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

Abstract

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.

Major bleeding with antithrombotic agents: a 2012–2015 study using the French nationwide Health Insurance database linked to emergency department records within five areas – rationale and design of SACHA study

“…Since 2014, several real‐world observational studies investigated the bleeding risk of NOAC in many countries . Annex 10 reports some characteristics of these postapproval published studies and shows heterogeneity for many aspects: most of them used retrospective data from nationwide administrative or insurance databases with limited clinical information – no access for patient's mortality .…”

“…Annex 10 reports some characteristics of these postapproval published studies and shows heterogeneity for many aspects: most of them used retrospective data from nationwide administrative or insurance databases with limited clinical information – no access for patient's mortality . Few studies were prospective . Medical validation of patient's bleeding events was scarce .…”

“…Few studies were prospective . Medical validation of patient's bleeding events was scarce . The follow‐up of included patients was very different (from 1 month to 2 years).…”

“…International multicentre trials have shown noninferiority to warfarin in patients with AF with lower risk of intracranial haemorrhage but a higher risk of gastrointestinal bleeding . Several reports from registries and analysis of claims databases have recently suggested, compared with VKA, a similar safety profile of NOAC in the community and in randomized trials. However, meta‐analyses highlighted inconsistency among those observational studies using different designs: Weeda et al.…”

Specific antidotes against direct oral anticoagulants: A comprehensive review of clinical trials data

“…Частота «больших» кровотечений на фоне приема этих препаратов оказалась примерно равной: 3,0; 2,8 и 2,3% на 100 пациен-то-лет соответственно [37][38][39].…”