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

Hypertension ◽  
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.

P57262018 ESC/ESH guideline-recommended age categories and intensive blood pressure management in high-risk adults: insights from SPRINT

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Pareek ◽  
T Biering-Sorensen ◽  
M Vaduganathan ◽  
C Byrne ◽  
A Qamar ◽  
...  
Keyword(s):  
Heart Failure ◽  
Blood Pressure ◽  
European Society ◽  
Proportional Hazards ◽  
Controlled Trial ◽  
Cox Proportional Hazards ◽  
Standard Group ◽  
Primary Efficacy ◽  
Serious Adverse Events ◽  
Similar Treatment

Abstract Background The 2018 European Society of Cardiology/European Society of Hypertension (ESC/ESH) guidelines for arterial hypertension propose different intensities of blood pressure (BP) lowering in patients <65 years, 65–79 years, and ≥80 years of age. However, it is unclear whether intensive BP management is well-tolerated and modifies risk uniformly across this age spectrum. Purpose To assess the relationship between age, treatment response to intensive BP lowering, and cardiovascular (CV) outcomes. Methods SPRINT was a randomized, controlled trial in which 9,361 individuals ≥50 years of age, at high CV risk but without diabetes who had a systolic BP (SBP) 130–180 mmHg, were randomized to intensive (target SBP <120mmHg) or standard antihypertensive treatment (target SBP <140mmHg). The primary efficacy endpoint was the composite of acute coronary syndromes, stroke, heart failure, or death from CV causes. The primary safety endpoint was the composite of serious adverse events (SAE). We examined the prognostic implications of age, using Cox proportional-hazards regression models adjusted for demographic, clinical, and laboratory variables. Whether a linear association was present between age and clinical endpoints was evaluated using restricted cubic splines. We further explored the effects of intensive BP lowering across the age spectrum using interaction analyses. Results Age was noted for all individuals, and 3,805 (41%), 4,390 (47%), and 1,166 (12%) were <65 years, 65–79 years, and ≥80 years, respectively. Mean age was similar between the two study groups (intensive group 67.9 years vs. standard group 67.9 years; P=0.94). Median follow-up was 3.3 years (range 0–4.8), with 562 primary efficacy events (6%) and 3,529 primary safety events (38%) recorded during the study period. Age was linearly associated with the risk of stroke (test for overall trend, P<0.001) and non-linearly associated with the risk of primary efficacy events, death from CV causes, death from any cause, heart failure, and SAE (test for non-linearity, P<0.05; test for overall trend, P<0.001). Age remained significantly associated with all tested endpoints after multivariable adjustment (P<0.001). Furthermore, the risk of primary events increased over guideline-recommended age-categories (65–79 years vs. <65 years; adj. HR 1.65, 95% CI 1.34–2.04; P<0.001 and ≥80 years vs. 65–79 years; adj. HR 1.92, 95% CI 1.54–2.40; P<0.001), as did the risk of SAE (P<0.001). The safety and efficacy of intensive BP lowering was not modified by age whether tested continuously or categorically (P>0.05). The Figure shows similar treatment effects (hazard ratios) across the spectrum of age. P-values are for the interaction between age and treatment effect for each endpoint. Figure 1 Conclusions In SPRINT, higher age was associated with a greater risk of both CV events and SAE. However, intensive BP lowering appeared to be associated with similar risks and benefits across the age spectrum.

Abstract P179: The Magnitude, And Not Direction, Of Blood Pressure Change Influences The Risk Of Serious Adverse Events In SPRINT

Hypertension ◽  
2020 ◽  
Vol 76 (Suppl_1) ◽  
Author(s):  
Michael Buhnerkempe ◽  
Vivek Prakash ◽  
Albert Botchway ◽  
Oritsegbubemi Adekola ◽  
John M Flack
Keyword(s):  
Blood Pressure ◽  
Adverse Events ◽  
Systolic Blood Pressure ◽  
Proportional Hazards ◽  
Pressure Change ◽  
Cox Proportional Hazards ◽  
Intensive Treatment ◽  
Atherosclerotic Cardiovascular Disease ◽  
Serious Adverse Events ◽  
Ascvd Risk

Background: The landmark Systolic Blood Pressure Intervention Trial (SPRINT) showed that more intensive systolic blood pressure treatment (SBP < 120 mm Hg) was associated with lower risk for cardiovascular events and mortality but higher risk for serious adverse events (SAEs). However, it is unclear if the magnitude and/or the direction of the BP change determines SAE risk. In this study, we aim to determine how the magnitude and direction of BP change impacts SAE risk. Methods: This is a secondary analysis of 7922 participants in SPRINT. Time-varying Cox proportional hazards models were used to explore the relationship between visit-to-visit BP change and SAE risk. BP change was categorized using five intervals: 1) decreases ≥30 mm Hg, 2) decreases 10-29 mm Hg, 3) increases or decreases <10 mm Hg (reference category), 4) increases 10-29 mm Hg, and 5) increases ≥30 mm Hg. Additional variables adjusted for in the model included: age, gender, race, estimated glomerular filtration rate, treatment group, and baseline atherosclerotic cardiovascular disease (ASCVD) risk. Hypotension was excluded as an SAE to prevent bias in SAE risk in the large BP decrease category. Results: The hazard ratio (HR) for SAEs compared to the minimal BP change category was greatest for BP increases above 30 mm Hg (HR = 1.62, 95% confidence interval [1.30, 2.01]). However, the HR was similar for sharp BP decreases over 30 mm Hg (HR = 1.52 [1.23, 1.87]). Milder BP increases and decreases were associated with lower SAE risk (HR = 1.18 [1.06, 1.32] and HR = 1.10 [0.98, 1.22] for BP changes 10 to 30 mm Hg and -30 to -10 mm Hg, respectively). There were no significant interactions between BP change, intensive treatment, and baseline ASCVD risk. Conclusions: SAE risk was similar for similarly sized increases and decreases in BP between visits, with higher magnitude changes associated with higher SAE risk. When accounting for the magnitude of BP change, no significant effect of intensive treatment or baseline ASCVD risk was found.

