Dataset Information

Arterial Thrombotic Events in Adult Inpatients With COVID-19.

ABSTRACT:

Objective

To evaluate the clinical course of and risk factors for arterial thrombotic events in adult inpatients with coronavirus disease 2019 (COVID-19).

Methods

All consecutive adult patients admitted for COVID-19 infection in a referral center in France and discharged from the hospital between April 1 and April 30, 2020, were included. All arterial thrombotic events that occurred through discharge were considered for analysis. Epidemiologic, demographic, clinical, laboratory, treatment, and outcome data were extracted from electronic medical records with use of a standardized data collection form.

Results

Overall, 531 COVID-19+ patients were analyzed. Among them, 30 (5.6%) experienced arterial thrombotic events. Arterial thrombotic events in the setting of COVID-19 infection happened at a median of 11 (5-20) days after the first symptoms of infection; occurred in high-risk patients according to traditional cardiovascular risk factors; had an atypical pattern, such as thrombosis of the aorta, upper limb, or renal arteries or cerebral microvasculopathy in 7 (23.3%) cases; and were associated with an in-hospital mortality rate of 40%. Arterial thrombotic events increased the risk of death by 3-fold in COVID-19+ patients (hazard ratio, 2.96; 95% CI, 1.4 to 4.7; P=.002). A subdistribution survival hazard model showed that a concentration of D-dimer above 1250 ng/mL increased the risk of arterial thrombotic events in COVID-19+ patients by more than 7 (subdistribution hazard ratio, 7.68; 95% CI, 2.9 to 20.6; P<.001).

Conclusion

A dramatically high rate of in-hospital death was observed in patients who suffered arterial thrombotic events in the setting of COVID-19 infection. A D-dimer level above 1250 ng/mL at entry may identify COVID-19+ patients at risk for arterial thrombotic events.

SUBMITTER: Fournier M

PROVIDER: S-EPMC7691140 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Arterial Thrombotic Events in Adult Inpatients With COVID-19.

Fournier Morgane M Faille Dorothée D Dossier Antoine A Mageau Arthur A Nicaise Roland Pascale P Ajzenberg Nadine N Borie Raphael R Bouadma Lila L Bunel Vincent V Castier Yves Y Choquet Christophe C Crestani Bruno B Daugas Eric E Deconinck Laurene L Descamps Diane D Descamps Vincent V Dieudé Philippe P Ducrocq Gregory G Faucher Nathalie N Goulenok Tiphaine T Guidoux Céline C Khalil Antoine A Lavallée Philippa P Lescure François Xavier FX Lortat-Jacob Brice B Mal Hervé H Mutuon Pierre P Pellenc Quentin Q Steg Philippe Gabriel PG Taille Camille C Timsit Jean Francois JF Yazdanpanah Yazdan Y Papo Thomas T Sacré Karim K

Mayo Clinic proceedings 20201127 2

<h4>Objective</h4>To evaluate the clinical course of and risk factors for arterial thrombotic events in adult inpatients with coronavirus disease 2019 (COVID-19).<h4>Methods</h4>All consecutive adult patients admitted for COVID-19 infection in a referral center in France and discharged from the hospital between April 1 and April 30, 2020, were included. All arterial thrombotic events that occurred through discharge were considered for analysis. Epidemiologic, demographic, clinical, laboratory, t ...[more]

