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1.
Khirurgiia (Mosk) ; (6): 55-61, 2022.
Article in Russian | MEDLINE | ID: covidwho-1879689

ABSTRACT

OBJECTIVE: To determine whether patients with perioperative or previous coronavirus infection (CVI) have a greater risk of venous thromboembolic events (VTE). MATERIAL AND METHODS: A multiple-center regional prospective retrospective cohort study included elective and emergency patients who underwent surgery in November 2020. The primary endpoint was VTE (PE/DVT) within 30 days after surgery. CVI was stratified as perioperative (7 days before surgery - 30 days after surgery), recent (1-6 weeks before surgery) and remote (≥7 weeks before surgery) infection. There was no information about prevention or preoperative anticoagulation at baseline data collection. RESULTS: Incidence of postoperative VTE was 1.5% (10/650) in patients without CVI, 33.3% (3/9) in patients with perioperative CVI, 18.1% (2/11) in patients with recent CVI and 8.3% (1/12) in patients with remote CVI. After adjusting the confounders, patients with perioperative and recent CVI remained at a higher risk of VTE. In general, VTEs were independently associated with 30-day mortality. In patients with CVI, mortality rate among ones without VTE was 21.7% (5/23), with VTE - 44.4% (4/9). CONCLUSION: Patients with perioperative CVI have a higher risk of postoperative VTE compared to those without CVI and patients with previous CVI and no residual symptoms. Mortality in this group is also higher than in other cohorts.


Subject(s)
Coronavirus Infections , Pulmonary Embolism , Venous Thromboembolism , Venous Thrombosis , Humans , Incidence , Postoperative Complications/diagnosis , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prospective Studies , Pulmonary Embolism/diagnosis , Pulmonary Embolism/epidemiology , Pulmonary Embolism/etiology , Retrospective Studies , Risk Factors , Venous Thromboembolism/diagnosis , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiology , Venous Thrombosis/etiology
2.
Zhonghua Jie He He Hu Xi Za Zhi ; 45(6): 588-592, 2022 Jun 12.
Article in Chinese | MEDLINE | ID: covidwho-1879503

ABSTRACT

In the past year, significant progress has been made in the field of venous thromboembolism (VTE) including risk assessment and anticoagulation prevention, diagnostic strategies and model exploration, new drug development and disease management. Particularly, major breakthroughs have been made in the prevention of VTE with FXI inhibitors and the prevention of novel coronavirus pneumonia with coagulation alterations and anticoagulation interventions. Here, we reviewed the progress and achievements in the field of VTE in the past year, aiming to provide evidence and ideas for the diagnosis, treatment and future studies of VTE.


Subject(s)
COVID-19 , Venous Thromboembolism , Anticoagulants/therapeutic use , Blood Coagulation , Humans , Risk Factors , SARS-CoV-2 , Venous Thromboembolism/diagnosis
3.
Clin Appl Thromb Hemost ; 28: 10760296221103864, 2022.
Article in English | MEDLINE | ID: covidwho-1879207

ABSTRACT

PURPOSE: Coagulation abnormalities are one of the most important complications of severe COVID-19, which might lead to venous thromboembolism (VTE). Hypercoagulability with hyperfibrinogenemia causes large vessel thrombosis and major thromboembolic sequelae. Statins are potentially a potent adjuvant therapy in COVID-19 infection due to their pleiotropic effect. This study aims to evaluate the effectiveness of statins in reducing the risk of thrombosis among hospitalized critically ill patients with COVID-19. METHODS: A multicenter, retrospective cohort study of all critically ill adult patients with confirmed COVID-19 admitted to Intensive Care Units (ICUs) between March 1, 2020, and March 31, 2021. Eligible patients were categorized based on their usage of statins throughout their ICU stay and were matched with a propensity score. The primary endpoint was the odds of all cases of thrombosis; other outcomes were considered secondary. RESULTS: A total of 1039 patients were eligible; following propensity score matching, 396 patients were included (1:1 ratio). The odds of all thrombosis cases and VTE events did not differ significantly between the two groups (OR 0.84 (95% CI 0.43, 1.66), P = 0.62 and OR 1.13 (95% CI 0.43, 2.98), P = 0.81, respectively. On multivariable Cox proportional hazards regression analysis, patients who received statin therapy had lower 30-day (HR 0.72 (95 % CI 0.54, 0.97), P = 0.03) and in-hospital mortality (HR 0.67 (95 % CI 0.51, 0.89), P = 0.007). Other secondary outcomes were not statistically significant between the two groups except for D-dimer levels (peak) during ICU stay. CONCLUSION: The use of statin therapy during ICU stay was not associated with thrombosis reduction in critically ill patients with COVID-19; however, it has been associated with survival benefits.


