COVID-19 and Risk of VTE in Ethnically Diverse Populations.

BACKGROUND: Limited existing data suggest that the novel COVID-19 may increase risk of VTE, but information from large, ethnically diverse populations with appropriate control participants is lacking. RESEARCH QUESTION: Does the rate of VTE among adults hospitalized with COVID-19 differ from matched hospitalized control participants without COVID-19? STUDY DESIGN AND METHODS: We conducted a retrospective study among hospitalized adults with laboratory-confirmed COVID-19 and hospitalized adults without evidence of COVID-19 matched for age, sex, race or ethnicity, acute illness severity, and month of hospitalization between January 2020 and August 2020 from two integrated health care delivery systems with 36 hospitals. Outcomes included VTE (DVT or pulmonary embolism ascertained using diagnosis codes combined with validated natural language processing algorithms applied to electronic health records) and death resulting from any cause at 30 days. Fine and Gray hazards regression was performed to evaluate the association of COVID-19 with VTE after accounting for competing risk of death and residual differences between groups, as well as to identify predictors of VTE in patients with COVID-19. RESULTS: We identified 6,319 adults with COVID-19 and 6,319 matched adults without COVID-19, with mean ± SD age of 60.0 ± 17.2 years, 46% women, 53.1% Hispanic, 14.6% Asian/Pacific Islander, and 10.3% Black. During 30-day follow-up, 313 validated cases of VTE (160 COVID-19, 153 control participants) and 1,172 deaths (817 in patients with COVID-19, 355 in control participants) occurred. Adults with COVID-19 showed a more than threefold adjusted risk of VTE (adjusted hazard ratio, 3.48; 95% CI, 2.03-5.98) compared with matched control participants. Predictors of VTE in patients with COVID-19 included age ≥ 55 years, Black race, prior VTE, diagnosed sepsis, prior moderate or severe liver disease, BMI ≥ 40 kg/m2, and platelet count > 217 k/µL. INTERPRETATION: Among ethnically diverse hospitalized adults, COVID-19 infection increased the risk of VTE, and selected patient characteristics were associated with higher thromboembolic risk in the setting of COVID-19.

Comparison of 2013 and 2009 versions of Caprini risk assessment models for predicting VTE in Chinese cancer patients: a retrospective study.

This study aimed to compare the predictive value of 2009 and 2013 version of Caprini risk assessment models (RAM) for venous thromboembolism (VTE) in cancer patients by receiver operating characteristic (ROC) analysis. This retrospective study reviewed a total of 1439 VTE and 1439 non-VTE Chinese cancer inpatients. The baseline demographic data of these patients were recorded. 2009 and 2013 versions Caprini RAMs were applied, and cumulative risk scores were obtained by adding the scores of each risk factor. The specificity, sensitivity, positive predictive value and negative predictive value of these two models were analyzed. ROC curve was drawn to calculate the area under the curve (AUC) and the Youden index. Significant differences were observed in the risk factors between VTE and non-VTE Group. The specificity and negative predictive value of 2013 version were higher than those of 2009 version (P < 0.05). No significant differences were found in the sensitivity or positive predictive value between 2009 and 2013 versions of the Caprini RAM (P > 0.05). The AUC and Youden index of 2013 Caprini RAM were significantly higher than those of 2009 Caprini RAM (P < 0.001), whereas the Youden index of the 2009 Caprini RAM at critical point 4 was higher than that at critical point 3 (0.362 vs 0.067, P < 0.05). Compared with 2009 version, 2013 version of the Caprini RAM provides a more accurate and efficacious method for the risk assessment of VTE in Chinese cancer patients.

Racial, Ethnic, and Socioeconomic Inequities in the Prescription of Direct Oral Anticoagulants in Patients With Venous Thromboembolism in the United States.

