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

Autor: Balsam P; 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland., Tymińska A; 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland. tyminska.agata@gmail.com., Ozierański K; 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland., Zaleska M; 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland., Żukowska K; 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland., Szepietowska K; 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland., Maciejewski K; 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland., Peller M; 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland., Grabowski M; 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland., Lodziński P; 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland., Kołtowski Ł; 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland., Praska-Ogińska A; Cardiology Unit, John Paul II Western Hospital, Grodzisk Mazowiecki, Poland., Zaboyska I; Cardiology Unit, John Paul II Western Hospital, Grodzisk Mazowiecki, Poland., Bednarski J; Cardiology Unit, John Paul II Western Hospital, Grodzisk Mazowiecki, Poland., Filipiak KJ; 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland., Opolski G; 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.
Jazyk: angličtina
Zdroj: Cardiology journal [Cardiol J] 2020; Vol. 27 (5), pp. 590-599. Date of Electronic Publication: 2018 Nov 08.
DOI: 10.5603/CJ.a2018.0135
Abstrakt: 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.
Databáze: MEDLINE