Predicting risk of symptomatic intracerebral hemorrhage and mortality after treatment with recombinant tissue-plasminogen activator using SEDAN score.

BACKGROUND AND PURPOSE: The most feared complication after treatment with recombinant tissue-plasminogen activator (rt-PA) is the occurrence of symptomatic intracerebral hemorrhage (sICH). The aims of the study were to predict the risk of sICH (ECASS II definition) after a therapy with rt-PA and to examine whether associations exist between SEDAN score and the early mortality in patients with acute ischemic stroke in a monocenter study.

METHODS: During a 6-year period (2008-2013), 542 consecutive stroke patients (mean age, 73 ± 3 years; 51.1% women; median NIHSS score, 11) treated with IV thrombolysis were included in a monocenter study. SICH was diagnosed in according to the with ECASS II definition.

RESULTS: The absolute risk for sICH revealed 9.2% (95% CI, 6.5-11.4) of patients treated with IV thrombolysis and was 0%, 4.6% (95% CI, 1.3-7.9), 6.6% (95% CI, 3.3-10.5), 13.5% (95% CI, 6.7-19.2), 23.6% (95% CI, 12.7-34.5), and 26.7% (95% CI, 12.7-34.5) for 0, 1, 2, 3, 4, and ≥5 SEDAN points. Logistic regression revealed that sICH was associated with increasing SEDAN scores (OR, 1.93 per SEDAN point; 95% CI, 1.51-2.46; P < 0.001). The predictive performance was assessed with area under a receiver operating characteristic curve (0.73; 95% CI, 0.65-0.80; P < 0.001). During hospitalization (median, 9 days), 53 patients (9.8%; 95% CI, 7.4-12.45) died. In-hospital mortality was higher in patients with than those without sICH (30 vs 7.7%; P < 0.001), and it was increased with increasing SEDAN score (OR, 1.45 per point; 95% CI, 1.12-1.89; P = 0.005).

CONCLUSIONS: Higher SEDAN score was associated with an increased risk of sICH and early mortality in this monocenter study.