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Effectiveness and Safety of Therapy with Vitamin K Antagonists in Italian Patients Aged 80 Years or Older: a Multicentre Retrospective Study Comparing the Zeus Algorithm with the PARMA Algorithm or Manual Therapy

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Abstract

Background

The use of oral anticoagulant therapy (OAT) has constantly increased in the prevention of thromboembolism, particularly in patients 80 years of age or older.

Objective

The aim of this multicentre study was to evaluate the efficacy and safety of vitamin K antagonists (VKAs) in elderly patients managed with a computer dosing algorithm compared with a dosage decided by expert physicians.

Materials and Methods

Nine Italian thrombosis centres utilising the Zeus dosing algorithm were involved. The before–after study enrolled patients managed firstly by medical staff (manual system) or with the PARMA algorithm for 12 months from July 2008 to June 2009 and then with the Zeus algorithm during the analogous period from 2010 to 2011. Of 7605 patients in the OAT maintenance phase, 2281 were older than 80 years (mean age 84.2 years). Data for these 2281 patients managed with both modalities were analysed.

Results

Of the 2281 patients 80 years of age or older, 1776 underwent OAT for atrial fibrillation (AF). Use of a dosing algorithm increased the OAT quality: time in therapeutic range (TTR) was significantly (p < 0.001) higher during the Zeus period than during the manual period (71.6 vs. 68.8 %). The TTR achieved with Zeus was similar to that obtained with the PARMA algorithm. In addition, patients managed with Zeus took a weekly drug dosage significantly (p < 0.01) lower than that both suggested by PARMA and prescribed by expert physicians, with a reduced number of adverse events.

Conclusions

This study confirms that the effectiveness and safety of VKA therapy in patients 80 years of age or older increases with computer dosing algorithms.

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Acknowledgments

We would like to thank Dr Clodomiro Cafolla who revised the English and Dr Renato Melizzi who provided support with the statistical analysis.

Funding

No funding was received for the conduct of this study or preparation of this manuscript.

Conflicts of interest

None of the authors have any conflicts of interest to declare.

Author information

Authors and Affiliations

  1. Dipartimento di Biotecnologie Cellulari ed Ematologia, “Sapienza” Università, Via Benevento, 6 00161, Rome, Italy

    Arturo Cafolla, Erminia Baldacci, Melissa Campanelli, Maria Concetta Cursano, Francesco Dragoni & Roberto Foà

  2. Ospedale Manerbio, Manerbio, Italy

    Luigia Manisco

  3. A.S.L.8 Cagliari, Cagliari, Italy

    Alessandro Porcu

  4. Ospedale “dell’Annunziata”, Cosenza, Italy

    Enza Rossi

Authors
  1. Arturo Cafolla
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  2. Luigia Manisco
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  3. Erminia Baldacci
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  4. Alessandro Porcu
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  5. Melissa Campanelli
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  6. Maria Concetta Cursano
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  7. Enza Rossi
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  8. Francesco Dragoni
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  9. Roberto Foà
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Corresponding author

Correspondence to Arturo Cafolla.

Appendix

Appendix

Participating investigators and corresponding FCSA centres

  1. 1.

    Pedrazzi E (Centro T.A.O., FCSA 190, Acqui Terme, Al);

  2. 2.

    Porcu A (Centro T.A.O., FCSA 141, A.S.L.8 Cagliari);

  3. 3.

    Calabrese S (Centro T.A.O., FCSA 301, PO “SS. Annunziata”, Chieti);

  4. 4.

    Rossi E (Emostasi-Trombosi-FCSA 86, Azienda Ospedaliera: “ dell’Annunziata”, Cosenza);

  5. 5.

    Milillo P, Musso E (Centro T.A.O., FCSA 259, Ospedale di Gradenigo, To);

  6. 6.

    Benedetti R, Scuotri L (Centro T.A.O., FCSA 374, A.S.L. 5, La Spezia);

  7. 7.

    Ciabatta C (Centro Emofilia e Malattie Tromboemboliche, FCSA 83, Ematologia, A. S. L. Latina);

  8. 8.

    Manisco L, Lelli E (Centro T.A.O., FCSA 127, Ospedale di Manerbio, BS);

  9. 9.

    Baldacci E, Campanelli M, Dragoni F (Emostasi Trombosi, Centro T.A.O., FCSA 45, Ematologia, Policlinico “Umberto I” Roma).

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Cafolla, A., Manisco, L., Baldacci, E. et al. Effectiveness and Safety of Therapy with Vitamin K Antagonists in Italian Patients Aged 80 Years or Older: a Multicentre Retrospective Study Comparing the Zeus Algorithm with the PARMA Algorithm or Manual Therapy. Drugs Aging 32, 235–241 (2015). https://doi.org/10.1007/s40266-015-0247-z

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  • DOI: https://doi.org/10.1007/s40266-015-0247-z

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