Hemorrhagic Infarction Does Not Worsen Functional Outcomes in Noncardioembolic Ischemic Stroke: Secondary Analysis From PACIFIC-STROKE

BACKGROUND: Hemorrhagic infarction (HI) of acute ischemic stroke is frequent. Whether radiologically detected HI affects stroke outcomes has been less explored. METHODS: This was a secondary analysis of the PACIFIC-STROKE trial (Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following Acute Noncardioembolic Stroke), which enrolled patients with acute noncardioembolic ischemic stroke receiving either asundexian or placebo in addition to guideline-based antiplatelet therapy. All patients received brain magnetic resonance imaging within 120 hours after stroke onset. Patients with hemorrhagic transformation detected on iron-sensitive sequences and classified as HI (H1 and H2) by the Heidelberg Bleeding Classification were included in the analysis. Primary outcome was poor functional outcome, defined by a modified Rankin Scale score of 2 to 6 at 90 days after stroke. RESULTS: From 1745 patients with adequate baseline brain magnetic resonance imaging (median, 47.8 hours; interquartile range, 28.2-69.4 hours after symptom onset), 10 with parenchymal hemorrhage and 191 without modified Rankin Scale score were excluded. Of the 1544 patients (mean age, 67 years; 67% male), 248 (16.1%) had HI type 1, and 189 (12.2%) had HI type 2. The proportion of patients with poor functional outcome was 27.4% (68/248) in HI type 1, 25.9% (49/189) in HI type 2, and 23.0% (255/1107) in no HI groups. In the multivariable logistic regression model adjusting for stroke severity, infarct size, type of iron-sensitive sequences used, and other covariates, the presence of HI type 1 (adjusted odds ratio, 1.05 [95% CI, 0.74-1.51]) or HI type 2 (adjusted odds ratio, 0.88 [95% CI, 0.57-1.34]) were not associated with poor functional outcome. Of note, the type of iron-sensitive sequences did not modify the results. CONCLUSIONS: The presence of HI did not lead to poor functional outcome on the modified Rankin Scale in patients with acute noncardioembolic ischemic stroke.