A Randomized Controlled Trial of Renin-Angiotensin-Aldosterone System Inhibitor Management in Patients Admitted in Hospital with COVID-19

Sharma, Abhinav; Elharram, Malik; Afilalo, Jonathan; Flannery, Alexandria; Afilalo, Marc; Tselios, Chris; Ni, Jiayi; Ezekowitz, Justin A; Cheng, Matthew P.; Ambrosy, Andrew P; Zannad, Faiez; Brophy, James G.; Giannetti, Nadia; Bessissow, Amal; Kronfli, Nadine; Marelli, Ariane J; Aziz, Haya; AlQahtani, Mohammad S.; Aflaki, Mona; Craig, Morgan; Lopes, Renato D; Ferreira, João Pedro

doi:10.1016/j.ahj.2022.01.015

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A Randomized Controlled Trial of Renin-Angiotensin-Aldosterone System Inhibitor Management in Patients Admitted in Hospital with COVID-19

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Author(s): Abhinav Sharma , MD, PhD ¹ ^, ² ^, ^* , Malik Elharram , MD, MSc ¹ ^, ² , Jonathan Afilalo , MD, MSc ³ , Alexandria Flannery , RN ² , Marc Afilalo , MD ⁴ , Chris Tselios , MD ⁴ , Jiayi Ni , MSc ¹ ^, ² , Justin A. Ezekowitz , MBBCh, MSc ⁵ , Matthew P. Cheng , MDCM ⁶ , Andrew P. Ambrosy , MD ⁷ ^, ⁸ , Faiez Zannad , MD, PhD ⁹ , James Brophy , MD, PhD ¹ , Nadia Giannetti , MD ¹ , Amal Bessissow , MD, MSc ¹⁰ , Nadine Kronfli , MD, MPH ⁸ , Ariane Marelli , MD, MSc ¹ , Haya Aziz , MDCM ¹ , Mohammad Alqahtani , MD ¹⁰ , Mona Aflaki , MD, PhD ¹⁰ , Morgan Craig , PhD ¹¹ , Renato D. Lopes , MD, PhD ¹² , João Pedro Ferreira , MD, PhD ⁹ ^, ¹²

Publication date (Electronic): 7 February 2022

Journal: American Heart Journal

Publisher: Elsevier Inc.

Keywords: Renin-angiotensin aldosterone system inhibitors, severe acute respiratory syndrome coronavirus 2 infection, continuation: discontinuation, randomized trial

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Abstract

Background

Renin-angiotensin aldosterone system inhibitors (RAASi) are commonly used among patients hospitalized with a severe acute respiratory syndrome coronavirus 2 infection (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= 0.60). The negative binomial analysis identified that discontinuation increased the risk of adverse outcomes (IRR 1.67 [95% CI 1.06 to 2.62]; p=0.027); RAASi discontinuation increased brain natriuretic peptide (BNP) levels (% change from baseline: +16.7% vs. -27.5%; p= 0.024) and the incidence of acute heart failure (33% vs. 4.2%, p=0.016).

Conclusion

RAASi continuation in participants hospitalized with COVID-19 appears safe; discontinuation increased BNP levels and may increase risk of acute heart failure; where possible, RAASi should be continued.

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Most cited references 37

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Clinical Characteristics of Coronavirus Disease 2019 in China

Wei-jie Guan, Zheng-yi Ni, Yu Hu … (2020)

Abstract Background Since December 2019, when coronavirus disease 2019 (Covid-19) emerged in Wuhan city and rapidly spread throughout China, data have been needed on the clinical characteristics of the affected patients. Methods We extracted data regarding 1099 patients with laboratory-confirmed Covid-19 from 552 hospitals in 30 provinces, autonomous regions, and municipalities in mainland China through January 29, 2020. The primary composite end point was admission to an intensive care unit (ICU), the use of mechanical ventilation, or death. Results The median age of the patients was 47 years; 41.9% of the patients were female. The primary composite end point occurred in 67 patients (6.1%), including 5.0% who were admitted to the ICU, 2.3% who underwent invasive mechanical ventilation, and 1.4% who died. Only 1.9% of the patients had a history of direct contact with wildlife. Among nonresidents of Wuhan, 72.3% had contact with residents of Wuhan, including 31.3% who had visited the city. The most common symptoms were fever (43.8% on admission and 88.7% during hospitalization) and cough (67.8%). Diarrhea was uncommon (3.8%). The median incubation period was 4 days (interquartile range, 2 to 7). On admission, ground-glass opacity was the most common radiologic finding on chest computed tomography (CT) (56.4%). No radiographic or CT abnormality was found in 157 of 877 patients (17.9%) with nonsevere disease and in 5 of 173 patients (2.9%) with severe disease. Lymphocytopenia was present in 83.2% of the patients on admission. Conclusions During the first 2 months of the current outbreak, Covid-19 spread rapidly throughout China and caused varying degrees of illness. Patients often presented without fever, and many did not have abnormal radiologic findings. (Funded by the National Health Commission of China and others.)

