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 AF patients with populations included in randomized clinical trials (ROCKET AF and RELY). 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 nonvitamin 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 RELY (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 pts from the RELY (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 RELY and ROCKET AF trials.

Administrative Data in Cardiovascular Research—A Comparison of Polish National Health Fund and CRAFT Registry Data

“…The current study aimed to evaluate the accuracy of administrative NHF data from a clinical researcher perspective. NHF data is compared against the data collected manually from the individual patients' medical documentation in the retrospective CRAFT registry (NCT02987062) [8]. We evaluated the main disease (AF) and several common comorbidities.…”

Effectiveness and safety of dabigatran compared to vitamin K antagonists in patients with atrial fibrillation: a systematic review and metanalysis.

“…exhibited a similar risk of stroke or systemic embolism than warfarin, but with a lower risk of major bleeding [8]. However, it has been widely reported that the clinical pro le of patients included in clinical trials is somewhat different to those of observational studies, suggesting that data from clinical trials could not be always directly translated into real-life patients [9]. In the last years, many database studies have analyzed the use of dabigatran among AF patients in clinical practice.…”