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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 than among those assigned a target below 140 mm Hg. The result came with a potential increase in a composite kidney outcome, while more severe kidney outcomes did not rise. A separate trial in people with type 2 diabetes did not find a statistically significant benefit on its primary outcome.
A Brazilian trial in 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 roughly four years. The result, presented at the American Heart Association annual meeting and published in the New England Journal of Medicine, was accompanied by a potential increase in a composite kidney outcome, though researchers reported no rise in severe kidney outcomes such as dialysis or end-stage kidney disease.
In OPTIMAL-STROKE, 4,368 patients with elevated blood pressure and a history of ischemic stroke or TIA were randomly assigned to intensive or standard treatment. The multicenter, open-label trial was conducted at 30 sites in Brazil. The reported primary cardiovascular outcome 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 comparison was between treatment strategies targeting systolic pressure below 120 mm Hg and below 140 mm Hg. The report describes a median follow-up of about four years. It also notes a potential increase in a composite renal outcome, mainly driven by a sustained decline in kidney function. Investigator Otavio Berwanger said the pattern was likely a hemodynamic effect; the trial report cited no increase in renal death, end-stage renal disease, or need for dialysis.
A second study, OPTIMAL-DIABETES, tested the same blood-pressure targets in people with type 2 diabetes and high cardiovascular risk. Its primary composite outcome occurred in 6% of those assigned intensive treatment and 6.7% of those assigned standard treatment, a difference that was not statistically significant (P=0.20). The two trials therefore do not show the same result across patient groups.
Blood Pressure Targets After Stroke
The stroke findings could affect how clinicians weigh blood-pressure targets 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 neurologist Cheryl Bushnell, who commented on the results. The trial tested a more intensive systolic target, below 120 mm Hg, and found fewer major cardiovascular events than with the less intensive strategy.
That does not mean the target will be straightforward to apply to every patient. Clinicians must weigh the cardiovascular outcome against the reported kidney-function signal and consider a patient’s individual health and ability to tolerate treatment. The finding is about a treatment target tested under trial conditions; it does not establish that every stroke survivor should aim for the same pressure without clinical guidance.
Implementation is also a practical issue. AHA discussant Daichi Shimbo said a substantial portion of participants assigned intensive treatment may not have reached systolic pressure below 120 mm Hg. He said achieving that level could be harder in routine care, and argued that any future guideline recommending it should explain how clinicians can pursue the target.
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Two Trials, Different Populations
The studies address a shared question—whether more intensive blood-pressure lowering reduces cardiovascular risk—but examined distinct patient populations. OPTIMAL-STROKE enrolled people with previous ischemic stroke or TIA; OPTIMAL-DIABETES enrolled people with type 2 diabetes and high cardiovascular risk. Their primary outcomes were composite measures of cardiovascular events, and their results should not be treated as interchangeable.
Berwanger described the diabetes trial as neutral, while cautioning against reading it alone. He cited a prespecified meta-analysis combining its results with earlier trials, including BPROAD in China and ACCORD BP in North America. That combined analysis found a 16% relative reduction in major cardiovascular events, he said. This is a pooled result across studies, not a finding from OPTIMAL-DIABETES by itself.
Bushnell said the stroke-trial findings address concern among some clinicians about lowering pressure in patients with narrowed brain arteries and the possibility of affecting cerebral blood flow. She called OPTIMAL-STROKE a landmark trial, but the study’s results still need to be considered alongside kidney outcomes, practical treatment challenges, and the population actually studied.
“We had one price to pay here that offset the benefits.”
— Otavio Berwanger, MD, PhD, the trial investigator
Kidney Risks and Real-World Use
The available report does not provide the full breakdown of how many participants reached the systolic target, how treatment was adjusted over time, or the detailed rates for each component of the kidney composite. Shimbo said a substantial portion of participants in the intensive arm may not have achieved a pressure below 120 mm Hg, but the supplied report does not quantify that share.
The kidney signal also needs careful interpretation: it was described as a potential increase in a composite outcome, primarily related to sustained loss of kidney function, while more severe outcomes did not increase. The source does not establish how often that decline persisted after treatment or how it affected patients over a longer period. It also remains unclear whether the trial results will lead to a change in guidelines or how clinicians would identify patients most suited to the lower target.
The diabetes trial’s nonsignificant difference does not prove that intensive treatment has no benefit for people with diabetes. Its result was 6% versus 6.7% with P=0.20; Berwanger pointed to pooled evidence from earlier trials, while commentator Shawna Nesbitt suggested the diabetes study might show a different pattern with longer follow-up. Those comments are interpretations, not additional outcomes established by the trial.
Guidelines and Clinical Implementation
Attention will turn to how professional groups assess the stroke-trial results alongside existing evidence and whether future blood-pressure guidelines recommend a systolic target below 120 mm Hg for some stroke survivors. The supplied report does not identify a timetable for any guideline decision.
Clinicians and researchers will also need to address how to reach a lower target safely and consistently outside a trial, including how to monitor kidney function and respond to treatment-related changes. Shimbo called for practical guidance if the target is recommended. Until that guidance is available, the findings support discussion of intensive treatment with a qualified clinician rather than a blanket instruction for all patients with a history of stroke.
Further follow-up and detailed reporting may clarify the durability of the cardiovascular benefit, the clinical meaning of the kidney-function changes, and how many participants achieved the assigned target. The diabetes findings will also be interpreted with prior trials, as Berwanger said, rather than treated as a standalone verdict on intensive blood-pressure control in that group.
Key Questions
What did the OPTIMAL-STROKE trial find?
Among people with a previous ischemic stroke or TIA, the trial reported major cardiovascular events in 10.9% of participants assigned a systolic blood-pressure target below 120 mm Hg and 13.5% assigned a target below 140 mm Hg. The difference was statistically significant (P=0.007) over roughly four years of median follow-up.
Did intensive treatment increase kidney problems?
The report describes a potential increase in a composite renal outcome, mainly driven by a sustained drop in kidney function. It reported no increase in renal death, end-stage kidney disease, or need for dialysis. The supplied material does not give full rates for the kidney outcomes.
Did the diabetes trial show the same benefit?
No statistically significant difference was found in OPTIMAL-DIABETES: the primary outcome occurred in 6% of the intensive-treatment group and 6.7% of the standard-treatment group (P=0.20). The investigator said that result should also be considered alongside prior trials in a prespecified meta-analysis.
Should stroke survivors target blood pressure below 120 mm Hg now?
The trial tested that target, but the report does not say that guidelines have changed. Treatment decisions should be discussed with a clinician, who can consider the patient’s circumstances, kidney function, and the practical challenges of reaching and monitoring a lower pressure.
Source: medpagetoday.com
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