Abstract 4137781: Relationship between Race, Predelivery Cardiology Care and Cardiovascular Outcomes in Pre-eclampsia/Eclampsia among a Commercially Insured Population
Background: Inequities in Preeclampsia/Eclampsia (PrE/E) persist. It is unknown if the receipt of cardiology care relates to future risk of major adverse cardiovascular events (MACE) in Black and White patients with PrE/E. We sought to determine the cumulative incidence of MACE by race and whether predelivery cardiology care was associated with the hazard of MACE up to 1-year post-delivery for Black and White patients with PrE/E. Methods: Using Optum’s Clinformatics® Data Mart Database (CDM), we identified Black and White patients with PrE/E who had a delivery between 2008 to 2019. MACE was defined as the composite of heart failure, acute myocardial infarction, stroke, and death. Cumulative incidence functions were used to compare the incidence of MACE by race. Cox regression models were used to assess the hazard of MACE by cardiology care for Black and White patients. Results: Among 29,336 patients (83.4% White, 16.6% Black, mean age of 30.9 years) with PrE/E, 11.2% received cardiology care (10.9% White, 13.0% Black). Black patients had a higher incidence of MACE than White patients at 1-yr post-delivery (2.7% vs 1.4%). After adjusting for age and clinical comorbidities, receipt of cardiology care was associated with lower hazard of MACE for White patients (HR= 0.68, 95%CI: 0.50-0.92 p=0.013) but not Black patients (HR: 1.22, 95% CI: 0.82-1.81; p= 0.328). The interaction effect between race and cardiology care was statistically significant (p=0.013) Conclusions: Among a well-insured population of patients with PrE/E, Black patients had a higher cumulative incidence of MACE up to a year post-delivery. However, cardiology care significantly lowered the hazard of MACE for only White women. This observation does not suggest that cardiology care is detrimental to Black individuals but underscores the necessity to investigate why outcomes are disparate among these racial groups.
Relationship Between Race, Predelivery Cardiology Care, and Cardiovascular Outcomes in Preeclampsia/Eclampsia Among a Commercially Insured Population
BACKGROUND: It is unknown whether predelivery cardiology care is associated with future risk of major adverse cardiovascular events (MACE) in preeclampsia/eclampsia (PrE/E). We sought to determine the cumulative incidence of MACE by race and whether predelivery cardiology care was associated with the hazard of MACE up to 1 year post-delivery for Black and White patients with PrE/E. METHODS: Using Optum’s de-identified Clinformatics Data Mart Database, we identified Black and White patients with PrE/E who had a delivery between 2008 and 2019. MACE was defined as the composite of heart failure, acute myocardial infarction, stroke, and death. Cumulative incidence functions were used to compare the incidence of MACE by race. Regression models were used to assess the hazard of MACE by cardiology care for each race. Separate hazards were calculated for the first 14 days and the remainder of the year. RESULTS: Among 29 336 patients (83.4% White patients, 16.6% Black patients, 99.5% commercially insured, mean age: 30.9 years) with PrE/E, 11.2% received cardiology care (10.9% White patients, 13.0% Black patients). Black patients had higher incidence of MACE than White patients at 1 year post-delivery (2.7% versus 1.4%) with the majority within 14 days of delivery (Black patients: 58.7%; White patients: 67.8%). After adjusting for age and comorbidities, receipt of cardiology care was associated with a lower hazard of MACE for White patients within 14 days after delivery (hazard ratio, 0.31 [95% CI, 0.21–0.46]; P <0.001) but not Black patients (hazard ratio, 1.00 [95% CI, 0.60–1.67]; P =0.999). The effect of the interaction between race and cardiology care was significant in the first 14 days ( P <0.001) but not the remainder of the year ( P =0.56). CONCLUSIONS: Among a well-insured population of patients with PrE/E, Black patients had a higher cumulative incidence of MACE up to a year post-delivery. Cardiology care was associated with a lower hazard of MACE only for White patients during the first 14 days after delivery.
