Microbleeds in the SPS3 Trial: Stroke, Mortality and Treatment Interactions

Abstract

Objectives: To characterize cerebral microbleeds (CMBs) in lacunar stroke patients in the SPS3 trial and to assess their relationship with recurrent stroke and death, and response to assigned treatment.

Methods: SPS3 is a randomized, clinical trial conducted between 2003 and 2011. Patients with recent MRI-documented lacunar infarcts were randomly assigned in a factorial design to target levels of systolic blood pressure (SBP; 130–149 mmHg vs <130 mmHg; open-label) and to antiplatelet treatment (aspirin/clopidogrel vs aspirin/placebo; double-blinded). The current analysis involves 1278 trial participants who had a baseline axial T2*- GRE MRI sequence allowing for CMB detection.

Results: CMBs were present in 30% of 1278 patients (mean age 63 y). Male gender (OR 1.7, 95%CI 1.3-2.3)·, history of hypertension (1.6, 1.2-2.3), increased systolic blood pressure (1.2 per 20 mmHg, 1.1-1.4), non-diabetic (1.4, 1.1-1.9), multiple old lacunar infarcts(1.9, 1.5-2.5) and moderate(1.7, 1.2-2.3) or severe (4.2, 3.0-5.9) white matter hyperintensities on MRI were independently associated with CMBs. During a mean follow-up of 3.3 y, overall stroke recurrence was 2.5% per patient-y. Patients with CMBs had an adjusted two-fold increased risk of recurrent stroke (HR 2.1, 1.4-3.1). CMBs were not a risk factor for death. There were no statistically significant interactions between CMBs and treatment assignments.

Interpretation: Patients with lacunar stroke and CMBs likely harbor a more advanced form of cerebral small vessel disease in need of efficacious therapeutic strategies. This article is protected by copyright. All rights reserved.

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