TL;DR
In the Brazilian OPTIMAL-STROKE trial, targeting systolic blood pressure below 120 mm Hg reduced major cardiovascular events compared with a target below 140 mm Hg among people with a previous ischemic stroke or transient ischemic attack. The result came with more events in a composite kidney outcome, mainly sustained declines in kidney function; researchers reported no increase in kidney 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 outcome.
Intensive blood-pressure treatment reduced major cardiovascular events among people with a previous ischemic stroke or transient ischemic attack in a large Brazilian trial, compared with a standard treatment target, researchers reported at the American Heart Association annual meeting on November 9. In OPTIMAL-STROKE, the event rate was 10.9% with a systolic target below 120 mm Hg and 13.5% with a target below 140 mm Hg; the difference was statistically significant.
The multicenter, open-label OPTIMAL-STROKE trial enrolled 4,368 people with elevated blood pressure and a history of ischemic stroke or transient ischemic attack (TIA) at 30 sites in Brazil. Participants were randomly assigned to a systolic blood-pressure target of less than 120 mm Hg or less than 140 mm Hg. After a median follow-up of roughly four years, the more intensive strategy was associated with fewer major adverse cardiovascular events: 10.9% versus 13.5% (P=0.007), according to the report by Susan Jeffrey in MedPage Today.
The researchers also reported a potential cost: an increase in a composite kidney outcome, driven mainly by sustained declines in kidney function. The source report said there was no increase in the more serious outcomes of kidney-related death, end-stage kidney disease or need for dialysis. The trial result does not establish that every patient with a prior stroke should pursue the lower target; treatment decisions and monitoring remain clinical matters.
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 the intensive-treatment group and 6.7% of the standard-treatment group (P=0.20), a difference that was not statistically significant. The two trials were published simultaneously in the New England Journal of Medicine, the report said.
A Lower Target After Stroke
For clinicians and patients managing blood pressure after an ischemic stroke or TIA, the findings add trial evidence that targeting systolic pressure below 120 mm Hg may reduce major cardiovascular events compared with a target below 140 mm Hg. The result also speaks to a concern in stroke care: whether lowering pressure aggressively could compromise blood flow to the brain, particularly in patients with narrowed arteries. At the meeting, neurologist Cheryl Bushnell said the findings addressed some of those concerns, but they do not remove the need to judge treatment in each patient.
The balance of benefit and harm will matter in practice. AHA discussant Daichi Shimbo said the kidney findings raised a question about whether clinicians would be comfortable with the reported trade-off. He cited an estimate that, per 1,000 patients treated intensively for about four years, 26 would benefit and 17 would be harmed, describing the kidney risk as a creatinine increase. That estimate reflects the trial’s reported risk-benefit calculation, not a guarantee of outcomes for an individual patient.
Implementing a lower target may also be difficult. Shimbo noted that a substantial portion of participants assigned to intensive treatment did not reach a systolic pressure below 120 mm Hg. Reaching and maintaining a target can be harder in routine care than in a clinical trial, where patients are followed under a study protocol.
Two Trials, Different Populations
The studies address related but distinct clinical questions. OPTIMAL-STROKE enrolled people with a previous ischemic stroke or TIA, while OPTIMAL-DIABETES enrolled people with type 2 diabetes and high cardiovascular risk. Though both compared targets below 120 and below 140 mm Hg and followed participants for a similar period, their primary findings differed. The diabetes result was neutral on its own trial endpoint; it should not be described as proof that intensive treatment has no benefit in that population.
Lead investigator Otavio Berwanger said the diabetes result should be considered alongside earlier studies, including BPROAD in China and ACCORD BP in North America. He cited a prespecified meta-analysis combining those trials with the new findings, which showed a 16% relative reduction in major cardiovascular events across the studies. That pooled estimate is separate from the neutral primary result in OPTIMAL-DIABETES and reflects the total evidence considered in the analysis.
Existing guidance cited in the MedPage Today report recommends a blood-pressure target of 130/80 mm Hg for the stroke population. The OPTIMAL-STROKE result tests a more intensive systolic target, below 120 mm Hg. Whether guidelines change will depend on how the findings are reviewed alongside other evidence and the practical considerations of treatment.
“We had one price to pay here that offset the benefits.”
— Otavio Berwanger, MD, PhD, lead investigator, as quoted by MedPage Today
Kidney Risks and Real-World Targets
The reported results do not settle how broadly the below-120 target should be used after stroke. The source report identifies a rise in the composite kidney endpoint but does not provide the event counts or enough detail here to assess how often the sustained kidney-function decline occurred, how reversible it was, or which patients faced the greatest risk. It reports no increase in kidney death, end-stage kidney disease or dialysis, but that does not mean the kidney-function signal is irrelevant.
It is also not clear from the supplied report how many participants reached the assigned target, how treatment effects varied across patient subgroups, or whether benefits and risks differ with longer follow-up. The report notes that many participants in the intensive arm did not achieve systolic pressure below 120 mm Hg, but gives no exact proportion. The findings also do not establish that the diabetes trial’s nonsignificant difference represents no effect; the result and its statistical uncertainty must be read in light of the trial and the wider evidence.
Finally, trial results alone do not determine future clinical guidelines. The study was open-label and conducted at Brazilian sites, and the practical ability to reach the target may differ across health systems and patients. The supplied material does not specify what guideline bodies will recommend or when they may review the evidence.
Guidelines and Clinical Implementation
Researchers, clinicians and guideline groups will weigh OPTIMAL-STROKE against existing evidence, including the potential cardiovascular benefit and kidney-function trade-off. The central implementation question is how a lower systolic target could be reached safely and consistently outside a trial. Shimbo said any future guideline recommending a target below 120 mm Hg should also provide practical guidance for achieving it.
For the diabetes findings, Berwanger pointed to the prespecified analysis combining the new trial with BPROAD and ACCORD BP. Further interpretation will depend on the full trial publications and how experts assess that pooled evidence alongside the neutral OPTIMAL-DIABETES primary result. The supplied report does not announce a guideline decision or a specific next analysis date.
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 blood-pressure target below 120 mm Hg and 13.5% of those assigned to a target below 140 mm Hg over a median follow-up of roughly four years. The difference was statistically significant (P=0.007).
Did intensive treatment affect kidney outcomes?
The study reported an increase in a composite kidney outcome, mainly driven by sustained declines in kidney function. The report said there was no increase in kidney-related death, end-stage kidney disease or need for dialysis. The available source material does not give the kidney event counts or establish how the finding should change care for an individual.
Did the diabetes trial show the same benefit?
No statistically significant difference was found in OPTIMAL-DIABETES: its primary composite outcome occurred in 6% of the intensive-treatment group and 6.7% of the standard-treatment group (P=0.20). Berwanger said the result should also be considered alongside prior trials and a prespecified meta-analysis reporting a 16% relative reduction across studies.
Does this mean everyone who has had a stroke should target below 120 mm Hg?
The trial supports a benefit for the study population, but it does not establish a target for every individual. Future guidelines and clinicians will need to weigh cardiovascular outcomes, kidney-function changes, patient circumstances and the difficulty of reaching the target. Patients should discuss blood-pressure treatment decisions with a qualified health professional.
Source: medpagetoday.com
