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International journal of stroke : official journal of the International Stroke Society
Published

Intravenous thrombolysis in patients with acute ischemic stroke and cerebral microbleeds: results from the ENCHANTED trial

Authors

Zien Zhou, Yilun Ge, Sohei Yoshimura, Takako Torii-Yoshimura, Yuki Sakamoto, Xiaoqiu Liu, Cheryl Carcel, Xiaoying Chen, Leibo Liu, Mark Parsons, Grant Mair, Richard Lindley, Joanna Wardlaw, Anderson Craig, Candice Delcourt

Abstract

Int J Stroke. 2025 Oct 23:17474930251392751. doi: 10.1177/17474930251392751. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine associations between cerebral microbleeds (CMB) and intracerebral hemorrhage (ICH) as well as functional recovery after thrombolysis in participants of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).

METHODS: ENCHANTED recruited acute ischemic stroke (AIS) patients eligible for thrombolytic therapy from 111 clinical centres in 13 countries. We included those with T2*-weighted or susceptibility-weighted brain magnetic resonance imaging within 6 hours after AIS. Associations between CMB (primary predictor), burden (0, 1, 2-4, or ≥5 CMBs), and location (deep, lobar, mixed) and any intracerebral hemorrhage (ICH) (primary outcome), symptomatic ICH (sICH), 90-day disability or death (modified Rankin scale [mRS] score 2-6), and other unfavorable functional outcomes (mRS 3-6, 6, and shift) were explored in logistic regression models, and in a stratification by alteplase dose.

RESULTS: Of 311 eligible AIS participants, 111 (35.7%) had CMB(s) and this was not associated with an increase in any ICH (adjusted odds ratio 1.49, 95% confidence interval [CI] 0.87-2.54) or sICH (2.05, 0.92-4.56). However, the presence of CMB(s) was associated with 90-day disability or death (1.75, 1.04-2.94) and other unfavorable functional outcomes. Comparable associations were seen between CMB burden (defined ordinally categorical; any ICH 1.16 [0.90-1.50]; mRS 2-6 1.44 [1.11-1.87]) or mixed deep-lobar distribution (any ICH 1.42 [0.61-3.29]; mRS 2-6 3.66 [1.48-9.05]) and these outcomes. There were no differences in associations between CMB presence/burden/distribution and outcomes between two different alteplase doses (Pinteraction >0.087).

CONCLUSIONS: In ENCHANTED, CMB(s) was associated with 90-day unfavorable function recovery but not with a significantly increased likelihood of ICH in post-intravenous thrombolytic AIS. Low-dose alteplase may not offer a better profile for AIS with CMB(s).

REGISTRATION NO: Clinicaltrials.gov (identifier no. NCT01422616).

PMID:41131698 | DOI:10.1177/17474930251392751

UK DRI Authors

Joanna Wardlaw

Prof Joanna Wardlaw

Group Leader and Clinical Director of the CVDR

Discovering how small vessel disease damages the brain and what we can do to prevent or treat it

Prof Joanna Wardlaw