Subject(s)
Blood Coagulation Disorders , COVID-19 , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Thrombosis , Venous Thromboembolism , Adult , COVID-19/complications , COVID-19/drug therapy , Cohort Studies , Critical Illness , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Intensive Care Units , Retrospective Studies , Thrombosis/chemically induced , Thrombosis/etiology , Venous Thromboembolism/chemically induced , Venous Thromboembolism/etiology
4.
Curr Opin Pediatr ; 34(3): 261-267, 2022 06 01.
Article in English | MEDLINE | ID: covidwho-1874057

ABSTRACT

PURPOSE OF REVIEW: To provide an update regarding what is known about thrombotic events and thromboprophylaxis in critically ill children with SARS-CoV-2 infection. RECENT FINDINGS: Pediatric patients with SARS-CoV-2 generally have mild illness; however, intensive care is required in about 20-30% of hospitalized children with COVID-19 and an even higher proportion in those with MIS-C. Increased rates of thrombosis have been observed in adults hospitalized with COVID-19, and clinical trials have attempted to optimize thromboprophylaxis. There is significant variability in the estimated incidence of thrombosis in pediatric patients (0-27%) because of variation in patient populations and study design. Multiple studies demonstrate an increased rate of thrombosis compared with baseline in hospitalized pediatric patients. Few studies have evaluated risk factors for thrombosis, but critical illness, older age, and other known thrombosis risk factors appear to increase the risk. Thromboprophylaxis strategies are inconsistent, with little evidence of efficacy but few reports of major bleeding. SUMMARY: Critically ill children with SARS-CoV-2-related illnesses are at increased risk of thrombosis. Thromboprophylaxis should be considered in select patients with COVID-19 or MIS-C, though the optimal strategy is not yet known. More data is required to guide practice to prevent thrombosis in this population.


Subject(s)
COVID-19 , Thrombosis , Venous Thromboembolism , Adult , Anticoagulants/therapeutic use , COVID-19/complications , COVID-19/epidemiology , Child , Critical Illness/therapy , Humans , SARS-CoV-2 , Systemic Inflammatory Response Syndrome , Thrombosis/epidemiology , Thrombosis/etiology , Thrombosis/prevention & control , Venous Thromboembolism/diagnosis , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiology
5.
Blood Coagul Fibrinolysis ; 33(4): 209-215, 2022 Jun 01.
Article in English | MEDLINE | ID: covidwho-1874043

ABSTRACT

Clinicians experience some challenges due to the lack of standardization of test, although D-dimer is a prognostic marker for COVID-19. We compared the clinical and analytical performances of D-dimer results obtained from different devices, kits and methods in patients with a diagnosis of COVID-19. Thirty-nine patients with a diagnosis of COVID-19 and 24 healthy individuals were included in the study. D-dimer levels were measured with Innovance D-DIMER kit (immunoturbidimetric method) on Sysmex CS-2500 and BCS XP and VIDAS D-Dimer Exclusion II kit (enzyme-linked fluorescence method) on mini VIDAS. The studies of precision, method comparison and clinic performance were performed. The variation coefficients in all systems were within the acceptable imprecision (7.8%). Bias%(12.5%) between BCS XP and Sysmex CS-2500 was lower than the acceptable Bias%(15.5%). Bias% values (19.2% and 33.3%, respectively) between Mini VIDAS with BCS XP and Sysmex CS-2500 were higher than the acceptable Bias%. The correlation coefficients among all systems were 0.89-0.98. For 500 ng/ml FEU, there was almost perfect agreement between BCS XP and Sysmex CS-2500, a moderate agreement between Mini VIDAS and BCS XP and Sysmex CS-2500. The cut-off values for distinguishing between individuals with and withoutCOVID-19 were Mini VIDAS, Sysmex CS-2500 and BCS XP 529, 380 and 390 ng/ml FEU, respectively. The immunoturbidimetric method can be used as an alternative to the enzyme-linked fluorescent method because of satisfactory agreement at the different thresholds proposed for venous thromboembolism. However, it is recommended to follow up COVID-19 with the D-dimer results obtained by the same assay system.


Subject(s)
COVID-19 , Venous Thromboembolism , COVID-19/diagnosis , Fibrin Fibrinogen Degradation Products , Humans , Immunoturbidimetry , Sensitivity and Specificity , Venous Thromboembolism/diagnosis
6.
Curr Neurol Neurosci Rep ; 21(10): 59, 2021 10 20.
Article in English | MEDLINE | ID: covidwho-1866682

ABSTRACT

PURPOSE OF REVIEW: The present review discusses in-depth about neurological complications following acute venous thromboembolism (VTE). RECENT FINDINGS: Intracranial hemorrhage, acute ischemic cerebrovascular events, and VTE in brain tumors are described as central nervous system (CNS) complications of PE, while peripheral neuropathy and neuropathic pain are reported as peripheral nervous system (PNS) sequelae of PE. Syncope and seizure are illustrated as atypical neurological presentations of PE. Mounting evidence suggests higher risk of venous thromboembolism (VTE) in patients with neurological diseases, but data on reverse, i.e., neurological sequelae following VTE, is underexplored. The present review is an attempt to explore some of the latter issues categorized into CNS, PNS, and atypical complications following VTE.