PMID: 33549252

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Project description:ImportanceThe incidence of arterial thromboembolism and venous thromboembolism in persons with COVID-19 remains unclear.ObjectiveTo measure the 90-day risk of arterial thromboembolism and venous thromboembolism in patients hospitalized with COVID-19 before or during COVID-19 vaccine availability vs patients hospitalized with influenza.Design, setting, and participantsRetrospective cohort study of 41 443 patients hospitalized with COVID-19 before vaccine availability (April-November 2020), 44 194 patients hospitalized with COVID-19 during vaccine availability (December 2020-May 2021), and 8269 patients hospitalized with influenza (October 2018-April 2019) in the US Food and Drug Administration Sentinel System (data from 2 national health insurers and 4 regional integrated health systems).ExposuresCOVID-19 or influenza (identified by hospital diagnosis or nucleic acid test).Main outcomes and measuresHospital diagnosis of arterial thromboembolism (acute myocardial infarction or ischemic stroke) and venous thromboembolism (deep vein thrombosis or pulmonary embolism) within 90 days. Outcomes were ascertained through July 2019 for patients with influenza and through August 2021 for patients with COVID-19. Propensity scores with fine stratification were developed to account for differences between the influenza and COVID-19 cohorts. Weighted Cox regression was used to estimate the adjusted hazard ratios (HRs) for outcomes during each COVID-19 vaccine availability period vs the influenza period.ResultsA total of 85 637 patients with COVID-19 (mean age, 72 [SD, 13.0] years; 50.5% were male) and 8269 with influenza (mean age, 72 [SD, 13.3] years; 45.0% were male) were included. The 90-day absolute risk of arterial thromboembolism was 14.4% (95% CI, 13.6%-15.2%) in patients with influenza vs 15.8% (95% CI, 15.5%-16.2%) in patients with COVID-19 before vaccine availability (risk difference, 1.4% [95% CI, 1.0%-2.3%]) and 16.3% (95% CI, 16.0%-16.6%) in patients with COVID-19 during vaccine availability (risk difference, 1.9% [95% CI, 1.1%-2.7%]). Compared with patients with influenza, the risk of arterial thromboembolism was not significantly higher among patients with COVID-19 before vaccine availability (adjusted HR, 1.04 [95% CI, 0.97-1.11]) or during vaccine availability (adjusted HR, 1.07 [95% CI, 1.00-1.14]). The 90-day absolute risk of venous thromboembolism was 5.3% (95% CI, 4.9%-5.8%) in patients with influenza vs 9.5% (95% CI, 9.2%-9.7%) in patients with COVID-19 before vaccine availability (risk difference, 4.1% [95% CI, 3.6%-4.7%]) and 10.9% (95% CI, 10.6%-11.1%) in patients with COVID-19 during vaccine availability (risk difference, 5.5% [95% CI, 5.0%-6.1%]). Compared with patients with influenza, the risk of venous thromboembolism was significantly higher among patients with COVID-19 before vaccine availability (adjusted HR, 1.60 [95% CI, 1.43-1.79]) and during vaccine availability (adjusted HR, 1.89 [95% CI, 1.68-2.12]).Conclusions and relevanceBased on data from a US public health surveillance system, hospitalization with COVID-19 before and during vaccine availability, vs hospitalization with influenza in 2018-2019, was significantly associated with a higher risk of venous thromboembolism within 90 days, but there was no significant difference in the risk of arterial thromboembolism within 90 days.

