Degree of compliance of hospitalized patients with atrial fibrillation with inclusion criteria in clinical studies with direct oral anticoagulants

• Pochinka Ilya G.
• Botova Svetlana N.
• Linnikova Elena V.
• Golubkina Elena S.
• Telitsina Ekaterina V.
• Leonid G. Strongin

Abstract

Modern clinical practice guidelines for direct oral anticoagulants administration (DOAA) for prevention of atrial fibrillation (AF) embolic complications are based on the results of randomized clinical trials (RCT). However, how far does patient setting (RCT participants) reflect general population of patients with AF? It is known that participation in clinical studies is limited to exclusion criteria. In this study we evaluated the proportion of patients with characteristics that limit participation in RCT with DOAA in the population of patients with AF who were hospitalized in cardiological, neurological, and therapeutic departments during 2 consecutive months of 2017 (211 cases in total). It turned out that 2.4% of patients have contra-indications to DOAA, and another 24.6% of patients have clinical or laboratory parameters that meet the exclusion criteria in RE-LY, ROCKET-AF and ARISTOTLE studies.

Keywords: atrial fibrillation, direct oral anticoagulants, randomized clinical trials, exclusionary criteria

All articles in our journal are distributed under the Creative Commons Attribution 4.0 International License (CC BY 4.0 license)