Literature DB >> 30406937

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

Paweł Balsam1, Agata Tymińska2, Krzysztof Ozierański1, Martyna Zaleska1, Katarzyna Żukowska1, Katarzyna Szepietowska1, Kacper Maciejewski1, Michał Peller1, Marcin Grabowski1, Piotr Lodziński1, Łukasz Kołtowski1, Anna Praska-Ogińska3, Inna Zaboyska3, Janusz Bednarski3, Krzysztof J Filipiak1, Grzegorz Opolski1.   

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.

Entities:  

Keywords:  non-valvular atrial fibrillation; oral anticoagulation; randomized trial; real-world study

Year:  2018        PMID: 30406937      PMCID: PMC8078963          DOI: 10.5603/CJ.a2018.0135

Source DB:  PubMed          Journal:  Cardiol J        ISSN: 1898-018X            Impact factor:   2.737


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