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The OPTIMAL-STROKE trial found fewer major cardiovascular events among people with a previous ischemic stroke or TIA assigned to a systolic blood-pressure target below 120 mm Hg than among those assigned below 140 mm Hg. Researchers also reported more composite renal events, mainly sustained declines in kidney function; the report said there was no increase in renal death, end-stage kidney disease or dialysis. A separate trial in people with type 2 diabetes did not find a statistically significant benefit on its primary endpoint.
A trial of 4,368 people with a previous ischemic stroke or transient ischemic attack found that targeting systolic blood pressure below 120 mm Hg reduced major cardiovascular events compared with a target below 140 mm Hg over a median follow-up of about four years. The result, from the Brazilian OPTIMAL-STROKE trial, came with a possible trade-off: more events in a composite measure of kidney outcomes, largely driven by sustained declines in renal function.
Participants were randomly assigned to intensive treatment, targeting systolic blood pressure below 120 mm Hg, or standard treatment, targeting below 140 mm Hg. The trial was multicenter and open-label, with recruitment at 30 sites in Brazil. 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), according to results reported by MedPage Today.
Otavio Berwanger, MD, PhD, of Imperial College London, presented the findings at the American Heart Association annual meeting in Chicago. He said the renal signal was mainly a sustained fall in kidney function and may reflect a hemodynamic effect. The report said researchers did not find an increase in the more serious outcomes of renal death, end-stage renal disease or dialysis.
A second Brazilian study, OPTIMAL-DIABETES, tested the same blood-pressure targets in people with type 2 diabetes and high cardiovascular risk. Its primary composite endpoint—cardiovascular death, nonfatal heart attack, nonfatal stroke, or hospitalization for unstable angina or heart failure—occurred in 6% of the intensive-treatment group and 6.7% of the standard-treatment group. The difference was not statistically significant (P=0.20), so that trial did not establish a benefit on its primary endpoint.
A Lower Target After Stroke
The stroke-trial result could affect how clinicians weigh blood-pressure goals for people who have already had an ischemic stroke or TIA. Current guidelines recommend a target of 130/80 mm Hg for this population, according to Cheryl Bushnell, MD, of Wake Forest University, who discussed the findings. OPTIMAL-STROKE tested a more intensive systolic target and found fewer major cardiovascular events, but it does not by itself settle how the target should be applied to every patient.
The kidney findings are part of that decision. At the meeting, discussant Daichi Shimbo, MD, of Columbia University Irving Medical Center, described an estimated trade-off of 26 people benefiting and 17 harmed per 1,000 treated for about four years, based on the trial’s number-needed-to-treat analysis. The reported harm was associated with the renal composite, while the report said the most serious renal outcomes did not increase. Individual risks and the clinical meaning of a kidney-function decline remain relevant to treatment decisions.
Implementation may also be difficult. Shimbo said a substantial portion of participants assigned to intensive treatment did not reach systolic pressure below 120 mm Hg, and achieving that target could be harder in routine care. The findings therefore raise both a clinical question—who is likely to benefit—and a practical one about monitoring and safely reaching the target.
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Two Trials, Different Populations
OPTIMAL-STROKE and OPTIMAL-DIABETES were conducted in Brazil and published simultaneously in the New England Journal of Medicine, according to the report. Both compared a systolic target below 120 mm Hg with a target below 140 mm Hg over a similar period, but they studied different groups and had different primary-endpoint results. The stroke study enrolled people with a previous ischemic stroke or TIA; the diabetes study enrolled people with type 2 diabetes and high cardiovascular risk.
Berwanger described the diabetes result as a neutral trial, while pointing to a prespecified meta-analysis that combined it with earlier studies, including BPROAD in China and ACCORD BP in North America. He said that analysis found a 16% relative reduction in major cardiovascular events across the included trials. That pooled estimate is distinct from the diabetes trial’s own finding, which was not statistically significant; the report does not provide enough detail to independently assess the meta-analysis here.
Bushnell said clinicians have been concerned about lowering pressure too much in some stroke patients, including those with carotid or middle cerebral artery stenosis, because of concerns about blood flow to the brain. She said the trial speaks to those concerns, but the study’s results should be understood within the population and treatment conditions it tested.
“We had one price to pay here that offset the benefits.”
— Otavio Berwanger, MD, PhD, of Imperial College London
Risks and Real-World Reach
The report does not give full details on how blood pressure changed during follow-up, how many participants reached their assigned targets, or how results differed across patient subgroups. Shimbo said a substantial portion of the intensive arm did not achieve a systolic pressure below 120 mm Hg, but the supplied report does not state the exact proportion.
The clinical importance and duration of the kidney-function changes also remain open questions in the material available. Although no increase was reported in renal death, end-stage kidney disease or dialysis, the composite renal signal may influence how clinicians balance cardiovascular benefits against monitoring and potential harm. The findings also do not establish that the same target is appropriate for every stroke survivor.
For diabetes, the trial’s primary result was neutral by statistical testing. Berwanger’s cited 16% relative reduction came from a pooled analysis with earlier trials, and should not be treated as the result of OPTIMAL-DIABETES alone. The report does not provide the pooled analysis’s full methods or uncertainty estimates.
Guidelines and Clinical Practice
Shimbo said future guidelines may recommend a systolic target below 120 mm Hg after stroke, but stressed that guidance would need to explain how clinicians can reach it in practice. The report does not say when guideline bodies will review or update their recommendations, or whether they will adopt the trial target.
Further discussion is likely to focus on patient selection, ways to achieve lower pressure safely, and how to monitor kidney function during intensive treatment. Until formal guidance changes, the trial provides evidence for clinicians and guideline panels to evaluate alongside existing recommendations; it does not announce a new standard of care.
For the diabetes findings, Berwanger pointed to the combined evidence from multiple trials rather than the neutral result in OPTIMAL-DIABETES alone. How future guidance interprets that broader evidence—and whether longer follow-up changes the picture—remains unresolved in the report.
Key Questions
What did OPTIMAL-STROKE find?
Among people with a previous ischemic stroke or TIA, major cardiovascular events occurred in 10.9% of participants assigned to a systolic blood-pressure target below 120 mm Hg and 13.5% assigned to below 140 mm Hg over roughly four years of median follow-up. The difference was statistically significant.
Did intensive treatment affect kidney outcomes?
The report described a potential increase in a composite renal endpoint, driven mainly by sustained declines in renal function. It reported no increase in renal death, end-stage renal disease or need for dialysis.
Did the diabetes trial show the same benefit?
No statistically significant benefit was found on OPTIMAL-DIABETES’ primary endpoint: events occurred in 6% of the intensive-treatment group and 6.7% of the standard-treatment group (P=0.20). Berwanger separately cited a 16% relative reduction in a prespecified meta-analysis that included previous trials.
Is a target below 120 mm Hg now the guideline standard after stroke?
The report says current guidelines recommend 130/80 mm Hg for this population. It does not report a guideline change; experts said future guidance may consider the trial findings and will need to address how the lower target can be achieved in practice.
Source: medpagetoday.com
