SPRINT results not driven by reduced HF risk; benefits of intensive BP lowering unchanged
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The benefits of an intensive BP-lowering strategy to less than 120 mm Hg, as assessed in the SPRINT trial, were consistent even with the exclusion of HF-related events, according to data published in Hypertension.
“The major finding of this study is that the main conclusion of SPRINT remains unchanged also when the primary composite endpoint event was redefined to exclude acute exacerbation of heart failure events,” Piotr Sobieraj, MD, PhD, of the department of internal medicine at the Central Teaching Hospital, Medical University of Warsaw in Poland, and colleagues wrote. “Our findings support recently published secondary analyses (with more complete adjudication of outcomes and of posttrial follow-up data) by the SPRINT investigators, where the exclusion of nonfatal heart failure events from the composite primary outcome did not change the benefit of more intensive antihypertensive treatment.”
HF inclusion in SPRINT composite endpoint
As Healio previously reported, a more aggressive target of systolic BP less than 120 mm Hg was associated with lower incidence of death and CV events compared with a target of less than 140 mm Hg.
In final results of the SPRINT trial, recently published in The New England Journal of Medicine, with more than 3 years of follow-up, researchers found that the intensive BP target of less than 120 mm Hg reduced risk for MI, HF and CVD death compared with the target of less than 140 mm Hg.
However, the results of SPRINT faced scrutiny due to the inclusion of HF in the clinical composite endpoint. According to the study, several papers argued that the trial results were mainly driven by reduction in HF events.
The researchers added that participants in the intensive treatment group experienced just 76 fewer incidents of the composite primary endpoint compared with the standard treatment group (243 vs. 319), and that the reduction in HF events was responsible for half of the effect; a finding that may have been confounded by the participants halting diuretic treatment.
To address these concerns, researchers designed the present analysis of SPRINT data with a redefined composite endpoint that included MI, ACS other than MI, stroke and CV death, and excluded any HF events.
After exclusion of HF in composite endpoint
Using the redefined composite endpoint, 461 events were recorded, with fewer occurring in the intensive treatment arm compared with the standard treatment group.
Intensive systolic BP lowering to less than 120 mm Hg was associated with lower risk for the refined composite endpoint events compared with the standard goal of less than 140 mm Hg (4.4% vs. 5.5%; HR = 0.79; 95% CI, 0.66-0.95; P = .012).
Excluding HF deaths, intensive treatment was associated with lower risk for CV-related and all-cause death compared with standard treatment (HR for CV death = 0.52; 95% CI, 0.33-0.81; P = .004; HR for all-cause death = 0.73; 95% CI, 0.59-0.9; P = .004), the researchers wrote.
“Hypertension carries the greatest attributable risk for incident heart failure,” the researchers wrote. “Heart failure prevention and surveillance strategies need to be developed, and further studies are needed to assess antihypertensive treatments and define the optimal target BP for the prevention of incident and recurrent heart failure in hypertensive patients. Thus, acute exacerbation of heart failure should be included in future studies on antihypertensive treatment and should be reported as an individual endpoint event and as part of primary or secondary composite outcomes.”
References:
- Johnson KC, et al. Hypertension. 2018;doi:10.1161/HYPERTENSIONAHA.117.10479.
- Kjeldsen SE, et al. Circ Res. 2018;doi:10.1161/CIRCRESAHA.118.312763.
- SPRINT Research Group, et al. N Engl J Med. 2021;doi:10.1056/NEJMoa1901281.
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