Investigators found no benefit from the discontinuation of ACE inhibitors/ARBs in patients hospitalized with COVID-19 in a prospective, randomized, phase 4 trial.
After months of debate and speculation, the BRACE CORONA trial has drawn a firm conclusion: there is no benefit from discontinuing treatment with ACE inhibitors and ARBs in patients with coronavirus disease 2019 (COVID-19).
Presented at the European Society of Cardiology (ESC) Congress 2020, BRACE CORONA provides insight into the effects of discontinuing ACEs/ARBs from a prospective, randomized trial, which had been lacking from previous data related to information from observational studies.
“This is the first randomized data assessing the role of continuing versus stopping ACE inhibitors and ARBs in patients with COVID-19,” said Renato Lopes, MD, of Duke Clinical Research Institute, in a statement from the ESC. “In patients hospitalized with COVID-19, suspending ACE inhibitors and ARBs for 30 days did not impact the number of days alive and out of hospital.”
After early research indicated ACE2 as the functional receptor for SARS-CoV-2, debate began over whether the discontinuation of ACEs/ARBs would result in benefit or contribute to worsening outcomes among patients hospitalized with COVID-19. With this in mind, Lopes and a team of colleagues designed the phase 4 study with a primary outcome of the number of days alive and out of the hospital at 30 days to provide an answer.
In total, 659 patients from 29 sites across Brazil were enrolled in the study. All patients included in the study had a history of chronic use of an ACE inhibitor or ARB and were hospitalized with COVID-19. Of note, patients using 3 or more antihypertensive agents, using sacubitril/valsartan, or who were hemodynamically unstable at presentation were excluded from the study.
Upon analysis, the mean number of days alive and out of the hospital was 21.9 days for patients who discontinued use of ACEs/ARBS and 22.9 days for patients who continued use of these agents (mean difference between groups: -1.1 days; 95% CI, -2.33 to 0.17). At 30 days, 91.8% of the patients in the discontinuation group were alive and out of the hospital at 30 days compared to 95% of patients in the group that continued use of the therapies—yielding mortality rates of 2.7% vs 2.8%, respectively.
For more on the results of BRACE CORONA and how these results can be applied to clinical practice, Practical Cardiology reached out to Lopes to take part in a special edition ESC 2020 House Call.
This study, “BRACE CORONA: Continuing vs. Suspending ACE Inhibitors and ARBs in COVID-19,” was presented at ESC Congress 2020.