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DOI: 10.1055/s-0040-1712449
Comparative Assessment of Predictive Performance of PRECISE-DAPT, CRUSADE, and ACUITY Scores in Risk Stratifying 30-Day Bleeding Events
Funding The GLOBAL LEADERS study was sponsored 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, interpretation of the data, preparation, approval, or making decision to submit the manuscript or publication.

Abstract
Background The utility of the PRECISE-DAPT score in predicting short-term major bleeding, either alone, or in comparison with the CRUSADE and ACUITY scores, has not been investigated. This analysis compared the predictive performances of the three bleeding scores in stratifying the risk of 30-day major bleeding postpercutaneous coronary intervention in patients with dual-antiplatelet therapy.
Methods In this post hoc subanalysis of the GLOBAL LEADERS trial, the primary safety objective (bleeding according to the Bleeding Academic Research Consortium [BARC] criteria [type 3 or 5]) was assessed at 30 days according to the three scores in the overall population, and in patients with acute (ACS) and chronic coronary syndrome (CCS).
Results In a total of 15,968 patients, we calculated all three scores in 14,709 (92.1%). Irrespective of clinical presentation, the PRECISE-DAPT (c-statistics: 0.648, 0.653, and 0.641, respectively), CRUSADE (c-statistics: 0.641, 0.639, and 0.644, respectively), and ACUITY (c-statistics: 0.633, 0.638, and 0.623, respectively) scores were no significant between-score differences in discriminatory performance for BARC 3 or 5 bleeding up to 30 days, and similarly the PRECISE-DAPT score had a comparable discriminative capacity according to the integrated discrimination improvement when compared with the other scores. In ACS, the CRUSADE score had a poor calibration ability (Hosmer–Lemeshow goodness-of-fit [GOF] chi-square = 15.561, p = 0.049), whereas in CCS, the PRECISE-DAPT score had poor calibration (GOF chi-square = 15.758, p = 0.046).
Conclusion The PRECISE-DAPT score might be clinically useful in the overall population and ACS patients for the prediction of short-term major bleeding considering its discriminative and calibration abilities.
Keywords
bleeding scores - major bleeding - percutaneous coronary intervention - dual-antiplatelet therapy - discrimination - calibrationPublikationsverlauf
Eingereicht: 22. Februar 2020
Angenommen: 19. April 2020
Artikel online veröffentlicht:
22. Juni 2020
© 2020. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
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References
- 1
Vranckx P,
Leonardi S,
Tebaldi M.
et al.
Prospective validation of the Bleeding Academic Research Consortium classification
in the all-comer PRODIGY trial. Eur Heart J 2014; 35 (37) 2524-2529
MissingFormLabel
- 2
Hamon M,
Lemesle G,
Tricot O.
et al.
Incidence, source, determinants, and prognostic impact of major bleeding in outpatients
with stable coronary artery disease. J Am Coll Cardiol 2014; 64 (14) 1430-1436
MissingFormLabel
- 3
Valgimigli M,
Bueno H,
Byrne RA.
et al;
ESC Scientific Document Group,
ESC Committee for Practice Guidelines (CPG),
ESC National Cardiac Societies.
2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed
in collaboration with EACTS: the Task Force for dual antiplatelet therapy in coronary
artery disease of the European Society of Cardiology (ESC) and of the European Association
for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2018; 39 (03) 213-260
MissingFormLabel
- 4
Levine GN,
Bates ER,
Bittl JA.
et al.
2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in
patients with coronary artery disease: a report of the American College of Cardiology/American
Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2016;
68 (10) 1082-1115
MissingFormLabel
- 5
Subherwal S,
Bach RG,
Chen AY.
et al.
Baseline risk of major bleeding in non-ST-segment-elevation myocardial infarction:
the CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse
outcomes with Early implementation of the ACC/AHA Guidelines) bleeding score. Circulation
2009; 119 (14) 1873-1882
MissingFormLabel
- 6
Mehran R,
Pocock SJ,
Nikolsky E.
et al.
A risk score to predict bleeding in patients with acute coronary syndromes. J Am Coll
Cardiol 2010; 55 (23) 2556-2566
MissingFormLabel
- 7
Liu R,
Lyu SZ,
Zhao GQ.
et al.
Comparison of the performance of the CRUSADE, ACUITY-HORIZONS, and ACTION bleeding
scores in ACS patients undergoing PCI: insights from a cohort of 4939 patients in
China. J Geriatr Cardiol 2017; 14 (02) 93-99
MissingFormLabel
- 8
Liu R,
Zheng W,
Zhao G.
et al.
Predictive validity of CRUSADE, ACTION and ACUITY-HORIZONS bleeding risk scores in
Chinese patients with ST-segment elevation myocardial infarction. Circ J 2018; 82
(03) 791-797
MissingFormLabel
- 9
Xi S,
Zhou S,
Wang X.
et al.
The performance of CRUSADE and ACUITY bleeding risk scores in ticagrelor-treated ACS
patients who underwent PCI. Thromb Haemost 2017; 117 (11) 2186-2193
MissingFormLabel
- 10
Castini D,
Centola M,
Ferrante G.
et al.
Comparison of CRUSADE and ACUITY-HORIZONS bleeding risk scores in patients with acute
coronary syndromes. Heart Lung Circ 2019; 28 (04) 567-574
MissingFormLabel
- 11
Costa F,
van Klaveren D,
James S.
et al;
PRECISE-DAPT Study Investigators.