Representation of women in clinical trials supporting
FDA
‐approval of contemporary cancer therapies
Abstract Contemporary anticancer therapies frequently have different efficacy and side effects in men and women. Yet, whether women are well‐represented in pivotal trials supporting contemporary anticancer drugs is unknown. Leveraging the Drugs@FDA database, clinicaltrials.gov , MEDLINE, and publicly available FDA‐drug‐reviews, we identified all pivotal (phase II and III) non‐sex specific trials supporting FDA‐approval of anticancer drugs (1998–2018). Observed‐enrollment‐rates were compared to expected‐population‐rates derived from concurrent US‐National‐Cancer‐Institute's Surveillance‐Epidemiology‐and‐End‐Results (SEER) reported rates and US‐Census databases. Primary outcome was the proportional representation of women across trials, evaluated by a participation‐to‐prevalence ratio (PPR), according to cancer type. Secondary outcome was the report of any sex‐specific analysis of efficacy and/or safety, irrespective of treatment‐arm. Overall, there were 148 trials, enrolling 60,216 participants (60.5 ± 4.0 years, 40.7% female, 79.1% biologic, targeted, or immune‐based therapies) evaluating 99 drugs. Sex was reported in 146 (98.6%) trials, wherein 40.7% (24,538) were women, compared to 59.3% (35,678) men ( p < .01). Altogether, women were under‐represented in 66.9% trials compared to the proportional incidence of cancers by respective disease type; weight‐average PPR of 0.91 (relative difference: ‐9.1%, p < .01). Women were most under‐represented in gastric (PPR = 0.63), liver (PPR = 0.71), and lung (PPR = .81) cancer trials. Sex‐based safety data was reported in 4.0% trials. There was no association between adequate female enrollment and drug efficacy (HR: 0.616 vs. 0.613, p = .96). Over time, there was no difference in the percentage of women recruited into clinical trials. Among pivotal clinical trials supporting contemporary FDA‐approved cancer drugs, women were frequently under‐represented and sex‐specific‐efficacy and safety‐outcomes were commonly not reported.
Neighborhood Socioeconomic Disadvantage Across the Life Course and Premature Mortality
ImportanceThere are consistent data demonstrating that socioeconomic disadvantage is associated with risk of premature mortality, but research on the relationship between neighborhood socioeconomic factors and premature mortality is limited. Most studies evaluating the association between neighborhood socioeconomic status (SES) and mortality have used a single assessment of SES during middle to older adulthood, thereby not considering the contribution of early life neighborhood SES.ObjectiveTo investigate the association of life course neighborhood SES and premature mortality.Design, Setting, and ParticipantsThis cohort study included Black and White participants of the multicenter Atherosclerosis Risk in Communities Study, a multicenter study conducted in 4 US communities: Washington County, Maryland; Forsyth County, North Carolina; Jackson, Mississippi; and the northwestern suburbs of Minneapolis, Minnesota. Participants were followed up for a mean (SD) of 18.8 (5.7) years (1996-2020). Statistical analysis was performed from March 2023 through May 2024.ExposureParticipants’ residential addresses during childhood, young adulthood, and middle adulthood were linked with US Census–based socioeconomic indicators to create summary neighborhood SES scores for each of these life epochs. Neighborhood SES scores were categorized into distribution-based tertiles.Main Outcomes and MeasuresPremature death was defined as all-cause mortality occurring before age 75 years. Multivariable-adjusted Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% CIs.ResultsAmong 12 610 study participants, the mean (SD) age at baseline was 62.6 (5.6) years; 3181 (25.2%) were Black and 9429 (74.8%) were White; and 7222 (57.3%) were women. The lowest, compared with the highest tertile, of neighborhood SES score in middle adulthood was associated with higher risk of premature mortality (HR, 1.28; 95% CI, 1.07-1.54). Similar associations were observed for neighborhood SES in young adulthood among women (HR, 1.25; 95% CI, 1.00-1.56) and neighborhood SES in childhood among White participants (HR, 1.25; 95% CI, 1.01-1.56). Participants whose neighborhood SES remained low from young to middle adulthood had an increased premature mortality risk compared with those whose neighborhood SES remained high (HR, 1.25; 95% CI, 1.05-1.49).Conclusions and RelevanceIn this study, low neighborhood SES was associated with premature mortality. The risk of premature mortality was greatest among individuals experiencing persistently low neighborhood SES from young to middle adulthood. Place-based interventions that target neighborhood social determinants of health should be designed from a life course perspective that accounts for early-life socioeconomic inequality.
