tetano
Editor, Senior Moderator
J Thromb Haemost
. 2021 Jul 8.
doi: 10.1111/jth.15450. Online ahead of print.
Standard prophylactic versus intermediate dose enoxaparin in adults with severe COVID-19: a multi-center, open-label, randomized controlled trial: zed controlled trial
Usha S Perepu[SUP] 1 [/SUP], Isaac Chambers[SUP] 1 [/SUP], Abdul Wahab[SUP] 1 [/SUP], Patrick Ten Eyck[SUP] 2 [/SUP], Chaorong Wu[SUP] 2 [/SUP], Sanjana Dayal[SUP] 1 [/SUP], Grerk Sutamtewagul[SUP] 1 [/SUP], Steven R Bailey[SUP] 3 [/SUP], Lori J Rosenstein[SUP] 4 [/SUP], Steven R Lentz[SUP] 1 [/SUP]
Affiliations
Abstract
Background: Coronavirus disease 2019 (COVID-19) is associated with coagulopathy but the optimal prophylactic anticoagulation therapy remains uncertain and may depend on COVID-19 severity.
Objective: To compare outcomes in hospitalized adults with severe COVID-19 treated with standard prophylactic versus intermediate dose enoxaparin.
Methods: We conducted a multi-center, open-label, randomized controlled trial comparing standard prophylactic dose versus intermediate dose enoxaparin in adults who were hospitalized with COVID-19 and admitted to an intensive care unit (ICU) and/or had laboratory evidence of coagulopathy. Patients were randomly assigned in a 1:1 ratio to receive standard prophylactic dose enoxaparin or intermediate weight-adjusted dose enoxaparin. The primary outcome was all-cause mortality at 30 days. Secondary outcomes included arterial or venous thromboembolism and major bleeding.
Results: A total of 176 patients (99 males and 77 females) underwent randomization. In the intention-to-treat population, all-cause mortality at 30 days was 15% for intermediate dose enoxaparin and 21% for standard prophylactic dose enoxaparin (odds ratio, 0.66; 95% confidence interval, 0.30-1.45; P=0.31 by chi-square test). Unadjusted Cox proportional hazards modeling demonstrated no significant difference in mortality between intermediate and standard dose enoxaparin (hazard ratio, 0.67; 95% confidence interval, 0.33 to 1.37; P=0.28). Arterial or venous thrombosis occurred in 13% of patients assigned to intermediate dose enoxaparin and 9% of patients assigned to standard dose enoxaparin. Major bleeding occurred in 2% of patients in each arm.
Conclusion: In hospitalized adults with severe COVID-19, standard prophylactic dose and intermediate dose enoxaparin did not differ significantly in preventing death or thrombosis at 30 days.
Keywords: Anticoagulant; Blood Coagulation; COVID-19 Virus Disease; Enoxaparin; Thrombosis.
. 2021 Jul 8.
doi: 10.1111/jth.15450. Online ahead of print.
Standard prophylactic versus intermediate dose enoxaparin in adults with severe COVID-19: a multi-center, open-label, randomized controlled trial: zed controlled trial
Usha S Perepu[SUP] 1 [/SUP], Isaac Chambers[SUP] 1 [/SUP], Abdul Wahab[SUP] 1 [/SUP], Patrick Ten Eyck[SUP] 2 [/SUP], Chaorong Wu[SUP] 2 [/SUP], Sanjana Dayal[SUP] 1 [/SUP], Grerk Sutamtewagul[SUP] 1 [/SUP], Steven R Bailey[SUP] 3 [/SUP], Lori J Rosenstein[SUP] 4 [/SUP], Steven R Lentz[SUP] 1 [/SUP]
Affiliations
- PMID: 34236768
- DOI: 10.1111/jth.15450
Abstract
Background: Coronavirus disease 2019 (COVID-19) is associated with coagulopathy but the optimal prophylactic anticoagulation therapy remains uncertain and may depend on COVID-19 severity.
Objective: To compare outcomes in hospitalized adults with severe COVID-19 treated with standard prophylactic versus intermediate dose enoxaparin.
Methods: We conducted a multi-center, open-label, randomized controlled trial comparing standard prophylactic dose versus intermediate dose enoxaparin in adults who were hospitalized with COVID-19 and admitted to an intensive care unit (ICU) and/or had laboratory evidence of coagulopathy. Patients were randomly assigned in a 1:1 ratio to receive standard prophylactic dose enoxaparin or intermediate weight-adjusted dose enoxaparin. The primary outcome was all-cause mortality at 30 days. Secondary outcomes included arterial or venous thromboembolism and major bleeding.
Results: A total of 176 patients (99 males and 77 females) underwent randomization. In the intention-to-treat population, all-cause mortality at 30 days was 15% for intermediate dose enoxaparin and 21% for standard prophylactic dose enoxaparin (odds ratio, 0.66; 95% confidence interval, 0.30-1.45; P=0.31 by chi-square test). Unadjusted Cox proportional hazards modeling demonstrated no significant difference in mortality between intermediate and standard dose enoxaparin (hazard ratio, 0.67; 95% confidence interval, 0.33 to 1.37; P=0.28). Arterial or venous thrombosis occurred in 13% of patients assigned to intermediate dose enoxaparin and 9% of patients assigned to standard dose enoxaparin. Major bleeding occurred in 2% of patients in each arm.
Conclusion: In hospitalized adults with severe COVID-19, standard prophylactic dose and intermediate dose enoxaparin did not differ significantly in preventing death or thrombosis at 30 days.
Keywords: Anticoagulant; Blood Coagulation; COVID-19 Virus Disease; Enoxaparin; Thrombosis.