Derivation and validation of the predicting bleeding complications in patients undergoing
stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score:
a pooled analysis of individual-patient datasets from clinical trials. Lancet 2017;
389 (10073): 1025-1034
MissingFormLabel
- 12
Choi SY,
Kim MH,
Cho YR.
et al.
Performance of PRECISE-DAPT score for predicting bleeding complication during dual
antiplatelet therapy. Circ Cardiovasc Interv 2018; 11 (12) e006837
MissingFormLabel
- 13
Knuuti J,
Wijns W,
Saraste A.
et al.
ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur
Heart J 2020; 41 (03) 407-477
MissingFormLabel
- 14
Vranckx P,
Valgimigli M,
Jüni P.
et al;
GLOBAL LEADERS Investigators.
Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months
vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy
for 12 months after implantation of a drug-eluting stent: a multicentre, open-label,
randomised superiority trial. Lancet 2018; 392 (10151): 940-949
MissingFormLabel
- 15
Serruys PW,
Takahashi K,
Chichareon P.
et al.
Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy
in patients who underwent complex percutaneous coronary intervention: insights from
the Global Leaders trial. Eur Heart J 2019; 40 (31) 2595-2604
MissingFormLabel
- 16
Vranckx P,
Valgimigli M,
Windecker S.
et al.
Long-term ticagrelor monotherapy versus standard dual antiplatelet therapy followed
by aspirin monotherapy in patients undergoing biolimus-eluting stent implantation:
rationale and design of the GLOBAL LEADERS trial. EuroIntervention 2016; 12 (10) 1239-1245
MissingFormLabel
- 17
Marshall A,
Altman DG,
Holder RL.
Comparison of imputation methods for handling missing covariate data when fitting
a Cox proportional hazards model: a resampling study. BMC Med Res Methodol 2010; 10:
112
MissingFormLabel
- 18
DeLong ER,
DeLong DM,
Clarke-Pearson DL.
Comparing the areas under two or more correlated receiver operating characteristic
curves: a nonparametric approach. Biometrics 1988; 44 (03) 837-845
MissingFormLabel
- 19
Alba AC,
Agoritsas T,
Walsh M.
et al.
Discrimination and calibration of clinical prediction models: users' guides to the
medical literature. JAMA 2017; 318 (14) 1377-1384
MissingFormLabel
- 20
Pencina MJ,
D'Agostino Sr RB,
D'Agostino Jr RB,
Vasan RS.
Evaluating the added predictive ability of a new marker: from area under the ROC curve
to reclassification and beyond. Stat Med 2008; 27 (02) 157-172
MissingFormLabel
- 21
Vasan MJPRBDASRBDAJRS.
Comments on integrated discrimination and net reclassification improvements – practical
advice. Stat Med 2008;
MissingFormLabel
- 22
Yates JF.
External correspondence: decompositions of the mean probability score. Organ Behav
Hum Perform 1982; 30 (01) 132-156
MissingFormLabel
- 23
Lemeshow S,
Hosmer Jr DW.
A review of goodness of fit statistics for use in the development of logistic regression
models. Am J Epidemiol 1982; 115 (01) 92-106
MissingFormLabel
- 24
Raposeiras-Roubín S,
Faxén J,
Íñiguez-Romo A.
et al.
Development and external validation of a post-discharge bleeding risk score in patients
with acute coronary syndrome: the BleeMACS score. Int J Cardiol 2018; 254: 10-15
MissingFormLabel
- 25
van Rein N,
Heide-Jørgensen U,
Lijfering WM,
Dekkers OM,
Sørensen HT,
Cannegieter SC.
Major bleeding rates in atrial fibrillation patients on single, dual, or triple antithrombotic
therapy. Circulation 2019; 139 (06) 775-786
MissingFormLabel
- 26
Simonsson M,
Winell H,
Olsson H.
et al.
Development and validation of a novel risk score for in-hospital major bleeding in
acute myocardial infarction:-the SWEDEHEART score. J Am Heart Assoc 2019; 8 (05) e012157
MissingFormLabel
- 27
Leonardi S,
Franzone A,
Piccolo R.
et al.
Rationale and design of a prospective substudy of clinical endpoint adjudication processes
within an investigator-reported randomised controlled trial in patients with coronary
artery disease: the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY). BMJ Open 2019;
9 (03) e026053
MissingFormLabel
- 28
Franzone A,
McFadden E,
Leonardi S.
et al;
GLASSY Investigators.
Ticagrelor alone versus dual antiplatelet therapy from 1 month after drug-eluting
coronary stenting. J Am Coll Cardiol 2019; 74 (18) 2223-2234
MissingFormLabel
- 29
Urban P,
Mehran R,
Colleran R.
et al.
Defining high bleeding risk in patients undergoing percutaneous coronary intervention:
a consensus document from the Academic Research Consortium for High Bleeding Risk.
Eur Heart J 2019; 40 (31) 2632-2653
MissingFormLabel
- 30
Natsuaki M,
Morimoto T,
Shiomi H.
et al.
Application of the Academic Research Consortium High Bleeding Risk Criteria in an
all-comers registry of percutaneous coronary intervention. Circ Cardiovasc Interv
2019; 12 (11) e008307
MissingFormLabel
- 31
Ueki Y,
Bär S,
Losdat S.
et al.
Validation of bleeding risk criteria (ARC-HBR) in patients undergoing percutaneous
coronary intervention and comparison with contemporary bleeding risk scores. EuroIntervention
2020; EIJ-D-20-00052
MissingFormLabel