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ESC 22: APOLLO: Apixaban for Prevention of Thromboembolic Outcomes in COVID-19

Published: 29 Aug 2022

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ESC Congress 22 — Prof Renato Lopes (Duke University Medical Center, US) talks about the data from the APOLLO trial (NCT04746339). 


This randomized, double-blinded trial compared a DOAC, Apixaban 2.5 MG twice daily with placebo for 30 days. The trial assessed this intervention in outpatients with symptomatic SARS-CoV2 infection and risk factors for thrombosis. The primary outcome measure focused on number of days alive out of hospital or emergency department. 

Questions:

  1. In 2020, you said that we "need less common sense" and more clinical trial evidence. After 2 years, where are we in relation to COVID-19? 
  2. How does the Apollo trial compare to other trials looking at DOACS in patients with COVID-19?
  3. What is the data presented at ESC and how does it add to the existing evidence?
  4. What are the take-home messages and what is next?

Recorded on-site at ESC Congress 22, Barcelona. 

Interviewer: Mirjam Boros

Videography: 

Transcript

- Hi, I'm Renato Lopes, cardiologist from Duke University in Durham, North Carolina.

Where are we in relation to COVID-19?

I think the last two years, we've made tremendous progress in the COVID field because at the beginning of the pandemic, everybody was treating patients based on no high-quality evidence, on several potential and mechanistic studies, and observational studies, trying to do something for patients. And we know that this can be very dangerous because we don't know if something really works or not. But I think the scientific community was able to really bring along amazing and well-designed studies in different fields, and really create a lot of high-quality evidence very rapidly. That, in two years now, we have a much better sense of what works, and what does not work for patients with COVID-19.

APOLLO trial compared to other trials on DOACs in patients with COVID-19

So, in this sense of bringing up high quality evidence, the Apollo trial, I think, is one, another piece for this puzzle of the role of anticoagulation for patients with COVID-19. Of course, we learnt that patients are at different risks for thrombotic events. If they are out of hospital, if they are in the hospital if they're in the hospital, but in the ICUs, or even when they go home, there are different risks of these patients having thrombotic events, and different studies look at different strategies on how to minimise these risks of thrombotic events. Particularly in the outpatient setting, we didn't have a lot of high-quality data.

We had some randomised trials. And what the APOLLO trial did is really try to test low dose apixaban, 2.5 milligrams, twice daily versus placebo. Now, double blind placebo control trial in patients who have COVID but are not sick enough to go to the hospital. So, they are at home being treated with symptomatic drugs, but at increased risk for thrombosis. So, with elevated D-dimer, or other classic risk factors for thrombotic events. So that's what the APOLLO trial wanted to answer. And what we showed is that when you treat these patients with low dose apixaban, it did not improve in general outcomes, and it did not have an impact in the number of days alive and out of hospital at the end of 30 days.

So, basically, giving high quality evidence that we don't need to routinely anticoagulate patients in the outpatient setting when they have COVID-19.

Data presented at ESC and how this adds to existing evidence

Yeah, so I think APOLLO is another piece to the puzzle. There have been already some studies demonstrating that there is no benefit of using anticoagulants, different types of anticoagulants for patients with COVID out of the hospital, patients with COVID that don't need to be hospitalised. And I think APOLLO brings and confirm this data now with a different agent of apixaban in a different dose, 2.5 milligrams, twice daily, which is a lower dose than the classic full dose of apixaban. But again, with the results aligned with the other pieces of data that we have so far in the outpatient setting.


Take-home message and next steps
Well, I think COVID continues to change, different variants, and different aspects and I think we're going to continue to learn about COVID and having to be very smart and fast in designing trials to try to answer the questions that we need in each given time of the infection.