open access

Vol 27, No 5 (2020)
Original articles — Clinical cardiology
Published online: 2018-11-06
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Randomized controlled clinical trials versus real-life atrial fibrillation patients treated with oral anticoagulants. Do we treat the same patients?

Paweł Balsam, Agata Tymińska, Krzysztof Ozierański, Martyna Zaleska, Katarzyna Żukowska, Katarzyna Szepietowska, Kacper Maciejewski, Michał Peller, Marcin Grabowski, Piotr Lodziński, Łukasz Kołtowski, Anna Praska-Ogińska, Inna Zaboyska, Janusz Bednarski, Krzysztof J. Filipiak, Grzegorz Opolski
DOI: 10.5603/CJ.a2018.0135
·
Pubmed: 30406937
·
Cardiol J 2020;27(5):590-599.

open access

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

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.

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.

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Keywords

non-valvular atrial fibrillation, oral anticoagulation, randomized trial, real-world study

About this article
Title

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

Journal

Cardiology Journal

Issue

Vol 27, No 5 (2020)

Pages

590-599

Published online

2018-11-06

DOI

10.5603/CJ.a2018.0135

Pubmed

30406937

Bibliographic record

Cardiol J 2020;27(5):590-599.

Keywords

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

Authors

Paweł Balsam
Agata Tymińska
Krzysztof Ozierański
Martyna Zaleska
Katarzyna Żukowska
Katarzyna Szepietowska
Kacper Maciejewski
Michał Peller
Marcin Grabowski
Piotr Lodziński
Łukasz Kołtowski
Anna Praska-Ogińska
Inna Zaboyska
Janusz Bednarski
Krzysztof J. Filipiak
Grzegorz Opolski

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