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 fibrillation; oral anticoagulation; randomized trial; real-world study.

Conflict of interest statement

Conflict of interest: Paweł Balsam, Marcin Grabowski, Piotr Lodziński, Grzegorz Opolski — grants, lectures, expert committees of companies producing NOAC; Janusz Bednarski — fees for lectures from Bayer, Boehringer Ingelheim and Pfizer.

Figures

Figure 1

Flow chart of patient enrollment in the current analysis; bid — twice daily, CRAFT — MultiCentre expeRience in AFib patients Treated with OAC; VKA — vitamin K antagonists.

Figure 2

Thromboembolic risk basing on CHADS2 score in different oral anticoagulants groups. Results are shown as mean value. *Significant difference (p < 0.05) where observed for comparison of vitamin K antagonists (VKAs) patients from the CRAFT study with both RE-LY and ROCKET AF trials.