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98 result(s) for "Jackson, Larry R."
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Racial/ethnic differences in atrial fibrillation symptoms, treatment patterns, and outcomes: Insights from Outcomes Registry for Better Informed Treatment for Atrial Fibrillation Registry
Significant racial/ethnic differences exist in the incidence of atrial fibrillation (AF). However, less is known about racial/ethnic differences in quality of life (QoL), treatment, and outcomes associated with AF. Using data from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation, we compared clinical characteristics, QoL, management strategies, and long-term outcomes associated with AF among various racial/ethnic groups. We analyzed 9,542 participants with AF (mean age 74 ± 11 years, 43% women, 91% white, 5% black, 4% Hispanic) from 174 centers. Compared with AF patients identified as white race, patients identified as Hispanic ethnicity and those identified as black race were younger, were more often women, and had more cardiac and noncardiac comorbidities. Black patients were more symptomatic with worse QoL and were less likely to be treated with a rhythm control strategy than other racial/ethnic groups. There were no significant racial/ethnic differences in CHA2DS2-VASc stroke or ATRIA bleeding risk scores and rates of oral anticoagulation use were similar. However, racial and ethnic minority populations treated with warfarin spent a lower median time in therapeutic range of international normalized ratio (59% blacks vs 68% whites vs 62% Hispanics, P < .0001). There was no difference in long-term outcomes associated with AF between the 3 groups at a median follow-up of 2.1 years. Relative to white and Hispanic patients, black patients with AF had more symptoms, were less likely to receive rhythm control interventions, and had lower quality of warfarin management. Despite these differences, clinical events at 2 years were similar by race and ethnicity.
Racial differences and geographic variations in oral anticoagulation treatment among Medicare patients with non-valvular atrial fibrillation
Use of oral anticoagulants (OACs) for stroke reduction in atrial fibrillation (AF) varies by race and geography within the United States. We seek to better understand the relationship between OAC underutilization, race, and US geography. Patients with AF were selected from the US Centers for Medicare & Medicaid Services claims database from January 1, 2013, to December 31, 2016. The final population consisted of patients with 12 months of health plan enrollment before and after their index AF diagnosis, with a baseline CHAD2S2-VASc ≥2 and of either Black or White race (other races are underrepresented in the data). Among those with AF that met the inclusion criteria, patients who were prescribed warfarin or DOACs within 12 months after the index date were extracted. Each patient was assigned to a US county based on their 5-digit zip code and OAC use was stratified by race. Statistically significant differences were determined by student's t-test and chi-square. Of the 2,390,830 final patients, 94.1% were White and 5.9% were Black patients. Mean (SD) age and HASBLED scores were 78 (9) and 3.9 (1.2) respectively, for Black patients and 80 (9) and 3.3 (1.2), respectively, for White patients (p<0.0001). The mean (SD) CHAD2S2-VASc scores were 4.5 (1.9) for White patients, and 5.3 (1.9) for Black patients with p<0.0001, respectively. Black patients (vs White patients) had a higher non-treatment (no DOAC or warfarin) rate (56.1% vs 47.4%, p<0.0001) across the US which was particularly notable in the southeast. In addition, treatment rates were highly variable within each US state. Counties with dense population more frequently demonstrated significant differences by race than counties with sparse population. Our study showed differences in the use of OACs across US counties and among various racial groups. These disparities highlighted the areas of unmet need for both Black and White patients.
Eliminating Health Disparities in Atrial Fibrillation, Heart Failure, and Dyslipidemia: A Path Toward Achieving Pharmacoequity
Purpose of Review Pharmacoequity refers to the goal of ensuring that all patients have access to high-quality medications, regardless of their race, ethnicity, gender, or other characteristics. The goal of this article is to review current evidence on disparities in access to cardiovascular drug therapies across sociodemographic subgroups, with a focus on heart failure, atrial fibrillation, and dyslipidemia. Recent Findings Considerable and consistent disparities to life-prolonging heart failure, atrial fibrillation, and dyslipidemia medications exist in clinical trial representation, access to specialist care, prescription of guideline-based therapy, drug affordability, and pharmacy accessibility across racial, ethnic, gender, and other sociodemographic subgroups. Summary Researchers, health systems, and policy makers can take steps to improve pharmacoequity by diversifying clinical trial enrollment, increasing access to inpatient and outpatient cardiology care, nudging clinicians to increase prescription of guideline-directed medical therapy, and pursuing system-level reforms to improve drug access and affordability.
