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

Felice Gragnano; Dik Heg; The GLASSY Investigators; 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

doi:10.1093/ehjcvp/pvaa106

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

Felice Gragnano, Dik Heg, The GLASSY Investigators, 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 BuszmanLeonardo 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^*

^*Corresponding author for this work

Cardiology

Research output: Contribution to journal › Article › Academic › peer-review

27 Citations (Scopus)

1 Downloads (Pure)

Abstract

Aims The five-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 The PRECISE-DAPT was calculated in 14 928 and 7134 patients from GLOBAL LEADERS and GLASSY trials, re- and results spectively. The ability of the score to predict Bleeding Academic Research Consortium 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 four-item PRECISE-DAPT. Conclusion 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.

Original language	English
Pages (from-to)	28-38
Number of pages	11
Journal	European Heart Journal - Cardiovascular Pharmacotherapy
Volume	8
Issue number	2
Early online date	2 Nov 2020
DOIs	https://doi.org/10.1093/ehjcvp/pvaa106
Publication status	Published - 2022

Bibliographical note

Funding Information:
The GLOBAL LEADERS study was supported by the European Clinical Research Institute, which received funding from AstraZeneca, Biosensors International and The Medicines Company. The study funders had no role in trial design, data collection, analysis and interpretation of the data. The authors received no funding for the present sub-analysis.

Funding Information:
Volcano, Xeltis, and HeartFlow. R.D. reports grants from AstraZeneca, outside the submitted work. P.G.S. reports grants and personal fees from Bayer/Janssen, Merck, Sanofi, Amarin, Servier, personal fees from Amgen, Bristol Myers Squibb, Boehringer-Ingelheim, Pfizer, Novartis, Regeneron, Lilly, and AstraZeneca, outside the submitted work. C.N. reports personal fees from Abbott, Medtronic, Bionsesors, and Biotronik, outside the submitted work. C.H. reports personal fees from AstraZeneca, during the conduct of the study. D.H. and M.B. are affiliated with CTU Bern, University of Bern, which has a staff policy of not accepting honoraria or consultancy fees. However, CTU Bern is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. For an up-to-date list of CTU Bern’s conflicts of interest see http://www.ctu.unibe.ch/research/declar ation_of_interest/index_eng.html. S.W. reports research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Johnson&Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed, outside the submitted work. P.J. serves as unpaid member of the steering group of trials funded by Astra Zeneca, Biotronik, Biosensors, St. Jude Medical, and The Medicines Company. M.V. reports grants and personal fees from Abbott, Astrazeneca and Terumo, personal fees from Chiesi, Bayer, Daiichi Sankyo, Amgen, Alvimedica, Biosensors, and Idorsia, grants from Medicure, outside the submitted work. All other authors reported no relationships relevant to the contents of this article to disclose.

Publisher Copyright:
© The Author(s) 2020.

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Gragnano, F., Heg, D., The GLASSY Investigators, Franzone, A., McFadden, E. P., Leonardi, S., Piccolo, R., Vranckx, P., Branca, M., Serruys, P. W., Benit, E., Liebetrau, C., Janssens, L., Ferrario, M., Zurakowski, A., Diletti, R., Dominici, M., Huber, K., Slagboom, T., ... Valgimigli, M. (2022). 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, 8(2), 28-38. Advance online publication. https://doi.org/10.1093/ehjcvp/pvaa106

@article{27dbb54d9c6c45bd8ed94d5a15ced145,

title = "PRECISE-DAPT score for bleeding risk prediction in patients on dual or single antiplatelet regimens: Insights from the GLOBAL LEADERS and GLASSY",

abstract = "Aims The five-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 The PRECISE-DAPT was calculated in 14 928 and 7134 patients from GLOBAL LEADERS and GLASSY trials, re- and results spectively. The ability of the score to predict Bleeding Academic Research Consortium 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 four-item PRECISE-DAPT. Conclusion 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.",

