Comparative Assessment of Predictive Performance of PRECISE-DAPT, CRUSADE, and ACUITY Scores in Risk Stratifying 30-Day Bleeding Events

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 - calibration

Publication History

Received: 22 February 2020

Accepted: 19 April 2020

Article published online:
22 June 2020

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 21 Vasan MJPRBDASRBDAJRS. Comments on integrated discrimination and net reclassification improvements – practical advice. Stat Med 2008;
• 22 Yates JF. External correspondence: decompositions of the mean probability score. Organ Behav Hum Perform 1982; 30 (01) 132-156
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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