Intensive lowering of blood pressure to a systolic target < 120 mm Hg reduced cardiovascular events among individuals at high-risk for cardiovascular disease compared with standard treatment using a target < 140 mm Hg in the ESPRIT trial.
“Intensive blood pressure lowering treatment targeting a systolic pressure below 120 mm Hg for 3 years resulted in a 12% lower incidence of major vascular events, a 39% lower cardiovascular mortality, and 21% lower all-cause mortality than the standard treatment targeting a systolic pressure below 140 mm Hg,” reported lead investigator, Jing Li, MD, director of the department of preventive medicine at the National Center for Cardiovascular Diseases in Beijing, China.
The trial included patients with diabetes and those with a history of stroke, two important groups that were excluded in the previous SPRINT trial of intensive blood pressure lowering. Results suggested that the benefit of intensive blood pressure lowering extends to these groups.
The results translate into the prevention of 14 major vascular events and eight deaths for every 1000 individuals are treated for 3 years to a target systolic pressure < 120 mm Hg rather than < 140 mm Hg, at the cost of an additional three patients experiencing the serious adverse event of syncope, Li said.
“Our study generates new evidence about benefit and safety of treatment targeting systolic blood pressure below 120 mm Hg among a diverse Asian population, which is generally consistent with those from other ethnicities. Implementing this intensive treatment strategy for high-risk adults has the potential to save more lives and reduce the public health burden of heart disease worldwide,” she concluded.
Ling presented the ESPRIT trial on November 13 at the recent American Heart Association (AHA) Scientific Sessions 2023, held in Philadelphia.
The ESPRIT trial included 11,255 Chinese adults (average age, 64 years; 41% women) who had a baseline systolic blood pressure measurement of 130-180 mm Hg (average was 147\83 mm Hg) and either established cardiovascular disease or at least two major risk factors for cardiovascular disease. Of those enrolled, 39% had diabetes, and 27% had a history of stroke.
They were randomly assigned to receive intensive blood pressure treatment, with a systolic blood pressure target < 120 mm Hg, or standard treatment, with a target measurement < 140 mm Hg, over a 3-year period. After 1 year, systolic pressure was lowered to 135.6 mm Hg in the standard care group and to 120.3 mm Hg in the intensive treatment group, with values remaining at around the same level for the remainder of the follow-up.
The primary outcome was a composite of myocardial infarction (MI), coronary or noncoronary revascularization, hospitalization/emergency room visit for heart failure, stroke, or cardiovascular death.
After 3.4 years of follow-up, 624 primary outcome events had occurred in the standard arm (3.6%) vs 547 events in intensive arm (3.2%), a reduction of 12% (hazard ratio [HR], 0.88; 95% CI, 0.78-0.99). This gives a number needed to treat to prevent one event of 74.
Cardiovascular death occurred in 0.5% of the standard group vs 0.3% of the intensive group (HR 0.61; 95% CI, 0.44-0.84); and all-cause death occurred in 1.1% of the standard group vs 0.9% of the intensive group (HR, 0.79; 95% CI, 0.64-0.97).
The individual endpoints of MI, stroke, and heart failure showed positive trends to a reduction with intensive blood pressure lowering, but these did not reach statistical significance.
In terms of serious adverse events, syncope was increased in the intensive group (0.4% vs 0.1%), but there were no significant differences in hypotension, electrolyte abnormality, falls resulting in an injury, acute kidney injury, or renal failure.
Should 120 mm Hg Be New Target?
Commenting on the study for theheart.org | Medscape Cardiology, Paul Whelton, MD, chair in Global Public Health at Tulane University School of Medicine, New Orleans, said that the results were consistent with several other trials.
“When we look at meta-analysis of trials of different levels of blood pressure reduction, all the studies show the same thing – the lower the blood pressure, the better the outcome, with those starting at higher levels gaining the greatest the benefit of blood pressure reductions,” he noted.
“There are four trials that have looked at systolic targets of less than 120 mm Hg vs less than 140 mm Hg (SPRINT, ACCORD BP, RESPECT, and now ESPRIT), and when analyzed properly, they all show a similar benefit for cardiovascular outcomes with the lower 120 target,” Whelton, who led the SPRINT trial, said.
“ESPRIT is a nicely done trial. It is reassuring because it is consistent with the other trials, in that it seems that the benefits are much greater than the risk of adverse effects,” he added.
Whelton pointed out that there are three more trials to come looking at this question, two in Brazil (one in individuals with diabetes and one in stroke survivors) and another trial in China in people with diabetes. “So, we will get more information from these.”
He said that guidelines committees will have to consider a lower systolic blood pressure of 120 mm Hg as the optimal treatment target. In the United States, at present, the target is 130 mm Hg.
The current US guidelines were based on the SPRINT trial, which showed a reduction in cardiovascular events in patients treated to a systolic target of 120 mm Hg vs 140 mm Hg.
Whelton, who was chair of the 2017 American College of Cardiology/American Heart Association hypertension guidelines committee, explained that at the time the guidelines were written there was only one trial, SPRINT, to base the evidence on.
“The committee could all comfortably agree on the 130 mm Hg target, but it was felt that there wasn’t enough evidence at the time to make a recommendation for 120 mm Hg,” he said. “But now we have four trials.”
He said that the trials included patients with high risk for cardiovascular disease, but they all brought some differences to the table, with ACCORD BP conducted in patients with diabetes; SPRINT having enrichment with African American patients, older adults, and patients with kidney disease; RESPECT was in stroke survivors; and ESPRIT had a mix of Chinese patients.
“I think we’ve got a nice mix of different participants and they’re all showing the same signal – that 120 mm Hg is better,” Whelton said.
But he stressed that although there is now good evidence in favor of lower blood pressure targets, these findings were not being implemented in clinical practice.
“We are doing very badly in terms of implementation. There is a big gap between science and what’s happening in the real world.”
Whelton pointed out that only 30% of patients in high-income countries are controlled to the 140/90 target and that in low- and middle-income countries, only 8.8% get to that level, never mind lower targets. “The next job is to work on implementing these findings,” he said.
He noted that several studies have shown better results in this regard using a team approach, with nonphysicians playing a major role in following up with patients.
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