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Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study

Fei Zhou, Ting Yu, Ronghui Du … (2020)

Summary Background Since December, 2019, Wuhan, China, has experienced an outbreak of coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Epidemiological and clinical characteristics of patients with COVID-19 have been reported but risk factors for mortality and a detailed clinical course of illness, including viral shedding, have not been well described. Methods In this retrospective, multicentre cohort study, we included all adult inpatients (≥18 years old) with laboratory-confirmed COVID-19 from Jinyintan Hospital and Wuhan Pulmonary Hospital (Wuhan, China) who had been discharged or had died by Jan 31, 2020. Demographic, clinical, treatment, and laboratory data, including serial samples for viral RNA detection, were extracted from electronic medical records and compared between survivors and non-survivors. We used univariable and multivariable logistic regression methods to explore the risk factors associated with in-hospital death. Findings 191 patients (135 from Jinyintan Hospital and 56 from Wuhan Pulmonary Hospital) were included in this study, of whom 137 were discharged and 54 died in hospital. 91 (48%) patients had a comorbidity, with hypertension being the most common (58 [30%] patients), followed by diabetes (36 [19%] patients) and coronary heart disease (15 [8%] patients). Multivariable regression showed increasing odds of in-hospital death associated with older age (odds ratio 1·10, 95% CI 1·03–1·17, per year increase; p=0·0043), higher Sequential Organ Failure Assessment (SOFA) score (5·65, 2·61–12·23; p<0·0001), and d-dimer greater than 1 μg/mL (18·42, 2·64–128·55; p=0·0033) on admission. Median duration of viral shedding was 20·0 days (IQR 17·0–24·0) in survivors, but SARS-CoV-2 was detectable until death in non-survivors. The longest observed duration of viral shedding in survivors was 37 days. Interpretation The potential risk factors of older age, high SOFA score, and d-dimer greater than 1 μg/mL could help clinicians to identify patients with poor prognosis at an early stage. Prolonged viral shedding provides the rationale for a strategy of isolation of infected patients and optimal antiviral interventions in the future. Funding Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences; National Science Grant for Distinguished Young Scholars; National Key Research and Development Program of China; The Beijing Science and Technology Project; and Major Projects of National Science and Technology on New Drug Creation and Development.

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Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention

Zunyou Wu, Jennifer M. McGoogan (2020)

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Author and article information

Journal

Journal ID (nlm-ta): Am Heart J

Journal ID (iso-abbrev): Am Heart J

Title: American Heart Journal

Publisher: Elsevier Inc.

ISSN (Print): 0002-8703

ISSN (Electronic): 1097-6744

Publication date PMC-release: 7 February 2022

Publication date (Electronic): 7 February 2022

Affiliations

[1 ]Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada

[2 ]DREAM-CV Lab, McGill University Health Centre Research Institute, McGill University, Montreal, Quebec, Canada

[3 ]Division of Cardiology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada

[4 ]Department of Emergency Medicine, Jewish General Hospital, McGill Hospital

[5 ]Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada

[6 ]Division of Infectious Disease, McGill University Health Centre, McGill University, Montreal, Quebec, Canada

[7 ]Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, California, USA

[8 ]Division of Research, Kaiser Permanente Northern California, Oakland, California, USA

[9 ]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

[10 ]Division of Internal Medicine, McGill University Health Centre, McGill University, Montreal, Quebec, Canada

[11 ]Sainte-Justine University Hospital Research Centre and Department of Mathematics and Statistics, Université de Montréal, Montreal, Quebec, Canada

[12 ]Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA

Author notes

[* ]Corresponding author

Article

Publisher Item ID: S0002-8703(22)00024-2

DOI: 10.1016/j.ahj.2022.01.015

PMC ID: 8820148

PubMed ID: 35143744

SO-VID: dc237189-7bf7-4615-bb47-0a3afd57cc0b

License:

Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.