Evaluating the effectiveness and risks of oral anticoagulant treatments in multimorbid frail older subjects with atrial fibrillation using the multidimensional prognostic index: the EURopean study of older subjects with atrial fibrillation—EUROSAF

Abstract

Background

Previous studies suggested that a different risk of mortality may influence the oral anticoagulant prescription in older patients with atrial fibrillation (AF). Recently, the Multidimensional Prognostic Index (MPI) demonstrated a high grade of accuracy, calibration and feasibility to predict mortality in hospitalized and community-dwelling older people. Prognostic information, as calculated by the MPI, however, is not included in the decision algorithm of treatments in older patients with AF

Purpose

The aim of this international multicenter prospective observational study was to evaluate whether a different prognostic profile, as determined by the MPI, is associated with different treatments for AF (no treatment vs oral anticoagulants) and differences in the main outcomes, i.e., mortality, major thromboembolic events and side effects.

Materials and methods

Older hospitalized patients (age ≥ 65 years) with non-valvular AF will be consecutively enrolled in an European, cross-national, prospective, observational study. At baseline, functional and clinical information will be collected to calculate the MPI, CHA2DS2-VASc score, HAS-BLED score, pharmacological treatments (and the compliance during follow-up) and main and secondary diagnoses. During the 12-month follow-up period, information on survival, major thromboembolic events and major bleeding will be collected. For these aims, a sample size of 3000 people was deemed as sufficient.

Conclusions

The EUROSAF study has the main objective of evaluating in a population of hospitalized older subjects with AF the clinical benefit/risk ratio of the oral anticoagulant treatments in terms of mortality, major thromboembolic events and bleeding side-effects, giving important information regarding the appropriate prescription of anticoagulant therapy in this population.

ClinicalTrials.gov Identifier

NCT02973984.

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Acknowledgements

EUROSAF Study Investigators group also includes: Nicolò Marchionni, Florence, Italy; Mario Durando, Padova, Italy; Nicola Ferrara, Napoli, Italy; Mario Bò, Torino, Italy; Mario Barbagallo, Palermo, Italy; Giovanni Ruotolo, Catanzaro, Italy; Hans Jurgen Heppner, Schwelm, Germany; Philipp Bahrmann, Wiesbaden, Germany; Regina Roller-Wirnsberger, Vienna, Austria; Gil Gregorio Pedro, Madrid, Spain; Alfonso Cruz-Jentoft, Madrid, Spain; Pedro Marques da Silva, Lisboa, Portugal; Heidi Gruner, Lisboa, Portugal; Nicolas Berg, Liege, Belgium; Eva Topinkova, Prague, Czech Republic; Hana Matejovska-Kubesova, Brno, Czech Republic; Tuomo Nieminen, Helsinki and Lappeenranta, Finland; Laura Pikkarainen,Helsinki, Finland; Juhani Rossinen, Helsinki, Finland Marc Paccalin, Poitiers, France; Anna Kearney-Schwartz, Nancy, France; Krzyszof Rewiuk, Cracow, Poland; Francesco Mattace-Raso, Rotterdam, The Netherlands; Peter Olexa, Košice, Slovakia.

Funding

This is a study of the Comprehensive Geriatric Assessment (CGA)-Special Interest Group of the European Union Geriatric Medicine Society. Funding for this study was provided by an unrestricted contribution by Bayer Pharma AG.

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Correspondence to Alberto Pilotto.

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Conflict of interest

The authors declare that they have no conflict of interest

Ethical approval

The study was approved by the Regione Liguria Ethics Committee, Genova, Italy. Registry Number 162REG2016, dated 08/06/2016, Section 2.

Informed consent

Informed consent will be obtained from all individual participants included in the study.

Additional information

The members of the EUROSAF Study Investigators are listed in acknowledgements section.

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Veronese, N., Argusti, A., Canepa, E. et al. Evaluating the effectiveness and risks of oral anticoagulant treatments in multimorbid frail older subjects with atrial fibrillation using the multidimensional prognostic index: the EURopean study of older subjects with atrial fibrillation—EUROSAF. Eur Geriatr Med 9, 149–154 (2018). https://doi.org/10.1007/s41999-018-0026-6

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Keywords

  • Atrial Fibrillation
  • Muldimensional Prognostic Index
  • Frailty
  • Elderly
  • Anticoagulants