Rates, management and outcome of bleeding complications during edoxaban therapy in daily care - results from the DRESDEN NOAC REGISTRY.

Edoxaban is licensed in many countries around the world, following successful phase-III trials in stroke prevention in atrial fibrillation (SPAF) and treatment of venous thromboembolism (VTE), but at present, little is known about edoxaban-related bleeding complications in daily care. Using data from a prospective, non-interventional oral anticoagulation registry, we analysed rates, management and outcome of edoxaban-related bleeding. Between 1 October 2011 and 28 February 2019, 996 patients were enrolled in the edoxaban cohort and a total of 891 bleeding events were observed (53.2% ISTH minor, 41.9% clinically relevant non-major and 4.9% major bleeding events). In case of major bleeding, surgical or interventional treatment was performed in 25.0% and prothrombin complex concentrate was given in 2 cases. In the time-to-first-event analysis, 100-patient-year rates of major bleeding were 3.1/100 patient-years (95% CI 2.2-4.2). In the as-exposed analysis, case-fatality rates of edoxaban-associated bleeding leading to hospitalizations were 7.5% and 9.0% at days 30 and 90 post bleeding, respectively. Taken together, our data indicate that, in real life, rates of edoxaban-related major bleeding in line with rates observed in phase III trials and that bleeding pattern, management and outcome of these events are not different from those reported for other direct factor Xa inhibitors. Clinical Trial Notation: Dresden NOAC Registry - ClinicalTrials.gov Identifier NCT01588119.

Effectiveness and safety of apixaban therapy in daily-care patients with atrial fibrillation: results from the Dresden NOAC Registry.

The effectiveness and safety of apixaban for stroke prevention in atrial fibrillation (SPAF) demonstrated in ARISTOTLE needs to be confirmed in daily care. To evaluate effectiveness and safety of apixaban therapy in SPAF patients in daily care, we used data from an ongoing, prospective, non-interventional registry of more than 3000 patients on novel oral anticoagulants in daily care. Between 1 December 2012 and 31 August 2015, 514 patients receiving apixaban were enrolled. During a mean follow-up of 803.5 ± 228.9 days, the combined endpoint of stroke/transient ischaemic attack/systemic embolism occurred at a rate of 2.4/100 patient-years in the intention-to-treat analysis (95% confidence interval [CI] 1.5-3.5) and at 1.8/100 patient-years (95% CI 1.0-2.8) in the on-treatment analysis (events within 3 days after last intake). On-treatment rates were numerically lower for patients selected for 5 mg apixaban (n = 404) twice daily [BID] compared with the 110 patients selected for 2.5 mg BID [1.6 (95% CI 0.8 to 2.7) vs. 2.6/100 patient-years (95% CI 0.8-6.1)]. On treatment, major bleeding occurred at a rate of 2.8/100 patient-years and significantly more often in patients receiving the 2.5 mg BID dose compared with the 5 mg BID dose (5.3 vs. 2.2/100 patient-years). Apixaban treatment discontinuation occurred in a total of 122 patients during follow-up (12.5/100 patient-years in Kaplan-Meier analysis). Our data contribute to the confirmation of effectiveness and relative safety of apixaban in daily-care patients. Furthermore, apixaban discontinuation rates were considerably lower than those reported for vitamin K antagonists.