Subject(s)
Brain Neoplasms , Pulmonary Embolism , Venous Thromboembolism , Venous Thrombosis , Anticoagulants , Humans , Pulmonary Embolism/complications , Pulmonary Embolism/epidemiology , Risk Factors , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiology
7.
Clin Appl Thromb Hemost ; 28: 10760296221102940, 2022.
Article in English | MEDLINE | ID: covidwho-1861966

ABSTRACT

OBJECTIVE: To evaluate the discriminative ability and the calibration of the Pulmonary Embolism Severity Index (PESI) to predict in-hospital mortality in patients with Pulmonary Embolism (PE) secondary to COVID 19 in two hospitals in Bogotá. METHODS: External validation study of a prediction model based on a retrospective cohort of patients with PE secondary to COVID-19 treated at Hospital Universitario San Ignacio and Hospital universitario La Samaritana, between March 2020 and August 2021. Calibration of the scale was evaluated using the Hosmer-Lemeshow test and a calibration belt diagram. Discrimination ability was evaluated using a ROC curve. RESULTS: 272 patients were included (median age 61.5 years, male 58.8%). PE was diagnosed in 45.6% of the patients at the time of admission. Of the remaining 54.4%, 95.9% received thromboprophylaxis until the time of diagnosis.17.6% of the patients died. Regarding calibration, the scale systematically underestimates risk in all classes of PESI. For class I, the ratio of observed/expected events was 4.4 vs 0.8%, class II 4.8 vs 1.8%, class III 15.2 vs 4.2%, class IV 14.3 vs 5.9% and class V 46.7 vs 5.8%. The calibration test rejected the adequate calibration hypothesis (p < 0.001). The discriminatory ability was adequate (AUC = 0.7128, 95% CI 0.63-0.79). CONCLUSIONS: The PESI scale in patients with PE secondary to COVID 19 underestimates the risk of in-hospital mortality, while maintaining adequate discrimination. It is suggested not to use the PESI scale until it is recalibrated in this context.


Subject(s)
COVID-19 , Pulmonary Embolism , SARS Virus , Venous Thromboembolism , Anticoagulants , COVID-19/complications , Hospital Mortality , Humans , Male , Middle Aged , Predictive Value of Tests , Prognosis , Pulmonary Embolism/diagnosis , Retrospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Venous Thromboembolism/complications
8.
Front Endocrinol (Lausanne) ; 13: 876028, 2022.
Article in English | MEDLINE | ID: covidwho-1855337

ABSTRACT

Background: An increasing level of evidence suggests that obesity not only is a major risk factor for cardiovascular diseases (CVDs) but also has adverse outcomes during COVID-19 infection. Methods: We used the German nationwide inpatient sample to analyze all hospitalized patients with confirmed COVID-19 diagnosis in Germany from January to December 2020 and stratified them for diagnosed obesity. Obesity was defined as body mass index ≥30 kg/m2 according to the WHO. The impact of obesity on in-hospital case fatality and adverse in-hospital events comprising major adverse cardiovascular and cerebrovascular events (MACCE), acute respiratory distress syndrome (ARDS), venous thromboembolism (VTE), and others was analyzed. Results: We analyzed data of 176,137 hospitalizations of patients with confirmed COVID-19 infection; among them, 9,383 (5.3%) had an additional obesity diagnosis. Although COVID-19 patients without obesity were older (72.0 [interquartile range (IQR) 56.0/82.0] vs. 66.0 [54.0/76.0] years, p < 0.001), the CVD profile was less favorable in obese COVID-19 patients (Charlson comorbidity index 4.44 ± 3.01 vs. 4.08 ± 2.92, p < 0.001). Obesity was independently associated with increased in-hospital case fatality (OR 1.203 [95% CI 1.131-1.279], p < 0.001) and MACCE (OR 1.168 [95% CI 1.101-1.239], p < 0.001), ARDS (OR 2.605 [95% CI 2.449-2.772], p < 0.001), and VTE (OR 1.780 [95% CI 1.605-1.973], p < 0.001) and also associated with increased necessity of treatment on intensive care unit (OR 2.201 [95% CI 2.097-2.310], p < 0.001), mechanical ventilation (OR 2.277 [95% CI 2.140-2.422], p < 0.001), and extracorporeal membrane oxygenation (OR 3.485 [95% CI 3.023-4.017], p < 0.001). Conclusions: Obesity independently affected case fatality, MACCE, ARDS development, VTE, and other adverse in-hospital events in patients with COVID-19 infection. Obesity should be taken into account regarding COVID-19 prevention strategies, risk stratification, and adequate healthcare planning. Maintaining a healthy weight is important not only to prevent cardiometabolic diseases but also for better individual outcomes during COVID-19 infection.


