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Longer-Term All-Cause and Cardiovascular Mortality With Intensive Blood Pressure Control: A Secondary Analysis of a
Byron C Jaeger1, Adam P Bress2,3, Joshua D Bundy4
1Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina.
Insights
Intensive blood pressure control initially reduced mortality in the SPRINT trial. However, this benefit did not persist long-term, emphasizing consistent hypertension management for sustained cardiovascular health.
Area of Science:
- Cardiovascular Medicine
- Hypertension Management
- Clinical Trials
Background:
- The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated that intensive blood pressure control significantly reduced cardiovascular morbidity and mortality.
- The long-term legacy effect of this intensive treatment strategy remained unknown following the trial's conclusion.
Purpose of the Study:
- To evaluate the long-term impact of intensive versus standard blood pressure treatment randomization on cardiovascular and all-cause mortality.
- To assess the persistence of treatment benefits approximately 4.5 years after the SPRINT trial intervention ended.
Main Methods:
- A secondary analysis of the multicenter SPRINT randomized clinical trial involving patients aged 50+ with hypertension and increased cardiovascular risk.
- Participants were randomized to intensive (systolic blood pressure <120 mm Hg) or standard (<140 mm Hg) treatment groups.
- Extended observational follow-up for mortality was conducted via the US National Death Index, with outpatient systolic blood pressure data examined in a subset.
Main Results:
- Intensive treatment initially showed benefits in reducing cardiovascular mortality (HR, 0.66) and all-cause mortality (HR, 0.83) during the intervention period.
- However, at long-term follow-up (median 8.8 years), there was no longer evidence of a significant benefit for cardiovascular mortality (HR, 1.02) or all-cause mortality (HR, 1.08).
- In a subgroup analysis, mean outpatient systolic blood pressure in the intensive treatment group increased over time, reaching 140.4 mm Hg at 10 years post-randomization.
Conclusions:
- The initial cardiovascular and all-cause mortality benefits observed with intensive blood pressure treatment in the SPRINT trial did not persist after the trial concluded.
- Increasing systolic blood pressure levels in the intensive treatment group post-trial underscore the critical need for consistent, long-term hypertension management.
- These findings highlight the importance of sustained adherence to treatment protocols for maintaining cardiovascular health in hypertensive individuals.
Importance:
The Systolic Blood Pressure Intervention Trial (SPRINT) showed that intensive blood pressure control reduced cardiovascular morbidity and mortality. However, the legacy effect of intensive treatment is unknown.
Objective:
To evaluate the long-term effects of randomization to intensive treatment with the incidence of cardiovascular and all-cause mortality approximately 4.5 years after the trial ended.
Design, Setting, And Participants:
In this secondary analysis of a multicenter randomized clinical trial, randomization began on November 8, 2010, the trial intervention ended on August 20, 2015, and trial close-out visits occurred through July 2016. Patients 50 years and older with hypertension and increased cardiovascular risk but without diabetes or history of stroke were included from 102 clinic sites in the US and Puerto Rico. Analyses were conducted between October 2021 and February 2022.
Interventions:
Randomization to systolic blood pressure (SBP) goal of less than 120 mm Hg (intensive treatment group; n = 4678) vs less than 140 mm Hg (standard treatment group; n = 4683).
Main Outcomes And Measures:
Extended observational follow-up for mortality via the US National Death Index from 2016 through 2020. In a subset of 2944 trial participants, outpatient SBP from electronic health records during and after the trial were examined.
Results:
Among 9361 randomized participants, the mean (SD) age was 67.9 (9.4) years, and 3332 (35.6%) were women. Over a median (IQR) intervention period of 3.3 (2.9-3.9) years, intensive treatment was beneficial for both cardiovascular mortality (hazard ratio [HR], 0.66; 95% CI, 0.49-0.89) and all-cause mortality (HR, 0.83; 95% CI, 0.68-1.01). However, at the median (IQR) total follow-up of 8.8 (8.3-9.3) years, there was no longer evidence of benefit for cardiovascular mortality (HR, 1.02; 95% CI, 0.84-1.24) or all-cause mortality (HR, 1.08; 95% CI, 0.94-1.23). In a subgroup of participants, the estimated mean outpatient SBP among participants randomized to intensive treatment increased from 132.8 mm Hg (95% CI, 132.0-133.7) at 5 years to 140.4 mm Hg (95% CI, 137.8-143.0) at 10 years following randomization.
Conclusions And Relevance:
The beneficial effect of intensive treatment on cardiovascular and all-cause mortality did not persist after the trial. Given increasing outpatient SBP levels in participants randomized to intensive treatment following the trial, these results highlight the importance of consistent long-term management of hypertension.
Trial Registration:
ClinicalTrials.gov Identifier: NCT01206062.
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