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JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Relation between change in blood pressure in acute stroke and risk of early adverse events and poor outcome.
Stroke; a Journal of Cerebral Circulation 2012 August
BACKGROUND AND PURPOSE: The Scandinavian Candesartan Acute Stroke Trial (SCAST) found no benefits of candesartan in acute stroke. In the present analysis we aim to investigate the effect of change in blood pressure during the first 2 days of stroke on the risk of early adverse events and poor outcome.
METHODS: SCAST was a multicenter, randomized controlled, double-blind trial of candesartan in acute stroke. The trial recruited 2029 patients presenting within 30 hours of acute stroke and with systolic blood pressure (SBP) ≥140 mm Hg. Treatment was given for 7 days. Change in blood pressure was defined as the difference in SBP between baseline and Day 2 and was used to divide patients into groups with increase/no change, a small decrease, moderate decrease, or large decrease in SBP. The primary effect parameter was early adverse events (recurrent stroke, stroke progression, and symptomatic hypotension) during the first 7 days, analyzed using logistic regression, with the group with a small decrease in SBP as the reference group. Secondary effect parameters were neurological status at 7 days and functional outcome at 6 months.
RESULTS: Patients with a large decrease or increase/no change in SBP had a significantly increased risk of early adverse events relative to patients with a small decrease (OR, 2.08; 95% CI, 1.19-3.65 and OR, 1.96; 95% CI, 1.13-3.38, respectively). Patients with an increase/no change in SBP had a significantly increased risk of poor neurological outcome as compared with the other groups (P=0.001). No differences were observed in functional outcome at 6 months.
CONCLUSIONS: Our findings support the suggestion from SCAST that blood pressure reduction may be harmful and that routine blood pressure-lowering treatment should probably be avoided in the acute phase.
CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov. Unique identifier: NCT00120003.
METHODS: SCAST was a multicenter, randomized controlled, double-blind trial of candesartan in acute stroke. The trial recruited 2029 patients presenting within 30 hours of acute stroke and with systolic blood pressure (SBP) ≥140 mm Hg. Treatment was given for 7 days. Change in blood pressure was defined as the difference in SBP between baseline and Day 2 and was used to divide patients into groups with increase/no change, a small decrease, moderate decrease, or large decrease in SBP. The primary effect parameter was early adverse events (recurrent stroke, stroke progression, and symptomatic hypotension) during the first 7 days, analyzed using logistic regression, with the group with a small decrease in SBP as the reference group. Secondary effect parameters were neurological status at 7 days and functional outcome at 6 months.
RESULTS: Patients with a large decrease or increase/no change in SBP had a significantly increased risk of early adverse events relative to patients with a small decrease (OR, 2.08; 95% CI, 1.19-3.65 and OR, 1.96; 95% CI, 1.13-3.38, respectively). Patients with an increase/no change in SBP had a significantly increased risk of poor neurological outcome as compared with the other groups (P=0.001). No differences were observed in functional outcome at 6 months.
CONCLUSIONS: Our findings support the suggestion from SCAST that blood pressure reduction may be harmful and that routine blood pressure-lowering treatment should probably be avoided in the acute phase.
CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov. Unique identifier: NCT00120003.
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