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Use of advanced statistical techniques to predict all-cause mortality in the Systolic Blood Pressure Intervention
William J Kostis1, Javier Cabrera2, Chun Pang Lin1
1Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, New Brunswick, 08901, NJ, USA.
Insights
Intensive blood pressure lowering in the Systolic Blood Pressure Intervention Trial (SPRINT) reduced mortality. However, using multiple medications increased death risk, and a U-shaped curve linked systolic blood pressure to mortality in the standard treatment group.
Area of Science:
- Cardiovascular Medicine
- Clinical Trials
- Hypertension Research
Background:
- The Systolic Blood Pressure Intervention Trial (SPRINT) investigated intensive (SBP < 120 mm Hg) versus standard (SBP < 140 mm Hg) blood pressure targets in hypertensive patients.
- Analyses focused on a matched cohort with similar gender, age, and baseline systolic blood pressure (SBP) at three months.
Purpose of the Study:
- To examine the impact of medication count on all-cause mortality in SPRINT participants.
- To investigate the relationship between on-treatment systolic blood pressure (SBP) and all-cause mortality, specifically looking for a U-shaped curve.
Main Methods:
- Conditional logistic regression was used to analyze the effect of the number of blood pressure-lowering medications on all-cause mortality.
- Quadratic equations were fitted to assess the U-shaped relationship between SBP and all-cause mortality in different treatment groups.
Main Results:
- Patients receiving more than one blood pressure-lowering medication had a significantly higher risk of all-cause mortality (OR = 1.6552, p = 0.0322).
- A significant U-shaped relationship between SBP and all-cause mortality was observed in the standard treatment group (p < 0.001).
- This U-shaped association was less pronounced in the combined and intensive treatment groups.
Conclusions:
- In matched SPRINT participants, polypharmacy (more than one drug) was associated with increased all-cause mortality.
- A U-shaped curve relationship between SBP and all-cause mortality was identified, particularly in the standard treatment arm.
Background:
The Systolic Blood Pressure Intervention Trial (SPRINT) was conducted in patients with hypertension and additional risk for cardiovascular disease who were randomized to the intensive blood pressure group targeting systolic blood pressure (SBP) less than 120 mm Hg and to the standard group where the target was less than 140 mm Hg. Analyses were done in the matched group of participants with the same gender, same age (±2 years) and same SBP (±3 mm Hg) at three months of treatment regardless of initial randomization to intensive or standard group (shaded area in Figure 1).
Methods And Results:
During 3.26 years of follow-up, intensive group participants had 14.8 mm Hg lower SBP and received on average one more (2.8 vs. 1.8) blood pressure lowering medications. This was associated with lower all-cause mortality in the intensive treatment group (hazard ratio, 0.73; 95% CI, 0.60 to 0.90, p = 0.003). The effect on SBP was achieved at 3 months and remained unchanged thereafter. This paper addresses two questions with respect to all-cause mortality in SPRINT in the matched set. 1) What is the effect of receiving more than one drug on all-cause mortality. Conditional logistic regression for all-cause mortality with respect to number of drugs indicated that during the 3.26 years of follow-up persons who received more than one drug were more likely to die (coefficient = 0.5039, OR = 1.6552, p = 0.0322) than patients who received one drug. 2) Was there a U curve relationship between on treatment SBP and all-cause mortality? A U curve fitting a quadratic equation (parabola) of SBP and all-cause death was observed. This was seen in the patients randomized to the standard target group in unadjusted analyses as well as in analyses adjusted for demographics or all covariates (p < 0.001 for all). The U curves in the combined group and the intensive treatment group were less pronounced.
Conclusion:
SPRINT participants who were matched for gender, age, and SBP at 3 months, and received more than one drug had higher all-cause mortality during the 3.26 years of follow-up. Those who were randomized to standard treatment target had a U curve relationship between SBP at three months and all-cause mortality. The U curves in the combined group and the intensive treatment group were less pronounced.
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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.