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

Abstract

Key Points• In a real-world setting, annualized bleeding rates of major rivaroxaban bleeding are lower than those reported for vitamin K antagonists.• Treatment of major rivaroxaban bleeding is simple and rarely requires pro-coagulants; outcome at 90 days is better than that reported for vitamin K antagonists.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. This trial was registered at www.clinicaltrials.gov as identifier #NCT01588119. (Blood. 2014;124(6):955-962)

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

“…Nie stwierdzono wzrostu częstości występowania incydentów krwawień z przewodu pokarmowego, natomiast w grupie leczonej riwaroksabanem nastąpiło istotne zmniejszenie częstości występowania udarów krwotocznych i krwawień wewnątrzczaszkowych w porównaniu z warfaryną. Podobną częstość występowania incydentów obserwowano w analizach przeprowadzonych po dopuszczeniu leku do stosowania w praktyce klinicznej, które są częścią procesu oceny ryzyka po rejestracji leku [406,407].…”

A pharmacoeconomic study of traditional anticoagulation versus direct oral anticoagulation for the treatment of venous thromboembolism in the emergency department

“…In this study, bleeding risk was assumed to be equivalent with traditional versus DOAC therapy; this finding has been confirmed in the literature. 15 However, bleeding risk has not been firmly established with DOACs, in comparison to traditional anticoagulation, outside clinical trial settings. This may alter outcomes and, therefore, have cost implications that may alter the conclusions from this analysis.…”

How to REVISIT the increasing “real world” evidence for stroke prevention in non-valvular atrial fibrillation?

“…The paper by Coleman et al 3 is one of a deluge of papers on real world observational data on the comparative effectiveness of the various non-Vitamin K antagonist oral anticoagulants (NOACs) against warfarin [8][9][10][11] , or against each other [12][13][14] . Many cohorts have had substantially larger sample sizes and, importantly, the present analysis provides no data on dabigatran despite the extensive real world data published for this drug 15 .…”