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Antithrombotic prophylaxis of no benefit in symptomatic outpatients with COVID-19: Lancet
Delhi: Results from two randomized trials indicate that routine use of antithrombotic therapies to prevent thromboembolic complications is futile among symptomatic outpatients with COVID-19. The results from the OVID and ETHIC trials were published in The Lancet Haematology.
ETHIC trial
In the trial, Frank Cools, Department of Cardiology, General Hospital Klina, Brasschaat, Belgium, and the team aimed to evaluate the safety and efficacy of prophylactic low-molecular-weight heparin (enoxaparin) versus standard of care (no enoxaparin) in at-risk outpatients with COVID-19.
Based on the trial, the researchers found the following:
· Following the advice of the Data and Safety Monitoring Board, this study was terminated early due to slow enrolment and a lower-than-expected event rate.
· 230 patients with COVID-19 were assessed for eligibility, of whom 219 were enrolled between Oct 27, 2020, and Nov 8, 2021, and randomly assigned to receive standard of care (n=114) or enoxaparin(n=105).
· 44% patients were women, 56% were men, and one patient had missing sex data.
· 65% of 218 participants with data on race and ethnicity were White, 28% were Asian, and 7% were Black, mixed race, or Arab or Middle Eastern. Median follow-up in both groups was 21 days.
· There was no difference in the composite of all-cause mortality and hospitalisation at 21 days between the enoxaparin group (12 of 105 patients) and the standard-of-care group (12 of 114 patients; unadjusted hazard ratio 1·09).
· At 21 days, two of 105 patients in the enoxaparin group (one minor bleed and one bleed of unknown severity) and one of 114 patients in the standard-of-care group (major abnormal uterine bleeding) had a bleeding event.
· 21% patients in the enoxaparin group and 11% patients in the standard-of-care group had adverse events.
· The most common adverse event in both groups was COVID-19-related pneumonia (6% patients in the enoxaparin group and 4% patients in the standard-of-care group).
· One patient in the enoxaparin group died and their cause of death was unknown.
Findings from the ETHIC trial indicated that prophylaxis with low-molecular-weight heparin was not beneficial for at-risk outpatients with COVID-19. The trial although terminated early, "the data combined with data from similar studies, provide further insights to influence clinical practice and inform international guidelines," the researchers wrote in their study.
OVID trial
In the trial, Stefano Barco, Department of Angiology, University Hospital Zurich, Zurich, Switzerland, and colleagues aimed to investigate whether thromboprophylaxis with enoxaparin would prevent untoward hospitalisation and death in symptomatic, but clinically stable outpatients with COVID-19.
Based on the trial, the researchers found the following:
· At the predefined formal interim analysis for efficacy (50% of total study population), the independent Data Safety Monitoring Board recommended early termination of the trial on the basis of predefined statistical criteria having considered the very low probability of showing superiority of thromboprophylaxis with enoxaparin for the primary outcome under the initial study design assumptions.
· Between Aug 15, 2020, and Jan 14, 2022, from 3319 participants prescreened, 472 were included in the intention-to-treat population and randomly assigned to receive enoxaparin (n=234) or standard of care (n=238). The median age was 57 years (IQR 53–62) and 46% were women.
· The 30-day risk of the primary outcome was similar in participants allocated to receive enoxaparin and in controls (8 of 234 vs 8 of 238; adjusted relative risk 0·98).
· All hospitalisations were related to COVID-19.
· No deaths were reported during the study.
· No major bleeding events were recorded.
· Eight serious adverse events were recorded in the enoxaparin group versus nine in the control group.
"These findings indicate that thromboprophylaxis with enoxaparin does not reduce early hospitalisations and deaths among outpatients with symptomatic COVID-19," the researchers wrote in their study.
"Owing to under-representation of older patients and consequent low event rates, futility of the treatment under the initial study design assumptions could not be conclusively assessed," they concluded.
To sum up the findings from two trials, the routine use of antithrombotic therapies to prevent thromboembolic complications provided no benefit for symptomatic outpatients with COVID-19.
Reference:
1) The Lancet Haematology
Source Reference: Cools F, et al "Thromboprophylactic low-molecular-weight heparin versus standard of care in unvaccinated, at-risk outpatients with COVID-19 (ETHIC): an open-label, multicentre, randomised, controlled, phase 3b trial" Lancet Haematol 2022; DOI: 10.1016/S2352-3026(22)00173-9.
2) The Lancet Haematology
Source Reference: Barco S, et al "Enoxaparin for primary thromboprophylaxis in symptomatic outpatients with COVID-19 (OVID): a randomised, open-label, parallel-group, multicentre, phase 3 trial" Lancet Haematol 2022; DOI: 10.1016/S2352-3026(22)00175-2.
MSc. Biotechnology
Medha Baranwal joined Medical Dialogues as an Editor in 2018 for Speciality Medical Dialogues. She covers several medical specialties including Cardiac Sciences, Dentistry, Diabetes and Endo, Diagnostics, ENT, Gastroenterology, Neurosciences, and Radiology. She has completed her Bachelors in Biomedical Sciences from DU and then pursued Masters in Biotechnology from Amity University. She has a working experience of 5 years in the field of medical research writing, scientific writing, content writing, and content management. She can be contacted at  editorial@medicaldialogues.in. Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751