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In the Brazilian OPTIMAL-STROKE trial, a systolic blood pressure target below 120 mm Hg was associated with fewer major cardiovascular events than a target below 140 mm Hg among people with a previous ischemic stroke or transient ischemic attack. The trial also recorded more composite renal events, mainly sustained declines in kidney function; researchers reported no increase in kidney failure, renal death or dialysis. A separate trial in people with type 2 diabetes did not show a statistically significant benefit on its primary outcome.
A Brazilian trial found that treating people with a previous ischemic stroke or transient ischemic attack to a systolic blood pressure target below 120 mm Hg reduced major cardiovascular events compared with a target below 140 mm Hg over roughly four years. The result, from the OPTIMAL-STROKE trial, came with a higher rate of a composite kidney outcome, making the balance of cardiovascular benefit and kidney monitoring relevant to decisions about care.
OPTIMAL-STROKE randomly assigned 4,368 participants with elevated blood pressure and a history of ischemic stroke or TIA to intensive treatment targeting systolic pressure below 120 mm Hg or standard treatment targeting below 140 mm Hg. The multicenter, open-label trial took place at 30 sites in Brazil. Over a median follow-up of about four years, the primary cardiovascular outcome occurred in 10.9% of the intensive-treatment group and 13.5% of the standard-treatment group; the reported difference was statistically significant (P=0.007).
Researchers also reported a possible cost to intensive treatment: more events in a composite renal outcome, largely driven by a sustained decline in kidney function. The report said there was no increase in the more serious outcomes of renal death, end-stage kidney disease or need for dialysis. The source did not provide the renal event rates in the supplied account, so the size of that difference cannot be stated here.
A second study, OPTIMAL-DIABETES, examined people with type 2 diabetes and high cardiovascular risk using the same systolic targets. Its primary composite outcome occurred in 6% of the intensive-treatment group and 6.7% of the standard-treatment group, a difference that was not statistically significant (P=0.20). The outcomes included cardiovascular death, nonfatal heart attack or stroke, and hospitalization for unstable angina or heart failure. The two trials were published simultaneously in the New England Journal of Medicine, according to the report.
A Lower Target After Stroke
The stroke result could affect how clinicians weigh blood pressure goals for people at elevated risk of another cardiovascular event. Current guidelines recommend a target of 130/80 mm Hg for this population, according to Cheryl Bushnell, a neurologist quoted in the report. OPTIMAL-STROKE tested a more intensive systolic target and found fewer major cardiovascular events, but the findings do not by themselves establish that every stroke survivor should be treated to below 120 mm Hg.
The kidney finding also matters when applying the result. Otavio Berwanger said the excess in the composite renal measure appeared to be driven mainly by a sustained drop in kidney function, which he described as likely hemodynamic. That interpretation is the researcher’s, not proof that every such decline is harmless. A clinician would need to weigh a patient’s cardiovascular risk, kidney function, treatment tolerance and ability to reach the target.
The diabetes trial’s neutral primary result is a reminder that the findings are not uniform across groups. Berwanger said a prespecified meta-analysis combining that trial with earlier studies, including BPROAD and ACCORD BP, showed a 16% relative reduction in major cardiovascular events. That pooled result is separate from OPTIMAL-DIABETES’s own primary outcome and should not be presented as a benefit demonstrated by that trial alone.
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Two Trials, Different Groups
Both studies tested whether more intensive blood pressure treatment could improve cardiovascular outcomes compared with a systolic target below 140 mm Hg. Their results differed by patient population: OPTIMAL-STROKE enrolled people with prior ischemic stroke or TIA, while OPTIMAL-DIABETES enrolled people with type 2 diabetes and high cardiovascular risk. The reported follow-up was similar, at roughly four years.
Bushnell called the stroke study a landmark trial and said it could ease concern among clinicians about lowering blood pressure in patients who may have narrowed arteries supplying the brain. She also said blood pressure management after stroke can be difficult and requires a clinician to take responsibility for follow-up. These are expert comments on the trial’s implications, not additional trial outcomes.
At the meeting, discussant Daichi Shimbo cautioned that many participants assigned to intensive treatment did not reach a systolic pressure below 120 mm Hg, according to the report. He said achieving the target may be harder in routine care than in a clinical trial. The supplied source does not give the proportion who reached the target, details of treatment regimens or a complete breakdown of results across participant subgroups.
“We had one price to pay here that offset the benefits.”
— Otavio Berwanger, MD, PhD, presenting investigator
Kidney Risks and Real-World Targets
The supplied report does not give the absolute rates for the composite renal outcome, the exact size of the kidney-function changes or how long they persisted. It says more serious renal outcomes did not rise, but clinicians and patients still need details to judge the practical significance of the less severe events. The source also does not specify what monitoring schedule or medication approach would be needed to pursue the lower target safely.
It remains unclear whether a future guideline will recommend a systolic target below 120 mm Hg after stroke, and for which patients. Shimbo said a guideline adopting that goal should explain how clinicians can reach it in practice. The trial’s findings also do not settle whether benefits or harms differ by age, sex, stroke characteristics or baseline kidney health; those details are not provided in the supplied material.
For OPTIMAL-DIABETES, the primary outcome difference was not statistically significant. Berwanger’s reference to a 16% relative reduction came from a prespecified analysis that combined the trial with earlier research. A pooled estimate may inform the broader evidence, but it does not change the individual trial’s neutral primary result.
Guidelines and Clinical Follow-Up
Clinicians and guideline groups will need to consider the stroke trial alongside existing recommendations, kidney outcomes and the difficulty of reaching a systolic pressure below 120 in ordinary care. If future guidance endorses that target, Shimbo said it should provide practical instructions for implementation. The source does not report a timetable for guideline changes or a specific next trial.
For now, the findings support a discussion between patients and their care teams rather than an automatic change to treatment for every stroke survivor. Follow-up should account for blood pressure readings, medication tolerance and kidney function. Further reporting on detailed trial results, including the renal event rates and how many participants reached their assigned targets, would help clarify how readily the findings can be applied in routine practice.
Key Questions
What did OPTIMAL-STROKE find?
Among people with a previous ischemic stroke or TIA, a systolic target below 120 mm Hg was associated with fewer major cardiovascular events than a target below 140 mm Hg: 10.9% versus 13.5% over roughly four years. The reported difference was statistically significant.
Did intensive treatment affect kidney outcomes?
The trial reported more events in a composite renal outcome, mainly due to sustained declines in kidney function. The report said renal death, end-stage kidney disease and dialysis did not increase, but the supplied account does not provide the absolute rates for the composite outcome.
Does the result mean every stroke survivor should target below 120?
No. The trial tested that target in a defined group, but the findings do not establish that it is right for every person after stroke. Treatment decisions should account for individual cardiovascular and kidney risks, tolerance and clinical guidance.
What did the diabetes trial show?
OPTIMAL-DIABETES did not find a statistically significant difference in its primary cardiovascular outcome: 6% with intensive treatment versus 6.7% with standard treatment (P=0.20). A separate prespecified meta-analysis combining this study with earlier trials reported a 16% relative reduction, according to Berwanger.
Source: medpagetoday.com
