Abstract
Background: COVID-19 patients are at high thrombotic risk. The safety and efficacy of different anticoagulation regimens in COVID-19 patients remain unclear. Methods: We searched for randomised controlled trials (RCTs) comparing intermediate- or therapeutic-dose anticoagulation to standard thromboprophylaxis in hospitalised patients with COVID-19 irrespective of disease severity. To assess efficacy and safety, we meta-analysed data for all-cause mortality, clinical status, thrombotic event or death, and major bleedings. Results: Eight RCTs, including 5580 patients, were identified, with two comparing intermediate- and six therapeutic-dose anticoagulation to standard thromboprophylaxis. Intermediate-dose anticoagulation may have little or no effect on any thrombotic event or death (RR 1.03, 95% CI 0.86–1.24), but may increase major bleedings (RR 1.48, 95% CI 0.53–4.15) in moderate to severe COVID-19 patients. Therapeutic-dose anticoagulation may decrease any thrombotic event or death in patients with moderate COVID-19 (RR 0.64, 95% CI 0.38–1.07), but may have little or no effect in patients with severe disease (RR 0.98, 95% CI 0.86–1.12). The risk of major bleedings may increase independent of disease severity (RR 1.78, 95% CI 1.15–2.74). Conclusions: Certainty of evidence is still low. Moderately affected COVID-19 patients may benefit from therapeutic-dose anticoagulation, but the risk for bleeding is increased.
Highlights
In its severe form, COVID-19, the clinical manifestation associated with SARS-CoV-2 infection, is characterized by respiratory failure and high rates of thromboembolic complications [1]
Given the pro-coagulant status and increased thrombotic risk of COVID-19, the question remains whether intensified prophylactic anticoagulation with intermediate or therapeutic doses can decrease the risk of disease progression, clinical worsening or death without increasing the risk for adverse events, such as major bleedings [7]
Intermediate-dose anticoagulation compared to standard thromboprophylaxis in patients with moderate to severe COVID-19 may have little or no effect on all-cause mortality at 30 days (RR 0.98, 95% confidence interval (CI) 0.74–1.32, 763 participants, two studies, low-certainty evidence) and 90 days (RR 1.07, 95% CI 0.89–1.28, 590 participants, one study, low-certainty evidence)
Summary
In its severe form, COVID-19, the clinical manifestation associated with SARS-CoV-2 infection, is characterized by respiratory failure and high rates of thromboembolic complications [1] Procoagulant markers, such as elevated D-Dimers are widely accepted as prognostic factors for severe disease progression [2,3]. For selected hospitalised medical and surgical non-COVID patients, prophylactic low-dose anticoagulation, typically with low molecular weight heparins or unfractionated heparin, has proven beneficial effects in several randomised prospective studies and is recommended by various national guidelines [4,5]. These recommendations have been widely adopted to COVID-19 patients. We performed a systematic review with meta-analysis of available randomised-controlled trials (RCTs) to determine the safety and efficacy of intensified anticoagulation with intermediate or therapeutic doses compared to standard-dose thromboprophylaxis in hospitalised patients with COVID-19
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