P3581Real-world effectiveness of stroke prevention in patients with non-valvular atrial fibrillation treated with rivaroxaban vs. phenprocoumon in Germany - insights from the reload study

Abstract

Background: Only limited evidence exists regarding the effectiveness and safety of rivaroxaban versus phenprocoumon in non‐valvular atrial fibrillation (NVAF) patients treated in a real world setting in Germany where phenprocoumon represents the predominantly prescribed VKA. Purpose: The RELOAD study is a retrospective study, using a new user approach based on a representative sample of a German insurance claims database to assess the real world comparative effectiveness and safety of rivaroxaban vs. VKA prescribed in non‐valvular atrial fibrillation (NVAF) routine care patients in Germany. This abstract analyses baseline characteristics of the two cohorts. Methods: The study analyses NVAF‐patients with an initial prescription of rivaroxaban or VKA between January 2012 and December 2015. Primary endpoints of this study will be the comparative risk of ischemic stroke (effectiveness) and intracranial haemorrhage (ICH, safety). Incidence rates and time‐to‐event analyses using adjusted multivariate Cox proportional hazard models and a 1:1 propensity score matching will be conducted to estimate hazard ratios and corresponding 95% confidence intervals. Results: A total of 13,155 patients on rivaroxaban (R) and 20,513 patients on phenprocoumon (VKA) were identified. Patients prescribed R were younger compared to patients prescribed VKA (mean age R: 71,8; VKA: 73,8) and had a lower CHA2DS2‐VASC score on average (mean score R: 3,5; VKA: 3,8). 27,5% of rivaroxaban patients have been initiated on the reduced dose of 15 mg od. Alongside the baseline characteristics the results of the analyses will be presented at the congress. Conclusions: This study is the largest database study of its kind to date conducted in Germany. It will contribute to understanding real‐world use, effectiveness and safety of rivaroxaban vs. phenprocoumon in Germany. VKA (phenprocoumon) patients seem to have more comorbidities. (Table Presented).