Apixaban for Prophylaxis of Thromboembolic Outcomes in COVID-19 - APOLLO

Aug 28, 2022
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Brazilian Clinical Research Institute; Pfizer
Date Presented:
08/28/2022
Date Updated:
08/28/2022
Original Posted Date:
08/28/2022
References

Contribution To Literature:

The APOLLO trial failed to show that low-dose apixaban prevents mortality and hospitalization for ambulatory COVID-19 patients.

Description:

The goal of the trial was to evaluate low-dose apixaban compared with placebo among ambulatory patients with coronavirus disease 2019 (COVID-19) infection.

Study Design

  • Randomization
  • Parallel
  • Placebo

Eligible patients were randomized to apixaban 2.5 mg BID (n = 207) versus placebo (n = 204).

  • Total number of enrollees: 411
  • Duration of follow-up: 30 days
  • Mean patient age: 44 years
  • Percentage female: 58%
  • Percentage with diabetes: 12%

Inclusion criteria:

  • Ambulatory patients ≥18 years of age
  • Symptomatic COVID-19 for up to 10 days
  • Additional risk factors (D-dimer ≥2 x upper limit of normal, C-reactive protein ≥10 mg/L or ≥2 risk factors)

Exclusion criteria:

  • Indication or contraindication for anticoagulation
  • High risk for bleeding

Principal Findings:

The trial was stopped prematurely due to slow recruitment and low event rates.

The primary outcome, mean number of days alive and outside of the hospital through 30 days, was 29.6 in the apixaban group vs. 29.5 in the placebo group (p = not significant).

Secondary outcomes:

  • Hospitalized within 30 days: 4.9% in the apixaban group vs. 6.9% in the placebo group
  • Any bleeding within 30 days: 2.0% in the apixaban group vs. 1.0% in the placebo group

Interpretation:

The APOLLO trial failed to show that low-dose apixaban prevents mortality and hospitalization for ambulatory COVID-19 patients. Bleeding was similar between the treatment groups. This trial was stopped prematurely due to slow recruitment and low event rates; therefore, the results are somewhat inconclusive.

References:

Presented by Dr. Renato Lopes at the European Society of Cardiology Congress (ESC 2022), Barcelona, Spain, August 28, 2022.

Clinical Topics: Anticoagulation Management, COVID-19 Hub, Prevention

Keywords: ESC22, ESC Congress, Ambulatory Care, Anticoagulants, COVID-19, Hemorrhage, Post-Exposure Prophylaxis, Primary Prevention, Risk Factors, Thrombosis


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