants; atrial fibrillation; dabigatran; hematologic agents; stroke; warfarin

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