Abstract
Therapeutic anticoagulation showed inconsistent results in hospitalized patients with COVID-19 and selection of the best patients to use this strategy still a challenge balancing the risk of thrombotic and hemorrhagic outcomes. The present post-hoc analysis of the ACTION trial evaluated the variables independently associated with both bleeding events (major bleeding or clinically relevant non-major bleeding) and the composite outcomes thrombotic events (venous thromboembolism, myocardial infarction, stroke, systemic embolism, or major adverse limb events). Variables were assessed one by one with independent logistic regressions and final models were chosen based on Akaike information criteria. The model for bleeding events showed an area under the curve of 0.63 (95% confidence interval [CI] 0.53 to 0.73), while the model for thrombotic events had an area under the curve of 0.72 (95% CI 0.65 to 0.79). Non-invasive respiratory support was associated with thrombotic but not bleeding events, while invasive ventilation was associated with both outcomes (Odds Ratio of 7.03 [95 CI% 1.95 to 25.18] for thrombotic and 3.14 [95% CI 1.11 to 8.84] for bleeding events). Beyond respiratory support, creatinine level (Odds Ratio [OR] 1.01 95% CI 1.00 to 1.02 for every 1.0 mg/dL) and history of coronary disease (OR 3.67; 95% CI 1.32 to 10.29) were also independently associated to the risk of thrombotic events. Non-invasive respiratory support, history of coronary disease, and creatinine level may help to identify hospitalized COVID-19 patients at higher risk of thrombotic complications.
ClinicalTrials.gov: NCT04394377.
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PGMBS and RDL wrote the initial draft of the manuscript. All other authors contributed intellectually relevant content. BB and LPD performed the statistical analysis.
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PGMBS reports fees and research grants from Pfizer, Roche Diagnostics, and Bayer. RDL reports research support from Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, and Pfizer; Consulting fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Medtronic, Merck, Pfizer, Portola. RHMF reports research grants and personal fees from AstraZeneca, Bayer, Servier, and Apsen; and research grants (received from his institution) from Pfizer, Libbs, Brazilian Ministry of Health, and University Health Network; none of them related to the current article.AA reports research grants from Bayer, Sanofi-Pasteur, and Population Health Research Institute. ABC reports research grants from Bayer. Dr OB reports research grants from AstraZeneca, Bayer, Amgen, Pfizer, Boehringer-Ingelheim, BMS, Servier, and Novartis. All other authors declare no conflicts of interest.
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de Barros e Silva, P.G.M., Furtado, R.H.M., de Alcântara Chaud, M.S. et al. Predictors of bleeding and thrombotic events among patients admitted to the hospital with COVID-19 and elevated D-dimer: insights from the ACTION randomized clinical trial. J Thromb Thrombolysis (2024). https://doi.org/10.1007/s11239-024-02995-y
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DOI: https://doi.org/10.1007/s11239-024-02995-y