Incremental Value of the CRUSADE, ACUITY, and HAS‐BLED Risk Scores for the Prediction of Hemorrhagic Events After Coronary Stent Implantation in Patients Undergoing Long or Short Duration of Dual Antiplatelet Therapy

Abstract

BackgroundMultiple scores have been proposed to stratify bleeding risk, but their value to guide dual antiplatelet therapy duration has never been appraised. We compared the performance of the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines), ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy), and HAS‐BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) scores in 1946 patients recruited in the Prolonging Dual Antiplatelet Treatment After Grading Stent‐Induced Intimal Hyperplasia Study (PRODIGY) and assessed hemorrhagic and ischemic events in the 24‐ and 6‐month dual antiplatelet therapy groups.Methods and ResultsBleeding score performance was assessed with a Cox regression model and C statistics. Discriminative and reclassification power was assessed with net reclassification improvement and integrated discrimination improvement. The C statistic was similar between the CRUSADE score (area under the curve 0.71) and ACUITY (area under the curve 0.68), and higher than HAS−BLED (area under the curve 0.63). CRUSADE, but not ACUITY, improved reclassification (net reclassification index 0.39, P=0.005) and discrimination (integrated discrimination improvement index 0.0083, P=0.021) of major bleeding compared with HAS‐BLED. Major bleeding and transfusions were higher in the 24‐ versus 6‐month dual antiplatelet therapy groups in patients with a CRUSADE score >40 (hazard ratio for bleeding 2.69, P=0.035; hazard ratio for transfusions 4.65, P=0.009) but not in those with CRUSADE score ≤40 (hazard ratio for bleeding 1.50, P=0.25; hazard ratio for transfusions 1.37, P=0.44), with positive interaction (P int=0.05 and P int=0.01, respectively). The number of patients with high CRUSADE scores needed to treat for harm for major bleeding and transfusion were 17 and 15, respectively, with 24‐month rather than 6‐month dual antiplatelet therapy; corresponding figures in the overall population were 67 and 71, respectively.ConclusionsOur analysis suggests that the CRUSADE score predicts major bleeding similarly to ACUITY and better than HAS BLED in an all‐comer population with percutaneous coronary intervention and potentially identifies patients at higher risk of hemorrhagic complications when treated with a long‐term dual antiplatelet therapy regimen.Clinical Trial Registration URL: http://clinicaltrials.gov. Unique identifier: NCT00611286.

Trade-off of myocardial infarction vs. bleeding types on mortality after acute coronary syndrome: lessons from the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) randomized trial

“…Taken together, these trials and our current findings strongly suggest that DAPT duration should be weighed considering the ischaemic vs. bleeding risk profile of the patient, as both complications may concur to significantly increase mortality, with comparative effects that largely depend on the bleeding severity. 14,15,[27][28][29] Net clinical benefit outcomes have become a popular endpoint to account for both efficacy and bleeding effect. However, there is an intrinsic risk of misinterpretation when heterogeneity among components exists with respect to either importance, number of events, or magnitude of treatment effect.…”

2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS

“…6 Most of the frequently used risk scores for assessing ischaemic events 7-9 and major bleeds [10][11][12] were originally developed and validated for the prediction of events occurring mainly during hospital stay or early on thereafter. 13,14 As a result, the application of these risk scores to decide upon DAPT duration remains problematic, as only limited data exist exploring their value to guide DAPT duration. 13 On the other hand, the use of risk scores that were specifically designed to guide and inform decision making on DAPT duration should be prioritized over other available risk scores ( low-risk score (<2) selected patients recruited in the DAPT trial who did not derive any reduction of ischaemic events from prolonging DAPT, with a significant increase in moderate/major bleeding (NNT for harm = 64).…”

“…13,14 As a result, the application of these risk scores to decide upon DAPT duration remains problematic, as only limited data exist exploring their value to guide DAPT duration. 13 On the other hand, the use of risk scores that were specifically designed to guide and inform decision making on DAPT duration should be prioritized over other available risk scores ( low-risk score (<2) selected patients recruited in the DAPT trial who did not derive any reduction of ischaemic events from prolonging DAPT, with a significant increase in moderate/major bleeding (NNT for harm = 64). As DAPT duration was not randomized in the PROTECT trial, the value of the DAPT score in guiding the duration of therapy has so far only been shown for patients recruited to the DAPT trial.…”

More, More, More: Reducing Thrombosis in Acute Coronary Syndromes Beyond Dual Antiplatelet Therapy—Current Data and Future Directions

“…The PRECISE‐DAPT (Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy)40 or PARIS (Patterns of Nonadherence to Antiplatelet Regimen in Stented Patients)41 scores in patients receiving coronary stents and treated with DAPT have been shown to be predictive of bleeding, but prospective validation in randomized controlled trials is lacking 38. Other risk scores for bleeding can be helpful, including HASBLED (Hypertension, Abnormal liver/renal function, Stroke history, Bleeding predisposition, Labile international normalized ratio, Elderly, Drug/alcohol usage),42 validated predominantly in patients with atrial fibrillation taking warfarin, or CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) scores in ACS patients undergoing coronary angiography 43, 44. There is clearly a need to identify circulating biomarkers that reflect platelet, inflammatory, coagulation, and endothelial function that identify patients at risk of bleeding and thrombosis and to incorporate those markers into trials for prospective validation.…”