The risk of developing bad outcomes such as DVT, PE, stroke, heart attack, need for hospital admission or death did not differ for people who received apixaban (at high or low doses) or aspirin compared with those who received placebo.
About 7 more people out of 100 taking apixaban at treatment dose had bleeding events.
Understanding the problem
About 1 in 40 people diagnosed with COVID-19 who is ill enough to need to be admitted to the hospital will develop a DVT or PE. If someone needs to be cared for in the intensive care unit (ICU), the risk of developing a DVT or PE increases to about 1 in 10 people. Having a DVT or PE is a serious complication of COVID-19 infection, because a PE can reduce the ability to get oxygen from the lungs into the blood, which can contribute to death.
Several studies tell us that using higher doses of injectable anticoagulants in people with COVID-19 infections who are admitted to the hospital can help prevent their lung function from getting worse and speed up recovery from the disease. On the other hand, higher doses of anticoagulants did not help people already on a breathing machine (mechanical ventilator) or in the ICU and increased their risk of bleeding.
The study investigators wanted to know if giving oral anticoagulants or aspirin to people with COVID-19 infections who do not need to stay in hospital might protect them from bad events like DVT, PE, stroke, heart attack or requirement for admission to hospital or death.
Who? The study included 657 people aged 40 to 80 years, who had COVID-19 infection mild enough to not require a hospital stay at diagnosis. **It is important to know that vaccines were not widely available during the time frame for this study.
What? The study compared 4 groups: apixaban at treatment dose, apixaban at prevention dose, aspirin, and placebo.
|Apixaban at treatment dose|
Apixaban at preventative dose
Apixaban 5mg twice a day
Apixaban 2.5mg twice a day
|Aspirin 81mg once a day|
Placebo: A pill/needle/lotion containing an inactive substance that has no effect on the outcome. Sometimes, it is referred to as a “sugar pill.”
Apixaban, aspirin, or placebo in people who have mild COVID-19 infections not needing to stay in hospital at diagnosis
Outcomes at 45 days
Rate of events with apixaban at treatment dose
|Rate of events with apixaban at preventative dose||Rate of events with aspirin|
Rate of events with placebo
Symptomatic DVT, PE, heart attack, stroke, hospital admission for heart or lung issues, or death
1 out of 100 people
|1 out of 100 people||1 out of 100 people|
1 out of 100 people
0 out of 100 people
|0 out of 100 people||0 out of 100 people|
0 out of 100 people
|Any bleeding||9 out of 100 people||7 out of 100 people||4 out of 100 people||2 out of 100 people||About 7 more people taking apixaban at treatment dose had bleeding compared to people taking placebo|
This Evidence Summary is based on the following article:
Connors JM, Brooks MM, Sciurba FC, et al. Effect of Antithrombotic Therapy on Clinical Outcomes in Outpatients With Clinically Stable Symptomatic COVID-19: The ACTIV-4B Randomized Clinical Trial. JAMA. 2021 Oct 11. pii: 2785218. doi: 10.1001/jama.2021.17272. PubMed
Yan Xu, MD
Yan Xu is a RCPSC Thrombosis Fellow in the Department of Medicine at the University of Ottawa, having recently completed his postgraduate training in hematology at the same institution. He is passionate about thrombosis and health policy, with a particular focus on the translation of data from randomized trials to real-world clinical practice.
Lori-Ann Linkins, MD, MSc (Clin Epi), FRCPC
Dr. Linkins is an Associate Professor of Medicine (thrombosis) at McMaster University in Hamilton, Canada. She holds a Masters Degree in Health Research Methodology and is a Deputy Editor with the Health Information Research Unit, McMaster. She is Co-Editor of the ACP Journal Club and Co-lead on the CanVECTOR Knowledge Translation Platform.
Published: Thursday, December 2, 2021