Subject(s)
COVID-19 , Respiratory Distress Syndrome , Venous Thromboembolism , COVID-19/complications , COVID-19/epidemiology , COVID-19/therapy , COVID-19 Testing , Hospitals , Humans , Obesity/complications , Obesity/epidemiology , Respiratory Distress Syndrome/epidemiology , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/therapy , SARS-CoV-2 , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiology
9.
BMC Infect Dis ; 22(1): 462, 2022 May 13.
Article in English | MEDLINE | ID: covidwho-1846799

ABSTRACT

BACKGROUND: Patients with COVID-19 infection are commonly reported to have an increased risk of venous thrombosis. The choice of anti-thrombotic agents and doses are currently being studied in randomized controlled trials and retrospective studies. There exists a need for individualized risk stratification of venous thromboembolism (VTE) to assist clinicians in decision-making on anticoagulation. We sought to identify the risk factors of VTE in COVID-19 patients, which could help physicians in the prevention, early identification, and management of VTE in hospitalized COVID-19 patients and improve clinical outcomes in these patients. METHOD: This is a multicenter, retrospective database of four main health systems in Southeast Michigan, United States. We compiled comprehensive data for adult COVID-19 patients who were admitted between 1st March 2020 and 31st December 2020. Four models, including the random forest, multiple logistic regression, multilinear regression, and decision trees, were built on the primary outcome of in-hospital acute deep vein thrombosis (DVT) and pulmonary embolism (PE) and tested for performance. The study also reported hospital length of stay (LOS) and intensive care unit (ICU) LOS in the VTE and the non-VTE patients. Four models were assessed using the area under the receiver operating characteristic curve and confusion matrix. RESULTS: The cohort included 3531 admissions, 3526 had discharge diagnoses, and 6.68% of patients developed acute VTE (N = 236). VTE group had a longer hospital and ICU LOS than the non-VTE group (hospital LOS 12.2 days vs. 8.8 days, p < 0.001; ICU LOS 3.8 days vs. 1.9 days, p < 0.001). 9.8% of patients in the VTE group required more advanced oxygen support, compared to 2.7% of patients in the non-VTE group (p < 0.001). Among all four models, the random forest model had the best performance. The model suggested that blood pressure, electrolytes, renal function, hepatic enzymes, and inflammatory markers were predictors for in-hospital VTE in COVID-19 patients. CONCLUSIONS: Patients with COVID-19 have a high risk for VTE, and patients who developed VTE had a prolonged hospital and ICU stay. This random forest prediction model for VTE in COVID-19 patients identifies predictors which could aid physicians in making a clinical judgment on empirical dosages of anticoagulation.


Subject(s)
COVID-19 , Pulmonary Embolism , Venous Thromboembolism , Venous Thrombosis , Adult , Anticoagulants/therapeutic use , COVID-19/complications , Cohort Studies , Humans , Pulmonary Embolism/diagnosis , Retrospective Studies , Risk Factors , Venous Thromboembolism/drug therapy , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiology , Venous Thrombosis/diagnosis
10.
J Hosp Med ; 17(5): 350-357, 2022 May.
Article in English | MEDLINE | ID: covidwho-1826034

ABSTRACT

BACKGROUND: Patient Safety Indicator (PSI)-12, a hospital quality measure designed by Agency for Healthcare Research and Quality (AHRQ) to capture potentially preventable adverse events, captures perioperative venous thromboembolism (VTE). It is unclear how COVID-19 has affected PSI-12 performance. OBJECTIVE: We sought to compare the cumulative incidence of PSI-12 in patients with and without acute COVID-19 infection. DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective cohort study including PSI-12-eligible events at three Mayo Clinic medical centers (4/1/2020-10/5/2021). EXPOSURE, MAIN OUTCOMES, AND MEASURES: We compared the unadjusted rate and adjusted risk ratio (aRR) for PSI-12 events among patients with and without COVID-19 infection using Fisher's exact χ2  test and the AHRQ risk-adjustment software, respectively. We summarized the clinical outcomes of COVID-19 patients with a PSI-12 event. RESULTS: Our cohort included 50,400 consecutive hospitalizations. Rates of PSI-12 events were significantly higher among patients with acute COVID-19 infection (8/257 [3.11%; 95% confidence interval {CI}, 1.35%-6.04%]) compared to patients without COVID-19 (210/50,143 [0.42%; 95% CI, 0.36%-0.48%]) with a PSI-12 event during the encounter (p < .001). The risk-adjusted rate of PSI-12 was significantly higher in patients with acute COVID-19 infection (1.50% vs. 0.38%; aRR, 3.90; 95% CI, 2.12-7.17; p < .001). All COVID-19 patients with PSI-12 events had severe disease and 4 died. The most common procedure was tracheostomy (75%); the mean (SD) days from surgical procedure to VTE were 0.12 (7.32) days. CONCLUSION: Patients with acute COVID-19 infection are at higher risk for PSI-12. The present definition of PSI-12 does not account for COVID-19. This may impact hospitals' quality performance if COVID-19 infection is not accounted for by exclusion or risk adjustment.


