Antithrombotic management and outcomes of patients with atrial fibrillation treated with NOACs early at the time of mark

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Antithrombotic management and outcomes of patients with atrial fibrillation treated with NOACs early at the time of market introduction: Main results from the PREFER in AF Prolongation Registry Giulia Renda1 · Ladislav Pecen2 · Giuseppe Patti3 · Fabrizio Ricci1 · Dipak Kotecha4 · Jolanta M. Siller‑Matula5,6 · Renate B. Schnabel7,8 · Rolf Wachter9,22 · Jean‑Marc Sellal10 · Miklos Rohla11 · Markus Lucerna12 · Kurt Huber13 · Freek W. A. Verheugt14 · Jose Luis Zamorano15 · Bernd Brüggenjürgen16 · Harald Darius17 · Mattias Duytschaever18 · Jean‑Yves Le Heuzey19 · Richard J. Schilling20 · Paulus Kirchhof4 · Raffaele De Caterina21  Received: 4 June 2020 / Accepted: 8 July 2020 © The Author(s) 2020

Abstract The management of patients with atrial fibrillation (AF) has rapidly changed with increasing use of non-vitamin K antagonist oral anticoagulants (NOACs) and changes in the use of rhythm control therapy. The prevention of thromboembolic events European Registry in Atrial Fibrillation Prolongation Registry (PREFER Prolongation) enrolled consecutive patients with AF on NOACs between 2014 and 2016 in a multicentre, prospective, observational study with one-year follow-up, focusing on the time of introduction of NOACs. Overall, 3783 patients were enrolled, with follow-up information available in 3223 (85%). Mean age was 72.2 ± 9.4 years, 40% were women, mean C ­ HA2DS2VASc score was 3.4 ± 1.6, and 2587 (88.6%) had a ­CHA2DS2VASc score ≥ 2. Rivaroxaban was used in half of patients, and dabigatran and apixaban were used in about a quarter of patients each; edoxaban was not available for use in Europe at the time. Major cardiovascular event rate was low: serious events occurred in 74 patients (84 events, 2%), including 24 strokes (1%), 62 major bleeds (2%), of which 30 were life-threatening (1%) and 3 intracranial (0.1%), and 28 acute coronary syndromes (1%). Mortality was 2%. Antiarrhythmic drugs were used in about 50% of patients, catheter ablation in 5%. Adverse events were low in this contemporary European cohort of unselected AF patients treated with NOACs already at the time of their first introduction, despite high thromboembolic risk. Keywords  Atrial fibrillation · Anticoagulants · NOAC · Registry · Major cardiac or cerebrovascular events · Bleeding

Introduction The non-vitamin K antagonist oral anticoagulants (NOACs) are increasingly used as an alternative to vitamin K antagonists (VKAs) to prevent strokes in patients with atrial fibrillation (AF) [1–4]. They include the direct thrombin inhibitor dabigatran, and the direct factor Xa inhibitors rivaroxaban, apixaban and edoxaban. When compared with warfarin in

phase III randomized clinical trials [5–8], NOACs showed a consistently favourable benefit-risk profile across a wide range of patients, with lower mortality and a lower rate of intracranial haemorrhage than patients randomized to VKA [9, 10]. The aim of the PREFER in AF Prolongation study was to collect information on unselected patients with AF treated with NOACs at the beginning of their wide