BACKGROUND: Beginning in 2012, direct oral anticoagulants (DOACs) were approved for treatment and prevention of venous thromboembolism. Prior investigations have demonstrated slow rates of adoption of novel therapeutics for black patients. We assessed the association of racial/ethnic and socioeconomic factors with DOAC use among commercially insured venous thromboembolism patients. METHODS AND RESULTS: We performed a retrospective cohort analysis of adult patients with an incident diagnosis of venous thromboembolism between January 2010 and December 2016 using OptumInsight's Clinformatics Data Mart. We identified the first filled oral anticoagulant prescription within 30 days of discharge of an inpatient admission. We performed a multivariable logistic regression, adjusting for age, sex, race/ethnicity, region, zip code-linked household income, and clinical covariates to identify factors associated with the use of DOACs. Race and ethnicity were determined in this database through a combination of public records, self-report, and proprietary ethnicity code tables. There were 14 140 patients included in the analysis. Treatment with DOACs increased from <0.1% in 2010 to 65.6% in 2016. In multivariable analyses, black patients were less likely to receive a DOAC compared with white patients (odds ratio, 0.86; 95% CI, 0.77-0.97; P=0.02). There were no differences in DOAC utilization among Asian (odds ratio, 1.06; 95% CI, 0.75-1.49; P=0.74) or Hispanic patients (odds ratio, 1.04; 95% CI, 0.88-1.22; P=0.66) compared with whites. Patients with a household income over $100 000 per year were more likely to receive DOAC therapy compared with patients with a household income of <$40 000 per year (odds ratio, 1.50; 95% CI, 1.33-1.69; P<0.0001). CONCLUSIONS: Although DOAC adoption has increased steadily since 2012, among a commercially insured population, black race and low household income were associated with lower use of DOACs for incident venous thromboembolism despite controlling for other clinical and socioeconomic factors. These findings suggest the possibility of both racial and socioeconomic inequity in access to this novel pharmacotherapy.

American Heart Association's Life's Simple 7 and risk of venous thromboembolism: the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study.

BACKGROUND: The American Heart Association's Life's Simple 7 metric is being used to track the population's cardiovascular health (CVH) toward a 2020 goal for improvement. The metric includes body mass index (BMI), blood pressure, cholesterol, glucose, physical activity (PA), cigarette smoking, and diet. We hypothesized a lower risk of venous thromboembolism (VTE) with favorable Life's Simple 7 scores. METHODS AND RESULTS: REGARDS recruited 30,239 black and white participants ≥45 years of age across the United States in 2003-2007. A 14-point summary score for Life's Simple 7 classified participants into inadequate (0 to 4 points), average (5 to 9 points), and optimal (10 to 14 points) categories. Hazard ratios (HRs) of incident VTE were calculated for these categories, adjusting for age, sex, race, income, education, and region of residence. For comparison, HRs of VTE were calculated using the Framingham 10-year coronary risk score. There were 263 incident VTE cases over 5.0 years of follow-up; incidence rates per 1000 person-years declined from 2.9 (95% confidence interval [CI], 2.3 to 3.7) among those in the inadequate category to 1.8 (95% CI, 1.4 to 2.4) in the optimal category. Compared to the inadequate category, participants in the average category had a 38% lower VTE risk (95% CI, 11 to 57) and participants in the optimal category had a 44% lower risk (95% CI, 18 to 62). The individual score components related to lower VTE risk were ideal PA and BMI. There was no association of Framingham Score with VTE. CONCLUSIONS: Life's Simple 7, a CVH metric, was associated with reduced VTE risk. Findings suggest that efforts to improve the population's CVH may reduce VTE incidence.

Review of race/ethnicity in non vitamin K antagonist oral anticoagulants clinical trials.

Non vitamin K antagonist oral anticoagulants (NOACs) have advantages relative to traditional vitamin K antagonist oral anticoagulants and represents an important advance in the management of patients with atrial fibrillation and venous thromboembolism. Yet it is unclear whether the clinical trials evaluating these agents were inclusive of diverse populations. To assess the inclusion and reporting of race and ethnicity in clinical trials of NOACs across disease states including, atrial fibrillation, venous thromboembolism, and acute coronary syndromes, we queried PubMed and ClinicalTrials.gov for trials of NOACs between 2007 and 2013. We determined the reporting rate and inclusion of the following ethnic groups: whites, blacks, Asians, and Hispanics. We reviewed data from 30 randomized clinical trials of NOACs that enrolled 184,414 patients. Among these trials, 21 (70%) reported race/ethnicity data in the primary manuscript or on ClinicalTrials.gov. Principal investigators provided race/ethnicity data for two additional trials. Enrollment by race included: 109,729 (75.2%) white, 20,901 (14.3%) Asian, 5,718 (3.9%) Hispanic, and 2,941 (2.0%) black. Hispanic ethnicity was only reported in 10 trials. The major clinical trials of NOACs inconsistently reported race/ethnicity and overall black and Hispanic patient enrollment was poor. As such, the relative safety and efficacy of NOACs in minority populations remains uncertain.

