Vol 27, No 5 (2020)
Original articles — Clinical cardiology
Published online: 2018-11-06
Randomized controlled clinical trials versus real-life atrial fibrillation patients treated with oral anticoagulants. Do we treat the same patients?
Abstract
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).
Methods: 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.
Results: 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).
Conclusions: Real-world patients had a lower risk of stroke than patients included in the RE-LY and ROCKET AF trials.
Keywords: non-valvular atrial fibrillationoral anticoagulationrandomized trialreal-world study
References
- 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.
- 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.
- 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.
- 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.
- Patel M, Mahaffey K, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011; 365(10): 883–891.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Avgil Tsadok M, Jackevicius CA, Rahme E, et al. Dabigatran use in elderly patients with atrial fibrillation. Thromb Haemost. 2016; 115(1): 152–160.
- 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.
- 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.
- 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.
- 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.
- 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].
