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Non-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)
Authors Monelli M, Molteni M, Cassetti G, Bagnara L, De Grazia V, Zingale L, Zilli F, Bussotti M, Totaro P, De Maria B, Dalla Vecchia LA
Received 21 October 2018
Accepted for publication 17 January 2019
Published 14 February 2019 Volume 2019:15 Pages 19—25
DOI https://doi.org/10.2147/VHRM.S191208
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 1
Editor who approved publication: Professor Daniel Duprez
Mauro Monelli, Mauro Molteni, Giuseppina Cassetti, Laura Bagnara, Valeria De Grazia, Lorenza Zingale, Franca Zilli, Maurizio Bussotti, Paolo Totaro, Beatrice De Maria, Laura Adelaide Dalla Vecchia
Cardiac Rehabilitation Department, IRCCS Istituti Clinici Scientifici Maugeri, Milano, Italy
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 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.
Conclusion: In a population of aged and clinically complex patients, mainly octogenarians, NOACs were safe and effective.
Keywords: NVAF, anticoagulation, elderly, octogenarians, cardiac rehabilitation, NOAC
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