Author + information
- Ignacio J. Amat-Santos, MD, PhD1,∗,# (, )@ignamatsant,
- Sandra Santos-Martinez, MD1,#,
- Diego López-Otero, MD, PhD2,
- Luis Nombela-Franco, MD, PhD3,
- Enrique Gutiérrez-Ibanes, MD4,
- Raquel Del Valle, MD5,
- Erika Muñoz-García, MD6,
- Víctor A. Jiménez-Diaz, MD7,
- Ander Regueiro, MD8,
- Rocío González-Ferreiro, MD9,
- Tomás Benito, MD10,
- Xoan Carlos Sanmartin-Pena, MD, PhD2,
- Pablo Catalá, MD1,
- Tania Rodríguez-Gabella, MD1,
- Jose Raúl Delgado-Arana, MD1,
- Manuel Carrasco-Moraleja, MSc1,
- Borja Ibañez, MD, PhD11 and
- J. Alberto San Román, MD, PhD1
- 1CIBERCV, Hospital Clínico Universitario, Valladolid, Spain
- 2CIBERCV, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain
- 3Cardiovascular Institute, Hospital Clínico San Carlos, IdISSC, Madrid, Spain
- 4CIBERCV, Hospital General Gregorio Marañón and Universidad Carlos III, Madrid, Spain
- 5Hospital Universitario Central de Asturias, Oviedo, Spain
- 6CIBERCV, Hospital Virgen de la Victoria, Málaga, Spain
- 7Hospital Universitario de Vigo, Vigo, Spain
- 8Hospital Clinic Univeristari, Barcelona, Spain
- 9Hospital Clínico Universitario, Salamanca, Spain
- 10Hospital Universitario de León, León, Spain
- 11CIBERCV, Centro Nacional de Investigaciones Cardiovasculares (CNIC), IIS-Hospital Fundación Jimenez Diaz, Madrid, Spain
- ↵∗Corresponding author: Ignacio J. Amat Santos, MD, PhD, Cardiology Dpt., Hospital Clínico Universitario de Valladolid, Spain Instituto de Ciencias del Corazón (ICICOR) Telephone: +34 983420026 Fax: +34 983255305, .
Background 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.
Objectives To analyze if RAAS-inhibitors modify the risk for COVID-19.
Methods 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.
Results 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).
Conclusions 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.
- Received April 27, 2020.
- Revision received May 20, 2020.
- Accepted May 20, 2020.
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