scholarly journals Intensive blood pressure lowering in different age categories: insights from the Systolic Blood Pressure Intervention Trial

2019 ◽  
Vol 6 (6) ◽  
pp. 356-363 ◽  
Author(s):  
Christina Byrne ◽  
Manan Pareek ◽  
Muthiah Vaduganathan ◽  
Tor Biering-Sørensen ◽  
Arman Qamar ◽  
...  
Keyword(s):  
Heart Failure ◽  
Blood Pressure ◽  
Adverse Events ◽  
Systolic Blood Pressure ◽  
Primary Efficacy ◽  
Intervention Trial ◽  
Blood Pressure Lowering ◽  
Serious Adverse Events ◽  
Pressure Lowering ◽  
Intensive Blood Pressure

Abstract Aims The 2018 ESC/ESH guidelines for hypertension recommend differential management of patients who are &lt;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 &lt;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 &lt; 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 &lt; 0.001). The safety and efficacy of intensive blood pressure lowering were not modified by age, whether tested continuously or categorically (P &gt; 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.

scholarly journals Sex-Specific Associations between Blood Pressure and Risk of Atrial Fibrillation Subtypes in the Tromsø Study

2021 ◽  
Vol 10 (7) ◽  
pp. 1514
Author(s):  
Hilde Espnes ◽  
Jocasta Ball ◽  
Maja-Lisa Løchen ◽  
Tom Wilsgaard ◽  
Inger Njølstad ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Blood Pressure ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Pressure Management ◽  
Reference Models ◽  
Proportional Hazards Regression ◽  
Hazard Ratios ◽  
Increased Risk

The aim of this study was to explore sex-specific associations between systolic blood pressure (SBP), hypertension, and the risk of incident atrial fibrillation (AF) subtypes, including paroxysmal, persistent, and permanent AF, in a general population. A total of 13,137 women and 11,667 men who participated in the fourth survey of the Tromsø Study (1994–1995) were followed up for incident AF until the end of 2016. Cox proportional hazards regression analysis was conducted using fractional polynomials for SBP to provide sex- and AF-subtype-specific hazard ratios (HRs) for SBP. An SBP of 120 mmHg was used as the reference. Models were adjusted for other cardiovascular risk factors. Over a mean follow-up of 17.6 ± 6.6 years, incident AF occurred in 914 (7.0%) women (501 with paroxysmal/persistent AF and 413 with permanent AF) and 1104 (9.5%) men (606 with paroxysmal/persistent AF and 498 with permanent AF). In women, an SBP of 180 mmHg was associated with an HR of 2.10 (95% confidence interval [CI] 1.60–2.76) for paroxysmal/persistent AF and an HR of 1.80 (95% CI 1.33–2.44) for permanent AF. In men, an SBP of 180 mmHg was associated with an HR of 1.90 (95% CI 1.46–2.46) for paroxysmal/persistent AF, while there was no association with the risk of permanent AF. In conclusion, increasing SBP was associated with an increased risk of both paroxysmal/persistent AF and permanent AF in women, but only paroxysmal/persistent AF in men. Our findings highlight the importance of sex-specific risk stratification and optimizing blood pressure management for the prevention of AF subtypes in clinical practice.

Abstract P169: Health Literacy and Outcomes in Heart Failure: a Prospective Community Study

Circulation ◽  
2017 ◽  
Vol 135 (suppl_1) ◽  
Author(s):  
Matteo Fabbri ◽  
Kathleen Yost ◽  
Lila Finney Rutten ◽  
Sheila Manemann ◽  
Susan Weston ◽  
...  
Keyword(s):  
Heart Failure ◽  
Health Literacy ◽  
Proportional Hazards ◽  
International Classification Of Diseases ◽  
Cox Proportional Hazards ◽  
Low Literacy ◽  
Adequate Health Literacy ◽  
Low Health Literacy ◽  
Increased Risk

Background: Growing evidence documents the association between low health literacy and poorer health outcomes. However, less is known about the relationship between health literacy and outcomes among patients with heart failure (HF). We examined the association of health literacy with risk of hospitalization and mortality in patients with HF. Methods: Residents in an 11-county region in southeastern Minnesota with incident HF from 1/01/2013 to 3/31/2015 were identified using the International Classification of Diseases, Ninth Revision code 428 (n=3715) and prospectively surveyed to measure health literacy using established screening questions. A total of 1992 patients returned a survey (response rate 54%); 1779 patients with complete clinical data and adequate follow up were retained for analysis. Health literacy, measured as a composite on three 5-point scales, was categorized as adequate (≤ 10) or low (> 10). Cox proportional hazards regression and Andersen-Gill models were used to determine the association of health literacy with mortality and hospitalization. Results: Among 1779 patients (mean age 74, 53% male), 10% had low health literacy. After a mean follow-up of 8±4 months, 72 deaths and 600 hospitalizations occurred. Low health literacy was associated with increased mortality and hospitalizations (Figure). After adjusting for age, sex, comorbidity, education and marital status, the hazard ratio for death and hospitalization in patients with low health literacy was 2.84 (95% CI: 1.63, 4.96) and 1.43 (95% CI: 1.04, 1.96) respectively, compared to patients with adequate health literacy. Conclusions: Low health literacy is associated with increased risk of hospitalization and death among patients with HF. Health literacy is critical to the self-management demands of living with heart failure. Evaluation of health literacy in the clinical setting may guide inventions to target patients with low literacy.

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