TL;DR
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In the Brazilian OPTIMAL-STROKE trial, targeting systolic blood pressure below 120 mm Hg was associated with fewer major cardiovascular events than targeting below 140 mm Hg among people with a prior ischemic stroke or TIA. The trial also found more events in a composite renal outcome, mainly sustained declines in kidney function; a separate diabetes trial did not show a statistically significant benefit on its primary outcome.
A Brazilian clinical trial found that adults with a previous ischemic stroke or transient ischemic attack had fewer major cardiovascular events when treatment targeted systolic blood pressure below 120 mm Hg rather than below 140 mm Hg. The OPTIMAL-STROKE results, presented at the American Heart Association annual meeting and published in the New England Journal of Medicine, also showed an increase in a composite kidney outcome, primarily reflecting sustained declines in kidney function.
Over a median follow-up of roughly four years, major adverse cardiovascular events occurred in 10.9% of participants assigned to the intensive target and 13.5% of those assigned to standard treatment, a statistically significant difference (P=0.007), according to the trial report. The primary outcome was a composite of cardiovascular events; the source material does not provide a breakdown of each component in this summary.
OPTIMAL-STROKE was a multicenter, open-label trial conducted at 30 sites in Brazil. Researchers randomly assigned 4,368 people with elevated blood pressure and a history of ischemic stroke or TIA in equal groups to targets below 120 mm Hg or below 140 mm Hg. Clinicians adjusted treatment after randomization. The available report does not give further details here on medication regimens or the degree to which participants reached their assigned targets.
The separate OPTIMAL-DIABETES trial studied people with type 2 diabetes and high cardiovascular risk. Over a similar period, its primary composite outcome occurred in 6% of participants assigned to intensive treatment and 6.7% assigned to standard treatment; the difference was not statistically significant (P=0.20). The two studies therefore do not establish the same result across these different patient groups.
A Lower Target After Stroke
The findings bear on a practical treatment question: whether clinicians should aim for a systolic reading below 120 mm Hg in 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 stroke specialist Cheryl Bushnell, who discussed the results. The trial offers evidence that a more intensive systolic target may reduce cardiovascular events, but it does not by itself settle how broadly the approach should be adopted.
That decision involves weighing fewer cardiovascular events against the renal signal. Trial presenter Otavio Berwanger said the composite kidney outcome was driven mainly by sustained decreases in kidney function, which he described as likely reflecting a hemodynamic effect. He reported no increase in the more serious outcomes of renal death, end-stage renal disease, or dialysis. Those distinctions matter, but clinicians and patients will still need to consider kidney function and the feasibility of close blood-pressure management.
Implementation may be difficult outside a trial. AHA discussant Daichi Shimbo said a substantial portion of participants in the intensive arm did not reach a systolic pressure below 120 mm Hg, and he cautioned that achieving the target may be harder in routine care. A treatment target is useful only if clinicians have practical guidance for reaching it and monitoring possible harms.
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Two Trials, Different Populations
The results came from two trials conducted in Brazil and reported at the same AHA meeting. Both compared an intensive systolic target below 120 mm Hg with a standard target below 140 mm Hg, over roughly four years. Their populations and outcomes differ: OPTIMAL-STROKE enrolled people with prior ischemic stroke or TIA, while OPTIMAL-DIABETES enrolled people with type 2 diabetes and high cardiovascular risk.
Berwanger called the diabetes study a neutral trial when considered on its own. He also pointed to a prespecified meta-analysis combining its findings with earlier trials, including BPROAD in China and ACCORD BP in North America. According to Berwanger, that combined analysis found a 16% relative reduction in major cardiovascular events. That estimate comes from the pooled evidence, not from OPTIMAL-DIABETES alone, and should not be confused with the individual trial’s statistically nonsignificant result.
Commentator Shawna Nesbitt noted that women made up 62% of OPTIMAL-DIABETES and said earlier trials had found less significant blood-pressure reductions among women than men. She suggested longer follow-up might produce a different result, while also interpreting the study as supporting rather than refuting earlier evidence. These are her views on the findings, not results established by the trial’s primary comparison.
“We had one price to pay here that offset the benefits.”
— Otavio Berwanger, MD, PhD, trial presenter
Kidney Risks and Real-World Targets
The report does not provide the exact rates or size of the difference in the composite renal outcome, nor does the supplied summary specify how kidney effects varied across patient subgroups. It says the increase was primarily driven by a sustained decline in renal function, with no increase reported in renal mortality, end-stage renal disease, or dialysis. The clinical meaning and longer-term course of those kidney-function changes remain important questions.
It is also unclear how many people could safely and consistently reach a systolic pressure below 120 mm Hg in everyday care. Shimbo said many participants in the intensive group did not achieve that level, but the provided report does not give the proportion. The stroke trial’s result applies to the population it studied; it does not establish that the same target has the same balance of benefits and risks for all people with high blood pressure or for the diabetes population.
The diabetes trial did not show a statistically significant reduction in its primary outcome, but that does not prove that intensive treatment has no effect. Berwanger cited a pooled analysis suggesting a reduction across several trials. The size and relevance of that combined effect, and how it should guide individual care, remain matters for clinical guidance and further interpretation.
Guidelines and Clinical Implementation
The results are likely to inform discussions about future blood-pressure recommendations, particularly for people with prior ischemic stroke or TIA. Bushnell said guidelines currently recommend 130/80 mm Hg for this group and that OPTIMAL-STROKE suggests a target below 120 mm Hg may improve outcomes. The trial findings do not themselves change existing guidelines.
As Shimbo argued, any future recommendation for a target below 120 mm Hg would need to address how clinicians can reach it in routine practice. That includes explaining how to adjust treatment and monitor patients, especially for changes in kidney function. The supplied report does not specify when guideline bodies will review the evidence or whether they will adopt a lower target.
For now, the central development is the trial’s reported reduction in cardiovascular events among stroke survivors, balanced against a kidney-function signal and practical questions about target attainment. The separate diabetes results remain statistically neutral on their own primary outcome, with interpretation affected by evidence from other trials. Further guideline review and detailed examination of the published results will shape how these findings are applied.
Key Questions
What did OPTIMAL-STROKE find?
Among 4,368 people with elevated blood pressure and a previous ischemic stroke or TIA, the trial found major cardiovascular events in 10.9% of those assigned a systolic target below 120 mm Hg, compared with 13.5% assigned a target below 140 mm Hg over a median follow-up of roughly four years. The difference was statistically significant.
Did intensive treatment affect kidney outcomes?
The report describes an increase in a composite renal outcome, mainly due to sustained declines in kidney function. It reports no increase in renal death, end-stage renal disease, or need for dialysis. The supplied summary does not give the exact rates for the composite outcome.
Did the diabetes trial show the same benefit?
No statistically significant difference was found in OPTIMAL-DIABETES: its primary outcome occurred in 6% of the intensive-treatment group and 6.7% of the standard-treatment group (P=0.20). The trial presenter also cited a prespecified meta-analysis of this and earlier trials that found a 16% relative reduction, a pooled result rather than a finding from this trial alone.
Does this change blood-pressure guidelines now?
The report says current guidance for the stroke population recommends a target of 130/80 mm Hg. The trial may inform future guideline discussions, but the supplied material does not report a guideline change or a date for one.
Source: medpagetoday.com
