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Vasc Health Risk Manag · Jan 2019
Observational StudyNon-vitamin K oral anticoagulant use in the elderly: a prospective real-world study - data from the REGIstry of patients on Non-vitamin K oral Anticoagulants (REGINA).
- Mauro Monelli, Mauro Molteni, Giuseppina Cassetti, Laura Bagnara, Valeria De Grazia, Lorenza Zingale, Franca Zilli, Maurizio Bussotti, Paolo Totaro, Beatrice De Maria, and Dalla VecchiaLaura AdelaideLACard... more
- Cardiac Rehabilitation Department, IRCCS Istituti Clinici Scientifici Maugeri, Milano, Italy, laura.dallavecchia@icsmaugeri.it.
- Vasc Health Risk Manag. 2019 Jan 1; 15: 19-25.
PurposeNumerous 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 MethodsREGIstry 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.ResultsWe enrolled 227 patients aged 81.6±6.1 years (range 67-95 years; ≥80 years in 59.4%). The median CHA2DS2-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.ConclusionIn a population of aged and clinically complex patients, mainly octogenarians, NOACs were safe and effective.
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