Author + information
- Received June 3, 2019
- Revision received July 25, 2019
- Accepted August 6, 2019
- Published online December 30, 2019.
- Nicholas Y. Tan, MD, MSa,
- Lindsey R. Sangaralingham, MPHb,
- S. Jeson Sangaralingham, MS, PhDa,
- Xiaoxi Yao, PhD, MPHb,c,
- Nilay D. Shah, PhDb,c,d and
- Shannon M. Dunlay, MD, MSa,b,∗ ()
- aDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota
- bThe Robert and Patricia E. Kern Center for the Sciences of Healthcare Delivery, Mayo Clinic, Rochester, Minnesota
- cDivision of Health Care Policy and Research in the Department of Health Services Research, Mayo Clinic, Rochester, Minnesota
- dOptumLabs, Cambridge, Massachusetts
- ↵∗Address for correspondence:
Dr. Shannon M. Dunlay, Department of Cardiovascular Medicine, Mayo Clinic, 200 First Street Southwest, Rochester, Minnesota 55905.
Objectives This paper aims to compare the effectiveness of sacubitril-valsartan and angiotensin-converting enzyme inhibitor (ACE)/angiotensin receptor blocker (ARB) in systolic heart failure (HF).
Background Sacubitril-valsartan reduced risks of death and hospitalization for HF versus enalapril in ambulatory patients with HF and reduced ejection fraction in the PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor with Angiotensin Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in HF) trial. However, the comparative effectiveness of sacubitril-valsartan and ACE/ARB in patients treated in routine clinical practice is unclear.
Methods We identified patients with systolic HF in a U.S. administrative claims database treated with sacubitril-valsartan or ACE/ARB from July 1, 2015, to February 2, 2018. One-to-one propensity score matching was used to balance patients on 29 clinical variables. Cox models were used to compare outcomes between treatment groups.
Results A total of 7,893 matched pairs were included; mean (SD) follow-up was 6.3 (5.4) months. Sacubitril-valsartan was associated with lower risks of all-cause mortality or all-cause hospitalization (hazard ratio [HR]: 0.86, 95% confidence interval (CI): 0.81 to 0.91; p < 0.001), all-cause mortality (HR: 0.80, 95% CI: 0.66 to 0.97; p = 0.027), and all-cause hospitalization (HR: 0.86, 95% CI: 0.80 to 0.91; p < 0.001), but not HF hospitalization (HR: 1.07, 95% CI: 0.96 to 1.19; p = 0.26). A lower risk of the primary outcome with sacubitril-valsartan was observed in white patients (HR: 0.83, 95% CI: 0.76 to 0.90) but not black patients (21% of population, HR: 1.00, 95% CI: 0.88 to 1.15; interaction p = 0.032). No statistically significant differences in treatment response by sex or age were observed.
Conclusions Sacubitril-valsartan was associated with lower risks of death and hospitalization compared with ACE/ARB in a heterogeneous cohort of patients with systolic HF. However, our finding that outcomes with sacubitril-valsartan and ACE/ARBs were similar in black patients warrants further evaluation.
Dr. Shah has received grants from Centers for Medicare & Medicaid Services (CMS)/Center for Medicare & Medicaid Innovation (CMMI), Food and Drug Administration (FDA), Agency for Healthcare Research and Quality (AHRQ), National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI), and National Science Foundation (NSF). Dr. S.J. Sangaralingham has received grants from the NIH and the FDA. Dr. Dunlay has received grants from the NIH and from the Patient Centered Outcomes Research Institute to develop a Clinical Data Research Network. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 3, 2019.
- Revision received July 25, 2019.
- Accepted August 6, 2019.
- 2020 American College of Cardiology Foundation
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