Senthil Selvaraj1, Brian Claggett2, Sanjiv J Shah3, Inder Anand4, Jean L Rouleau5, Akshay S Desai2, Eldrin F Lewis2, Bertram Pitt6, Nancy K Sweitzer7, Marc A Pfeffer2, Scott D Solomon2. 1. Division of Cardiology, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA. 2. Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA. 3. Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. 4. VA Medical Center and University of Minnesota, Minneapolis, MN, USA. 5. Department of Medicine, Montreal Heart Institute, University of Montreal, Quebec, Canada. 6. University of Michigan, Ann Arbor, MI, USA. 7. Sarver Heart Center, University of Arizona College of Medicine, Tucson, USA.
Abstract
AIMS: Recent guidelines have advocated for stricter systolic blood pressure (SBP) control in heart failure with preserved ejection fraction (HFpEF), though data regarding the optimal SBP in HFpEF are sparse. METHODS AND RESULTS: We analysed participants from the Americas from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) study with available baseline and 8-weekvisit SBP data (n = 1645). We related baseline SBP to several efficacy and safety outcomes. To determine whether blood pressure lowering was responsible for the potential beneficial effects of spironolactone observed in the Americas, we assessed the randomized treatment adjusting for baseline and change in 8-week SBP. The average age was 71.7 ± 9.7 years, 50% were women, and 79% were White. Patients in the lowest baseline SBP quartile were less often female, more often White, had lower body mass index, lower baseline diastolic blood pressure and pulse pressure, and more often had atrial fibrillation. After multivariable adjustment, there was no relationship observed between baseline SBP quartiles and any outcome. Spironolactone reduced SBP by 4.4 ± 0.6 mmHg compared with placebo (and consistently across baseline SBP quartiles). There was minimal change in the treatment effect for all outcomes after adjusting for baseline SBP and 8-week change in SBP. CONCLUSION: No relationship was observed between baseline SBP quartiles and outcomes in TOPCAT. The anti-hypertensive effects of spironolactone did not account for the potential benefit in cardiovascular outcomes in the Americas.
RCT Entities:
AIMS: Recent guidelines have advocated for stricter systolic blood pressure (SBP) control in heart failure with preserved ejection fraction (HFpEF), though data regarding the optimal SBP in HFpEF are sparse. METHODS AND RESULTS: We analysed participants from the Americas from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) study with available baseline and 8-week visit SBP data (n = 1645). We related baseline SBP to several efficacy and safety outcomes. To determine whether blood pressure lowering was responsible for the potential beneficial effects of spironolactone observed in the Americas, we assessed the randomized treatment adjusting for baseline and change in 8-week SBP. The average age was 71.7 ± 9.7 years, 50% were women, and 79% were White. Patients in the lowest baseline SBP quartile were less often female, more often White, had lower body mass index, lower baseline diastolic blood pressure and pulse pressure, and more often had atrial fibrillation. After multivariable adjustment, there was no relationship observed between baseline SBP quartiles and any outcome. Spironolactone reduced SBP by 4.4 ± 0.6 mmHg compared with placebo (and consistently across baseline SBP quartiles). There was minimal change in the treatment effect for all outcomes after adjusting for baseline SBP and 8-week change in SBP. CONCLUSION: No relationship was observed between baseline SBP quartiles and outcomes in TOPCAT. The anti-hypertensive effects of spironolactone did not account for the potential benefit in cardiovascular outcomes in the Americas.
Authors: Senthil Selvaraj; Brian Claggett; Sanjiv J Shah; Inder S Anand; Jean L Rouleau; Akshay S Desai; Eldrin F Lewis; Muthiah Vaduganathan; Stephen Y Wang; Bertram Pitt; Nancy K Sweitzer; Marc A Pfeffer; Scott D Solomon Journal: Circ Heart Fail Date: 2019-06-21 Impact factor: 8.790
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