Subject(s)
COVID-19 , Venous Thromboembolism , COVID-19/epidemiology , Delivery of Health Care , Humans , Patient Safety , Retrospective Studies
11.
PLoS One ; 17(5): e0266944, 2022.
Article in English | MEDLINE | ID: covidwho-1822269

ABSTRACT

BACKGROUND: Early reports of increased thrombosis risk with SARS-CoV-2 infection led to changes in venous thromboembolism (VTE) management. Real-world data on the prevalence, efficacy and harms of these changes informs best practices. OBJECTIVE: Define practice patterns and clinical outcomes related to VTE diagnosis, prevention, and management in hospitalized patients with coronavirus disease-19 (COVID-19) using a multi-hospital US sample. METHODS: In this retrospective cross-sectional study of 1121 patients admitted to 33 hospitals, exposure was dose of anticoagulant prescribed for VTE prophylaxis (standard, intensified, therapeutic), and primary outcome was VTE (pulmonary embolism [PE] and deep vein thrombosis [DVT]); secondary outcomes were PE, DVT, arterial thromboembolism (ATE), and bleeding events. Multivariable logistic regression models accounting for clustering by site and adjusted for risk factors were used to estimate odds ratios (ORs). Inverse probability weighting was used to account for confounding by indication. RESULTS: 1121 patients (mean age 60 ± 18, 47% female) admitted with COVID-19 between February 2, 2020 and December 31, 2020 to 33 US hospitals were included. Pharmacologic VTE prophylaxis was prescribed in 86%. Forty-seven patients (4.2%) had PE, 51 (4.6%) had DVT, and 23 (2.1%) had ATE. Forty-six patients (4.1%) had major bleeding and 46 (4.1%) had clinically relevant non-major bleeding. Compared to standard prophylaxis, adjusted odds of VTE were 0.67 (95% CI 0.21-2.1) with no prophylaxis, 1.0 (95% CI 0.06-17) with intensified, and 3.0 (95% CI 0.89-10) with therapeutic. Adjusted odds of bleeding with no prophylaxis were 5.6 (95% CI 3.0-11) and 5.3 (95% CI 3.0-10) with therapeutic (no events on intensified dosing). CONCLUSIONS: Therapeutic anticoagulation was associated with a 3-fold increased odds of VTE and 5-fold increased odds of bleeding. While higher bleeding rates with high-intensity prophylaxis were likely due to full-dose anticoagulation, we conclude that high thrombosis rates were due to clinical concern for thrombosis before formal diagnosis.


Subject(s)
COVID-19 , Pulmonary Embolism , Venous Thromboembolism , Adult , Aged , Anticoagulants , Cross-Sectional Studies , Female , Hemorrhage/epidemiology , Hospitals , Humans , Male , Middle Aged , Pulmonary Embolism/drug therapy , Pulmonary Embolism/epidemiology , Pulmonary Embolism/prevention & control , Retrospective Studies , SARS-CoV-2 , Venous Thromboembolism/drug therapy , Venous Thromboembolism/epidemiology , Venous Thromboembolism/prevention & control
12.
J Thromb Haemost ; 20(5): 1056-1066, 2022 05.
Article in English | MEDLINE | ID: covidwho-1822054

ABSTRACT

Venous thromboembolism is a very common and costly health problem worldwide. Anticoagulant treatment for VTE is imperfect: all have the potential for significant bleeding, and none prevent the development of post thrombotic syndrome after deep vein thrombosis or chronic thromboembolic pulmonary hypertension after pulmonary embolism. For these reasons, alternate forms of therapy with improved efficacy and decreased bleeding are needed. Selectins are a family (P-selectin, E-selectin, L-selectin) of glycoproteins that facilitate and augment thrombosis, modulating neutrophil, monocyte, and platelet activity. P- and E-selectin have been investigated as potential biomarkers for thrombosis. Inhibition of P-selectin and E-selectin decrease thrombosis and vein wall fibrosis, with no increase in bleeding. Selectin inhibition is a promising avenue of future study as either a stand-alone treatment for VTE or as an adjunct to standard anticoagulation therapies.


