Perfil de pacientes con fibrilación auricular no valvular tratados con rivaroxaban en España: la desigualdad en el acceso a los anticoagulantes orales directos (estudio HEROIC)

Abstract

Introduction and objectives

Restrictions on the prescription of direct oral anticoagulants (DOACs) for non-valvular atrial fibrillation (NVAF) treatment imposed in Spain by the 2013 Therapeutic Positioning Report (TPR) may limit access to this medication. With the aim of assessing the impact of the TPR, we analysed the reasons to prescribe the DOAC rivaroxaban, the profile of patients with NVAF treated and how long it takes accessing to the treatment in hospitals belonging to the National Health System, both overall and by autonomous regions.

Methods

An observational, cross-sectional, multicenter study of patients with NVAF treated with rivaroxaban in specialist practice. The autonomous regions were grouped according to the most common prescribing practices: per Summary of Product Characteristics (SmPC), TPR or a more restrictive or modified TPR (mTPR).

Results

73 researchers providing data on 1,727 patients participated. 93.7% of patients were at high thromboembolic risk (CHA₂DS₂-Vasc ≥ 3) and 46.2% were at high risk for bleeding (HAS-BLED ≥ 3). Median time since diagnosis of NVAF for receiving rivaroxaban was 21.1 months. 57.0% patients had received vitamin K antagonists (VKA). With respect to autonomous regions where prescribing practices are guided by SmPC, patients where TPR/mTPR restrictions were followed were at higher thromboembolic and bleeding risk, had received VKA more frequently and waited a median of ∼ 20 months longer before receiving rivaroxaban.

Conclusions

Patients treated with rivaroxaban in Spain show high thromboembolic and bleeding risks. Median time for rivaroxaban prescription is 21.1 months. The differences in the adhesion to the TPR create inequalities between autonomous regions. Patients from autonomous regions following the TPR/mTPR receive rivaroxaban up to 20 months later and show higher thromboembolic and bleeding risks.