[External validation of the ORACLE bleeding risk score using the database of the RECORD 3 registry].

ABSTRACT

AIM: To validate a domestic scale for assessment risk of bleeding ORACUL (ОРАКУЛ) based on an independent sample of patients with acute coronary syndrome (ACS). MATERIALS AND METHODS: External validation of the ORACUL score was carried out using database of an independent observational study RECORD-3 which comprised data from all patients hospitalized for 1 month (march-april 2015) in 47 centers of 37 cities in 21 regions of Russia. Total number of included patients was 2370, mean age 64.2±11.96 years, 821 patients (34.6%) had ST-elevation, other patients - non-ST elevation ACS. RESULTS: The following bleeding events were registered in RECORD-3 bleedings during hospitalization (n=34, 1.43%), inhospital bleedings requiring withdrawal of antithrombotic treatment (n=16, 0.68%), inhospital bleedings, which required drug or surgical treatment or hemotransfusion (n=16, 0.68%). Forty eight hemorrhagic complications were registered during 6 months of observation after hospital discharge. Diagnostic value of the ORACUL score for estimation of risk of bleedings during index hospitalization was good (C-criterion 0.691±0.050; р<0.001), sensitivity of the model was 58.1%, specificity 79.9%. Earlier on the cohort of patients of the ORACUL study diagnostic value of the score for inhospital bleedings was found to be 0.777±0.046. Difference of diagnostic values was inessential. For estimation of the bleeding risk during 6 months of post discharge observation area under the ROC curve (C-criterion) was 0.628±0.045 (р=0.003), sensitivity and specificity of the model were 53.9 and 73.7%, respectively. On the ORACUL study cohort AUC 0.748±0.048 (р=0.071). CONCLUSION: External validation confirmed that statistical power of the OCACUL score is sufficient for prediction of bleedings during both periods of hospitalization and after hospital discharge.