Trade-off Between Bleeding and Thrombotic Risk in Patients With Academic Research Consortium for High Bleeding Risk

Urban et al 1 recently developed the Academic Research Consortium for high bleeding risk (ARC-HBR) trade-off model.The new scores provide the predicted 1-year risk of nonperiprocedural major bleeding (Bleeding Ac ademic Research Consortium [BARC] types 3-5 bleeding) and thrombotic events (myocardial infarction [MI] and/or definite or probable stent thrombosis [ST]) after coronary stenting in patients with HBR.In the development and validation cohorts, the C statistics were 0.68 and 0.74 for major bleeding and 0.68 and 0.74 for thrombotic events, respectively; C statistics in validation cohorts typically are lower than those observed in the development cohort.To support individual optimal antiplatelet therapy, bleeding and thrombotic risk scores should achieve helpful discrimination (C statistics, ≥0.60) in contemporary treatment strategies. 2 We applied the scores to the GLOBAL LEADERS trial population. 3 Methods | The GLOBAL LEADERS trial investigated aspirinfree antiplatelet treatment (experimental arm, 1 month of dual antiplatelet therapy [DAPT] followed by 11 months of ticagrelor monotherapy vs reference arm, 12 months of DAPT) in an all-comers population.All patients provided informed consent.The trial was approved by the institutional review board at each center and followed the ethical principles of the Declaration of Helsinki (Supplement 1).Patients were enrolled between July 2013 to November 2015 and had an outpatient clinic visit at 30 days and 3, 6, 12, 18, and 24 months after the index procedure.Data were analyzed during January 2021.The ARC-HBR trade-off model was externally validated in patients with ARC-HBR in the GLOBAL LEADERS trial.Multiple imputation (20 times) of missing values was conducted based on the correlation between all potential predictors and clinical outcomes to make efficient use of the available data without introducing bias under the missing-at-random assumption. 4 The discriminative abilities for BARC types 3 to 5 bleeding and MI and/or ST between 3 to 365 days were assessed using the Harrell C statistic (C index).Agreement between observed and predicted rates was assessed by calibration plot. 4 The discriminative abilities of the PARIS and PRECISE-DAPT scores were also assessed.Analyses were performed using R, version 3.6.0(R Foundation for Statistical Computing).