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The OPTIMAL-STROKE trial found fewer major cardiovascular events among people with a prior ischemic stroke or transient ischemic attack assigned to a systolic blood pressure target below 120 mm Hg rather than below 140 mm Hg. A potential increase in a composite kidney outcome was reported, mainly linked to sustained kidney-function decline; the trial did not find more kidney deaths, end-stage kidney disease or dialysis. A separate trial in high-risk patients with type 2 diabetes did not show a statistically significant benefit on its primary outcome.
A trial in Brazil found that people with a previous ischemic stroke or transient ischemic attack assigned to intensive blood pressure treatment had fewer major cardiovascular events than those assigned to a standard target, although researchers also reported a potential kidney-function trade-off. In OPTIMAL-STROKE, the event rate was 10.9% for a systolic blood pressure target below 120 mm Hg, compared with 13.5% for a target below 140 mm Hg, over a median follow-up of roughly four years.
The difference in the trial’s primary outcome was statistically significant, with P=0.007. The study enrolled 4,368 people with elevated blood pressure and a history of ischemic stroke or TIA, randomly assigning them to intensive or standard treatment. The report says the multicenter, open-label trial was conducted at 30 sites in Brazil. Its results were presented at the American Heart Association annual meeting and published alongside the diabetes trial in the New England Journal of Medicine.
Researchers reported a possible increase in a composite renal endpoint in the intensive-treatment group, driven mainly by a sustained decline in kidney function. The report says there was no increase in the more serious outcomes of renal death, end-stage kidney disease or dialysis. The findings do not establish that every stroke survivor should pursue a target below 120; treatment decisions and the risks for individual patients require clinical judgment.
A separate trial, OPTIMAL-DIABETES, tested the same systolic targets in people with type 2 diabetes and high cardiovascular risk. Its primary outcome occurred in 6% of participants assigned to intensive treatment and 6.7% assigned to standard treatment, a difference that was not statistically significant (P=0.20). The outcome combined cardiovascular death, nonfatal heart attack, nonfatal stroke and hospitalization for unstable angina or heart failure. The two trials thus produced different results in distinct patient groups.
A Lower Target After Stroke
For stroke survivors, the results add trial evidence to a long-running clinical concern: lowering blood pressure may reduce cardiovascular risk, but clinicians have worried that doing so too aggressively could impair blood flow to the brain, particularly in patients with narrowed arteries. At the meeting, Cheryl Bushnell of Wake Forest University said the stroke findings addressed some of those concerns about cerebral perfusion. Her assessment is a clinician’s interpretation of the trial, not proof that the target is appropriate for every patient.
The potential kidney effect complicates the decision. AHA discussant Daichi Shimbo said the reported numbers implied that, for every 1,000 people treated intensively for about four years, 26 might benefit and 17 might be harmed on the outcomes discussed. He described the harm as a creatinine increase, while the study report identifies sustained kidney-function decline as the main driver of the composite renal result. The figures help frame the trade-off but do not determine how an individual should be treated.
Putting the target into routine care may also be difficult. Shimbo said a substantial share of participants in the intensive arm did not reach systolic pressure below 120 mm Hg, and that achieving the target could be harder in ordinary practice. Any future guidance would need to address both whether to aim lower and how clinicians can monitor patients while pursuing that goal.
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Two Trials, Different Populations
Both studies compared intensive treatment aimed at systolic blood pressure below 120 mm Hg with standard treatment aimed below 140 mm Hg, over a similar period. Their results should not be treated as interchangeable: OPTIMAL-STROKE enrolled people with prior ischemic stroke or TIA, while OPTIMAL-DIABETES studied people with type 2 diabetes at high cardiovascular risk. The trials measured composite cardiovascular outcomes, but the patient groups and reported results differed.
Current guidelines for the stroke population recommend a blood pressure target of 130/80 mm Hg, according to Bushnell’s comments at the meeting. The new stroke-trial result may inform future discussion of lower targets, but it does not itself change a guideline. For diabetes, trial leader Otavio Berwanger said the neutral OPTIMAL-DIABETES result should be read alongside earlier research, including the BPROAD trial in China and ACCORD BP in North America. He cited a prespecified meta-analysis combining those studies with the new findings that showed a 16% relative reduction in major cardiovascular events; that pooled estimate is distinct from the result of OPTIMAL-DIABETES alone.
“This kind of abolishes some of the concerns that a lot of neurologists and primary care physicians have had about cerebral perfusion.”
— Cheryl Bushnell, MD, Wake Forest University
Kidney Risks and Real-World Targets
The available report does not provide the full breakdown of the kidney composite, the exact share of participants who reached their assigned blood pressure targets, or all details needed to judge how broadly the findings apply. The potential kidney-function decline was not accompanied by an increase in the more severe kidney outcomes listed in the report, but the balance of benefit and harm for particular patients remains a clinical question.
It is also not yet clear whether guidelines will recommend a systolic target below 120 mm Hg for stroke survivors or what monitoring and treatment steps would be advised. OPTIMAL-DIABETES did not show a statistically significant reduction in its primary outcome, while the cited 16% relative reduction comes from a prespecified meta-analysis of several trials. That pooled estimate does not turn the individual diabetes trial into a positive result.
Guidelines and Clinical Implementation
The next steps are likely to include consideration of the findings by guideline groups and further discussion of how clinicians could safely pursue lower targets. Shimbo said that, if future guidance recommends a target below 120 mm Hg, it should include practical advice on achieving it in clinical care. Clinicians will also need to weigh blood pressure response and kidney-function monitoring against each patient’s health history.
The trial results are now published in the New England Journal of Medicine, but the source report does not specify a timetable for guideline changes or additional follow-up analyses. Until those details emerge, the central finding is population-specific: intensive treatment reduced the measured cardiovascular event rate in OPTIMAL-STROKE, while the separate diabetes trial’s primary result was statistically neutral.
Key Questions
What did OPTIMAL-STROKE find?
Among people with a previous ischemic stroke or TIA, the reported major cardiovascular event rate was 10.9% with a systolic target below 120 mm Hg and 13.5% with a target below 140 mm Hg over roughly four years of median follow-up.
Did intensive treatment affect kidney outcomes?
The report describes a potential increase in a composite renal endpoint, mainly due to sustained decline in kidney function. It says there was no increase in renal death, end-stage kidney disease or need for dialysis.
Did the diabetes trial show the same benefit?
No statistically significant benefit was found for OPTIMAL-DIABETES on its primary outcome: event rates were 6% with intensive treatment and 6.7% with standard treatment (P=0.20). Researchers also cited a meta-analysis of this and earlier trials, which reported a 16% relative reduction in major cardiovascular events.
Does the result change blood pressure guidelines?
The report says current guidance for the stroke population recommends 130/80 mm Hg. The trial may inform future guidance, but no change is reported, and the findings do not amount to an individual treatment recommendation.
Why might the target be hard to use in practice?
Discussant Daichi Shimbo said many participants in the intensive arm did not reach systolic pressure below 120 mm Hg and argued that doing so could be harder in routine care. The report does not give the full target-attainment figures.
Source: medpagetoday.com
