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Randomized Controlled Trial
. 2025 Jul;56(7):1730-1737.
doi: 10.1161/STROKEAHA.124.049188. Epub 2025 Apr 8.

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

Chih-Hao Chen  1   2 , Ashkan Shoamanesh  3 , Pablo Colorado  4 , Feryal Saad  1 , Robin Lemmens  5 , Gian Marco De Marchis  6   7 , Valeria Caso  8 , Lizhen Xu  9 , Laura Heenan  9 , Jaime Masjuan  10 , Hanne Christensen  11 , Pooja Khatri  12 , Hardi Mundl  13 , Robert G Hart  3 , Eric E Smith  1
Affiliations
Randomized Controlled Trial

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

Chih-Hao Chen et al. Stroke. 2025 Jul.

Abstract

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.

Keywords: embolism; hemorrhage; infarction; ischemic stroke; magnetic resonance imaging.

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Conflict of interest statement

Dr Caso reports consulting for Boehringer Ingelheim, a grant from Daichi Sankyo, and other funding from EVER Neuro Pharma. Dr Christensen reports being employed by the Capital Region of Denmark and consulting for Alexion Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Daichi Sankyo, and Medtronic and serves as Senior Guest Editor for American Stroke Association (ASA) Stroke Journal. Dr Khatri reports grants from the National Institutes of Health; a grant from Johnson and Johnson Health Care Systems; royalties from UpToDate; consulting for Basking Biosciences, Lumosa, and Shinogi Inc; and other funding from Translational Sciences. Dr Shoamanesh reports consulting for AstraZeneca, Bayer, Daiichi Sankyo, and Takeda Pharmaceutical Company; grants from AstraZeneca, Bayer, Canadian Institutes of Health Research, Daiichi Sankyo, Heart and Stroke Foundation of Canada, National Institutes of Health, Octapharma USA Inc, and Servier Affaires Medicales. Dr Smith serves as the Deputy Editor for ASA Stroke Journal. Except for Dr Chen, the other authors or their institutions received financial support from Bayer for participation in the PACIFIC-STROKE trial (Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following Acute Noncardioembolic Stroke). The other author reports no conflicts.

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