External validation of the SEDAN score for prediction of intracerebral hemorrhage in stroke thrombolysis.

BACKGROUND AND PURPOSE The SEDAN score is a prediction rule for assessment of the risk of symptomatic intracerebral hemorrhage (SICH) per the European Cooperative Acute Stroke Study (ECASS) II definition in patients with acute ischemic stroke treated with intravenous thrombolysis. We assessed the performance of the score in predicting SICH per the ECASS II and Safe Implementation of Treatments in Stroke Monitoring Study (SITS-MOST) definitions in the SITS-International Stroke Thrombolysis Register (SITS-ISTR). METHODS We calculated the SEDAN score in 34 251 patients with complete data, enrolled into the SITS-ISTR. The risk for SICH by both definitions was calculated per score category. Odds ratios for SICH per point increase of the score were obtained using logistic regression. The predictive performance was assessed using area under the curve of the receiver operating characteristic (AUC-ROC). RESULTS The predictive capability for SICH per ECASS II was moderate at AUC-ROC=0.66. With rising scores, there was a moderate increase in risk for SICH per ECASS II (odds ratio, 1.65 per point; 95% confidence interval, 1.59-1.72; P<0.001), with SICH rates between 1.6% for 0 points and 16.9% for ≥ 5 points, average 5.1%. The predictive capability for SICH per SITS-MOST was weaker, AUC-ROC=0.60, with lower increase per score point (odds ratio, 1.36 per point; 95% confidence interval, 1.28-1.46; P<0.001), and SICH rates between 0.8% for 0 points and 5.4% for ≥ 5 points, average 1.8%. CONCLUSIONS In this very large data set, the predictive and discriminatory performances of the SEDAN score were only moderate for SICH per ECASS II and low for SICH per SITS-Monitoring Study.