Author + information
- Received April 15, 2020
- Revision received June 16, 2020
- Accepted June 25, 2020
- Published online September 28, 2020.
- Cecilia Berardi, MD, MSca,
- Eugene Braunwald, MDb,
- David A. Morrow, MD, MPHb,
- Hillary S. Mulder, MSc,
- Carol I. Duffy, DOd,
- Terrence X. O’Brien, MDe,f,
- Andrew P. Ambrosy, MDg,h,
- Hrishikesh Chakraborty, DrPHc,
- Eric J. Velazquez, MDa,
- Adam D. DeVore, MD, MHSb,c,∗ (, )
- for the PIONEER-HF Investigators
- aSection of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut
- bThrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
- cDuke Clinical Research Institute and Department of Medicine, Duke University School of Medicine, Durham, North Carolina
- dNovartis Pharmaceuticals Corporation, East Hanover, New Jersey
- eRalph H. Johnson Veterans Affairs Medical Center, South Carolina, Charleston
- fMedical University of South Carolina, Charleston, South Carolina
- gDepartment of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, California
- hDivision of Research, Kaiser Permanente Northern California, Oakland, California
- ↵∗Address for correspondence:
Dr. Adam D. DeVore, Duke Clinical Research Institute, 200 Morris Street, 6318, Durham, North Carolina 27701.
Objectives This study compared the efficacy and safety of sacubitril/valsartan to enalapril in Black and non-Black Americans with acute decompensated heart failure (ADHF).
Background Black patients have a different response to treatment with angiotensin-converting enzyme inhibitors compared with other racial and ethnic groups. How Black patients with ADHF respond to sacubitril/valsartan, an angiotensin receptor–neprilysin inhibitor, is unclear. PIONEER-HF was a double-blind randomized clinical trial of sacubitril/valsartan versus enalapril in hospitalized patients with ADHF following hemodynamic stabilization.
Methods In a pre-specified subgroup analysis, we examined changes in N-terminal pro–B-type natriuretic peptide, clinical outcomes, and safety according to race.
Results The study population, all enrolled in the United States, included 316 (36%) Black participants, 515 (58%) White participants, and 50 (5.7%) participants of other racial groups. The reduction in N-terminal pro–B-type natriuretic peptide concentration at weeks 4 and 8 was significantly greater with sacubitril/valsartan than enalapril in both Black (ratio of change with sacubitril/valsartan vs. enalapril: 0.71; 95% confidence interval [CI]: 0.58 to 0.88) and non-Black patients (ratio of change: 0.71; 95% CI: 0.61 to 0.83; interaction p = 1.00). Compared with enalapril, sacubitril/valsartan also reduced the pre-specified exploratory composite of cardiovascular death or HF rehospitalization in both Black (hazard ratio: 0.47; 95% CI: 0.24 to 0.93) and non-Black patients (hazard ratio: 0.65; 95% CI: 0.40 to 1.06; interaction p = 0.44).
Conclusions Among Black patients admitted with ADHF in the United States, the in-hospital initiation of sacubitril/valsartan was more effective than enalapril in reducing natriuretic peptide levels and the composite of cardiovascular death or HF rehospitalization. The effect of sacubitril/valsartan did not differ by race. (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode [PIONEER-HF]; NCT02554890)
PIONEER-HF was sponsored by Novartis Pharmaceuticals Corporation. Dr. Braunwald reports research grants through his institution from AstraZeneca, Daiichi Sankyo, Merck, and Novartis; and consulting fees from Amgen, Cardurion, MyoKardia, Novo Nordisk, and Verve. Dr. Duffy is an employee of Novartis Pharmaceuticals Corporation. Dr. Ambrosy has received significant research funding from Amarin Pharma, Abbott Laboratories, Novartis, the National Heart, Lung, and Blood Institute (NHLBI), and the Kaiser Permanente Northern California Community Benefit Program; and modest reimbursement for travel from Novartis. Dr. Velazquez has received research funding from the NHLBI and Novartis; and has received consulting fees from Novartis. Dr. DeVore has received research funding through his institution from AstraZeneca, Amgen, the American Heart Association, Bayer, Luitpold Pharmaceuticals, Medtronic, the NHLBI, the Patient-Centered Outcomes Research Institute, and Novartis; and has received consulting with Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Heart Failure author instructions page.
- Received April 15, 2020.
- Revision received June 16, 2020.
- Accepted June 25, 2020.
- 2020 American College of Cardiology Foundation
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