Subject(s)
Pulmonary Embolism , Thrombosis , Venous Thromboembolism , Venous Thrombosis , Anticoagulants/therapeutic use , E-Selectin , Hemorrhage , Humans , Pulmonary Embolism/drug therapy , Selectins , Venous Thromboembolism/drug therapy , Venous Thrombosis/prevention & control
13.
J Thromb Thrombolysis ; 53(4): 766-776, 2022 May.
Article in English | MEDLINE | ID: covidwho-1820966

ABSTRACT

This study describes demographics, thrombotic and bleeding events, mortality, and anticoagulant use among hospitalized patients with COVID-19 in the United States. Premier Healthcare Database data were analyzed to identify inpatients with a discharge diagnosis for COVID-19 (ICD-10-CM code: U07.1) from April 1, 2020 to March 31, 2021, and matched historical controls without COVID-19 (inpatients discharged between April 1, 2018 and March 31, 2019). Thrombotic [including venous thromboembolism (VTE)] and bleeding events were based on ICD-10-CM discharge diagnosis codes. Of the 546,656 patients hospitalized with COVID-19, 20.1% were admitted to the ICU, 62.8% were aged ≥ 60 years, 51.5% were male, and 31.0% were non-white. Any thrombotic event was diagnosed in 10.0% of hospitalized and 20.8% of ICU patients with COVID-19 versus (vs) 11.5% and 24.4% for historical controls, respectively. More VTE events were observed in hospitalized and ICU patients with COVID-19 than historical controls (hospitalized: 4.4% vs 2.7%, respectively; ICU: 8.3% vs 5.2%, respectively; both P < 0.0001). Bleeding events were diagnosed in 10.2% of hospitalized and 21.8% of ICU patients with COVID-19 vs 16.0% and 33.2% for historical controls, respectively. Mortality among hospitalized (12.4%) and ICU (38.5%) patients with COVID-19 was higher vs historical controls (2.4%, P < 0.0001 and 9.4%, P < 0.0001, respectively) and higher in hospitalized patients with COVID-19 who had thrombotic events (29.4%) vs those without thrombotic events (10.8%, P < 0.0001). VTE and mortality were higher in hospitalized and ICU patients with COVID-19 vs historical controls. The presence of thrombotic events was associated with worse outcomes.


Subject(s)
COVID-19 , Thrombosis , Venous Thromboembolism , Anticoagulants/adverse effects , COVID-19/complications , Female , Hemorrhage/chemically induced , Humans , Male , Retrospective Studies , Thrombosis/chemically induced , United States/epidemiology , Venous Thromboembolism/chemically induced , Venous Thromboembolism/epidemiology
14.
Lancet ; 399(10319): 50-59, 2022 01 01.
Article in English | MEDLINE | ID: covidwho-1815305

ABSTRACT

BACKGROUND: Patients hospitalised with COVID-19 are at risk for thrombotic events after discharge; the role of extended thromboprophylaxis in this population is unknown. METHODS: In this open-label, multicentre, randomised trial conducted at 14 centres in Brazil, patients hospitalised with COVID-19 at increased risk for venous thromboembolism (International Medical Prevention Registry on Venous Thromboembolism [IMPROVE] venous thromboembolism [VTE] score of ≥4 or 2-3 with a D-dimer >500 ng/mL) were randomly assigned (1:1) to receive, at hospital discharge, rivaroxaban 10 mg/day or no anticoagulation for 35 days. The primary efficacy outcome in an intention-to-treat analysis was a composite of symptomatic or fatal venous thromboembolism, asymptomatic venous thromboembolism on bilateral lower-limb venous ultrasound and CT pulmonary angiogram, symptomatic arterial thromboembolism, and cardiovascular death at day 35. Adjudication was blinded. The primary safety outcome was major bleeding. The primary and safety analyses were carried out in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT04662684. FINDINGS: From Oct 8, 2020, to June 29, 2021, 997 patients were screened. Of these patients, 677 did not meet eligibility criteria; the remaining 320 patients were enrolled and randomly assigned to receive rivaroxaban (n=160 [50%]) or no anticoagulation (n=160 [50%]). All patients received thromboprophylaxis with standard doses of heparin during hospitalisation. 165 (52%) patients were in the intensive care unit while hospitalised. 197 (62%) patients had an IMPROVE score of 2-3 and elevated D-dimer levels and 121 (38%) had a score of 4 or more. Two patients (one in each group) were lost to follow-up due to withdrawal of consent and not included in the intention-to-treat primary analysis. The primary efficacy outcome occurred in five (3%) of 159 patients assigned to rivaroxaban and 15 (9%) of 159 patients assigned to no anticoagulation (relative risk 0·33, 95% CI 0·12-0·90; p=0·0293). No major bleeding occurred in either study group. Allergic reactions occurred in two (1%) patients in the rivaroxaban group. INTERPRETATION: In patients at high risk discharged after hospitalisation due to COVID-19, thromboprophylaxis with rivaroxaban 10 mg/day for 35 days improved clinical outcomes compared with no extended thromboprophylaxis. FUNDING: Bayer.


