Objective: To determine associations between cerebral microbleeds (CMB) and intracerebral hemorrhage (ICH) and functional recovery after thrombolysis in participants of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).
Methods: Patients with T2*-weighted brain MRI within 6 hours after acute ischemic stroke (AIS) were included. Associations between CMB (primary predictor), burden (0, 1, 2-4, or ≥5 CMBs), and location (deep, lobar, mixed deep-lobar) 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 by alteplase dose stratification.
Results: Of 311 eligible AIS participants, 111 (35.7%) had CMB(s) and this was not associated with a significant 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 location 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/location and outcomes across different alteplase doses (Pinteraction >0.051).
Conclusions: In ENCHANTED, CMB(s) is associated with 90-day unfavorable function recovery but not with increased likelihood of ICH in post-intravenous thrombolytic AIS. Low-dose alteplase may not offer safety for AIS with CMB(s).