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This interim analysis examined the risk of COVID 19 in 102 participants in the RASTAVI trial who had been randomized to treatment with the ACE inhibitor ramipril (50 patients) or control (52) after undergoing TAVR. A similar number of patients were diagnosed with COVID-19 in each treatment group (HR, 1.150). Older age was associated with an increased risk of COVID-19 infection. Risk may be elevated in patients with more comorbidities (P = .065), atrial fibrillation (P = .066), and lower hematocrit (P = .084). There was a significant association between higher BMI and an increased rate of mortality (P = .039).
This small study suggests that ramipril treatment does not influence risk of COVID-19 infection in an elderly population. However, larger studies are needed that also address related issues such as whether treatment affects disease severity in infected patients.
This abstract is available on the publisher's site.
The coronavirus disease 2019 (COVID-19) is caused by SARS-CoV2 that interfaces with the renin-angiotensin-aldosterone system (RAAS) through angiotensin-converting enzyme 2 (ACE-2). This interaction has been proposed as a potential risk factor in patients treated with RAAS-inhibitors.
To analyze if RAAS-inhibitors modify the risk for COVID-19.
RASTAVI (NCT03201185) is an ongoing randomized clinical trial randomly allocating Ramipril or control after successful transcatheter aortic valve replacement at 14 centers is Spain. We performed a non-pre-specified interim analysis to evaluate its impact on COVID-19 risk in this vulnerable population.
As in April 1st 2020, 102 patients (50 Ramipril and 52 controls) were included in the trial. Mean age was 82.3±6.1 years, 56.9% males. Median time of Ramipril treatment was 6 months [IQR:2.9-11.4]. Eleven patients (10.8%) have been diagnosed with COVID-19 (6 in control group and 5 receiving Ramipril, HR=1.150 [95%CI: 0.351-3.768]). The risk of COVID-19 was increased in older patients (p=0.019), those with atrial fibrillation (p=0.066), lower hematocrit (p=0.084), and more comorbidities according to Society of thoracic surgeons score (p=0.065). Admission and oxygen supply was required in 4.9% (2 patients in the Ramipril and 3 in control), and 4 of them died (two in each randomized group). A higher body mass index was the only factor increasing the mortality rate (p=0.039).
In a high risk population of old patients with cardiovascular disease, randomization to Ramipril had no impact in the incidence or severity of COVID-19. This analysis supports the maintenance of RAAS-inhibitor treatment during COVID-19 crisis.
JACC: Journal of the American College of Cardiology
Ramipril in High Risk Patients With COVID-19
J Am Coll Cardiol 2020 May 22;[EPub Ahead of Print], IJ Amat-Santos, S Santos-Martinez, D López-Otero, L Nombela-Franco, E Gutiérrez-Ibanes, R Del Valle, E Muñoz-García, VA Jiménez-Diaz, A Regueiro, R González-Ferreiro, T Benito, XC Sanmartin-Pena, P Catalá, T Rodríguez-Gabella, JR Delgado-Arana, M Carrasco-Moraleja, B Ibañez, JA San Román