Blood-Pressure Targets in Patients With Recent Lacunar Stroke: The SPS3 Randomised Trial
Lowering of blood pressure (BP) prevents stroke, but optimum target levels to prevent recurrent stroke are unknown. The authors investigated the effects of different BP targets on the rate of recurrent stroke in patients with recent lacunar stroke.
This randomized open-label trial was conducted in patients with recent (within 180 days) magnetic resonance imaging (MRI)–defined symptomatic lacunar infarctions, and who had no source of cardioemboli or surgically amenable ipsilateral carotid artery stenosis. Patients were recruited between March 2003 and April 2011, and randomly assigned, according to a two-by-two multifactorial design, to a systolic BP (sBP) target of 130-149 mm Hg or <130 mm Hg. The primary endpoint was reduction in all strokes (including ischemic strokes and intracranial hemorrhages). Analysis was done by intention to treat. Patients with a baseline sBP <130 mm Hg without treatment were excluded.
A total of 3,020 enrolled patients, 1,519 in the higher-target group and 1,501 in the lower-target group, were followed up for a mean of 3.7 (standard deviation [SD] 2.0) years with a median time from stroke to randomization of 62 days. Mean age was 63 (SD 11) years. After 1 year, mean sBP was 138 mm Hg (95% confidence interval [CI], 137-139) in the higher-target group and 127 mm Hg (95% CI, 126-128) in the lower-target group. Nonsignificant rate reductions were seen for all stroke (hazard ratio, 0.81; 95% CI, 0.64-1.03; p = 0.08), disabling or fatal stroke (0.81; 0.53-1.23; p = 0.32), and the composite outcome of myocardial infarction or vascular death (0.84; 0.68-1.04; p = 0.32) with the lower target. The rate of intracerebral hemorrhage was reduced significantly (0.37; 0.15-0.95; p = 0.03). Treatment-related serious adverse events were infrequent.
Although the reduction in stroke was not significant, the results support that in patients with recent lacunar stroke, the use of a sBP target of <130 mm Hg is likely to be beneficial.
The strength of this study was the testing of target BP, rather than specific antihypertensive agents in patients with a well-defined ischemic stroke subtype. The number needed to treat to prevent one intracerebral hemorrhage at 4 years is approximately 175. Whether there is a lower sBP that is associated with an increase in stroke risk was not reported. The SPS3 Study Group also assessed antiplatelet regimens in lacunar strokes. The annual rate of stroke in the aspirin cohort was 2.7%, and was not significantly reduced in the aspirin/clopidogrel group (2.5%; 95% CI, 0.72-1.16).
Keywords: Stroke, Stroke, Lacunar, Myocardial Infarction, Ticlopidine, Blood Pressure, Intracranial Hemorrhages, Secondary Prevention, Cardiology, Cardiovascular Diseases, Confidence Intervals, Carotid Stenosis, Cerebral Hemorrhage
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