Suboptimal use of non-vitamin K antagonist oral anticoagulants

Abstract

This study aimed to investigate the potential misuse of novel oral anticoagulants (NOACs) and the physicians’ adherence to current European guideline recommendations in real-world using a large dataset from Real-life Multicenter Survey Evaluating Stroke Prevention Strategies in Turkey (RAMSES Study).RAMSES study is a prospective, multicenter, nationwide registry (ClinicalTrials.gov identifier NCT02344901). In this subgroup analysis of RAMSES study, patients who were on NOACs were classified as appropriately treated (AT), undertreated (UT), and overtreated (OT) according to the European Society of Cardiology (ESC) guidelines. The independent predictors of UT and OT were determined by multivariate logistic regression.Of the 2086 eligible patients, 1247 (59.8%) received adequate treatment. However, off-label use was detected in 839 (40.2%) patients; 634 (30.4%) patients received UT and 205 (9.8%) received OT. Independent predictors of UT included >65 years of age, creatinine clearance ≥50 mL/min, urban living, existing dabigatran treatment, and HAS-BLED score of <3, whereas that of OT were creatinine clearance <50 mL/min, ongoing rivaroxaban treatment, and HAS-BLED score of ≥3.The suboptimal use of NOACs is common because of physicians’ poor compliance to the guideline recommendations in patients with nonvalvular atrial fibrillation (NVAF). Older patients who were on dabigatran treatment with good renal functions and low risk of bleeding were at risk of UT, whereas patients who were on rivaroxaban treatment with renal impairment and high risk of bleeding were at risk of OT. Therefore, a greater emphasis should be given to prescribe the recommended dose for the specified patients.

Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

“…Results from dose adjustment of the more relevant studies about dabigatran are schemed in Figure A. In these studies, frequencies were reported of potentially inappropriate dabigatran prescriptions from 8 to 49% and underdosing was more common than overdosing …”

“…(C) Real‐world studies results concerning dose adjustments of apixaban. (D) Results from direct oral anticoagulants overall adjustments regarding dose appropriateness…”

“…In these studies, frequencies were reported of potentially inappropriate dabigatran prescriptions from 8 to 49% and underdosing was more common than overdosing. 52,53,62,63 Other real-world studies with dabigatran, such as that published by Graham et al 18 75 showing that underdosing is also significantly present.…”

Comparison of Treatment Persistence with Dabigatran or Rivaroxaban versus Vitamin K Antagonist Oral Anticoagulants in Atrial Fibrillation Patients: A Competing Risk Analysis in the French National Health Care Databases

“…Non‐persistence involves a complex interplay between medical and non‐medical environmental factors . Suboptimal management of DOAC therapy, less‐frequent contact with the health care system in the absence of INR monitoring or worsening of the patient's renal function may explain the better persistence observed with VKA therapy . It is likely that adverse events play a role such as gastrointestinal adverse effects reported with dabigatran …”

Hospital admissions for bleeding events associated with treatment with apixaban, dabigatran and rivaroxaban

“…This can be explained by the heterogeneity in the dose adjustment criteria among DOACs and because in certain cases dose reduction should be considered if two or more risk factors are present. In other studies, some bleeding risk factors were independent predictors for using the lower or higher doses of DOACs 27. Considering jointly the recommendations in clinical guidelines for DOAC dose adjustment,16 25 26 on first admission, four patients (12.5%) were receiving full doses and had ’dose reduction indication´.…”