Project description:BackgroundThe efficacy and safety of prophylactic full-dose anticoagulation and antiplatelet therapy in critically ill COVID-19 patients remain uncertain.MethodsCOVID-PACT (Prevention of Arteriovenous Thrombotic Events in Critically-ill COVID-19 Patients Trial) was a multicenter, 2×2 factorial, open-label, randomized-controlled trial with blinded end point adjudication in intensive care unit-level patients with COVID-19. Patients were randomly assigned to a strategy of full-dose anticoagulation or standard-dose prophylactic anticoagulation. Absent an indication for antiplatelet therapy, patients were additionally randomly assigned to either clopidogrel or no antiplatelet therapy. The primary efficacy outcome was the hierarchical composite of death attributable to venous or arterial thrombosis, pulmonary embolism, clinically evident deep venous thrombosis, type 1 myocardial infarction, ischemic stroke, systemic embolic event or acute limb ischemia, or clinically silent deep venous thrombosis, through hospital discharge or 28 days. The primary efficacy analyses included an unmatched win ratio and time-to-first event analysis while patients were on treatment. The primary safety outcome was fatal or life-threatening bleeding. The secondary safety outcome was moderate to severe bleeding. Recruitment was stopped early in March 2022 (≈50% planned recruitment) because of waning intensive care unit-level COVID-19 rates.ResultsAt 34 centers in the United States, 390 patients were randomly assigned between anticoagulation strategies and 292 between antiplatelet strategies (382 and 290 in the on-treatment analyses). At randomization, 99% of patients required advanced respiratory therapy, including 15% requiring invasive mechanical ventilation; 40% required invasive ventilation during hospitalization. Comparing anticoagulation strategies, a greater proportion of wins occurred with full-dose anticoagulation (12.3%) versus standard-dose prophylactic anticoagulation (6.4%; win ratio, 1.95 [95% CI, 1.08-3.55]; P=0.028). Results were consistent in time-to-event analysis for the primary efficacy end point (full-dose versus standard-dose incidence 19/191 [9.9%] versus 29/191 [15.2%]; hazard ratio, 0.56 [95% CI, 0.32-0.99]; P=0.046). The primary safety end point occurred in 4 (2.1%) on full dose and in 1 (0.5%) on standard dose (P=0.19); the secondary safety end point occurred in 15 (7.9%) versus 1 (0.5%; P=0.002). There was no difference in all-cause mortality (hazard ratio, 0.91 [95% CI, 0.56-1.48]; P=0.70). There were no differences in the primary efficacy or safety end points with clopidogrel versus no antiplatelet therapy.ConclusionsIn critically ill patients with COVID-19, full-dose anticoagulation, but not clopidogrel, reduced thrombotic complications with an increase in bleeding, driven primarily by transfusions in hemodynamically stable patients, and no apparent excess in mortality.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT04409834.

Project description:ImportanceThe actual risk of thrombotic events after Covid-19 vaccination is unknown.ObjectiveTo evaluate the risk of thrombotic events after Covid-19 vaccination.DesignRetrospective cohort study which included consecutive adult patients vaccinated with the first dose of Covid-19 vaccine between January 1 and May 30, 2021, and a historic control group, defined as consecutive patients vaccinated with influenza vaccine between March 1 and July 30, 2019.SettingHospital Italiano de Buenos Aires, a tertiary hospital in Argentina.ParticipantsNon-Hospitalized Adults vaccinated with the first dose of a Covid-19 vaccine.ExposureVaccination with Covid-19 vaccines available during the study period: Gam-COVID-Vac (Sputnik), ChAdOx1 nCoV-19 (AstraZeneca/Oxford or Covishield), BBIBP-CorV (Beijing Institute of Biological Products) (Sinopharm). Active comparator group exposure was Influenza vaccine.Main outcomePrimary endpoint was cumulative incidence of any symptomatic thrombotic event at 30 days, defined as the occurrence of at least one of the following: symptomatic acute deep venous thrombosis (DVT); symptomatic acute pulmonary embolism (PE); acute ischemic stroke (AIS); acute coronary syndrome (ACS) or arterial thrombosis.ResultsFrom a total of 29,985 adult patients who received at least a first dose of Covid-19 vaccine during study period and 24,777 who received Influenza vaccine in 2019, we excluded those who were vaccinated during hospitalization. We finally included 29,918 and 24,753 patients respectively. Median age was 73 years old (IQR 75-81) and 67% were females in both groups. Thirty six subjects in the Covid-19 vaccination group (36/29,918) and 15 patients in the Influenza vaccination group (15/24,753) presented at least one thrombotic event. The cumulative incidence of any thrombotic event at 30 days was 12 per 10,000 (95%CI 9-17) for Covid-19 group and 6 per 10,000 (95%CI 4-10) for Influenza group (p-value=0.022).Conclusions and relevanceThis study shows a significant increase in thrombotic events in subjects vaccinated with Covid-19 vaccines in comparison to a control group. The clinical implication of these findings should be interpreted with caution, in light of the high effectiveness of vaccination and the inherent risk of thrombosis from Covid-19 infection itself.

Dataset Information

Arterial Thrombotic Events in Adult Inpatients With COVID-19.

Objective

Methods

Results

Conclusion

Publications

Arterial Thrombotic Events in Adult Inpatients With COVID-19.

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