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OPTIMAL-STROKE: systolic target below 120 mm Hg lowered cardiovascular event risk 21.6% after stroke

In a trial of 4,368 adults in Brazil after ischemic stroke or TIA, a target below 120 mm Hg gave fewer cardiovascular events than below 140, with more renal events.

OPTIMAL-STROKE: systolic target below 120 mm Hg lowered cardiovascular event risk 21.6% after stroke
Photo: ad-hoc-news.de

The OPTIMAL-STROKE trial compared two systolic blood pressure targets after ischemic stroke or transient ischemic attack (TIA). It was presented on 7 November 2026 at the American Heart Association Scientific Sessions in Chicago and published in the New England Journal of Medicine, according to ad-hoc-news.de ad-hoc-news.dead-hoc-news.dead-hoc-news.deOpen source ↗. The trial enrolled 4,368 adults at 30 centers in Brazil. It was conducted by Hospital Israelita Albert Einstein with the Brazilian Ministry of Health under the Proadi-SUS program.

Mean age was 63.9 years, 47.9% of participants were women, and mean baseline systolic pressure was 146.7 mm Hg (range 130 to 180 mm Hg). A total of 2,172 people were assigned to intensive treatment with a target below 120 mm Hg, and 2,196 to standard treatment with a target below 140 mm Hg.

Primary endpoint and pressure achieved

Over a median follow-up of 3.9 years, the intensive group reached a mean systolic pressure of 122.0 ± 11.5 mm Hg on an average of three drugs. The standard group reached 135.2 ± 9.7 mm Hg on two drugs.

The primary composite endpoint included cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for unstable angina or heart failure. It occurred in 10.9% of the intensive group and 13.5% of the standard group (hazard ratio 0.79; 95% CI 0.67–0.94; P=0.007). This is a relative risk reduction of 21.6%, with event rates of 3.25 versus 4.11 per 100 person-years ad-hoc-news.dead-hoc-news.dead-hoc-news.deOpen source ↗. Recurrent stroke occurred in 4.7% versus 6.4%, a relative decrease of 27%. The extended 5-point MACE endpoint fell by 16% (HR 0.84; P=0.02).

Renal events, falls and the diabetes sister trial

Adverse renal events, defined as a reduction in estimated glomerular filtration rate of at least 50% or end-stage kidney disease, occurred in 3.9% of the intensive group and 2.2% of the standard group. End-stage kidney disease or dialysis and serious adverse events overall did not differ significantly between the arms. Falls were less frequent with intensive treatment: 1.0% versus 1.7% (HR 0.57; 95% CI 0.33–0.98). The authors list the open-label design and the restriction to Brazilian sites as limitations.

The same team presented the sister trial OPTIMAL-DIABETES on 7 November 2026, reported by Otavio Berwanger of the George Institute for Global Health. In 9,476 participants with type 2 diabetes and high cardiovascular risk, lowering pressure below 120 mm Hg did not significantly reduce the primary endpoint after four years (6.0% versus 6.7%; HR 0.90; P=0.2). Renal events rose from 3.7% to 5.7%. A meta-analysis including ACCORD-BP and BPROAD gave a relative risk reduction of 16% (HR 0.84) for intensive lowering in diabetes.

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