No benefit of low-dose apixaban after acute COVID-19

The long-term adverse effects of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of the ongoing coronavirus disease 2019 (COVID-19) pandemic, are well documented. . The manifestations of these symptoms in her heavily infected COVID-19 patients are often referred to as ‘long-term COVID’ and have been reported in many studies as well.

study: Post-discharge apixaban in adults hospitalized with COVID-19: preliminary results from a multicenter, open-label, randomized controlled platform clinical trial. Image Credit: WHYFRAME / Shutterstock.com

Background

Individuals severely infected with SARS-CoV-2 are at increased risk of developing pulmonary and cardiovascular complications, with possible long-term consequences such as persistent inflammation, venous thromboembolism, and pulmonary fibrosis. I have. Several therapeutic approaches have been identified to treat the acute phase of COVID-19. However, there is still a lack of specific treatments that can effectively treat his long-term COVID.

In a recent retrospective cohort study involving approximately 48,000 acute SARS-CoV-2 infected persons admitted to National Health Service (NHS) hospitals in the United Kingdom, approximately 29% of these patients were readmitted and 12% died after discharge. revealed to have died. A similar pattern was also observed in another US-based study.

In cases of severe SARS-CoV-2 infection, coagulation abnormalities associated with platelet activation and coagulation factors were observed. Additionally, a high incidence of thromboembolism was reported during the post-acute phase of COVID-19.

Inconsistent anticoagulant risk estimates prevented us from making effective therapeutic decisions regarding anticoagulant use. Therefore, it is imperative to identify effective pharmacological prophylactic agents that can reduce the risk of venous thromboembolism in adults recovering from COVID-19.

The National Institute for Health and Care Excellence (NICE) is unable to identify studies that have determined the efficacy and safety of pharmacological prophylaxis to reduce the risk of venous thromboembolism in adults treated for COVID-19 was. However, NICE has published some relevant guidelines for the clinical management of COVID-19.

About research

HEAL-COVID is a recent adaptive, randomized, open-label, multicenter, multiarm, multistep platform trial that addresses this gap in research. The trial compared posthospital care with standard care in adults who required hospitalization after having severe SARS-CoV-2 infection.

Apixaban, an oral direct-acting anticoagulant, was selected as the trial arm. Apixaban was chosen because of its oral route of administration, promising safety profile, and wide availability. The results of this study recently of medRxiv* preprint server.

In this study, follow-up data were obtained through data linking to routine clinical data sources. Additionally, patient self-reported data were collected through an app/web-based system (ATOM5) or a phone call conducted by the research team.

A total of 1,194 participants were selected from NHS hospitals in England, Wales, Northern Ireland and Scotland between 19 May 2021 and 21 November 2022.

All participants were randomly assigned to two groups. In one group he received 2.5 mg apixaban twice daily for 14 days and in the other group she received standard postdischarge non-anticoagulant therapy. Patients in both groups were monitored for 12 months.

Survey results

Apixaban treatment for 14 days did not reduce subsequent readmissions or mortality. Moreover, hospitalization rates remained similar to those recorded before initiation of the COVID-19 vaccination program and before application of various therapeutic agents such as tocilizumab, dexamethasone, and antiviral agents.

An increased risk of thromboembolism has been reported in the first 4 weeks after SARS-CoV-2 infection. This observation is consistent with his HEAL-COVID analysis data, which revealed that most venous thromboembolic events occurred within his first 30 days of the trial.

Four pulmonary embolisms occurred within the first 30 days in the standard-of-care group. However, this event was not reported in his Apixaban group. Nonetheless, his two participants in the apixaban group required readmission for bleeding during the same period.

These findings demonstrate a finely balanced risk-benefit ratio between standard and anticoagulant therapy. Therefore, the HEAL-COVID trial failed to demonstrate an overall benefit of apixaban treatment in terms of mortality and readmissions, even after 1 year.

Inpatient anticoagulation plus rivaroxaban did not improve mortality, length of stay, or oxygen requirements for up to 30 days. Notably, in multiple patient cohorts, rivaroxaban caused higher bleeding rates than apixaban.

Conclusion

Apixaban treatment for 14 days after hospitalization failed to reduce mortality or readmission in adults recently recovered from severe SARS-CoV-2 infection. Not recommended. In particular, the authors hypothesized that longer treatment provided no additional benefit and increased the risk of bleeding in these patients.

*Important Notices

medrex sib We publish a non-peer-reviewed, preliminary scientific report and should not be taken as conclusive, to guide clinical practice/health-related actions, or to be treated as established information.