Karola S Jering1, Brian Claggett1, Marc A Pfeffer1, Christopher Granger2, Lars Køber3, Eldrin F Lewis4, Aldo P Maggioni5, Douglas Mann6, John J V McMurray7, Jean-Lucien Rouleau8, Scott D Solomon1, Philippe G Steg9, Peter van der Meer10, Margaret Wernsing11, Katherine Carter11, Weinong Guo11, Yinong Zhou11, Martin Lefkowitz11, Jianjian Gong11, Yi Wang11, Bela Merkely12, Stella M Macin13, Urmil Shah14, Jose C Nicolau15, Eugene Braunwald16. 1. Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA. 2. Duke University Medical Center, Durham, NC, USA. 3. Rigshospitalet, Copenhagen, Denmark. 4. Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford University, Palo Alto, CA, USA. 5. ANMCO Research Center, Florence, Italy. 6. Washington University Medical Center, St Louis, MO, USA. 7. British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK. 8. Montreal Heart Institute, University of Montreal, Montreal, Canada. 9. Université de Paris, AP-HP (Assistance Publique-Hôpitaux de Paris), FACT (French Alliance for Cardiovascular Trials) and INSERM U-1148, Paris, France. 10. Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 11. Novartis Pharmaceutical Corporation, East Hanover, NJ, USA. 12. Semmelweis University, Heart and Vascular Center, Budapest, Hungary. 13. Instituto de Cardiología JF Cabral Corrientes, Corrientes, Argentina. 14. Care Institute of Medical Sciences, Ahmedabad, India. 15. Instituto do Coracao, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil. 16. TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA.
Abstract
AIMS: Patients surviving an acute myocardial infarction (AMI) are at risk of developing symptomatic heart failure (HF) or premature death. We hypothesized that sacubitril/valsartan, effective in the treatment of chronic HF, prevents development of HF and reduces cardiovascular death following high-risk AMI compared to a proven angiotensin-converting enzyme (ACE) inhibitor. This paper describes the study design and baseline characteristics of patients enrolled in the Prospective ARNI vs. ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE-MI) trial. METHODS AND RESULTS: PARADISE-MI, a multinational (41 countries), double-blind, active-controlled trial, randomized patients within 0.5-7 days of presentation with index AMI to sacubitril/valsartan or ramipril. Transient pulmonary congestion and/or left ventricular ejection fraction (LVEF) ≤40% and at least one additional factor augmenting risk of HF or death (age ≥70 years, estimated glomerular filtration rate <60 mL/min/1.73 m2 , diabetes, prior myocardial infarction, atrial fibrillation, LVEF <30%, Killip class ≥III, ST-elevation myocardial infarction without reperfusion) were required for inclusion. PARADISE-MI was event-driven targeting 708 primary endpoints (cardiovascular death, HF hospitalization or outpatient development of HF). Randomization of 5669 patients occurred 4.3 ± 1.8 days from presentation with index AMI. The mean age was 64 ± 12 years, 24% were women. The majority (76%) qualified with ST-segment elevation myocardial infarction; acute percutaneous coronary intervention was performed in 88% and thrombolysis in 6%. LVEF was 37 ± 9% and 58% were in Killip class ≥II. CONCLUSIONS: Baseline therapies in PARADISE-MI reflect advances in contemporary evidence-based care. With enrollment complete PARADISE-MI is poised to determine whether sacubitril/valsartan is more effective than a proven ACE inhibitor in preventing development of HF and cardiovascular death following AMI.
AIMS: Patients surviving an acute myocardial infarction (AMI) are at risk of developing symptomatic heart failure (HF) or premature death. We hypothesized that sacubitril/valsartan, effective in the treatment of chronic HF, prevents development of HF and reduces cardiovascular death following high-risk AMI compared to a proven angiotensin-converting enzyme (ACE) inhibitor. This paper describes the study design and baseline characteristics of patients enrolled in the Prospective ARNI vs. ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE-MI) trial. METHODS AND RESULTS: PARADISE-MI, a multinational (41 countries), double-blind, active-controlled trial, randomized patients within 0.5-7 days of presentation with index AMI to sacubitril/valsartan or ramipril. Transient pulmonary congestion and/or left ventricular ejection fraction (LVEF) ≤40% and at least one additional factor augmenting risk of HF or death (age ≥70 years, estimated glomerular filtration rate <60 mL/min/1.73 m2 , diabetes, prior myocardial infarction, atrial fibrillation, LVEF <30%, Killip class ≥III, ST-elevation myocardial infarction without reperfusion) were required for inclusion. PARADISE-MI was event-driven targeting 708 primary endpoints (cardiovascular death, HF hospitalization or outpatient development of HF). Randomization of 5669 patients occurred 4.3 ± 1.8 days from presentation with index AMI. The mean age was 64 ± 12 years, 24% were women. The majority (76%) qualified with ST-segment elevation myocardial infarction; acute percutaneous coronary intervention was performed in 88% and thrombolysis in 6%. LVEF was 37 ± 9% and 58% were in Killip class ≥II. CONCLUSIONS: Baseline therapies in PARADISE-MI reflect advances in contemporary evidence-based care. With enrollment complete PARADISE-MI is poised to determine whether sacubitril/valsartan is more effective than a proven ACE inhibitor in preventing development of HF and cardiovascular death following AMI.
Authors: Agata Tymińska; Krzysztof Ozierański; Marcin Grabowski; Grzegorz Opolski; Paweł Balsam Journal: Cardiol J Date: 2020-07-10 Impact factor: 2.737
Authors: Marc A Pfeffer; Brian Claggett; Eldrin F Lewis; Christopher B Granger; Lars Køber; Aldo P Maggioni; Douglas L Mann; John J V McMurray; Jean-Lucien Rouleau; Scott D Solomon; Philippe Gabriel Steg; Otavio Berwanger; Maja Cikes; Carmine G De Pasquale; Alberto Fernandez; Gerasimos Filippatos; Karola Jering; Ulf Landmesser; Venugopal Menon; Béla Merkely; Mark C Petrie; Ivo Petrov; Morten Schou; Michele Senni; David Sim; Peter van der Meer; Martin Lefkowitz; Yinong Zhou; Yi Wang; Eugene Braunwald Journal: Circulation Date: 2021-11-19 Impact factor: 29.690
Authors: Amil M Shah; Brian Claggett; Narayana Prasad; Guichu Li; Mayra Volquez; Karola Jering; Maja Cikes; Attila Kovacs; Wilfried Mullens; Jose C Nicolau; Lars Køber; Peter van der Meer; Pardeep S Jhund; Ghionul Ibram; Martin Lefkowitz; Yinong Zhou; Scott D Solomon; Marc A Pfeffer Journal: Circulation Date: 2022-09-09 Impact factor: 39.918
Authors: Bo Xiong; Dan Nie; Jun Qian; Yuanqing Yao; Gang Yang; Shunkang Rong; Que Zhu; Yun Du; Yonghong Jiang; Jing Huang Journal: ESC Heart Fail Date: 2021-10-30
Authors: Kieran F Docherty; Ross T Campbell; Katriona J M Brooksbank; John G Dreisbach; Paul Forsyth; Rosemary L Godeseth; Tracey Hopkins; Alice M Jackson; Matthew M Y Lee; Alex McConnachie; Giles Roditi; Iain B Squire; Bethany Stanley; Paul Welsh; Pardeep S Jhund; Mark C Petrie; John J V McMurray Journal: Circulation Date: 2021-05-13 Impact factor: 29.690