tetano
Editor, Senior Moderator
Am Heart J
. 2022 Feb 7;S0002-8703(22)00024-2.
doi: 10.1016/j.ahj.2022.01.015. Online ahead of print.
A Randomized Controlled Trial of Renin-Angiotensin-Aldosterone System Inhibitor Management in Patients Admitted in Hospital with COVID-19
Abhinav Sharma[SUP] 1 [/SUP], Malik Elharram[SUP] 2 [/SUP], Jonathan Afilalo[SUP] 3 [/SUP], Alexandria Flannery[SUP] 4 [/SUP], Marc Afilalo[SUP] 5 [/SUP], Chris Tselios[SUP] 5 [/SUP], Jiayi Ni[SUP] 2 [/SUP], Justin A Ezekowitz[SUP] 6 [/SUP], Matthew P Cheng[SUP] 7 [/SUP], Andrew P Ambrosy[SUP] 8 [/SUP], Faiez Zannad[SUP] 9 [/SUP], James Brophy[SUP] 10 [/SUP], Nadia Giannetti[SUP] 10 [/SUP], Amal Bessissow[SUP] 11 [/SUP], Nadine Kronfli[SUP] 12 [/SUP], Ariane Marelli[SUP] 10 [/SUP], Haya Aziz[SUP] 10 [/SUP], Mohammad Alqahtani[SUP] 11 [/SUP], Mona Aflaki[SUP] 11 [/SUP], Morgan Craig[SUP] 13 [/SUP], Renato D Lopes[SUP] 14 [/SUP], João Pedro Ferreira[SUP] 15 [/SUP]
Affiliations
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.
Keywords: Renin-angiotensin aldosterone system inhibitors; continuation: discontinuation; randomized trial; severe acute respiratory syndrome coronavirus 2 infection.
. 2022 Feb 7;S0002-8703(22)00024-2.
doi: 10.1016/j.ahj.2022.01.015. Online ahead of print.
A Randomized Controlled Trial of Renin-Angiotensin-Aldosterone System Inhibitor Management in Patients Admitted in Hospital with COVID-19
Abhinav Sharma[SUP] 1 [/SUP], Malik Elharram[SUP] 2 [/SUP], Jonathan Afilalo[SUP] 3 [/SUP], Alexandria Flannery[SUP] 4 [/SUP], Marc Afilalo[SUP] 5 [/SUP], Chris Tselios[SUP] 5 [/SUP], Jiayi Ni[SUP] 2 [/SUP], Justin A Ezekowitz[SUP] 6 [/SUP], Matthew P Cheng[SUP] 7 [/SUP], Andrew P Ambrosy[SUP] 8 [/SUP], Faiez Zannad[SUP] 9 [/SUP], James Brophy[SUP] 10 [/SUP], Nadia Giannetti[SUP] 10 [/SUP], Amal Bessissow[SUP] 11 [/SUP], Nadine Kronfli[SUP] 12 [/SUP], Ariane Marelli[SUP] 10 [/SUP], Haya Aziz[SUP] 10 [/SUP], Mohammad Alqahtani[SUP] 11 [/SUP], Mona Aflaki[SUP] 11 [/SUP], Morgan Craig[SUP] 13 [/SUP], Renato D Lopes[SUP] 14 [/SUP], João Pedro Ferreira[SUP] 15 [/SUP]
Affiliations
- PMID: 35143744
- PMCID: PMC8820148
- DOI: 10.1016/j.ahj.2022.01.015
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.
Keywords: Renin-angiotensin aldosterone system inhibitors; continuation: discontinuation; randomized trial; severe acute respiratory syndrome coronavirus 2 infection.