Vascular Health and Risk Management (Feb 2019)

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)

  • 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

Journal volume & issue
Vol. Volume 15
pp. 19 – 25

Abstract

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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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