Associations Between the Superwoman Schema, Stress, and Cardiovascular Health Among African-American Women
Abstract Background African-American (AA) women are less likely to achieve ideal cardiovascular (CV) health compared with women of other racial/ethnic subgroups, primarily due to structural and psychosocial barriers. A potential psychosocial construct relevant to ideal CV health is the superwoman schema (SWS). Purpose We explored whether the SWS was associated with perceived stress, CV risk factors, and overall CV health among AA women. Methods This cross-sectional analysis of the FAITH! Heart Health+ Study was conducted among AA women with high cardiometabolic risk. Pearson correlation evaluated associations between SWS and CV risk factors (e.g., stress, hypertension, diabetes, etc.). The 35-item SWS questionnaire includes five domains. Stress was measured by the 8-item Global Perceived Stress Scale (GPSS). CV health was assessed using the American Heart Association Life’s Simple 7 (LS7) rubric of health behaviors/biometrics. Data acquisition spanned from February to August 2022. Results The 38 women included in the analysis (mean age 54.3 [SD 11.5] years) had a high CV risk factor burden (71.1% hypertension, 76.3% overweight/obesity, 28.9% diabetes, 39.5% hyperlipidemia). Mean GPSS level was 7.7 (SD 5.2), CV health score 6.7 (SD 1.8), and SWS score 60.3 (SD 18.0). Feeling an “obligation to help others” and “obligation to present an image of strength” had strongest correlations with GPSS score among all SWS domains (r = 0.51; p = .002 and r = 0.39; p = .02, respectively). Correlation among the SWS domains and traditional CV risk factors was not statistically significant. Conclusion Our findings suggest that an obligation to help others and to project an image of strength could be contributing to stress among AA women.
Harnessing Social Needs Data to Advance Health Equity in Federally Qualified Health Centers
Abstract Background Despite advances in cardiovascular (CV) care, African American adults experience worse CV disease (CVD) outcomes than White adults, warranting the investigation of CVD prediction biomarkers. Plasma ceramides are bioactive lipids that are biomarkers of adverse cardiovascular risk for both primary and secondary prevention. However, racial/ethnic differences in ceramide levels and their link to CV health (CVH) in African American adults remain underexplored. Purpose This study aimed to: 1) assess the association between ceramide scores and CVH and atherosclerotic CVD (ASCVD) risk among African American adults and 2) compare ceramide scores between African American and White adults. Methods Health surveys and ceramides measurements were conducted for African American and White adults, both recruited from population-based observational study cohorts. Ten-year pooled cohort risk ASCVD scores were calculated based on American College of Cardiology guidelines. CVH was assessed using Life’s Essential 8 (LE8) scores, as per American Heart Association rubrics. CV risk factors in the two cohorts were compared using Chi-squared tests. Linear regression and Pearson correlation assessed the association between ceramide, LE8, and ASCVD risk scores. Linear regression, adjusted for age and sex, compared ASCVD risk and ceramide scores between the two cohorts. Results In total, 58 African American (mean age [SD] 54.5 [11.9] years, 67.9% women) and 1103 White (mean age [SD] 64.5 [11.9] years, 52.1% women) adults were included (Table 1). Compared to White adults, African American adults had a higher prevalence of overweight/obesity (92.9% vs 33.6%; p<0.001), hypertension (69.6% vs 42.5%; p<0.001), diabetes (30.4% vs 12.2%; p<0.001), and hyperlipidaemia (42.9% vs 30.0%; p=0.03). No difference in mean ASCVD risk was observed between the African American (12.8% [SD 10.4]) and White (12.6% [SD 11.1]) cohorts (p= 0.91). African American adults had lower 18:0 (0.08 [0.03] vs 0.10 [0.04] μmol/L) and 24:1 (0.91 [0.31] vs 1.17 [0.33] μmol/L) ceramides compared to White adults (p<0.001). Ceramide scores among African American adults were not associated with LE8 scores (p=0.077) or ASCVD risk scores (r=-0.12, p=0.428). Adjusting for age and sex, African American adults had lower ceramide scores compared to White adults (mean [SD] 1.90 [1.97] vs 3.48 [2.88], p=0.006). Conclusions In our study comparing African American and White adults in the community, the association observed between ceramide scores and CVH or ASCVD risk scores in the African American cohort did not reach statistical significance. Interestingly, despite a more suboptimal cardiometabolic profile, African American adults had lower ceramide scores compared to White adults. Our findings suggest that ceramide profiles may not accurately reflect cardiovascular risk in African American adults, warranting further exploration of alternative sphingolipid biomarkers of risk for this population.
