• Robert A Phillips, Jiaqiong Xu, Leif E Peterson, Ryan M Arnold, Joseph A Diamond, and Adam E Schussheim.
• Department of Cardiology, Houston Methodist, Houston, Texas; Center for Outcomes Research, Houston Methodist Research Institute, Houston, Texas; Department of Medicine, Weill Cornell Medical College, New York, New York. Electronic address: RAPhillips@houstonmethodist.org.
• J. Am. Coll. Cardiol. 2018 Apr 17; 71 (15): 1601-1610.

BackgroundThe lower rate of primary outcome events in the intensive treatment group in SPRINT (Systolic Pressure Intervention Trial) was associated with increased clinically significant serious adverse events (SAEs). In 2017, the American College of Cardiology/American Heart Association issued risk-based blood pressure treatment guidelines. The authors hypothesized that stratification of the SPRINT population by degree of future cardiovascular disease (CVD) risk might identify a group which could benefit the most from intensive treatment.ObjectivesThis study investigated the effect of baseline 10-year CVD risk on primary outcome events and all-cause SAEs in SPRINT.MethodsStratifying by quartiles of baseline 10-year CVD risk, Cox proportional hazards models were used to examine the associations of treatment group with the primary outcome events and SAEs. Using multiplicative Poisson regression, a predictive model was developed to determine the benefit-to-harm ratio as a function of CVD risk.ResultsWithin each quartile, there was a lower rate of primary outcome events in the intensive treatment group, with no differences in all-cause SAEs. From the first to fourth quartiles, the number needed to treat to prevent primary outcomes decreased from 91 to 38. The number needed to harm for all-cause SAEs increased from 62 to 250. The predictive model demonstrated significantly increasing benefit-to-harm ratios (± SE) of 0.50 ± 0.15, 0.78 ± 0.26, 2.13 ± 0.73, and 4.80 ± 1.86, for the first, second, third, and fourth quartile, respectively (p for trend <0.001). All possible pairwise comparisons of between-quartile mean values of benefit-to-harm ratios were significantly different (p < 0.001).ConclusionsIn SPRINT, those with lower baseline CVD risk had more harm than benefit from intensive treatment, whereas those with higher risk had more benefit. With the 2017 American College of Cardiology/American Heart Association blood pressure treatment guidelines, this analysis may help providers and patients make decisions regarding the intensity of blood pressure treatment.Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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