Subject(s)
Aftercare , Blood Coagulation/drug effects , COVID-19/complications , Factor Xa Inhibitors/pharmacology , Factor Xa Inhibitors/therapeutic use , Rivaroxaban/pharmacology , Rivaroxaban/therapeutic use , Venous Thromboembolism/prevention & control , Adult , Aged , COVID-19/drug therapy , Female , Heparin/administration & dosage , Heparin/therapeutic use , Hospitalization , Humans , Male , Middle Aged , Patient Discharge , Treatment Outcome
15.
Thromb Res ; 213: 138-144, 2022 05.
Article in English | MEDLINE | ID: covidwho-1815210

ABSTRACT

BACKGROUND: The aim of this study was to detail the incidence of venous thromboembolism (VTE) in patients hospitalised with COVID-19 in England. METHODS: This was an exploratory retrospective analysis of observational data from the Hospital Episode Statistics dataset for England. All patients aged ≥18 years in England with a diagnosis of COVID-19 who had a hospital stay that was completed between 1st March 2020 and 31st March 2021 were included. A recorded diagnosis of VTE during the index stay or during a subsequent admission in the six weeks following discharge was the primary outcome in the main analysis. In secondary analysis, VTE diagnosis was the primary exposure and in-hospital mortality the primary outcome. RESULTS: Over the 13 months, 374,244 unique patients had a diagnosis of COVID-19 during a hospital stay, of whom 17,346 (4.6%) had a recorded diagnosis of VTE. VTE was more commonly recorded in patients aged 40-79 years, males and in patients of Black ethnicity, even after adjusting for covariates. Recorded VTE diagnosis was associated with longer hospital stay and higher adjusted in-hospital mortality (odds ratio 1.35 (95% confidence interval 1.29 to 1.41)). CONCLUSIONS: VTE was a common complication of hospitalisation with COVID-19 in England. VTE was associated with both increased length of stay and mortality rate.


Subject(s)
COVID-19 , Venous Thromboembolism , Adolescent , Adult , COVID-19/complications , Hospitalization , Humans , Length of Stay , Male , Retrospective Studies , Risk Factors , Venous Thromboembolism/diagnosis , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiology
16.
BMC Med Inform Decis Mak ; 22(1): 59, 2022 03 04.
Article in English | MEDLINE | ID: covidwho-1808363

ABSTRACT

BACKGROUND: Venous thromboembolism (VTE) risk assessment in surgical patients is important for the appropriate diagnosis and treatment of patients. The commonly used Caprini model is limited by its inadequate ability to discriminate between risk stratums on the surgical population in southwest China and lengthy risk factors. The purpose of this study was to establish an improved VTE risk assessment model that is accurate and simple. METHODS: This study is based on the clinical data from 81,505 surgical patients hospitalized in the Southwest Hospital of China between January 1, 2019 and June 18, 2021. Among the population, 559 patients developed VTE. An improved VTE risk assessment model, SW-model, was established through Logistic Regression, with comparisons to both Caprini and Random Forest. RESULTS: The SW-model incorporated eight risk factors. The area under the curve (AUC) of SW-model (0.807 [0.758, 0.853], 0.804 [0.765, 0.840]), are significantly superior (p = 0.001 and p = 0.044) to those of the Caprini (0.705 [0.652, 0.757], 0.758 [0.719, 0795]) on two test sets, but inferior (p < 0.001 and p = 0.002) to Random Forest (0.854 [0.814, 0.890], 0.839 [0.806, 0.868]). In decision curve analysis, within threshold range from 0.015 to 0.04, the DCA curves of the SW-model are superior to Caprini and two default strategies. CONCLUSIONS: The SW-model demonstrated a higher discriminative capability to distinguish VTE positive in surgical patients compared with the Caprini model. Compared to Random Forest, Logistic Regression based SW-model provided interpretability which is essential in guarantee the procedure of risk assessment transparent to clinicians.


Subject(s)
Venous Thromboembolism , Hospitalization , Humans , Retrospective Studies , Risk Assessment/methods , Risk Factors , Venous Thromboembolism/diagnosis , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiology
17.
JAMA ; 327(13): 1247-1259, 2022 04 05.
Article in English | MEDLINE | ID: covidwho-1801957