Abstract P466: A Culturally Tailored mHealth Lifestyle Intervention Improves Diet and Physical Activity Self-Regulation Among African Americans
Background: Physical inactivity and poor adherence to healthy eating guidelines impact cardiovascular health (CVH) outcomes in African American (AAs). Our randomized controlled trial (RCT) testing the FAITH! App, an mHealth lifestyle intervention, showed efficacy in promoting ideal CVH, particularly diet and physical activity (PA) among AAs, warranting exploration of underlying factors. Psychosocial factors (e.g., self-regulation, self-efficacy, social support) are key to healthy behavior adoption. Hypothesis: The intervention group would have greater improvements in diet and PA-related psychosocial factors than the control group after using the FAITH! App. Methods: A 2-arm cluster RCT was conducted among AAs from 16 churches in Minnesota comparing the FAITH! App intervention to a delayed intervention control group. The FAITH! App included culturally relevant, CVH-focused education modules, diet/PA self-monitoring and a sharing board. The outcomes were change in diet and PA self-regulation and self-efficacy (primary) and social support and barriers (secondary) at 6 months post-intervention. The intervention effect was assessed using linear regression. Results: Sixty-eight participants were included (71% female; mean age [SD]: 54.7 [12.6] years) ( Table 1 ). The intervention group showed a significantly greater increase in diet self-regulation [planning/tracking nutrition] (+0.66, p<.03) and PA self-regulation [step count strategies] (+0.47, p=.003) than the control group. Within groups, the intervention group demonstrated significant improvements across diet and PA self-regulation measures, while the control group showed an improvement only in fruit/vegetable and grain intake. No effect was observed in self-efficacy, social support, or barriers. Conclusions: Our culturally tailored mHealth lifestyle intervention was associated with notable increases in diet and PA self-regulation, suggesting a potential mechanism by which the FAITH! App improves healthy eating and PA among AAs.
Association of Socioeconomic Status With Life's Essential 8 in the National Health and Nutrition Examination Survey: Effect Modification by Sex
Background Higher scores for the American Heart Association Life's Essential 8 (LE8) metrics, blood pressure, cholesterol, glucose, body mass index, physical activity, smoking, sleep, and diet, are associated with lower risk of chronic disease. Socioeconomic status (SES; employment, insurance, education, and income) is associated with LE8 scores, but there is limited understanding of potential differences by sex. This analysis quantifies the association of SES with LE8 for each sex, within Hispanic Americans, non‐Hispanic Asian Americans, non‐Hispanic Black Americans, and non‐Hispanic White Americans. Methods and Results Using cross‐sectional data from the National Health and Nutrition Examination Survey, years 2011 to 2018, LE8 scores were calculated (range, 0–100). Age‐adjusted linear regression quantified the association of SES with LE8 score. The interaction of sex with SES in the association with LE8 score was assessed in each racial and ethnic group. The US population representatively weighted sample (13 529 observations) was aged ≥20 years (median, 48 years). The association of education and income with LE8 scores was higher in women compared with men for non‐Hispanic Black Americans and non‐Hispanic White Americans ( P for all interactions <0.05). Among non‐Hispanic Asian Americans and Hispanic Americans, the association of SES with LE8 was not different between men and women, and women had greater LE8 scores than men at all SES levels (eg, high school or less, some college, and college degree or more). Conclusions The factors that explain the sex differences among non‐Hispanic Black Americans and non‐Hispanic White Americans, but not non‐Hispanic Asian Americans and Hispanic Americans, are critical areas for further research to advance cardiovascular health equity.
Abstract 18027: Contribution of Sex and Age Differences to Life's Simple 7 Metrics in Cardiac Rehabilitation
Background: Life's Simple 7 (LS7) have been identified as key health factors aimed at achieving ideal cardiovascular health (CVH) and improving healthy life expectancy; however, it is unclear if different patient populations respond similarly to optimization of health behaviors. We sought to quantify the contribution of sex and age differences to changes in LS7 components in patients participating in cardiac rehabilitation. Methods: We included 937 adult patients who participated in CR from January 2018 to September 2020. LS7 metrics at baseline (pre-CR) and completion of CR (post-CR) were collected and changes in LS7 components (body mass index (BMI), diet, smoking, physical activity (PA), blood pressure (PB), cholesterol, glucose) were assessed by sex and age groups (<65 vs ≥65 years old). Each LS7 component was assigned 0 (poor), 1 (intermediate), or 2 (ideal) points and a final score was computed to estimate an individual’s level of CVH (0-14 pts): 0-6 = poor, 7-8= intermediate, 9 -14= ideal. Results: The mean age was 64±13 years, and 34% were female. Patients attended a mean of 11.1±12.5 CR sessions. LS7 components with the highest proportion within the poor category were HbA1c (41%) and BMI (50%) at the time of CR enrollment; neither women nor men showed improvement on either component. The trend towards improvement from poor to intermediate range on cholesterol and BP metrics was seen only in older patients (Table 1). Mean LS7 score improvement was greater in the older group, P=.01 (Fig 1). Both women and men equally improved LS7 scores (Table 2, Fig 2). Conclusions: Patients participating in CR demonstrated improvement in overall LS7 scores regardless of sex and age. However, age disparities exist in LS7 metrics, with exacerbated differences noted by a lack of improvement in LS7 components such as BP and cholesterol in younger patients. Our insights provide opportunities to explore equitable CVH.