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In the Brazilian OPTIMAL-STROKE trial, patients with a prior ischemic stroke or TIA assigned to a systolic blood pressure target below 120 mm Hg had fewer major cardiovascular events over about four years than those assigned below 140 mm Hg. Researchers also reported more composite kidney events, mainly sustained declines in kidney function; the separate OPTIMAL-DIABETES trial did not find a statistically significant benefit on its primary outcome.
A trial of 4,368 people with a previous ischemic stroke or transient ischemic attack (TIA) found that targeting systolic blood pressure below 120 mm Hg reduced major cardiovascular events compared with a target below 140 mm Hg over roughly four years. The OPTIMAL-STROKE results, reported at the American Heart Association annual meeting and published in the New England Journal of Medicine, also showed a rise in a composite kidney outcome, mainly driven by sustained declines in kidney function.
In OPTIMAL-STROKE, participants with elevated blood pressure were randomly assigned to intensive treatment targeting systolic pressure below 120 mm Hg or standard treatment targeting below 140 mm Hg. Major adverse cardiovascular events occurred in 10.9% of the intensive-treatment group and 13.5% of the standard-treatment group, a statistically significant difference (P=0.007). The study was conducted at 30 sites in Brazil. The supplied report describes median follow-up of roughly four years.
Study presenter Otavio Berwanger said the kidney finding was a potential cost of the intensive strategy. The composite renal outcome was driven mainly by a sustained drop in kidney function, which he said was likely a hemodynamic effect. The report said there was no increase in the more serious outcomes of renal death, end-stage renal disease or need for dialysis.
A second Brazilian study, OPTIMAL-DIABETES, tested the same systolic targets in people with type 2 diabetes and high cardiovascular risk. Its primary composite outcome occurred in 6% of participants assigned to intensive treatment and 6.7% assigned to standard treatment; the difference was not statistically significant (P=0.20). The outcome included cardiovascular death, nonfatal heart attack, nonfatal stroke, or hospitalization for unstable angina or heart failure. The trials therefore produced different results in the populations studied, rather than establishing one target’s effect for every patient group.
A Lower Target After Stroke
The findings could affect discussions about blood-pressure goals for people who have had an ischemic stroke or TIA. Current guidelines recommend a target of 130/80 mm Hg for this population, according to stroke specialist Cheryl Bushnell, who commented on the study. OPTIMAL-STROKE tested a more intensive systolic target and found fewer major cardiovascular events, giving clinicians new trial evidence to weigh against the kidney signal and the practical difficulty of reaching that level.
The result is not a blanket instruction for patients to change medication or targets. The trial compared assigned treatment strategies in a specific population, and treatment decisions require clinical judgment, including consideration of kidney function and a patient’s overall health. The neutral primary result in OPTIMAL-DIABETES also cautions against assuming the stroke-trial finding applies equally to people with diabetes who have not had a stroke.
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Two Trials, Different Populations
Both studies tested whether aiming for systolic blood pressure below 120 mm Hg, rather than below 140 mm Hg, would reduce cardiovascular events. The stroke trial enrolled people with a prior ischemic stroke or TIA; the diabetes trial enrolled people with type 2 diabetes and high cardiovascular risk. Their differing primary results underline that a treatment effect observed in one group does not automatically carry over to another.
Berwanger described the diabetes trial as neutral but said its result should be considered alongside earlier trials, including BPROAD in China and ACCORD BP in North America. He cited a prespecified meta-analysis combining those studies with OPTIMAL-DIABETES, which found a 16% relative reduction in major cardiovascular events across the pooled evidence. That pooled estimate is not the result of OPTIMAL-DIABETES alone. Commenter Shawna Nesbitt said the diabetes study’s larger share of women—62%—might have affected the result, but that was her interpretation, not a demonstrated explanation.
“A lot of times when patients are discharged from the hospital, they have carotid stenosis, and middle cerebral artery stenosis, and everybody’s nervous about lowering their blood pressure too much.”
— Cheryl Bushnell, MD, Wake Forest University
Kidney Risks and Real-World Use
The supplied report does not give the exact rates or definitions for the composite renal outcome, so the size of that increase cannot be assessed from the reported figures here. It says the finding was mainly a sustained decline in kidney function and that more severe renal outcomes did not increase. How clinicians and patients should weigh this trade-off will depend on the detailed results and individual circumstances.
It is also unclear how readily the trial’s intensive target can be reached in routine care. Shimbo said a substantial portion of participants assigned to the intensive arm may not have achieved systolic pressure below 120 mm Hg; the report provides no exact proportion. The study’s open-label design and conduct at Brazilian sites are also relevant when considering how its results translate to other settings. The article does not provide subgroup results or enough detail to determine which patients might have different benefit or risk.
Guidelines and Clinical Practice
Guideline panels will need to consider OPTIMAL-STROKE alongside existing evidence before changing recommendations. Bushnell said the trial suggests a systolic target below 120 mm Hg can improve outcomes after stroke, while Shimbo said any future recommendation should include practical guidance on reaching the target. The supplied report does not identify a timetable for guideline updates.
For now, the reported findings add evidence for clinicians managing blood pressure after ischemic stroke or TIA, but they do not establish that every patient should pursue the same target. Further interpretation will depend on the full trial publication, clinical guidance and discussion of cardiovascular benefits, kidney outcomes and feasibility.
Key Questions
What did OPTIMAL-STROKE find?
Among people with a previous ischemic stroke or TIA, major cardiovascular events occurred in 10.9% of those assigned to a systolic target below 120 mm Hg and 13.5% of those assigned below 140 mm Hg over roughly four years. The difference was statistically significant.
Did intensive treatment affect kidney outcomes?
The report describes a potential increase in a composite kidney outcome, mainly driven by a sustained decline in kidney function. It says there was no increase in renal death, end-stage renal disease or dialysis, but does not provide the kidney event rates in the supplied material.
Did the diabetes trial show the same benefit?
No statistically significant difference was found in OPTIMAL-DIABETES: its primary outcome occurred in 6% of the intensive-treatment group and 6.7% of the standard-treatment group (P=0.20). Berwanger said a prespecified meta-analysis with earlier trials found a 16% relative reduction across the combined evidence.
Should stroke survivors change their blood-pressure target?
The study is evidence for clinicians and guideline groups to consider, not an instruction for individuals to change treatment. Patients should discuss blood-pressure goals and medication decisions with a qualified health professional.
Source: medpagetoday.com
