Download PDF
Thromb Haemost 2015; 113(06): 1247-1257
DOI: 10.1160/TH14-11-0954
Coagulation and Fibrinolysis
Schattauer GmbH

Effectiveness and safety of dabigatran therapy in daily-care patients with atrial fibrillation

Results from the Dresden NOAC Registry
Jan Beyer-Westendorf
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” der Technischen Universität Dresden, Dresden, Germany
,
Franziska Ebertz
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” der Technischen Universität Dresden, Dresden, Germany
,
Kati Förster
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” der Technischen Universität Dresden, Dresden, Germany
,
Vera Gelbricht
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” der Technischen Universität Dresden, Dresden, Germany
,
Franziska Michalski
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” der Technischen Universität Dresden, Dresden, Germany
,
Christina Köhler
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” der Technischen Universität Dresden, Dresden, Germany
,
Sebastian Werth
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” der Technischen Universität Dresden, Dresden, Germany
,
Heike Endig
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” der Technischen Universität Dresden, Dresden, Germany
,
Sven Pannach
2   Department of Medicine I, Division of Gastroenterology, University Hospital “Carl Gustav Carus” der Technischen Universität Dresden, Dresden, Germany
,
Luise Tittl
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” der Technischen Universität Dresden, Dresden, Germany
,
Kurtulus Sahin
3   ClinStat GmbH, Institute for Clinical Research and Statistics, Cologne, Germany
,
Katharina Daschkow
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” der Technischen Universität Dresden, Dresden, Germany
,
Norbert Weiss
1   Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” der Technischen Universität Dresden, Dresden, Germany
› Author Affiliations
Further Information

Publication History

Received: 18 November 2014

Accepted after major revision: 10 January 2015

Publication Date:
22 November 2017 (online)

Also available at
    Permissions and Reprints

summary

The effectiveness and safety of dabigatran for stroke prevention in atrial fibrillation (SPAF) demonstrated in RE-LY needs to be confirmed in daily care. To evaluate treatment persistence, effectiveness and safety of dabigatran therapy in SPAF patients in daily care, we used data from an ongoing, prospective, non-interventional registry of more than 2,500 patients on novel oral anticoagulants in daily care. Between October 1, 2011 and February 28, 2013, a total of 341 SPAF patients receiving dabigatran were enrolled. The combined endpoint of stroke/transient ischaemic attack/systemic embolism occurred at a rate of 2.93/100 patient-years in the intention-to-treat analysis (95%-CI 1.6–4.9) and at 1.9/100 patient-years in the on treatment analysis (events within three days after last intake). On-treatment rates were higher in patients selected for 110 mg dabigatran (n=183) BID compared to the 158 patients selected for 150 mg BID (2.88 [95% CI 1.16–5.93] vs 0.86/100 patient-years [95% CI 0.10, 3.12]). On treatment, major bleeding occurred at a rate of 2.3/100 patient-years and numerically more often in patients receiving the 110 mg BID dose compared to the 150 mg BID dose (2.9 vs 1.7/100 patient-years). Dabigatran treatment discontinuation occurred in a total of 124 patients during follow-up (25.8 per 100 patient-years in Kaplan Meier analysis). Main reasons for treatment discontinuation were nonbleeding side effects. Our data contribute to the confirmation of effectiveness and relative safety of dabigatran in unselected patients in daily care. However, discontinuation rates are not lower than those reported for patients treated with vitamin K antagonists.

Keywords

Anticoagulation - atrial fibrillation - bleeding - dabigatran

 

