Author + information
- Received November 20, 2017
- Revision received January 29, 2018
- Accepted January 30, 2018
- Published online April 9, 2018.
- Robert A. Phillips, MD, PhDa,b,c,∗ (, )
- Jiaqiong Xu, PhDb,c,
- Leif E. Peterson, PhD, MPHb,d,
- Ryan M. Arnold, MPHe,
- Joseph A. Diamond, MDf and
- Adam E. Schussheim, MDg
- aDepartment of Cardiology, Houston Methodist, Houston, Texas
- bCenter for Outcomes Research, Houston Methodist Research Institute, Houston, Texas
- cDepartment of Medicine, Weill Cornell Medical College, New York, New York
- dDepartment of Healthcare Policy & Research, Weill Cornell Medical College, New York, New York
- eHouston Methodist, Houston, Texas
- fDepartment of Cardiology, Hofstra Northwell School of Medicine, Hempstead, New York
- gCardiac Specialists, Northeast Medical Group, Bridgeport Hospital, Yale-New Haven Health System, Bridgeport, Connecticut
- ↵∗Address for correspondence:
Dr. Robert A. Phillips, Houston Methodist Hospital, 6565 Fannin Street, Dunn 200, Houston, Texas 77030-2707.
Background The 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.
Objectives This study investigated the effect of baseline 10-year CVD risk on primary outcome events and all-cause SAEs in SPRINT.
Methods Stratifying 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.
Results Within each quartile, there was a lower rate of primary outcome events and no significant differences in all-cause SAEs for the intensive treatment group compared to the standard treatment group. 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).
Conclusions In 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.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 20, 2017.
- Revision received January 29, 2018.
- Accepted January 30, 2018.
- 2018 American College of Cardiology Foundation
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