Abstract

Aim. To study the efficacy, safety, and adherence to therapy with new oral anticoagulants in patients older than 75 years with atrial fibrillation.Material and methods. Patients (n=431) over 75 years old (82.7±3.4 years) with various types of atrial fibrillation/flutter (AF) were included in a nonrandomized observational study of new oral anticoagulants (NOAC) in real clinical practice. A history of cardiac surgery was in 27.6% of patients. All patients had >3 risk factors for ischemic stroke (CHA2DS2-VASс 4.81±0.4 points) and >1 risk factor for bleeding (HAS-BLED 3.01±0.2 points). The duration of the observation study was from 12 to 42 (26.9±4.9) months. Dabigatran was taken in 38.5% (n=166) of patients, rivaroxaban – in 41.3% (n=178), apixaban – in 20.2% (n=87) of patients.Results. The incidence of new cases of myocardial infarction was 0.8% per year, surgical revascularization – 0.9% per year, cardiovascular death – 0.8% per year. The frequency of ischemic stroke was 1.1% per year, transient ischemic attacks – 0.4% per year, all thromboembolic episodes – 1.77% per year. The incidence of intracranial hemorrhage was 0.2% per year, of minor bleeding – 4.4% per year, of the combined cardiac point (the total frequency of all strokes, major bleeding, myocardial infarction, mortality from cardiovascular causes, revascularization procedures) – 4.2% per year. Significant differences in the frequency of endpoints depending on the drug of NOAC taken by patients were not found. Violations of the regimen and doses were more often observed with twice daily intake (63.9% for dabigatran and 59.8% for apixaban) than with a single dosage regimen per day (45.5% for rivaroxaban). The leading causes of non-adherence to NOAC therapy in patients over 75 years of age included skipping the next scheduled dose (43.6%) and changing the frequency of the drug taking (16.9%). For NOAC with a double dose per day, dabigatran and apixaban, the frequency of administration was violated in 27.7% and 28.7%, respectively, and with a single dose per day, rivaroxaban – in 1.1%.Conclusion. Therapy with NOAC in patients older than 75 years with AF is effective and safe. There were no statistically significant differences in the incidence of thromboembolic or hemorrhagic events during three NOACs treatment in patients with AF older than 75 years. The incidence of non-adherence was less

Highlights

  • Для цитирования: Туров А.Н., Панфилов С.В., Чиглинцева О.В

  • Violations of the regimen and doses were more often observed with twice daily intake (63.9% for dabigatran and 59.8% for apixaban) than with a single dosage regimen per day (45.5% for rivaroxaban)

  • Eikelboom J.W., Wallentin L., Connolly S.J., et al Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial

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Summary

Дизайн исследования

Критерии включения: в данное нерандомизированное проспективное исследование включали пациентов с любой формой ФП, которые на момент назначения НОАК достигли возраста 75 лет и старше. Конечная точка эффективности: ишемический инсульт или транзиторная ишемическая атака. При рекомендации приема НОАК до сведения пациента доводилась информация о наличии на российском рынке трех препаратов (дибигатран, ривароксабан и апиксабан), которые показали преимущества или сопоставимость по эффективности и безопасности в сравнении с варфарином, однако прямого сравнения между этими препаратами не проводилось. Антиаритмические препараты принимали 414 пациентов (96%), из них препараты I или III классов – 197 больных (45,7%). Все пациенты имели более трех факторов риска ишемического инсульта (CHA2DS2-VASC от 3 до 8; 4,81±0,4 балла). Все пациенты имели более одного фактора риска кровоточивости (HAS-BLED от 2 до 7; 3,01±0,2 балла).

Drugs or alcohol excess
Характеристика антикоагулянтной терапии
Анализ показателей эффективности и безопасности
Apixaban Апиксабан
Анализ приверженности лечению
Findings
Ограничения исследования
Full Text
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