  • References

  • 1 Ageno W, Gallus AS, Wittkowsky A. et al. Oral anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl. 02) e44S-e88S.
    CrossrefPubMedSearch in Google Scholar
  • 2 van Walraven C, Jennings A, Oake N. et al. Effect of study setting on anticoagulation control: a systematic review and metaregression. Chest 2006; 129: 1155-1166.
    CrossrefPubMedSearch in Google Scholar
  • 3 Connolly SJ, Ezekowitz MD, Yusuf S. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139-1151.
    CrossrefPubMedSearch in Google Scholar
  • 4 Beyer-Westendorf J, Gelbricht V, Forster K. et al. Peri-interventional management of novel oral anticoagulants in daily care: results from the prospective Dresden NOAC registry. Eur Heart J 2014; 35: 1888-1896.
    CrossrefPubMedSearch in Google Scholar
  • 5 Beyer-Westendorf J, Gelbricht V, Forster K. et al. Safety of switching from Vitamin-K antagonists to dabigatran or rivaroxaban in daily care -results from the Dresden NOAC registry. Br J Clin Pharmacol. 2014. Epub ahead of print
    Search in Google Scholar
  • 6 Beyer-Westendorf J, Forster K, Pannach S. et al. Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood 2014; 124: 955-962.
    CrossrefPubMedSearch in Google Scholar
  • 7 Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 03: 692-694.
    CrossrefPubMedSearch in Google Scholar
  • 8 Graham DJ, Reichman ME, Wernecke M. et al. Cardiovascular, Bleeding, and Mortality Risks in Elderly Medicare Patients Treated with Dabigatran or Warfarin for Non-Valvular Atrial Fibrillation. Circulation. 2014. Epub ahead of print
    Search in Google Scholar
  • 9 Sorensen R, Gislason G, Torp-Pedersen C. et al. Dabigatran use in Danish atrial fibrillation patients in 2011: a nationwide study. Br Med J Open 2013; 3.
    PubMedSearch in Google Scholar
  • 10 Gomes T, Mamdani MM, Holbrook AM. et al. Rates of hemorrhage during warfarin therapy for atrial fibrillation. Cmaj 2013; 185: E121-E127.
    CrossrefPubMedSearch in Google Scholar
  • 11 Patel MR, Mahaffey KW, Garg J. et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: 883-891.
    CrossrefPubMedSearch in Google Scholar
  • 12 Granger CB, Alexander JH, McMurray JJ. et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365: 981-992.
    CrossrefPubMedSearch in Google Scholar
  • 13 Giugliano RP, Ruff CT, Braunwald E. et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013; 369: 2093-2104.
    CrossrefPubMedSearch in Google Scholar
  • 14 Albers GW, Diener HC, Frison L. et al. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. J Am Med Assoc 2005; 293: 690-698.
    CrossrefPubMedSearch in Google Scholar
  • 15 Zalesak M, Siu K, Francis K. et al. Higher persistence in newly diagnosed nonvalvular atrial fibrillation patients treated with dabigatran versus warfarin. Circulation Cardiovasc Qual Outcom 2013; 06: 567-574.
    PubMedSearch in Google Scholar
  • 16 Gallagher AM, Rietbrock S, Plumb J. et al. Initiation and persistence of warfarin or aspirin in patients with chronic atrial fibrillation in general practice: do the appropriate patients receive stroke prophylaxis?. J Thromb Haemost 2008; 06: 1500-1506.
    CrossrefPubMedSearch in Google Scholar
  • 17 Hylek EM, Evans-Molina C, Shea C. et al. Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation 2007; 115: 2689-2696.
    CrossrefPubMedSearch in Google Scholar
  • 18 Fang MC, Go AS, Chang Y. et al. Warfarin discontinuation after starting warfarin for atrial fibrillation. Circulation Cardiovasc Qual Outcom 2010; 03: 624-631.
    PubMedSearch in Google Scholar
  • 19 Gomes T, Mamdani MM, Holbrook AM. et al. Persistence with therapy among patients treated with warfarin for atrial fibrillation. Arch Intern Med 2012; 172: 1687-1689.
    CrossrefPubMedSearch in Google Scholar
  • 20 Lane DA, Lip GY. Patient’s values and p References for stroke prevention in atrial fibrillation: balancing stroke and bleeding risk with oral anticoagulation. Thromb Haemost 2014; 111: 381-383.
    Thieme ConnectPubMedSearch in Google Scholar
  • 21 Lane DA, Barker RV, Lip GY. Best practice for atrial fibrillation patient education. Curr Pharmaceut Des 2014; 21: 533-543.
    CrossrefPubMedSearch in Google Scholar
  • 22 Lahaye S, Regpala S, Lacombe S. et al. Evaluation of patients’ attitudes towards stroke prevention and bleeding risk in atrial fibrillation. Thromb Haemost 2014; 111: 465-473.
    Thieme ConnectPubMedSearch in Google Scholar
  • 23 Clarkesmith DE, Pattison HM, Lip GY. et al. Educational intervention improves anticoagulation control in atrial fibrillation patients: the TREAT randomised trial. PloS one 2013; 08: e74037.
    CrossrefPubMedSearch in Google Scholar