ABSTRACT

Importance: The efficacy of antiplatelet therapy in critically ill patients with COVID-19 is uncertain. Objective: To determine whether antiplatelet therapy improves outcomes for critically ill adults with COVID-19. Design, Setting, and Participants: In an ongoing adaptive platform trial (REMAP-CAP) testing multiple interventions within multiple therapeutic domains, 1557 critically ill adult patients with COVID-19 were enrolled between October 30, 2020, and June 23, 2021, from 105 sites in 8 countries and followed up for 90 days (final follow-up date: July 26, 2021). Interventions: Patients were randomized to receive either open-label aspirin (n = 565), a P2Y12 inhibitor (n = 455), or no antiplatelet therapy (control; n = 529). Interventions were continued in the hospital for a maximum of 14 days and were in addition to anticoagulation thromboprophylaxis. Main Outcomes and Measures: The primary end point was organ support-free days (days alive and free of intensive care unit-based respiratory or cardiovascular organ support) within 21 days, ranging from -1 for any death in hospital (censored at 90 days) to 22 for survivors with no organ support. There were 13 secondary outcomes, including survival to discharge and major bleeding to 14 days. The primary analysis was a bayesian cumulative logistic model. An odds ratio (OR) greater than 1 represented improved survival, more organ support-free days, or both. Efficacy was defined as greater than 99% posterior probability of an OR greater than 1. Futility was defined as greater than 95% posterior probability of an OR less than 1.2 vs control. Intervention equivalence was defined as greater than 90% probability that the OR (compared with each other) was between 1/1.2 and 1.2 for 2 noncontrol interventions. Results: The aspirin and P2Y12 inhibitor groups met the predefined criteria for equivalence at an adaptive analysis and were statistically pooled for further analysis. Enrollment was discontinued after the prespecified criterion for futility was met for the pooled antiplatelet group compared with control. Among the 1557 critically ill patients randomized, 8 patients withdrew consent and 1549 completed the trial (median age, 57 years; 521 [33.6%] female). The median for organ support-free days was 7 (IQR, -1 to 16) in both the antiplatelet and control groups (median-adjusted OR, 1.02 [95% credible interval {CrI}, 0.86-1.23]; 95.7% posterior probability of futility). The proportions of patients surviving to hospital discharge were 71.5% (723/1011) and 67.9% (354/521) in the antiplatelet and control groups, respectively (median-adjusted OR, 1.27 [95% CrI, 0.99-1.62]; adjusted absolute difference, 5% [95% CrI, -0.2% to 9.5%]; 97% posterior probability of efficacy). Among survivors, the median for organ support-free days was 14 in both groups. Major bleeding occurred in 2.1% and 0.4% of patients in the antiplatelet and control groups (adjusted OR, 2.97 [95% CrI, 1.23-8.28]; adjusted absolute risk increase, 0.8% [95% CrI, 0.1%-2.7%]; 99.4% probability of harm). Conclusions and Relevance: Among critically ill patients with COVID-19, treatment with an antiplatelet agent, compared with no antiplatelet agent, had a low likelihood of providing improvement in the number of organ support-free days within 21 days. Trial Registration: ClinicalTrials.gov Identifier: NCT02735707.


Subject(s)
COVID-19 , Critical Illness , Platelet Aggregation Inhibitors , Venous Thromboembolism , Adult , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Aspirin/adverse effects , Aspirin/therapeutic use , Bayes Theorem , COVID-19/complications , COVID-19/drug therapy , COVID-19/mortality , COVID-19/therapy , Critical Illness/mortality , Critical Illness/therapy , Female , Hemorrhage/chemically induced , Humans , Male , Middle Aged , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Purinergic P2Y Receptor Antagonists/adverse effects , Purinergic P2Y Receptor Antagonists/therapeutic use , Respiration, Artificial , Venous Thromboembolism/drug therapy , Venous Thromboembolism/etiology
19.
Viruses ; 14(4)2022 04 14.
Article in English | MEDLINE | ID: covidwho-1792420

ABSTRACT

Critically ill COVID-19 patients are at high risk for venous thromboembolism (VTE), namely deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and death. The optimal anticoagulation strategy in critically ill patients with COVID-19 remains unknown. This study investigated the ante mortem incidence as well as postmortem prevalence of VTE, the factors predictive of VTE, and the impact of changed anticoagulation practice on patient survival. We conducted a consecutive retrospective analysis of postmortem COVID-19 (n = 64) and non-COVID-19 (n = 67) patients, as well as ante mortem COVID-19 (n = 170) patients admitted to the University Medical Center Hamburg-Eppendorf (Hamburg, Germany). Baseline patient characteristics, parameters related to the intensive care unit (ICU) stay, and the clinical and autoptic presence of VTE were evaluated and statistically compared between groups. The occurrence of VTE in critically ill COVID-19 patients is confirmed in both ante mortem (17%) and postmortem (38%) cohorts. Accordingly, comparing the postmortem prevalence of VTE between age- and sex-matched COVID-19 (43%) and non-COVID-19 (0%) cohorts, we found the statistically significant increased prevalence of VTE in critically ill COVID-19 cohorts (p = 0.001). A change in anticoagulation practice was associated with the statistically significant prolongation of survival time (HR: 2.55, [95% CI 1.41-4.61], p = 0.01) and a reduction in VTE occurrence (54% vs. 25%; p = 0.02). In summary, in the autopsy as well as clinical cohort of critically ill patients with COVID-19, we found that VTE was a frequent finding. A change in anticoagulation practice was associated with a statistically significantly prolonged survival time.


Subject(s)
COVID-19 , Venous Thromboembolism , Anticoagulants/therapeutic use , Autopsy , COVID-19/epidemiology , Critical Illness , Humans , Retrospective Studies , Risk Factors , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiology
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