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A single centre experience of the efficacy and safety of dabigatran etexilate used for stroke prevention in atrial fibrillation

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Abstract

The use of novel anticoagulants such as dabigatran are increasing. Despite increased risks of intracerebral haemorrhage with warfarin among Asians, there is little published data on dabigatran to assess ‘real world’ efficacy and safety of dabigatran therapy in Asia. This was a retrospective observational study of patients prescribed dabigatran between 2010 and 2013. Data was available for 510 patients: median age 68 years (range 20–91), median CHA2DS2-VASc score was 2 and median HAS-BLED score was 2. The average follow-up duration of 315 days (range: 1–1,096). The overall discontinuation rate was 16 % after a median 252 days of treatment with dabigatran. There were 17 (3.3 %) patients with minor bleeding, 2 (0.4 %) had major bleeding episodes. 20 patients (3.9 %) developed dyspepsia which was the most common side effect. The rate of occurrences of adverse effects and bleeding were lower than those seen in the RE-LY trial. None of the patients had an ischaemic stroke, 1 (0.2 %) patient had a haemorrhagic stroke. Out of 510 patients, 158 patients (31 %) were switched to dabigatran from warfarin. This showed that patients frequently preferred the dabigatran due to convenience when given a choice to switch from warfarin. We report one of the largest registry of Asian patients. Reassuringly, we found that our cohort had a low rate of rate of ischaemic stroke, low rates of side effects and bleeding with the drug.

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References

  1. Boehringer Ingelheim. Pradaxa 110 mg: summary of product characteristics. http://www.medicines.org.uk/emc/medicine/20760 Accessed 22 Oct 2013

  2. Connolly SJ, Ezekowitz MD, Yusuf S et al (2009) Dabigatran versus warfarin in patients with atrial fibrillation (RE-LY). N Engl J Med 361:1139–1151

    Article  CAS  PubMed  Google Scholar 

  3. Connolly SJ, Wallentin L, Ezekowitz MD et al (2013) The long term multi-center observational study of dabigatran treatment in patients with atrial fibrillation: (RELY-ABLE) study. Circulation 128(3):237–243

    Article  CAS  PubMed  Google Scholar 

  4. Patel MR, Mahaffey KW, Garg J et al (2011) Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (with supplementary appendix). N Engl J Med 365:883–891

    Article  CAS  PubMed  Google Scholar 

  5. Granger CB, Alexander JH, McMurray JJV et al (2011) Apixaban versus warfarin in patients with atrial fibrillation (including supplementary appendix and study protocol). N Engl J Med 365:981–992

    Article  CAS  PubMed  Google Scholar 

  6. Camm AJ, Lip GYH, De Caterina R et al (2012) 2012 focused update of the ESC guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Europace 14:1385–1413

    Article  PubMed  Google Scholar 

  7. Camm J, Kirchhof P, Lip G et al (2010) Guidelines for the management of atrial fibrillation. The task force for the management of atrial fibrillation of the European Society of Cardiology (ESC). Eur Heart J 31:2369–2429

    Article  PubMed  Google Scholar 

  8. Shen AY, Yao JF, Brar SS et al (2007) Racial/ethnic differences in the risk of intracranial hemorrhage among patients with atrial fibrillation. J Am Coll Cardiol 50(4):309–315

    Article  PubMed  Google Scholar 

  9. Guo Y, Pisters R, Apostolakis S et al (2013) Stroke risk and suboptimal thromboprophylaxis in Chinese patients with atrial fibrillation: Would the novel oral anticoagulants have an impact? Int J Cardiol 168(1):515–522

    Article  PubMed  Google Scholar 

  10. Truumees E, Gaudu T, Dieterichs C et al (2012) Epidural hematoma and intraoperative hemorrhage in a spine trauma patient on Pradaxa (dabigatran). Spine 37:E863–E865

    Article  PubMed  Google Scholar 

  11. Wychowski MK, Kouides PA (2012) Dabigatran-induced gastrointestinal bleeding in an elderly patient with moderate renal impairment. Ann Pharmacother 46:e10

    Article  PubMed  Google Scholar 

  12. Flaker G, Ezekowitz M, Yusuf S et al (2012) Efficacy and safety of dabigatran compared to warfarin in patients with paroxysmal, persistent, and permanent atrial fibrillation: results from the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) study. J Am Coll Cardiol 59(9):854–855

    Article  CAS  PubMed  Google Scholar 

  13. Lakkireddy D, Reddy YM, Di Biase L et al (2012) Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry. J Am Coll Cardiol 59(13):1168–1174

    Article  CAS  PubMed  Google Scholar 

  14. Nagarakanti R, Ezekowitz MD, Oldgren J et al (2011) Dabigatran versus warfarin in patients with atrial fibrillation: an analysis of patients undergoing cardioversion. Circulation 123(2):131–136

    Article  CAS  PubMed  Google Scholar 

  15. Hori M, Connolly SJ, Zhu J, The RE-LY Investigators et al (2013) Dabigatran versus warfarin: effects on ischemic and hemorrhagic strokes and bleeding in Asians and Non-Asians with atrial fibrillation. Stroke 44(7):1891–1896

    Article  CAS  PubMed  Google Scholar 

  16. Wallentin L, Yusuf S, Ezekowitz MD, RE-LY investigators et al (2010) Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet 376(9745):975–983

    Article  CAS  PubMed  Google Scholar 

  17. Ho JC, Chang AM, Yan BP, Yu CM, Lam YY, Lee VW (2012) Dabigatran compared with warfarin for stroke prevention with atrial fibrillation: experience in Hong Kong. Clin Cardiol 35(12):E40–E45

    Article  PubMed  Google Scholar 

  18. Larsen TB, Rasmussen LH, Skjøth F et al (2013) Efficacy and safety of dabigatran etexilate and warfarin in ‘real world’ patients with atrial fibrillation: A prospective nationwide cohort study. J Am Coll Cardiol 61(22):2264–2273

    Article  CAS  PubMed  Google Scholar 

  19. Michel J, Mundell D, Boga T et al (2013) Dabigatran for anticoagulation in atrial fibrillation—early clinical experience in a hospital population and comparison to trial data. Heart Lung Circ 22:50–55

    Article  PubMed  Google Scholar 

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The authors declare that they have no conflict of interest.

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Correspondence to Lok Bin Yap.

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Yap, L.B., Rusani, B.I., Umadevan, D. et al. A single centre experience of the efficacy and safety of dabigatran etexilate used for stroke prevention in atrial fibrillation. J Thromb Thrombolysis 38, 39–44 (2014). https://doi.org/10.1007/s11239-013-1020-y

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  • DOI: https://doi.org/10.1007/s11239-013-1020-y

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