author = "Felice Gragnano and Dik Heg and {The GLASSY Investigators} and Anna Franzone and McFadden, {Eug{\`e}ne P.} and Sergio Leonardi and Raffaele Piccolo and Pascal Vranckx and Mattia Branca and Serruys, {Patrick W.} and Edouard Benit and Christoph Liebetrau and Luc Janssens and Maurizio Ferrario and Aleksander Zurakowski and Roberto Diletti and Marcello Dominici and Kurt Huber and Ton Slagboom and Pawe{\l} Buszman and Leonardo Bolognese and Carlo Tumscitz and Krzysztof Bryniarski and Adel Aminian and Mathias Vrolix and Ivo Petrov and Scot Garg and Christoph Naber and Janusz Prokopczuk and Christian Hamm and Steg, {Philippe Gabriel} and Peter J{\"u}ni and Stephan Windecker and Marco Valgimigli",

note = "Funding Information: The GLOBAL LEADERS study was supported by the European Clinical Research Institute, which received funding from AstraZeneca, Biosensors International and The Medicines Company. The study funders had no role in trial design, data collection, analysis and interpretation of the data. The authors received no funding for the present sub-analysis. Funding Information: Volcano, Xeltis, and HeartFlow. R.D. reports grants from AstraZeneca, outside the submitted work. P.G.S. reports grants and personal fees from Bayer/Janssen, Merck, Sanofi, Amarin, Servier, personal fees from Amgen, Bristol Myers Squibb, Boehringer-Ingelheim, Pfizer, Novartis, Regeneron, Lilly, and AstraZeneca, outside the submitted work. C.N. reports personal fees from Abbott, Medtronic, Bionsesors, and Biotronik, outside the submitted work. C.H. reports personal fees from AstraZeneca, during the conduct of the study. D.H. and M.B. are affiliated with CTU Bern, University of Bern, which has a staff policy of not accepting honoraria or consultancy fees. However, CTU Bern is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. For an up-to-date list of CTU Bern{\textquoteright}s conflicts of interest see http://www.ctu.unibe.ch/research/declar ation_of_interest/index_eng.html. S.W. reports research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Johnson&Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed, outside the submitted work. P.J. serves as unpaid member of the steering group of trials funded by Astra Zeneca, Biotronik, Biosensors, St. Jude Medical, and The Medicines Company. M.V. reports grants and personal fees from Abbott, Astrazeneca and Terumo, personal fees from Chiesi, Bayer, Daiichi Sankyo, Amgen, Alvimedica, Biosensors, and Idorsia, grants from Medicure, outside the submitted work. All other authors reported no relationships relevant to the contents of this article to disclose. Publisher Copyright: {\textcopyright} The Author(s) 2020.",

year = "2022",

doi = "10.1093/ehjcvp/pvaa106",

language = "English",

volume = "8",

pages = "28--38",

journal = "European Heart Journal - Cardiovascular Pharmacotherapy",

issn = "2055-6837",

publisher = "Oxford University Press",

number = "2",

}

Gragnano, F, Heg, D, The GLASSY Investigators, Franzone, A, McFadden, EP, Leonardi, S, Piccolo, R, Vranckx, P, Branca, M, Serruys, PW, Benit, E, Liebetrau, C, Janssens, L, Ferrario, M, Zurakowski, A, Diletti, R, Dominici, M, Huber, K, Slagboom, T, Buszman, P, Bolognese, L, Tumscitz, C, Bryniarski, K, Aminian, A, Vrolix, M, Petrov, I, Garg, S, Naber, C, Prokopczuk, J, Hamm, C, Steg, PG, Jüni, P, Windecker, S & Valgimigli, M 2022, '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, vol. 8, no. 2, pp. 28-38. https://doi.org/10.1093/ehjcvp/pvaa106

PRECISE-DAPT score for bleeding risk prediction in patients on dual or single antiplatelet regimens: Insights from the GLOBAL LEADERS and GLASSY. / Gragnano, Felice; Heg, Dik; The GLASSY Investigators et al.
In: European Heart Journal - Cardiovascular Pharmacotherapy, Vol. 8, No. 2, 2022, p. 28-38.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - PRECISE-DAPT score for bleeding risk prediction in patients on dual or single antiplatelet regimens

T2 - Insights from the GLOBAL LEADERS and GLASSY

AU - Gragnano, Felice

AU - Heg, Dik

AU - The GLASSY Investigators

AU - Franzone, Anna

AU - McFadden, Eugène P.