Discontinuation rates of warfarin versus direct acting oral anticoagulants in US clinical practice: Results from Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II)
While oral anticoagulation is a cornerstone of stroke prevention therapy in atrial fibrillation (AF), few studies have evaluated comparative discontinuation rates in clinical practice. The objective of this study is to evaluate discontinuation rates among patients on warfarin and direct oral anticoagulants (DOACs) in clinical practice. The ORBIT-AF II Registry enrolled 10,005 total AF patients with a CHA2DS2VASc score of ≥2 on warfarin or DOACs from 235 clinical practices across the US from February 13, 2013 and July 12, 2017. Descriptive statistics and multivariable Cox regression modeling were used to describe baseline characteristics and predictors of discontinuation. Unadjusted and adjusted discontinuation rates and 95% confidence intervals (CI) were calculated using Cox proportional hazards models and propensity score adjustment, respectively. At baseline, 16.4% (N = 1642/10,005) were treated with warfarin, 83.6% (N = 8363/10,005) with DOACs and 1498/10,005 patients (15.0%) discontinued therapy [warfarin = 236/1642 (14.4%) vs DOACs = 1262/8363 (15.1%)]. At 6 and 12 months respectively, among 7049 patients with a new diagnosis of AF within 6 months, adjusted discontinuation rates for warfarin versus DOACs were as follows: [6 months: 7.9%, 95%CI (6.8%-9.0%) vs 9.6% (8.4%-10.7%), P = .16]; [12 months: 12.7% (11.0%-14.3%) vs 15.3% (13.6%-16.9%), P = .02)]. Patients who discontinued therapy with warfarin or DOACs had higher risk of adverse clinical outcomes including: all-cause mortality and cardiovascular death (CV) than those who continued treatment. In a community based AF cohort, adjusted rates of discontinuation at 12-months were higher in DOAC-treated versus VKA-treated patients. Discontinuation of oral anticoagulation was associated with increased absolute risk of all-cause mortality and CV death. URL:https://clinicaltrials.gov. Unique Identifier: NCT01701817
Assessing heterogeneity of treatment effect analyses in health-related cluster randomized trials: A systematic review
Cluster-randomized trials (CRTs) are being increasingly used to test a range of interventions, including medical interventions commonly used in clinical practice. Policies created by the NIH and the Food and Drug Administration (FDA) require the reporting of demographics and the examination of demographic heterogeneity of treatment effect (HTE) for individually randomized trials. Little is known about how frequent demographics are reported and HTE analyses are conducted in CRTs. We sought to understand the prevalence of HTE analyses and the statistical methods used to conduct them in CRTs focused on treating cardiovascular disease, cancer, and chronic lower respiratory diseases. Additionally, we also report on the proportion of CRTs that reported on baseline demographics of its populations and conducted demographic HTE analyses. We searched PubMed and Embase for CRTs published between 1/1/2010 and 3/29/2016 that focused on treating the top 3 Center for Disease Control causes of death (cardiovascular disease, chronic lower respiratory disease, and cancer). Evidence Screening And Review: Of 1,682 unique titles, 117 abstracts were screened. After excluding 53 articles, we included 64 CRT publications and abstracted information on study characteristics and demographic information, statistical analysis, HTE analysis, and study quality. Age and sex were reported in greater than 95.3% of CRTs, while race and ethnicity were reported in only 20.3% of CRTs. HTE analyses were conducted in 28.1% (n = 18) of included CRTs and 77.8% (n = 12) were prespecified analyses. Four CRTs conducted a demographic subgroup analysis. Only 6/18 CRTs used interaction testing to determine whether HTE existed. Baseline demographic reporting was high for age and sex in CRTs, but was uncommon for race and ethnicity. HTE analyses were uncommon and was rare for demographic subgroups, which limits the ability to examine the extent of benefits or risks for treatments tested with CRT designs.
Race and Ethnic and Sex Differences in Rhythm Control Treatment of Incident Atrial Fibrillation
Atrial fibrillation (AF) is associated with considerable morbidity and mortality. Timely management and treatment is critical in alleviating AF disease burden. Variation in treatment by race and ethnic and sex could lead to inequities in health outcomes. To identify racial and ethnic and sex differences in rhythm treatment for patients with incident AF. Using 2010-2019 Optum Clinformatics database, an administrative claims data for commercially insured patients in the United States (US), incident AF patients ≥20 years old who were continuously enrolled 12-months pre- and post-index diagnosis were identified. Rhythm control treatment (ablation, antiarrhythmic drugs [AAD], and cardioversion) for AF were compared by patient race and ethnicity (Asian, Hispanic, Black vs White) and sex (female vs male). Multivariable regression analysis was used to examine the relationship of race and ethnicity and sex with rhythm control AF treatment. A total of 77,932 patients were identified with incident AF. Black and Hispanic female patients had the highest CHA DS VASc scores (4.3 ± 1.8) and Elixhauser scores (4.1 ± 2.8 and 4.0 ± 6.7), respectively. Black males were less likely to receive AAD treatment (adjusted odds ratio [aOR] 0.87; 95% confidence interval [CI], 0.79-0.96) or ablation (aOR, 0.72; 95% CI, 0.58-0.90). Compared to White males, all groups had lower likelihood of receiving cardioversion with Asian females having the lowest [aOR, 0.48; 95% CI, (0.37-0.63)]. Black patients were less likely to receive pharmacologic and procedural rhythm control therapies. Further research is needed to understand the drivers of undertreatment among racial and ethnic groups and females with AF.
