The SPRINT trial was the first to demonstrate the benefit of further reduction in blood pressure, but it included a limited Asian population and excluded patients with diabetes or history of stroke.
Targeting systolic blood pressure below 120 mmHg reduces risk of major vascular adverse events compared to standard treatment in patients with high cardiovascular risk, explained Jing Li, MD, PhD, director of the Department of Preventive Medicine at the National Center for Cardiovascular Diseases in Beijing, China, during a session at the American Heart Association (AHA) Scientific Sessions 2023 in Philadelphia, Pennsylvania. According to Li, the SPRINT trial was the first to demonstrate the benefit of further reduction over the standard treatment of reducing systolic blood pressure to below 140 mmHg.
“Elevated systolic blood pressure is the largest modifiable risk factor for cardiovascular disease,” Li said during the session. “Blood pressure lowering is one of the most effective treatments to prevent risk of cardiovascular disease. Reducing systolic blood pressure to below 140 [mmHg] is well-established and considered as standard treatment.”
However, Li noted that the SPRINT trial included a limited Asian population and excluded patients with diabetes or history of stroke. For this reason, a meta-analysis drew controversial conclusions because of the limitation in methods of the study.
“Currently, the optimal target for systolic blood pressure remains uncertain, especially in an Asian population and in patients with diabetes and a history of stroke,” Li said.
For this reason, Li and her colleagues conducted a randomized controlled trial called ESPRIT that compared the efficacy and safety of an intensive blood pressure lowering strategy (systolic blood pressure target <120 mmHg) to a standard blood pressure lowering strategy (systolic blood pressure target <140 mmHg) in Chinese patients with high cardiovascular risk. The trial included 11,252 participants from 116 sites in China. Participants were randomly assigned to either an intensive treatment arm or a standard treatment arm. Eligible participants were aged 50 years or older with hypertension and increased cardiovascular risk.
“We excluded patients with secondary cause of hypertension and reduced left ventricular ejection fraction and EGFR less than 45, which meant moderately or severely reduced renal function,” Li said. “These characteristics were well-balanced between the 2 arms.”
The average age of participants in the trial was 65 years, and 40% were women and 40% were patients with diabetes, with more than 25% of patients having a history of stroke. During the median follow up of 3.4 years, local physicians adjusted the antihypertensive treatment according to the standard office blood pressure measurement and the set blood pressure target. The primary outcome was the major vascular events, which was a composite of heart attack, stroke, revascularization, hospitalization for heart failure, or cardiovascular death.
“We also compared the components of primary outcome, all-cause death, and a composite of primary outcome or all-cause death. After 2 years of treatment, we can see the 2 arms separated,” Li said. “There were less major vascular events in the intensive treatment arm, indicating 12% lower risk.”
Additionally, the data showed all-cause death was at a 21% lower risk. Further, the reduced risk of individual components of primary outcome were generally consistent, with revascularization also consistent across subgroups.
“We can say that the results were consistent regardless of history of diabetes, stroke, or baseline systolic blood pressure level,” Li said. “Safety concerns of intensive treatment exists because previous trials showed increased risk of hypertension, syncope, and acute kidney injury or acute renal failure. In our trial, the safety of intensive treatment is very good and better than we expected. The incidence of serious adverse events of interest was very low in both arms.”
Li noted that these data showed that in hypertensive participants with high risk of cardiovascular disease and a normal, mildly reduced renal function, intensive blood pressure lowering treatment targeting systolic blood pressure below 120 mmHg for 3 years resulted in a 12% lower incidence of major vascular events, 39% lower cardiovascular mortality, and 21% lower all-cause mortality than the standard treatment.
“When 1000 patients were treated targeting systolic blood pressure below 120 rather than 140 for 3 years, 14 major vascular events and 8 deaths will be further prevented, and 3 people will experience serious adverse events of syncope,” Li said. “The effects of preventing major vascular events were consistent regardless of diabetes status or history of stroke. The study generates new evidence about the benefits and the safety of treatment targeting systolic blood pressure below 120 among a diverse Asian population, which is generally consistent with that of other ethnic [groups].”
Li J. AHA Scientific Sessions 2023 Late-Breaking Science. Presented at: AHA Scientific Sessions 2023; November 11, 2023.