Intensive Blood-Pressure Control in Patients with Previous Ischemic Stroke

Whether intensive blood-pressure control reduces cardiovascular risk after cerebrovascular events remains uncertain.

In this multicenter, open-label, randomized trial conducted at 30 sites in Brazil, we assigned participants with elevated blood pressure and previous ischemic stroke or transient ischemic attack to receive intensive treatment targeting a systolic blood pressure of less than 120 mm Hg or to receive standard treatment targeting a systolic blood pressure of less than 140 mm Hg. The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina or heart failure.

A total of 4368 participants were enrolled, with 2172 assigned to intensive treatment and 2196 to standard treatment. The mean (±SD) age of the participants was 63.9±11.2 years, and 2093 (47.9%) were women. During the follow-up period, excluding the first 3 months, the mean systolic blood pressure was 122.0±11.5 mm Hg (median, 119.6 mm Hg) in the intensive-treatment group and 135.2±9.7 mm Hg (median, 135.0 mm Hg) in the standard-treatment group, with a between-group mean difference of 13.1 mm Hg (95% confidence interval [CI], 12.5 to 13.8). Over a median follow-up of 3.9 years, a primary-outcome event occurred in 236 participants (10.9%; 3.25 events per 100 person-years) with intensive treatment and in 297 (13.5%; 4.11 events per 100 person-years) with standard treatment (hazard ratio, 0.79; 95% CI, 0.67 to 0.94; P = 0.007). The composite renal outcome (sustained reduction of ≥50% in the estimated glomerular filtration rate or progression to end-stage renal disease) was more common with intensive treatment. The overall incidence of serious adverse events was similar in the two groups.

Among participants with previous ischemic stroke or transient ischemic attack, targeting a systolic blood pressure of less than 120 mm Hg resulted in a lower incidence of major cardiovascular events than targeting a systolic blood pressure of less than 140 mm Hg. (Funded by Hospital Israelita Albert Einstein and the Brazilian Ministry of Health; OPTIMAL-STROKE ClinicalTrials.gov number, NCT04036409.).