Bleeding risk in patients with venous thromboembolic events treated with new oral anticoagulants
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Bleeding risk in patients with venous thromboembolic events treated with new oral anticoagulants Niklas Wallvik1 · Henrik Renlund2 · Anders Själander1 Accepted: 21 October 2020 © The Author(s) 2020
Abstract New oral anticoagulants (NOACs) is the preferred treatment in secondary prophylaxis of venous thromboembolic events (VTE). The aim of this study was to investigate possible risk factors associated with major bleeding in VTE-patients treated with NOACs. In this retrospective register-based study we screened the Swedish anticoagulation register Auricula (during 2012.01.01–2017.12.31) to find patients and used other national registers for outcomes. Primary endpoint was major bleeding defined as bleeding leading to hospital care. Multivariate Cox-regression analysis was used to reveal risk factors. 18 219 patients with NOAC due to VTE were included. 85.6% had their first VTE, mean age was 69.4 years and median follow-up time was 183 days. The most common NOAC was rivaroxaban (54.8%), followed by apixaban (42.0%), dabigatran (3.2%) and edoxaban (0.1%). The rate of major bleeding was 6.62 (95% CI 6.19–7.06) per 100 treatment years in all patients and 11.27 (CI 9.96–12.57) in patients above 80 years of age. Statistically independent risk factors associated with major bleeding were age (normalized HR 1.38, CI 1.27–1.50), earlier major bleeding (HR 1.58, Cl 1.09–2.30), COPD (HR 1.28, CI 1.04–1.60) and previous stroke (HR 1.28, Cl 1.03–1.58) or transient ischemic attack (TIA) (HR 1.33, Cl 1.01–1.76). Prior warfarin treatment was protective (HR 0.67, CI 0.58–0.78). This real world cohort shows a high bleeding rate especially among the elderly and in patients with previous major bleeding, COPD and previous stroke or TIA. This should be considered when deciding on treatment duration and NOAC dose in these patients. Keywords New oral anticoagulants · Venous thromboembolism · Major bleeding · Risk factors
Highlights • Register study to examine risk factors for major bleeding
Introduction
stroke or TIA increase the risk of major bleeding.
The incidence of first VTE in the general population is about 0.1% per year [1, 2]. Total mortality associated with the diagnosis of acute pulmonary embolism is 8–17% in three months follow-up time and more than doubles after discharge from hospital [3]. In 1960, a medical breakthrough was made when vitamin K-antagonists (VKAs) was introduced as oral anticoagulant treatment of VTE [4]. A systematic review of patients with VTE on vitamin K antagonist treatment found a risk of recurrence of 3.5% (0.5% lethal) and a risk of major bleeding of 1.6–2.1% (0.2% lethal) during 3–6 months [5]. After 3 months, the risk of major bleeding is estimated to be 0.8% per patient year or 2,6 times more than without anticoagulant treatment [6]. A metaanalysis of available randomized controlled trials (RCTs)
• Previous anticoagulation with warfarin confers lower
bleeding risk.
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s11239-020-02319-w) contains sup
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