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Impact of Cardiovascular Risk on the Relative Benefit and Harm of Intensive Treatment of Hypertension
Robert A Phillips1, Jiaqiong Xu2, Leif E Peterson3
1Department 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.
Insights
Intensive blood pressure treatment in the SPRINT trial offered more benefit than harm for individuals with higher cardiovascular disease (CVD) risk. Lower-risk individuals experienced more harm than benefit from intensive treatment, guiding personalized care decisions.
Area of Science:
- Cardiology
- Clinical Trials
- Public Health
Background:
- The Systolic Blood Pressure Intervention Trial (SPRINT) showed intensive blood pressure treatment reduced primary outcome events but increased serious adverse events (SAEs).
- Current guidelines (2017 ACC/AHA) recommend risk-based blood pressure management.
- Stratifying SPRINT participants by cardiovascular disease (CVD) risk may identify optimal candidates for intensive treatment.
Purpose of the Study:
- To investigate the impact of baseline 10-year CVD risk on primary outcomes and SAEs within the SPRINT trial.
- To determine the benefit-to-harm ratio of intensive blood pressure treatment across different CVD risk strata.
Main Methods:
- Participants were stratified into quartiles based on baseline 10-year CVD risk.
- Cox proportional hazards models analyzed treatment effects on primary outcomes and SAEs.
- Multiplicative Poisson regression developed a predictive model for the benefit-to-harm ratio as a function of CVD risk.
Main Results:
- Intensive treatment consistently lowered primary outcome events across all CVD risk quartiles.
- No significant differences in all-cause SAEs were observed between treatment groups within quartiles.
- The number needed to treat decreased, and the number needed to harm increased with higher CVD risk quartiles.
- Benefit-to-harm ratios significantly increased across CVD risk quartiles, indicating greater net benefit at higher risk levels.
Conclusions:
- Individuals with lower baseline CVD risk experienced more harm than benefit from intensive blood pressure treatment in SPRINT.
- Conversely, those with higher baseline CVD risk derived greater benefit from intensive treatment.
- This risk-stratified analysis can inform clinical decision-making for personalized blood pressure management, aligning with 2017 ACC/AHA guidelines.
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 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).
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.
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