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Eur Heart J Cardiovasc Pharmacother. 2020 Sep 17; doi: 10.1093/ehjcvp/pvaa106. Epub 2020 Sep 17.

PRECISE-DAPT score for bleeding risk prediction in patients on dual or single antiplatelet regimens: insights from the GLOBAL LEADERS and GLASSY.

European heart journal. Cardiovascular pharmacotherapy

Felice Gragnano, Dik Heg, Anna Franzone, Eugène P McFadden, Sergio Leonardi, Raffaele Piccolo, Pascal Vranckx, Mattia Branca, Patrick W Serruys, Edouard Benit, Christoph Liebetrau, Luc Janssens, Maurizio Ferrario, Aleksander Zurakowski, Roberto Diletti, Marcello Dominici, Kurt Huber, Ton Slagboom, Paweł Buszman, Leonardo Bolognese, Carlo Tumscitz, Krzysztof Bryniarski, Adel Aminian, Mathias Vrolix, Ivo Petrov, Scot Garg, Christoph Naber, Janusz Prokopczuk, Christian Hamm, Philippe Gabriel Steg, Peter Jüni, Stephan Windecker, Marco Valgimigli,

Affiliations

  1. Department of Cardiology, Inselspital, University of Bern.
  2. Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland.
  3. Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
  4. Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands and Department of Cardiology, Cork University Hospital, Cork, Ireland.
  5. University of Pavia and Fondazione IRCCS Policlinico S.Matteo, Pavia, Italy.
  6. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Belgium.
  7. Department of Cardiology, Imperial College of London, London, United Kingdom.
  8. Jessa Hospital, Department of Cardiology, Hasselt, Belgium.
  9. Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany and German Center for Cardiovascular Research (DZHK), partner site RheinMain, Frankfurt am Main, Germany.
  10. Imelda Hospital, Bonheiden, Belgium.
  11. Center of Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland.
  12. Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
  13. S. Maria University-Hospital, Terni, Italy.
  14. 3rd Medical Department, Cardiology, Wilhelminenhospital, and Sigmund Freud University Medical School, Vienna, Austria.
  15. OLVG Amsterdam, Amsterdam, the Netherlands.
  16. Center for Cardiovascular Research and Development American Heart of Poland, and Department of Epidemiology, Medical University of Silesia, Katowice, Poland.
  17. Azienda Toscana Usl Sudest, Arezzo, Italy.
  18. Cardiology Unit Sant'Anna Hospital, Ferrara, Italy.
  19. Jagiellonian University Medical College, The John Paul II Hospital, Krakow, Poland.
  20. Department of cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.
  21. Ziekenhuis Oost Limburg, Genk, Belgium.
  22. Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria.
  23. East Lancashire Hospitals NHS Trust, Blackburn, UK.
  24. Klinikum Wilhelmshaven, Wilhelmshaven, Germany.
  25. PAKS Kozle, Poland.
  26. Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany and German Center for Cardiovascular Research (DZHK); Partner site RheinMain, Frankfurt am Main, Germany.
  27. Hôpital Bichat, AP-HP, Université Paris-Diderot, Paris, France.
  28. Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine, University of Toronto, Ontario, Canada.
  29. Cardiocentro Ticino, Lugano, Switzerland.

PMID: 32941620 DOI: 10.1093/ehjcvp/pvaa106

Abstract

AIMS: The 5-item PRECISE-DAPT, integrating age, haemoglobin, white-blood-cell count, creatinine clearance, and prior bleeding, predicts bleeding risk in patients on dual antiplatelet therapy (DAPT) after stent implantation. We sought to assess whether the bleeding risk prediction offered by the PRECISE-DAPT remains valid among patients receiving ticagrelor monotherapy from 1 month onwards after coronary stenting instead of standard DAPT and having or not having centrally-adjudicated bleeding endpoints.

METHODS AND RESULTS: The PRECISE-DAPT was calculated in 14,928 and 7,134 patients from GLOBAL LEADERS and GLASSY trials, respectively. The ability of the score to predict BARC 3 or 5 bleeding was assessed and compared among patients on ticagrelor monotherapy (experimental strategy) or standard DAPT (reference strategy) from 1 month after drug-eluting stent implantation. Bleeding endpoints were investigator-reported or centrally-adjudicated in GLOBAL LEADERS and GLASSY, respectively.At 2 years, the c-indexes for the score among patients treated with the experimental or reference strategy were 0.67 (95% confidence interval [CI]:0.63-0.71) vs. 0.63 (95% CI:0.59-0.67) in GLOBAL LEADERS (p = 0.27), and 0.67 (95% CI:0.61-0.73) vs. 0.66 (95% CI:0.61-0.72) in GLASSY (p = 0.88). Decision curve analysis showed net benefit using the PRECISE-DAPT to guide bleeding risk assessment under both treatment strategies. Results were consistent between investigator-reported and adjudicated endpoints and using the simplified 4-item PRECISE-DAPT.

CONCLUSIONS: The PRECISE-DAPT offers a prediction model that proved similarly effective to predict clinically-relevant bleeding among patients on ticagrelor monotherapy from 1 month after coronary stenting compared with standard DAPT and appears to be unaffected by the presence or absence of adjudicated bleeding endpoints.

© Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2020. For permissions, please email: [email protected].

Keywords: Aspirin; Bleeding; Dual antiplatelet therapy; Percutaneous coronary intervention; Ticagrelor

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