Background: Reported results of clinical trials assessing higher-dose anticoagulation in patients hospitalized for COVID-19 have been inconsistent. Purpose: To estimate the association of higher- versus lower-dose anticoagulation with clinical outcomes. Data Sources: Randomized trials were identified from the World Health Organization's International Clinical Trials Registry Platform and ClinicalTrials.gov with no restriction by trial status or language. Study Selection: Eligible randomized trials assigned patients hospitalized for COVID-19 to higher- versus lower-dose anticoagulation. Data Extraction: 20 eligible trials provided data in a prospectively agreed format. Two further studies were included based on published data. The primary outcome was all-cause mortality 28 days after randomization. Secondary outcomes were progression to invasive mechanical ventilation or death, thromboembolic events, and major bleeding. Data Synthesis: Therapeutic- compared with prophylactic-dose anticoagulation with heparins reduced 28-day mortality (OR, 0.77 [95% CI, 0.64 to 0.93]; I2 ¼ 29%; 11 trials, 6297 patients, of whom 5456 required low or no oxygen at randomization). The ORs for 28-day mortality were 1.21 (CI, 0.93 to 1.58; I2 ¼ 0%) for therapeutic-dose compared with intermediate-dose anticoagulation (6 trials, 1803 patients, 843 receiving noninvasive ventilation at randomization) and 0.95 (CI, 0.76 to 1.19; I2 ¼ 0%; 10 trials, 3897 patients, 2935 receiving no or low oxygen at randomization) for intermediate- versus prophylactic-dose anticoagulation. Treatment effects appeared broadly consistent across predefined patient subgroups, although some analyses were limited in power. Higher- compared with lower-dose anticoagulation was associated with fewer thromboembolic events, but a greater risk for major bleeding. Conclusion: Therapeutic-dose compared with prophylactic-dose anticoagulation reduced 28-day mortality. Mortality was similar for intermediate-dose compared with prophylactic-dose anticoagulation and higher for therapeutic-dose compared with intermediate-dose anticoagulation, although this comparison was not estimated precisely.
Anticoagulation Among Patients Hospitalized for COVID-19 A Systematic Review and Prospective Meta-analysis / Vale, C. L.; Godolphin, P. J.; Fisher, D. J.; Higgins, J. P. T.; Mcaleenan, A.; Spiga, F.; Tritschler, T.; De Barros E Silva, P. G. M.; Berg, D. D.; Berger, J. S.; Berry, L. R.; Bikdeli, B.; Blondon, M.; Bohula, E. A.; Cattaneo, M.; Colombo, R.; Coluccio, V.; Desancho, M. T.; Farkouh, M. E.; Fuster, V.; Girardis, M.; Hochman, J. S.; Jensen, T. P.; Jha, V.; Juni, P.; Kirtane, A. J.; Lawler, P. L.; Le Gal, G.; Lecumberri, R.; Lentz, S. R.; Lopes, R. D.; Lorenzi, E.; Marietta, M.; Miranda, C. H.; Morici, N.; Morpeth, S. C.; Morrow, D. A.; Mcquilten, Z. K.; Munoz-Rivas, N.; Neal, M. D.; Pant, S.; Parikh, S. A.; Perepu, U.; Sadeghipour, P.; Sethi, S.; Sholzberg, M.; Spyropoulos, A. C.; Stone, G. W.; Talasaz, A. H.; Tong, S. Y. C.; Totterdell, J.; Venkatesh, B.; Wu, M. A.; Zarychanski, R.; Zuily, S.; Viry, J.; Rylance, J.; Adhikari, N. K. J.; Diaz, J. V.; Marshall, J. C.; Sterne, J. A. C.; Murthy, S.. - In: ANNALS OF INTERNAL MEDICINE. - ISSN 0003-4819. - 178:1(2025), pp. 59-69. [10.7326/ANNALS-24-00800]
Anticoagulation Among Patients Hospitalized for COVID-19 A Systematic Review and Prospective Meta-analysis
Spiga F.;Cattaneo M.;Coluccio V.;Girardis M.;Lorenzi E.;Marietta M.;
2025
Abstract
Background: Reported results of clinical trials assessing higher-dose anticoagulation in patients hospitalized for COVID-19 have been inconsistent. Purpose: To estimate the association of higher- versus lower-dose anticoagulation with clinical outcomes. Data Sources: Randomized trials were identified from the World Health Organization's International Clinical Trials Registry Platform and ClinicalTrials.gov with no restriction by trial status or language. Study Selection: Eligible randomized trials assigned patients hospitalized for COVID-19 to higher- versus lower-dose anticoagulation. Data Extraction: 20 eligible trials provided data in a prospectively agreed format. Two further studies were included based on published data. The primary outcome was all-cause mortality 28 days after randomization. Secondary outcomes were progression to invasive mechanical ventilation or death, thromboembolic events, and major bleeding. Data Synthesis: Therapeutic- compared with prophylactic-dose anticoagulation with heparins reduced 28-day mortality (OR, 0.77 [95% CI, 0.64 to 0.93]; I2 ¼ 29%; 11 trials, 6297 patients, of whom 5456 required low or no oxygen at randomization). The ORs for 28-day mortality were 1.21 (CI, 0.93 to 1.58; I2 ¼ 0%) for therapeutic-dose compared with intermediate-dose anticoagulation (6 trials, 1803 patients, 843 receiving noninvasive ventilation at randomization) and 0.95 (CI, 0.76 to 1.19; I2 ¼ 0%; 10 trials, 3897 patients, 2935 receiving no or low oxygen at randomization) for intermediate- versus prophylactic-dose anticoagulation. Treatment effects appeared broadly consistent across predefined patient subgroups, although some analyses were limited in power. Higher- compared with lower-dose anticoagulation was associated with fewer thromboembolic events, but a greater risk for major bleeding. Conclusion: Therapeutic-dose compared with prophylactic-dose anticoagulation reduced 28-day mortality. Mortality was similar for intermediate-dose compared with prophylactic-dose anticoagulation and higher for therapeutic-dose compared with intermediate-dose anticoagulation, although this comparison was not estimated precisely.
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