SPRINT Analysis Supports Intensive Blood Pressure Goal for Further Reducing Cardiovascular Risk

Cora Lewis, MD

New data from the SPRINT trial provides evidence further supporting use of a more intensive blood pressure goal in patients with hypertension.

Results of the most recent analysis of SPRINT data indicate targeting a systolic blood pressure less than 120 mmHg was associated with significant reductions in risk of myocardial infarction, acute coronary syndromes, and stroke, as well as cardiovascular and all-cause mortality when compared to a standard treatment target of less than 140 mmHg.

"One criticism of the original SPRINT findings was that, of the components of the primary outcome, only heart failure and death due to CVD were significantly lower in the intensively treated group," Cora Lewis, MD, Professor and Chair of the Department of Epidemiology in the University of Alabama at Birmingham School of Public Health, in a statement. "The final results found that risk of heart attack, along with heart failure, and death from CVD, was significantly lower in the group treated to less than 120, and the risk of the primary outcome excluding heart failure was still significantly lower in the more intensively treated group."

Funded in part by the National Institutes of Health, the Systolic Blood Pressure Intervention Trial (SPRINT) was conducted between November 2010 and 2015 and enrolled more than 9000 patients with elevated systolic blood pressure to a blood pressure target of less than 140 mmHg or less than 120 mmHg. The trial was halted by the Data and Safety Monitoring Board due to apparent benefit seen with the intensive blood pressure on risk of the study’s composite endpoint, which was a composite outcome made up of myocardial infarction, other acute coronary syndromes, stroke, acute decompensated heart failure, or death from cardiovascular causes. The current analysis of SPRINT details the incidence of efficacy and safety events occurring in the post-trial observational follow-up occurring from August 20, 2015 through July 29, 2016.

Briefly, the original trial enrolled and randomized 9361 patients in a 1:1 ratio to either of the aforementioned blood pressure targets. Patients included in the study were required to be at least 50 years of age, have a systolic blood pressure of 130-180 mmHg, and at least one clinical indicator of cardiovascular risk. Participants were excluded based on presence of diabetes mellitus, history of stroke, or presence of dementia. Upon conclusion, results indicated the intensive blood pressure goal was associated with a 25% decrease in the primary composite endpoint and a 27% decrease in all-cause mortality compared to the standard target.

For the most recent analysis, which had a median follow-up of 3.3 years, suggested the intensive blood pressure goal was associated with a 27% reduction in risk of the primary composite outcome (1.77% vs 2.40%; [HR, 0.73; 95% CI, 0.63-0.86; P=.001)]) and a 25% reduction in risk of all-cause mortality (1.06% vs 1.41%; [HR, 0.75; 95% CI, 0.61-0.92; P=.006]). Investigators pointed out no significant differences were observed in the composite renal outcome among those with chronic kidney disease at baseline.

When assessing incidence of adverse events, investigators noted rates of serious adverse events did not differ significantly between the study groups. However, investigators did note incidence of hypotension, electrolyte abnormalities, acute kidney injury or failure, and syncope were greater among those with a more intensive blood pressure goal.

"We know a lot about how to prevent and treat hypertension and SPRINT continues to greatly expand this knowledge, including the benefits of treatment on the heart, kidney and brain," said David Goff, MD, PhD, director of the Division of Cardiovascular Sciences at NHLBI. "As we implement what we know, more research is still needed to develop more effective prevention strategies for hypertension, improve its monitoring and control, and reduce the large health disparities associated with this disorder. Research teams supported by the NIH are continuing to work on these challenges."

This study, “Final Report of a Trial of Intensive versus Standard Blood-Pressure Control,” was published in the New England Journal of Medicine.