Scott D Solomon1, Brian Claggett2, Milton Packer3, Akshay Desai2, Michael R Zile4, Karl Swedberg5, Jean Rouleau6, Victor Shi7, Martin Lefkowitz7, John J V McMurray8. 1. Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: ssolomon@rics.bwh.harvard.edu. 2. Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts. 3. Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas. 4. Medical University of South Carolina and Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, South Carolina. 5. University of Gothenburg, Gothenburg, Sweden. 6. University of Montreal, Montreal, Quebec, Canada. 7. Novartis, East Hanover, New Jersey. 8. University of Glasgow, Glasgow, United Kingdom.
Abstract
OBJECTIVES: This study assessed whether the benefit of sacubtril/valsartan therapy varied with clinical stability. BACKGROUND: Despite the benefit of sacubitril/valsartan therapy shown in the PARADIGM-HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial, it has been suggested that switching from an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker should be delayed until occurrence of clinical decompensation. METHODS: Outcomes were compared among patients who had prior hospitalization within 3 months of screening (n = 1,611 [19%]), between 3 and 6 months (n = 1,009 [12%]), between 6 and 12 months (n = 886 [11%]), >12 months (n = 1,746 [21%]), or who had never been hospitalized (n = 3,125 [37%]). RESULTS: Twenty percent of patients without prior HF hospitalization experienced a primary endpoint of cardiovascular death or heart failure (HF) hospitalization during the course of the trial. Despite the increased risk associated with more recent hospitalization, the efficacy of sacubitril/valsartan therapy did not differ from that of enalapril according to the occurrence of or time from hospitalization for HF before screening, with respect to the primary endpoint or with respect to cardiovascular or all-cause mortality. CONCLUSIONS:Patients with recent HF decompensation requiring hospitalization were more likely to experience cardiovascular death or HF hospitalization than those who had never been hospitalized. Patients who were clinically stable, as shown by a remote HF hospitalization (>3 months prior to screening) or by lack of any prior HF hospitalization, were as likely to benefit from sacubitril/valsartan therapy as more recently hospitalized patients. (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255).
RCT Entities:
OBJECTIVES: This study assessed whether the benefit of sacubtril/valsartan therapy varied with clinical stability. BACKGROUND: Despite the benefit of sacubitril/valsartan therapy shown in the PARADIGM-HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial, it has been suggested that switching from an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker should be delayed until occurrence of clinical decompensation. METHODS: Outcomes were compared among patients who had prior hospitalization within 3 months of screening (n = 1,611 [19%]), between 3 and 6 months (n = 1,009 [12%]), between 6 and 12 months (n = 886 [11%]), >12 months (n = 1,746 [21%]), or who had never been hospitalized (n = 3,125 [37%]). RESULTS: Twenty percent of patients without prior HF hospitalization experienced a primary endpoint of cardiovascular death or heart failure (HF) hospitalization during the course of the trial. Despite the increased risk associated with more recent hospitalization, the efficacy of sacubitril/valsartan therapy did not differ from that of enalapril according to the occurrence of or time from hospitalization for HF before screening, with respect to the primary endpoint or with respect to cardiovascular or all-cause mortality. CONCLUSIONS:Patients with recent HF decompensation requiring hospitalization were more likely to experience cardiovascular death or HF hospitalization than those who had never been hospitalized. Patients who were clinically stable, as shown by a remote HF hospitalization (>3 months prior to screening) or by lack of any prior HF hospitalization, were as likely to benefit from sacubitril/valsartan therapy as more recently hospitalized patients. (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255).
Authors: Elena-Laura Antohi; Andrew P Ambrosy; Sean P Collins; Ali Ahmed; Vlad Anton Iliescu; Gad Cotter; Peter S Pang; Javed Butler; Ovidiu Chioncel Journal: Am J Ther Date: 2019 Mar/Apr Impact factor: 2.688
Authors: Meaghan Lunney; Marinella Ruospo; Patrizia Natale; Robert R Quinn; Paul E Ronksley; Ioannis Konstantinidis; Suetonia C Palmer; Marcello Tonelli; Giovanni Fm Strippoli; Pietro Ravani Journal: Cochrane Database Syst Rev Date: 2020-02-27
Authors: Stefan Koudstaal; Mar Pujades-Rodriguez; Spiros Denaxas; Johannes M I H Gho; Anoop D Shah; Ning Yu; Riyaz S Patel; Chris P Gale; Arno W Hoes; John G Cleland; Folkert W Asselbergs; Harry Hemingway Journal: Eur J Heart Fail Date: 2016-12-23 Impact factor: 15.534