Manuel R Blum1,2,3, Rebecca Scherzer4,5, Jesse C Ikeme5,6, Oscar R Benavente7,8, Leslie A McClure9, Carmen A Peralta10, Michelle C Odden1. 1. Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, California, USA. 2. Department of General Internal Medicine, Inselspital, Bern University Hospital. 3. Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland. 4. Division of General Internal Medicine, Department of Medicine, San Francisco Veterans Affair Medical Center. 5. Kidney Health Research Collaborative, University of California. 6. San Francisco Veterans Affairs Medical Center, San Francisco, California, USA. 7. SPS3 Coordinating Center. 8. Division of Neurology, Department of Medicine, Brain Research Center, University of British Columbia, Vancouver, Canada. 9. Department of Epidemiology and Biostatistics, Dornsife School of Public Health, Drexel University, Philadelphia, Pennsylvania. 10. Department of Medicine, Epidemiology and Biostatistics, University of California, San Francisco, California, USA.
Abstract
OBJECTIVE: To determine whether cerebral small vessel disease or disability modify the effect of SBP treatment on cognitive and vascular outcomes in older patients with recent lacunar stroke. METHODS:Participants aged at least 65 years of the Secondary Prevention of Small Subcortical Strokes Trial were randomized to a higher (130-149 mmHg) or lower (<130 mmHg) SBP target. The primary outcome was change in cognitive function (Cognitive Abilities Screening Instrument); secondary outcomes were incident mild cognitive impairment, stroke, major vascular events (all-stroke, myocardial infarction), and all-cause death. Results were stratified by severity of white matter hyperintensities (WMH; none/mild, moderate, severe) on baseline MRI, and by disability (no vs. at least one limitation in activities of daily living). RESULTS: One thousand, two hundred and sixty-three participants (mean age 73.8± 5.9 years, 40% women) were included. Participants with severe WMH or disability had worsecognitive function at baseline and after a mean follow-up of 3.9 years. No significant interactions existed between treatment group and effect modifiers (WMH, disability) for change in cognitive function (P for interaction 0.42 and 0.66, respectively). A lower SBP target appeared more beneficial among those with worse WMH burden for vascular outcomes (P for interaction = 0.01 for stroke and 0.03 for major vascular events). CONCLUSION: There was no difference in the effect of lowering SBP to less than 130 mmHg on cognitive function by cerebral small vessel disease or disability among older adults with a history of lacunar stroke. Those with evidence of small vessel disease may derive greater benefit from lower SBP on prevention of subsequent vascular events. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00059306.
RCT Entities:
OBJECTIVE: To determine whether cerebral small vessel disease or disability modify the effect of SBP treatment on cognitive and vascular outcomes in older patients with recent lacunar stroke. METHODS:Participants aged at least 65 years of the Secondary Prevention of Small Subcortical Strokes Trial were randomized to a higher (130-149 mmHg) or lower (<130 mmHg) SBP target. The primary outcome was change in cognitive function (Cognitive Abilities Screening Instrument); secondary outcomes were incident mild cognitive impairment, stroke, major vascular events (all-stroke, myocardial infarction), and all-cause death. Results were stratified by severity of white matter hyperintensities (WMH; none/mild, moderate, severe) on baseline MRI, and by disability (no vs. at least one limitation in activities of daily living). RESULTS: One thousand, two hundred and sixty-three participants (mean age 73.8 ± 5.9 years, 40% women) were included. Participants with severe WMH or disability had worse cognitive function at baseline and after a mean follow-up of 3.9 years. No significant interactions existed between treatment group and effect modifiers (WMH, disability) for change in cognitive function (P for interaction 0.42 and 0.66, respectively). A lower SBP target appeared more beneficial among those with worse WMH burden for vascular outcomes (P for interaction = 0.01 for stroke and 0.03 for major vascular events). CONCLUSION: There was no difference in the effect of lowering SBP to less than 130 mmHg on cognitive function by cerebral small vessel disease or disability among older adults with a history of lacunar stroke. Those with evidence of small vessel disease may derive greater benefit from lower SBP on prevention of subsequent vascular events. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00059306.
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