EDITORS' NOTE: This story was updated January 19, 2021 when the study was published in Journal of the American Medical Association.
The study examined whether suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers would have a clinical benefit when treating patients hospitalized with mild or moderate cases of COVID-19.
New randomized controlled trial data presented at the virtual European Society of Cardiology Congress 2020 and later published in Journal of the American Medical Association confirm that certain commonly used hypertension and heart failure treatments are safe for patients with COVID-19.
The trial, called BRACE-CORONA and chaired by the DCRI’s Renato Lopes, MD, PhD, sought to examine whether a 30-day suspension of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs) would improve outcomes for COVID-19 patients. The primary outcome of the study was the number of days a patient spent alive and out of the hospital through the 30-day follow-up period. The study was sponsored by the D’Or Institute for Research and Education and the Brazilian Clinical Research Institute.
Patients who use ACEI and ARBs as a treatment for hypertension or heart failure may experience an increase in expression of membrane-bound angiotensin-converting enzyme (ACE2). Because ACE2 is the functional receptor for SARS-CoV-2, the virus that causes COVID-19, there was some concern in the medical community about the safety of continuing usage of ACEI and ARBs in patients with COVID-19. These concerns were further complicated by conflicting observational evidence surrounding the use of these therapies in this clinical setting. BRACE-CORONA provides the first data in this field from a randomized controlled trial.
The study team randomized 659 patients who were hospitalized with confirmed mild or moderate cases of COVID-19. The study had two arms: one group served as a control and continued usage of ACEI and ARBs, while the other group had their ACEI and ARB treatment suspended for 30 days. Study results showed no significant difference between the two groups, with a 2.8 percent mortality rate for the continued treatment group and a 2.7 percent mortality rate for the treatment suspension group.
Furthermore, the continued treatment group experienced a slightly better clinical status at 30 days than the other group, with 94.8 percent of patients alive and out of the hospital at day 30, as compared to 91.9 percent in the treatment suspension group.
“These therapies have well-known benefits for patients with hypertension and heart failure, and this trial supplies high-quality randomized evidence to guide their usage while treating hospitalized patients with mild and moderate cases of COVID-19,” Lopes said. “Our trial found no overall clinical benefit to routinely suspending these medications, and this supports the recommendation that they should generally be continued for those who rely on them for managing hypertension or heart failure.”
“Interestingly, we found a significant interaction among the treatment effect, oxygen saturation, and COVID-19 clinical severity at hospital admission, with the results slightly favoring the group continuing ACEI or ARB therapy among patients with lower oxygen saturation and greater disease severity at presentation,” Lopes said.