AU - Leonardi, Sergio

AU - Piccolo, Raffaele

AU - Vranckx, Pascal

AU - Branca, Mattia

AU - Serruys, Patrick W.

AU - Benit, Edouard

AU - Liebetrau, Christoph

AU - Janssens, Luc

AU - Ferrario, Maurizio

AU - Zurakowski, Aleksander

AU - Diletti, Roberto

AU - Dominici, Marcello

AU - Huber, Kurt

AU - Slagboom, Ton

AU - Buszman, Paweł

AU - Bolognese, Leonardo

AU - Tumscitz, Carlo

AU - Bryniarski, Krzysztof

AU - Aminian, Adel

AU - Vrolix, Mathias

AU - Petrov, Ivo

AU - Garg, Scot

AU - Naber, Christoph

AU - Prokopczuk, Janusz

AU - Hamm, Christian

AU - Steg, Philippe Gabriel

AU - Jüni, Peter

AU - Windecker, Stephan

AU - Valgimigli, Marco

N1 - Funding Information: The GLOBAL LEADERS study was supported by the European Clinical Research Institute, which received funding from AstraZeneca, Biosensors International and The Medicines Company. The study funders had no role in trial design, data collection, analysis and interpretation of the data. The authors received no funding for the present sub-analysis. Funding Information: Volcano, Xeltis, and HeartFlow. R.D. reports grants from AstraZeneca, outside the submitted work. P.G.S. reports grants and personal fees from Bayer/Janssen, Merck, Sanofi, Amarin, Servier, personal fees from Amgen, Bristol Myers Squibb, Boehringer-Ingelheim, Pfizer, Novartis, Regeneron, Lilly, and AstraZeneca, outside the submitted work. C.N. reports personal fees from Abbott, Medtronic, Bionsesors, and Biotronik, outside the submitted work. C.H. reports personal fees from AstraZeneca, during the conduct of the study. D.H. and M.B. are affiliated with CTU Bern, University of Bern, which has a staff policy of not accepting honoraria or consultancy fees. However, CTU Bern is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. For an up-to-date list of CTU Bern’s conflicts of interest see http://www.ctu.unibe.ch/research/declar ation_of_interest/index_eng.html. S.W. reports research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Johnson&Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed, outside the submitted work. P.J. serves as unpaid member of the steering group of trials funded by Astra Zeneca, Biotronik, Biosensors, St. Jude Medical, and The Medicines Company. M.V. reports grants and personal fees from Abbott, Astrazeneca and Terumo, personal fees from Chiesi, Bayer, Daiichi Sankyo, Amgen, Alvimedica, Biosensors, and Idorsia, grants from Medicure, outside the submitted work. All other authors reported no relationships relevant to the contents of this article to disclose. Publisher Copyright: © The Author(s) 2020.

PY - 2022

Y1 - 2022

N2 - Aims The five-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 The PRECISE-DAPT was calculated in 14 928 and 7134 patients from GLOBAL LEADERS and GLASSY trials, re- and results spectively. The ability of the score to predict Bleeding Academic Research Consortium 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 four-item PRECISE-DAPT. Conclusion 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.

AB - Aims The five-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 The PRECISE-DAPT was calculated in 14 928 and 7134 patients from GLOBAL LEADERS and GLASSY trials, re- and results spectively. The ability of the score to predict Bleeding Academic Research Consortium 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 four-item PRECISE-DAPT. Conclusion 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.

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U2 - 10.1093/ehjcvp/pvaa106

DO - 10.1093/ehjcvp/pvaa106

M3 - Article

C2 - 32941620

AN - SCOPUS:85122779635

SN - 2055-6837

VL - 8

SP - 28

EP - 38

JO - European Heart Journal - Cardiovascular Pharmacotherapy

JF - European Heart Journal - Cardiovascular Pharmacotherapy

IS - 2

ER -

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

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