Vol 27, No 5 (2020)
Original articles — Clinical cardiology
Published online: 2018-11-06

open access

Page views 1965
Article views/downloads 1426
Get Citation

Connect on Social Media

Connect on Social Media

Randomized controlled clinical trials versus real-life atrial fibrillation patients treated with oral anticoagulants. Do we treat the same patients?

Paweł Balsam1, Agata Tymińska1, Krzysztof Ozierański1, Martyna Zaleska1, Katarzyna Żukowska1, Katarzyna Szepietowska1, Kacper Maciejewski1, Michał Peller1, Marcin Grabowski1, Piotr Lodziński1, Łukasz Kołtowski1, Anna Praska-Ogińska2, Inna Zaboyska2, Janusz Bednarski2, Krzysztof J. Filipiak1, Grzegorz Opolski1
Pubmed: 30406937
Cardiol J 2020;27(5):590-599.


Background: The aim of the study was to compare clinical characteristics of real-life atrial fibrillation (AF) patients with populations included in randomized clinical trials (ROCKET AF and RE-LY).

The analysis included 3528 patients who are participants of the ongoing, multicentre, retrospective CRAFT study. The study is registered in ClinicalTrials.gov: NCT02987062. The study is based on a retrospective analysis of hospital records of AF patients treated with vitamin K antagonists (VKAs) (acenocoumarol, warfarin) and non-vitamin K oral anticoagulants (NOACs) (dabigatran, rivaroxaban). CHADS2 score was used for risk of stroke stratification.

VKA was prescribed in 1973 (56.0%), while NOAC in 1549 (44.0%), including dabigatran — 504 (14.3%) and rivaroxaban — 1051 (29.8%), of the 3528 patients. VKA patients in the CRAFT study were at significantly lower risk of stroke (CHADS2 1.9 ± 1.3), compared with the VKA population from the RE-LY (2.1 ± 1.1) and the ROCKET-AF (3.5 ± 1.0). Patients in the CRAFT study treated with NOAC (CHADS2 for patients on dabigatran 150 mg — 1.3 ± 1.2 and on rivaroxaban — 2.2 ± 1.4) had lower risk than patients from the RE-LY (2.2 ± 1.2) and the ROCKET AF (3.5 ± 0.9).

Real-world patients had a lower risk of stroke than patients included in the RE-LY and ROCKET AF trials.

