TL;DR
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In the OPTIMAL-STROKE trial, people 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 result came with more events in a composite kidney-function measure, mainly a sustained decline in renal function. A separate trial in people with type 2 diabetes did not find a statistically significant benefit on its primary outcome.
A large Brazilian trial found that targeting systolic blood pressure below 120 mm Hg, rather than below 140 mm Hg, reduced major cardiovascular events among people with a previous ischemic stroke or transient ischemic attack. The OPTIMAL-STROKE results, presented at the American Heart Association annual meeting and published in the New England Journal of Medicine, also showed a potential trade-off: more events in a composite kidney-function measure.
During a median follow-up of about four years, the primary cardiovascular outcome occurred in 10.9% of participants assigned to intensive treatment and 13.5% of those assigned to standard treatment. The difference was statistically significant, with P=0.007, according to the report by MedPage Today. The trial’s primary outcome was a composite of major adverse cardiovascular events; the supplied report does not list every component of that outcome.
OPTIMAL-STROKE enrolled 4,368 people with elevated blood pressure and a history of ischemic stroke or TIA. Participants were randomly assigned to a systolic target below 120 mm Hg or below 140 mm Hg. The multicenter, open-label study ran at 30 sites in Brazil. Researchers adjusted treatment after randomization to pursue the assigned target.
The report also describes a separate trial, OPTIMAL-DIABETES, involving people with type 2 diabetes and high cardiovascular risk. Over a similar follow-up period, its primary outcome occurred in 6% of those assigned to intensive treatment and 6.7% of those assigned to standard treatment; the difference was not statistically significant (P=0.20). The two trials therefore do not support treating their findings as interchangeable: the stroke trial showed a significant reduction, while the diabetes trial was neutral on its primary endpoint.
A Lower Target After Stroke
The result bears on a treatment question for people who have already had an ischemic stroke or TIA: whether lowering systolic pressure beyond the standard trial target can further reduce cardiovascular risk. The report says current guidelines recommend a target of 130/80 mm Hg for this population. OPTIMAL-STROKE tested a more intensive systolic target, below 120 mm Hg, and its findings may inform future guideline discussions.
That does not mean every stroke survivor should automatically be treated to the trial target. The kidney-function signal and the practical difficulty of reaching below 120 matter when clinicians weigh potential benefit against risk for an individual. American Heart Association discussant Daichi Shimbo said the trial’s reported risk-benefit estimate suggested that, per 1,000 patients treated intensively for about four years, 26 would benefit and 17 would be harmed. The report describes the potential harm mainly as a creatinine increase, not as more kidney failure or dialysis.
The contrast with OPTIMAL-DIABETES also matters. Its result did not establish a significant benefit from the intensive target on the trial’s primary outcome. Lead investigator Otavio Berwanger said a prespecified meta-analysis combining it with earlier studies found a 16% relative reduction in major cardiovascular events. That pooled finding is separate from the neutral result of OPTIMAL-DIABETES itself and should be understood as evidence across studies, not as a positive primary result in that trial.
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Two Trials, Different Groups
Both studies were conducted in Brazil and examined a systolic blood-pressure target below 120 mm Hg against a target below 140 mm Hg. They addressed different patient groups and reported different results on their respective primary cardiovascular outcomes. The studies were published simultaneously in the New England Journal of Medicine, according to MedPage Today.
Stroke specialists have raised concerns about lowering blood pressure too far in some patients with narrowed arteries, including carotid or middle cerebral artery stenosis, because of possible effects on blood flow to the brain. Cheryl Bushnell of Wake Forest University said the stroke-trial findings eased some of those concerns, while also describing the study as a landmark. Her comments are expert interpretation of the results, not a separate trial finding.
The diabetes result sits alongside earlier trials, including BPROAD in China and ACCORD BP in North America. Berwanger said the combined evidence from those studies and OPTIMAL-DIABETES suggested a possible, more modest cardiovascular reduction for intensive treatment in diabetes. The source report gives no detailed pooled-analysis methods or confidence interval, so the reported 16% relative reduction should not be read as a result from OPTIMAL-DIABETES alone.
“We had one price to pay here that offset the benefits.”
— Otavio Berwanger, MD, PhD, lead investigator, as reported by MedPage Today
Kidney Risks and Real-World Targets
The supplied report does not provide the exact frequency or size of the decline in renal function in OPTIMAL-STROKE, nor does it give the full set of kidney-outcome figures. It says there was no increase in the more serious outcomes of renal mortality, end-stage renal disease, or dialysis. The balance between the cardiovascular benefit and kidney-function changes will still require clinical interpretation.
It is also unclear from the report how many participants in the intensive-treatment group actually reached a systolic pressure below 120 mm Hg, how far blood pressure fell on average, and how consistently participants maintained the target. Shimbo said a substantial portion of the intensive group may not have reached it, but the excerpt does not provide the trial’s exact achieved-pressure data.
The results do not establish that the same target is appropriate for all people with prior stroke or TIA, or that the diabetes trial’s neutral outcome rules out benefit in every high-risk patient with diabetes. The report does not give subgroup estimates, detailed adverse-event counts, or enough information to assess how the results apply to people with particular forms of arterial narrowing or other health conditions.
Guidelines and Clinical Practice
Clinicians and guideline groups will need to assess OPTIMAL-STROKE alongside existing evidence before deciding whether recommendations for blood-pressure targets after stroke should change. No guideline revision or implementation plan is identified in the supplied report. If a target below 120 mm Hg is recommended, Shimbo said practical guidance will be needed because achieving that level may be difficult in routine care.
The next questions for clinicians include how to adjust medications and monitor kidney function while pursuing lower pressure, and which patients are most likely to benefit. The source does not specify a new follow-up schedule or clinical protocol. For now, the reported trial results add evidence for more intensive treatment after ischemic stroke or TIA, while the renal signal, the challenges of reaching the target, and the separate neutral diabetes-trial result remain part of the assessment.
Key Questions
What did OPTIMAL-STROKE find?
Among people with a previous ischemic stroke or TIA, major cardiovascular events occurred in 10.9% of participants assigned to a systolic target below 120 mm Hg and 13.5% assigned to a target below 140 mm Hg over a median follow-up of about four years. The difference was statistically significant (P=0.007).
Did intensive treatment increase kidney problems?
The report describes a potential increase in a composite renal endpoint, mainly driven by a sustained decline in renal function. It says there was no increase in renal mortality, end-stage renal disease, or the need for dialysis. Exact event rates for the kidney outcomes are not provided in the supplied report.
Did the diabetes trial show the same benefit?
No. In OPTIMAL-DIABETES, the primary 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). Berwanger cited a 16% relative reduction in a prespecified meta-analysis combining this trial with earlier studies.
Does the result change current blood-pressure guidance?
The report says current guidelines recommend a target of 130/80 mm Hg for this population, but it does not report a guideline change. The findings may inform future recommendations; whether a target below 120 mm Hg is adopted remains unresolved.
Source: medpagetoday.com