Effect of using population-specific body mass index cutoff points in the risk assessment of pregnant Asian women for venous thromboembolism.

INTRODUCTION: Current international Royal College of Obstetricians and Gynaecologists (RCOG) guidelines list maternal obesity (body mass index [BMI] ≥ 30.0 kg/m2) as a risk factor for venous thromboembolism (VTE). Although the World Health Organization (WHO) has recommended lower BMI cutoff points for Asians when risk stratifying for diseases associated with obesity, this has not been extended to maternal obesity. In the present study, we compared the difference in using Asian-specific BMI cutoff points as opposed to those in international guidelines in determining the population at risk for VTE, as defined by RCOG guidelines. METHODS: All spontaneous deliveries (n = 94) and Caesarean sections (n = 41) over a three-week period, and instrumental deliveries (n = 15) over a two-month period, were reviewed and risk stratified based on Asian-specific, as well as international, BMI cut-off points. RESULTS: For the group that underwent spontaneous vaginal delivery, the percentage of patients at risk for VTE nearly doubled (from 8.5% to 16.0%) with the revised risk stratification, while that of patients who had instrumental delivery had more than a two-fold increase (250%). In the initial risk stratification of the post-Caesarean patients, none were at high risk of VTE. However, when the lower cut-off points of 27.5 kg/m2 and 23.0 kg/m2 were used, one and three patients were respectively identified to be at high risk. CONCLUSION: Further research and consideration regarding the adjustment of international risk stratification guidelines to accommodate population-specific differences are required so that at-risk patients are not missed.

Incidence of venous thromboembolism in Korea: from the Health Insurance Review and Assessment Service database.

BACKGROUND: Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), represents a major health concern in Caucasians. Although the incidence of VTE is generally known to be lower in Asians than in Caucasians, results of epidemiologic studies among Asians have been conflicting. In this study we performed a nationwide population-based epidemiologic study to provide basic information regarding the incidence of VTE in the Korean population. METHODS: Using the Korean Health Insurance Review and Assessment Service (HIRA) database, VTE patients from 2004 to 2008 were retrospectively identified by both diagnostic codes and medication codes for drugs used in initial treatment of VTE. RESULTS: The respective age- and sex-adjusted annual incidences of VTE, DVT and PE per 100,000 individuals increased significantly from 8.83, 3.91 and 3.74 in 2004 to 13.8, 5.31 and 7.01 in 2008 (P = 0.0001), with successive increments each year. All three annual incidences also increased steadily with age (P = 0.0001 for all), particularly among those over 60 years old. CONCLUSIONS: This represents the largest epidemiologic study that demonstrates a lower incidence of VTE in Asian compared with Western populations; however, it also demonstrates a yearly increasing incidence of VTE in the Korean population.

Effects of race and ethnicity on the incidence of venous thromboembolism.

Although there is strong evidence that the prevalence of venous thrombo-embolism (VTE) varies significantly among different ethnic/racial groups, the genetic, physiologic and/or clinical basis for these differences remain largely undefined. African-American patients have a significantly higher rate of incident VTE, particularly following exposure to a provoking risk factor such as surgery, medical illness, trauma, etc. In addition, African-Americans are more likely to be diagnosed with pulmonary embolism (PE) than deep-vein thrombosis (DVT) compared to Caucasian and other racial groups. On the other extreme, Asians/Pacific Islanders have a 70% lower prevalence of VTE and this is true for both idiopathic VTE and provoked, or 'secondary', VTE. Hispanics have a significantly lower prevalence of VTE compared to Caucasians, but higher than Asians/Pacific Islanders. The incidence of recurrent VTE varies depending on gender, type of thromboembolic event and race. Further research is needed in order to determine the fundamental differences between racial/ethnic groups that explain the observed differences in the prevalence of VTE. Race/ethnicity should be considered an important factor in the risk-stratification of patients with suspected VTE or patients at some risk for developing VTE.