Potential Deaths Averted and Serious Adverse Events Incurred From Adoption of the SPRINT (Systolic Blood Pressure Intervention Trial) Intensive Blood Pressure Regimen in the United States

Abstract Aims The 2018 ESC/ESH guidelines for hypertension recommend differential management of patients who are <65, 65–79, and ≥80 years of age. However, it is unclear whether intensive blood pressure lowering is well-tolerated and modifies risk uniformly across the age spectrum. Methods and results SPRINT randomized 9361 high-risk adults without diabetes and age ≥50 years with systolic blood pressure 130–180 mmHg to either intensive or standard antihypertensive treatment. The primary efficacy endpoint was the composite of acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. The primary safety endpoint was composite serious adverse events. We assessed whether age modified the efficacy and safety of intensive vs. standard blood pressure lowering using Cox proportional-hazards regression and restricted cubic splines. In all, 3805 (41%), 4390 (47%), and 1166 (12%) were <65, 65–79, and ≥80 years. Mean age was similar between the two study groups (intensive group 67.9 ± 9.4 years vs. standard group 67.9 ± 9.5 years; P = 0.94). Median follow-up was 3.3 years. In multivariable models, age was linearly associated with the risk of stroke (P < 0.001) and non-linearly associated with the risk of primary efficacy events, death from cardiovascular causes, death from any cause, heart failure, and serious adverse events (P < 0.001). The safety and efficacy of intensive blood pressure lowering were not modified by age, whether tested continuously or categorically (P > 0.05). Conclusion In SPRINT, the benefits and risks of intensive blood pressure lowering did not differ according to the age categories proposed by the ESC/ESH guidelines for hypertension. Trial Registration SPRINT (Systolic Blood Pressure Intervention Trial); ClinicalTrials.gov Identifier: NCT01206062, https://clinicaltrials.gov/ct2/show/NCT01206062.

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Risk-Based Intensive Blood Pressure Lowering and Prevention of Heart Failure: A SPRINT Post Hoc Analysis

Hypertension ◽

10.1161/hypertensionaha.121.18315 ◽

2021 ◽

Author(s):

Rebecca J. Molsberry ◽

Leah Rethy ◽

Michael C. Wang ◽

Rupal C. Mehta ◽

Donald M. Lloyd-Jones ◽

...

Keyword(s):

Heart Failure ◽

Blood Pressure ◽

Adverse Events ◽

Proportional Hazards ◽

The United States ◽

Cox Proportional Hazards ◽

Risk Category ◽

Serious Adverse Events ◽

Intensive Blood Pressure

The SPRINT (Systolic Blood Pressure Intervention Trial) demonstrated that intensive blood pressure (BP) lowering (target<120 mm Hg) was more effective in preventing heart failure (HF) compared with standard BP goals (target<140 mm Hg). However, intensive BP lowering also led to an increase in serious adverse events. We aimed to identify a subset of the clinical trial population who might derive the greatest benefit from intensive BP lowering for prevention of HF using a previously validated HF risk prediction model. SPRINT participants without prevalent cardiovascular disease were stratified into HF risk tertiles based on predicted HF risk. We performed Kaplan-Meier Survival analysis and multivariable Cox proportional hazards models to test the effect of intensive versus standard BP lowering on incident HF in each tertile of predicted HF risk. A total of 6911 individuals were included and 77 incident HF events occurred over a median follow-up time of 3.3 (interquartile range, 2.9–3.8) years. A reduction in risk of HF was observed among those randomized to intensive BP lowering in each risk tertile but was significant only in the highest HF risk category (risk tertile 1: hazard ratio, 0.86 [95% CI, 0.29–2.56]; risk tertile 2: 0.54 [0.23–1.30]; risk tertile 3: 0.46 [0.24–0.88]). Serious adverse events were frequent in all groups. While the short follow-up may lead to an underestimation of benefit in the lower predicted risk groups, prioritizing intensive BP lowering in those at highest predicted HF risk may help to reduce the high burden of HF in the United States.

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Abstract P2054: Experiencing the Primary Composite Cardiovascular Outcome is More Strongly Associated With Serious Adverse Events Than Intensive Treatment in the Systolic Blood Pressure Intervention Trial

Hypertension ◽

10.1161/hyp.74.suppl_1.p2054 ◽

2019 ◽

Vol 74 (Suppl_1) ◽

Author(s):

Albert Botchway ◽

Michael G Buhnerkempe ◽

Vivek Prakash ◽

Mohammad Al-Akchar ◽

Oritsegbubemi Adekola ◽

...

Keyword(s):

Blood Pressure ◽

Adverse Events ◽

Systolic Blood Pressure ◽

Intensive Treatment ◽

Cardiovascular Outcome ◽

Intervention Trial ◽

Serious Adverse Events

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Intensive antihypertensive treatment and serious adverse events in older people

Drug and Therapeutics Bulletin ◽

10.1136/dtb.2018.12.000046 ◽

2018 ◽

Vol 56 (12) ◽

pp. 143-143

Keyword(s):

Blood Pressure ◽

Adverse Events ◽

Older People ◽

Systolic Blood Pressure ◽

Antihypertensive Treatment ◽

Intervention Trial ◽

Serious Adverse Events ◽

Treatment Of Hypertension

Review of: Sink KM, et al. Syncope, hypotension and falls in the treatment of hypertension: results from the randomized clinical systolic blood pressure intervention trial. J Am Ger Soc 2018;66:679–86.

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