Rates, management, and outcome of rivaroxaban bleeding in daily care: Results from the Dresden NOAC registry

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Jan Beyer-Westendorf - , Department of Internal Medicine III, University Hospital Carl Gustav Carus Dresden (Author)
  • Kati Förster - , University Hospital Carl Gustav Carus Dresden (Author)
  • Sven Pannach - , Department of internal Medicine I (Author)
  • Franziska Ebertz - , University Hospital Carl Gustav Carus Dresden (Author)
  • Vera Gelbricht - , University Hospital Carl Gustav Carus Dresden (Author)
  • Christoph Thieme - , University Hospital Carl Gustav Carus Dresden (Author)
  • Franziska Michalski - , University Hospital Carl Gustav Carus Dresden (Author)
  • Christina Köhler - , University Hospital Carl Gustav Carus Dresden (Author)
  • Sebastian Werth - , Department of Internal Medicine III, University Hospital Carl Gustav Carus Dresden (Author)
  • Kurtulus Sahin - , ClinStat GmbH (Author)
  • Luise Tittl - , Department of Internal Medicine III, University Hospital Carl Gustav Carus Dresden (Author)
  • Ulrike Hänsel - , University Hospital Carl Gustav Carus Dresden (Author)
  • Norbert Weiss - , Department of Internal Medicine III, University Hospital Carl Gustav Carus Dresden (Author)

Abstract

Worldwide, rivaroxaban is increasingly used for stroke prevention in atrial fibrillation and treatment of venous thromboembolism, but little is known about rivaroxaban-related bleeding complications in daily care. Using data from a prospective, noninterventional oral anticoagulation registry of daily care patients (Dresden NOAC registry), we analyzed rates, management, and outcome of rivaroxaban-related bleeding. Between October 1, 2011, and December 31, 2013, 1776 rivaroxaban patients were enrolled. So far, 762 patients (42.9%) reported 1082 bleeding events during/within 3 days after last intake of rivaroxaban (58.9% minor, 35.0% of nonmajor clinically relevant, and 6.1% major bleeding according to International Society on Thrombosis and Haemostasis definition). In case of major bleeding, surgical or interventional treatment was needed in 37.8% and prothrombin complex concentrate in 9.1%. In the time-to-first-event analysis, 100-patientyear rates of major bleeding were 3.1 (95% confidence interval 2.2-4.3) for stroke prevention in atrial fibrillation and 4.1 (95% confidence interval 2.5-6.4) for venous thromboembolism patients, respectively. In the as-treated analysis, case fatality rates of bleeding leading to hospitalizations were 5.1% and 6.3% at days 30 and 90 after bleeding, respectively. Our data indicate that, in real life, rates of rivaroxaban-related major bleeding may be lower and that the outcome may at least not be worse than that of major vitamin K antagonist bleeding, and probably better.

Details

Original languageEnglish
Pages (from-to)955-962
Number of pages8
JournalBlood
Volume124
Issue number6
Publication statusPublished - 7 Aug 2014
Peer-reviewedYes

External IDs

PubMed 24859362

Keywords