학술논문
A randomized controlled trial of renin-angiotensin-aldosterone system inhibitor management in patients admitted in hospital with COVID-19.
Document Type
Academic Journal
Author
Sharma A; Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada; DREAM-CV Lab, McGill University Health Centre Research Institute, McGill University, Montreal, Quebec, Canada. Electronic address: Abhinav.sharma@mcgill.ca.; Elharram M; Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada; DREAM-CV Lab, McGill University Health Centre Research Institute, McGill University, Montreal, Quebec, Canada.; Afilalo J; Division of Cardiology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada.; Flannery A; DREAM-CV Lab, McGill University Health Centre Research Institute, McGill University, Montreal, Quebec, Canada.; Afilalo M; Department of Emergency Medicine, Jewish General Hospital, McGill Hospital, Montreal, Quebec, Canada.; Tselios C; Department of Emergency Medicine, Jewish General Hospital, McGill Hospital, Montreal, Quebec, Canada.; Ni J; Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada; DREAM-CV Lab, McGill University Health Centre Research Institute, McGill University, Montreal, Quebec, Canada.; Ezekowitz JA; Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.; Cheng MP; Division of Infectious Disease, McGill University Health Centre, McGill University, Montreal, Quebec, Canada.; Ambrosy AP; Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA; Division of Research, Kaiser Permanente Northern California, Oakland, CA.; Zannad F; Centre D'Investigation Clinique- Plurithématique Inserm CIC-P 1433, Inserm U1116, CHRU Nancy Hôpitaux de Brabois, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Université de Lorraine, Nancy, France.; Brophy JM; Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada.; Giannetti N; Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada.; Bessissow A; Division of General Internal Medicine, McGill University Health Centre, McGill University, Montreal, Quebec, Canada.; Kronfli N; Division of Research, Kaiser Permanente Northern California, Oakland, CA.; Marelli A; Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada.; Aziz H; Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada.; Alqahtani M; Division of General Internal Medicine, McGill University Health Centre, McGill University, Montreal, Quebec, Canada.; Aflaki M; Division of General Internal Medicine, McGill University Health Centre, McGill University, Montreal, Quebec, Canada.; Craig M; Sainte-Justine University Hospital Research Centre and Department of Mathematics and Statistics, Université de Montréal, Montreal, Quebec, Canada.; Lopes RD; Duke Clinical Research Institute, Duke University, Durham, NC.; Ferreira JP; Centre D'Investigation Clinique- Plurithématique Inserm CIC-P 1433, Inserm U1116, CHRU Nancy Hôpitaux de Brabois, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Université de Lorraine, Nancy, France; Cardiovascular Research and Development Center, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Porto, Portugal.
Source
Publisher: Mosby Country of Publication: United States NLM ID: 0370465 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6744 (Electronic) Linking ISSN: 00028703 NLM ISO Abbreviation: Am Heart J Subsets: MEDLINE
Subject
Language
English
Abstract
Background: Renin-angiotensin aldosterone system inhibitors (RAASi) are commonly used among patients hospitalized with a severe acute respiratory syndrome coronavirus 2 infection coronavirus disease 2019 (COVID-19). We evaluated whether continuation versus discontinuation of RAASi were associated with short term clinical or biochemical outcomes.
Methods: The RAAS-COVID-19 trial was a randomized, open label study in adult patients previously treated with RAASi who are hospitalized with COVID-19 (NCT04508985). Participants were randomized 1:1 to discontinue or continue RAASi. The primary outcome was a global rank score calculated from baseline to day 7 (or discharge) incorporating clinical events and biomarker changes. Global rank scores were compared between groups using the Wilcoxon test statistic and the negative binomial test (using incident rate ratio [IRR]) and the intention-to-treat principle.
Results: Overall, 46 participants were enrolled; 21 participants were randomized to discontinue RAASi and 25 to continue. Patients' mean age was 71.5 years and 43.5% were female. Discontinuation of RAASi, versus continuation, resulted in a non-statistically different mean global rank score (discontinuation 6 [standard deviation [SD] 6.3] vs continuation 3.8 (SD 2.5); P = .60). The negative binomial analysis identified that discontinuation increased the risk of adverse outcomes (IRR 1.67 [95% CI 1.06-2.62]; P = .027); RAASi discontinuation increased brain natriuretic peptide levels (% change from baseline: +16.7% vs -27.5%; P = .024) and the incidence of acute heart failure (33% vs 4.2%, P = .016).
Conclusion: RAASi continuation in participants hospitalized with COVID-19 appears safe; discontinuation increased brain natriuretic peptide levels and may increase risk of acute heart failure; where possible, RAASi should be continued.
(Copyright © 2022 Elsevier Inc. All rights reserved.)
Methods: The RAAS-COVID-19 trial was a randomized, open label study in adult patients previously treated with RAASi who are hospitalized with COVID-19 (NCT04508985). Participants were randomized 1:1 to discontinue or continue RAASi. The primary outcome was a global rank score calculated from baseline to day 7 (or discharge) incorporating clinical events and biomarker changes. Global rank scores were compared between groups using the Wilcoxon test statistic and the negative binomial test (using incident rate ratio [IRR]) and the intention-to-treat principle.
Results: Overall, 46 participants were enrolled; 21 participants were randomized to discontinue RAASi and 25 to continue. Patients' mean age was 71.5 years and 43.5% were female. Discontinuation of RAASi, versus continuation, resulted in a non-statistically different mean global rank score (discontinuation 6 [standard deviation [SD] 6.3] vs continuation 3.8 (SD 2.5); P = .60). The negative binomial analysis identified that discontinuation increased the risk of adverse outcomes (IRR 1.67 [95% CI 1.06-2.62]; P = .027); RAASi discontinuation increased brain natriuretic peptide levels (% change from baseline: +16.7% vs -27.5%; P = .024) and the incidence of acute heart failure (33% vs 4.2%, P = .016).
Conclusion: RAASi continuation in participants hospitalized with COVID-19 appears safe; discontinuation increased brain natriuretic peptide levels and may increase risk of acute heart failure; where possible, RAASi should be continued.
(Copyright © 2022 Elsevier Inc. All rights reserved.)