Representation of black patients in randomized clinical trials of heart failure with reduced ejection fraction
Black individuals have a disproportionately higher burden of heart failure with reduced ejection fraction (HFrEF) relative to other racial and ethnic populations. We conducted a systematic review to determine the representation, enrollment trends, and outcomes of black patients in historic and contemporary randomized clinical trials (RCTs) for HFrEF. We searched PubMed and Embase for RCTs of patients with chronic HFrEF that evaluated therapies that significantly improved clinical outcomes. We extracted trial characteristics and compared them by trial type. Linear regression was used to assess trends in enrollment among HFrEF RCTs over time. A total of 25 RCTs, 19 for pharmacotherapies and 6 (n=9,501) for implantable cardioverter defibrillators, were included in this analysis. Among these studies, there were 78,816 patients, 4,640 black (5.9%), and the median black participation per trial was 162 patients. Black race was reported in the manuscript of 14 (56.0%) trials, and outcomes by race were available for 12 (48.0%) trials. Implantable cardiac defibrillator trials enrolled a greater percentage of black patients than pharmacotherapy trials (7.1% vs 5.7%). Overall, patient enrollment among the 25 RCTs increased over time (P = .075); however, the percentage of black patients has decreased (P = .001). Outcomes varied significantly between black and white patients in 6 studies. Black patients are modestly represented among pivotal RCTs of individuals with HFrEF for both pharmacotherapies and implantable cardioverter defibrillators. The current trend for decreasing black representation in trials of HF therapeutics is concerning and must improve to ensure the generalizability for this vulnerable population.
African American-Caucasian American differences in aortic valve replacement in patients with severe aortic stenosis
Among patients with severe aortic stenosis (AS), there are limited data on aortic valve replacement (AVR), reasons for nonreceipt and mortality by race. Utilizing the Duke Echocardiography Laboratory Database, we analyzed data from 110,711 patients who underwent echocardiography at Duke University Medical Center between 1999 and 2013. We identified 1,111 patients with severe AS who met ≥1 of 3 criteria for AVR: ejection fraction ≤50%, diagnosis of heart failure, or need for coronary artery bypass surgery. Logistic regression models were used to assess the association between race, AVR and 1-year mortality. χ2 testing was used to assess potential racial differences in reasons for AVR nonreceipt. Among the 1,111 patients (143 AA and 968 CA) eligible for AVR, AA were more often women, had more diabetes, renal insufficiency, aortic regurgitation and left ventricular hypertrophy. CA were more often smokers, had more ischemic heart disease, hyperlipidemia and higher median income levels. There were no racial differences in surgical risk utilizing logistic euroSCORES. Relative to CA, AA had lower rates of AVR (adjusted odds ratio 0.46, 95% CI 0.3-0.71, P < .001) yet similar 1-year mortality (aHR 0.81, 95% CI 0.57-1.17, P = .262). There were no significant differences in reasons for AVR nonreceipt. We identified 143 African Americans (AA) and 968 Caucasian Americans(CA) with severe AS who met prespecified criteria for AVR.. AA relative to CA were more often women, had more diabetes, renal insufficiency, and left ventricular hypertrophy, however had less tobacco use, ischemic heart disease, hyperlipidemia and lower median income levels. Among patients with severe AS, AA relative to CA had lower rates of AVR (adjusted odds ratio 0.46, 95% CI 0.3-0.71, P < .001) without significant differences in reasons for AVR nonreceipt and similar 1-year mortality.
Racial and Ethnic Disparities in Implantable Cardioverter-Defibrillator Utilization: A Contemporary Review
Purpose of review Sudden cardiac arrest is associated with high morbidity and mortality. Despite having a disproportionate burden of sudden cardiac death (SCD), rates of primary and secondary prevention of SCD with implantable cardioverter-defibrillator (ICD) therapy are lower among eligible racially minoritized patients. This review highlights the racial and ethnic disparities in ICD utilization, associated barriers to ICD care, and proposed interventions to improve equitable ICD uptake. Recent findings Racially minoritized populations are disproportionately eligible for ICD therapy but are less likely to see cardiac specialists, be counseled on ICD therapy, and ultimately undergo ICD implantation, fueling disparate outcomes. Racial disparities in ICD utilization are multifactorial, with contributions at the patient, provider, health system, and structural/societal level. Summary Racial and ethnic disparities have been demonstrated in preventing SCD with ICD use. Proposed strategies to mitigate these disparities must prioritize care delivery and access to care for racially minoritized patients, increase the diversification of clinical and implementation trial participants and the healthcare workforce, and center reparative justice frameworks to rectify a long history of racial injustice.