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Patient Selection for Intensive Blood Pressure Management Based on Benefit and Adverse Events
Adam P Bress1, Tom Greene1, Catherine G Derington1
1Department of Population Health Sciences, University of Utah, Salt Lake City, Utah, USA.
Insights
Intensive systolic blood pressure treatment offers significant cardiovascular benefits, particularly for high-risk individuals. However, greater benefits often correlate with increased risk of adverse events, necessitating careful patient selection.
Area of Science:
- Cardiology
- Preventive Medicine
- Clinical Trials
Background:
- Intensive systolic blood pressure (SBP) treatment is known to prevent cardiovascular disease (CVD) events in high-risk patients.
- Individual patient benefits from intensive SBP treatment can vary significantly.
Purpose of the Study:
- To predict the magnitude of benefit (reduced CVD and all-cause mortality risk) from intensive versus standard SBP treatment.
- To predict the risk of adverse events (AEs) associated with intensive SBP treatment.
Main Methods:
- Secondary analysis of the Systolic Blood Pressure Intervention Trial (SPRINT).
- Used modified elastic net Cox regression with 36 baseline variables to predict absolute risk for CVD composite, all-cause mortality, and treatment-related AEs.
- Assessed outcomes including CVD composite events, all-cause mortality, and specific AEs like hypotension and syncope.
Main Results:
- Higher baseline CVD risk was associated with greater absolute benefit from intensive SBP treatment.
- Predicted CVD benefit and predicted treatment-related AE risk were negatively correlated (Spearman correlation = -0.72).
- Most participants with high predicted benefit also had moderate to high predicted AE risk; few had high benefit with low AE risk.
Conclusions:
- Patients with higher predicted CVD risk gain the most absolute benefit from intensive SBP treatment.
- While intensive treatment increases AE risk, these events are generally mild and transient.
- Prioritizing patients for intensive SBP treatment based on predicted benefit is recommended.
Background:
Intensive systolic blood pressure (SBP) treatment prevents cardiovascular disease (CVD) events in patients with high CVD risk on average, though benefits likely vary among patients.
Objectives:
The aim of this study was to predict the magnitude of benefit (reduced CVD and all-cause mortality risk) along with adverse event (AE) risk from intensive versus standard SBP treatment.
Methods:
This was a secondary analysis of SPRINT (Systolic Blood Pressure Intervention Trial). Separate benefit outcomes were the first occurrence of: 1) a CVD composite of acute myocardial infarction or other acute coronary syndrome, stroke, heart failure, or CVD death; and 2) all-cause mortality. Treatment-related AEs of interest included hypotension, syncope, bradycardia, electrolyte abnormalities, injurious falls, and acute kidney injury. Modified elastic net Cox regression was used to predict absolute risk for each outcome and absolute risk differences on the basis of 36 baseline variables available at the point of care with intensive versus standard treatment.
Results:
Among 8,828 SPRINT participants (mean age 67.9 years, 35% women), 600 CVD composite events, 363 all-cause deaths, and 481 treatment-related AEs occurred over a median follow-up period of 3.26 years. Individual participant risks were predicted for the CVD composite (C index = 0.71), all-cause mortality (C index = 0.75), and treatment-related AEs (C index = 0.69). Higher baseline CVD risk was associated with greater benefit (i.e., larger absolute CVD risk reduction). Predicted CVD benefit and predicted increased treatment-related AE risk were correlated (Spearman correlation coefficient = -0.72), and 95% of participants who fell into the highest tertile of predicted benefit also had high or moderate predicted increases in treatment-related AE risk. Few were predicted as high benefit with low AE risk (1.8%) or low benefit with high AE risk (1.5%). Similar results were obtained for all-cause mortality.
Conclusions:
SPRINT participants with higher baseline predicted CVD risk gained greater absolute benefit from intensive treatment. Participants with high predicted benefit were also most likely to experience treatment-related AEs, but AEs were generally mild and transient. Patients should be prioritized for intensive SBP treatment on the basis of higher predicted benefit. (Systolic Blood Pressure Intervention Trial [SPRINT]; NCT01206062).
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Monitoring Both Arms:
Monitoring BP in both arms during the initial assessment is advisable, as the systolic value may differ by five to ten mm Hg between arms. For subsequent BP assessments, use the arm with the higher reading.