Article available in PDF format

View PDF Download PDF file


  1. Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. 2016; 18(11): 1609–1678.
  2. Ozierański K, Kapłon-Cieślicka A, Peller M, et al. Clinical characteristics and predictors of one-year outcome of heart failure patients with atrial fibrillation compared to heart failure patients in sinus rhythm. Kardiol Pol. 2016; 74(3): 251–261.
  3. Balsam P, Ozierański K, Tymińska A, et al. Comparison of clinical characteristics of real-life atrial fibrillation patients treated with vitamin K antagonists, dabigatran, and rivaroxaban: results from the CRAFT study. Kardiol Pol. 2018; 76(5): 889–898.
  4. Connolly S, Ezekowitz M, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009; 361(12): 1139–1151.
  5. Patel M, Mahaffey K, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011; 365(10): 883–891.
  6. Ezekowitz M, Connolly S, Parekh A, et al. Rationale and design of RE-LY: Randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009; 157(5): 805–810.e2.
  7. Saturni S, Bellini F, Braido F, et al. Randomized Controlled Trials and real life studies. Approaches and methodologies: a clinical point of view. Pulm Pharmacol Ther. 2014; 27(2): 129–138.
  8. Singer DE, Hughes RA, Gress DR, et al. Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators. The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. N Engl J Med. 1990; 323(22): 1505–1511.
  9. Petersen P, Boysen G, Godtfredsen J, et al. Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study. Lancet. 1989; 1(8631): 175–179.
  10. Stangier J, Rathgen K, Stähle H, et al. The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects. Br J Clin Pharmacol. 2007; 64(3): 292–303.
  11. Kubitza D, Becka M, Wensing G, et al. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939--an oral, direct Factor Xa inhibitor--after multiple dosing in healthy male subjects. Eur J Clin Pharmacol. 2005; 61(12): 873–880.
  12. Jackevicius CA, Tsadok MA, Essebag V, et al. Early non-persistence with dabigatran and rivaroxaban in patients with atrial fibrillation. Heart. 2017; 103(17): 1331–1338.
  13. Lasek-Bal A, Urbanek T, Puz P, et al. Rivaroxaban in secondary cardiogenic stroke prevention: two-year single-centre experience based on follow-up of 209 patients. Kardiol Pol. 2016; 74(5): 418–424.
  14. Lasek-Bal A, Urbanek T, Gierek D. Analysis of the efficacy and safety of new oral anticoagulant drugs in the secondary stroke prevention in patients with AF: single center experience based on 311 patients. Int Angiol. 2015; 34(6): 552–561.
  15. DeFelipe-Mimbrera A, Alonso Cánovas A, Guillán M, et al. Dabigatran in secondary stroke prevention: clinical experience with 106 patients. Biomed Res Int. 2014; 2014: 567026.
  16. Camm AJ, Amarenco P, Haas S, et al. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J. 2016; 37(14): 1145–1153.
  17. Lenarczyk R, Mitręga K, Mazurek M, et al. Polish and European management strategies in patients with atrial fibrillation. Data from the EURObservational Research Programme-Atrial Fibrillation General Registry Pilot Phase (EORP-AF Pilot). Pol Arch Med Wewn. 2016; 126(3): 138–148.
  18. de Vos CB, Pisters R, Nieuwlaat R, et al. Progression from paroxysmal to persistent atrial fibrillation clinical correlates and prognosis. J Am Coll Cardiol. 2010; 55(8): 725–731.
  19. Gorczyca-Michta I, Wożakowska-Kapłon B. New oral anticoagulants for the prevention of thromboembolic complications in atrial fibrillation: a single centre experience. Kardiol Pol. 2015; 73(2): 85–93.
  20. Coleman CI, Antz M, Ehlken B, et al. REal-LIfe Evidence of stroke prevention in patients with atrial Fibrillation--The RELIEF study. Int J Cardiol. 2016; 203: 882–884.
  21. Bednarski J, Balsam P, Tymińska A, et al. District versus academic hospitals: differences in the clinical characteristics of patients with atrial fibrillation without valvular heart disease treated with oral anticoagulants. Pol Arch Intern Med. 2018; 128(5): 274–279.
  22. Singer DE, Hellkamp AS, Piccini JP, et al. Impact of global geographic region on time in therapeutic range on warfarin anticoagulant therapy: data from the ROCKET AF clinical trial. J Am Heart Assoc. 2013; 2(1): e000067.
  23. Mearns ES, White CM, Kohn CG, et al. Quality of vitamin K antagonist control and outcomes in atrial fibrillation patients: a meta-analysis and meta-regression. Thromb J. 2014; 12: 14.
  24. Avgil Tsadok M, Jackevicius CA, Rahme E, et al. Dabigatran use in elderly patients with atrial fibrillation. Thromb Haemost. 2016; 115(1): 152–160.
  25. Lopatowska P, Tomaszuk-Kazberuk A, Mlodawska E, et al. Do CHA2 DS2 VASc and HAS-BLED scores influence 'real-world' anticoagulation management in atrial fibrillation? 1556 patient registry from the reference cardiology centre. Pharmacoepidemiol Drug Saf. 2015; 24(12): 1297–1303.
  26. Steinberg BA, Greiner MA, Hammill BG, et al. Contraindications to anticoagulation therapy and eligibility for novel anticoagulants in older patients with atrial fibrillation. Cardiovasc Ther. 2015; 33(4): 177–183.
  27. Stępińska J, Kremis E, Konopka A, et al. Stroke prevention in atrial fibrillation patients in Poland and other European countries: insights from the GARFIELD-AF registry. Kardiol Pol. 2016; 74(4): 362–371.
  28. Proietti M, Nobili A, Raparelli V, et al. Adherence to antithrombotic therapy guidelines improves mortality among elderly patients with atrial fibrillation: insights from the REPOSI study. Clin Res Cardiol. 2016; 105(11): 912–920.
  29. Balsam P, Borodzicz S, Malesa K, et al. OCULUS study: Virtual reality-based education in daily clinical practice. Cardiol J. 2018 [Epub ahead of print].