<p>Non-vitamin K oral anticoagulant use in the elderly: a prospective real-world study &ndash; data from the REGIstry of patients on Non-vitamin K oral Anticoagulants (REGINA)</p>

Abstract

Purpose Numerous studies on thromboembolic prevention for non-valvular atrial fibrillation (NVAF) have shown either equal or better efficacy and safety of non-vitamin K oral anticoagulants (NOACs) compared to warfarin, even for patients aged ≥75 years. Data on elderly patients, in particular, octogenarians, are lacking. Paradoxically, this population is the one with the highest risk of bleeding and stroke with a worse prognosis. This study aims to describe safety and effectiveness of NOACs in an elderly comorbid population. Patients and methods REGIstry of patients on Non-vitamin K oral Anticoagulants (REGINA) is a prospective observational study enrolling consecutive NVAF patients started on NOACs and followed up to 1 year (at 1, 6, 12 months). The primary endpoint was the incidence rate of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB). The secondary endpoints were the incidence of 1) stroke or systemic embolism, 2) hospitalization, 3) death, and 4) drug-related adverse events. Results We enrolled 227 patients aged 81.6±6.1 years (range 67–95 years; ≥80 years in 59.4%). The median CHA 2 DS 2 -VASc was 5 (IQR 4–5) and HAS-BLED was 4 (IQR 3–5). The estimated glomerular filtration rate was 59.27±24.12 mL/min. During follow-up, only 10 MB and 23 CRNMB occurred, with a total incidence of 4.4% (95% CI: 1.7%–7.17%) and 5.7% (95% CI: 2.68%–8.72%), respectively. There were 2 cerebral ischemic events, with a total incidence of 0.88% (95% CI: 0.84%–0.92%), 23 NOAC-related hospitalizations, no NOAC-related deaths, and 4 minor drug-related adverse effects. Conclusion In a population of aged and clinically complex patients, mainly octogenarians, NOACs were safe and effective.

Evaluation of oral anticoagulants in atrial fibrillation patients over 80 years of age with nonsevere frailty

“…The present study had a non-inferior safety and efficacy outcome while on the OAC treatment compared to the real-world studies that included patients older than 65 years. 11,12 Our data revealed that the OAC treatment was safe and effective for the management of AF in octogenarians if their frailty was not so severe. Note: Data are expressed as the number (incidence rates).…”

Safety of Non-Vitamin K Oral Anticoagulants in Elderly Patients with Atrial Fibrillation

“…Группы в исследовании были практически идентичны по своим клиническим и анамнестическим характеристикам, что внушает доверие к полученным результатам. Данные регистра REGINA [9]в значительной степени идентичны нашим: группы были однородны по своей структуре, единственным значимым различием был возраст (как и в нашем исследовании, самыми возрастными оказались пациенты, включенные в группу апиксабана). Пациенты в обоих исследованиях демонстрировали высокий риск тромботических осложнений по шкале CHA 2 DS 2 -VASc.…”

“…Об этом свидетельствуют результаты самых крупных исследований [4][5][6] и данные реальной клинической практики [7,8]. Единственным исследованием, в котором проведено прямое сравнение ПОАК между собой, стал недавно опубликованный регистр REGINA: сравнивались пациенты с ФП в возрасте ≥67 лет, принимающие дабигатран, апиксабан и ривароксабан в соответствующих дозировках [9].…”

Towards appropriate polypharmacy in older cardiovascular patients: How many medications do I have to take?

“…44,45 Newer agents such as the direct oral anticoagulants (DOACs) are now considered the preferred option demonstrating similar efficacy in preventing stroke and systemic embolism, with a lower risk of major bleeding compared to warfarin. 46 Warfarin also seems to be associated with increased risk of osteoporotic fractures compared to the DOACs. 47 All DOACs require dose adjustments for renal function.…”