Association Between Diagnosis-to-Limb Revascularization Time and Clinical Outcomes in Outpatients With Chronic Limb-Threatening Ischemia: Insights From the CLIPPER Cohort.

BACKGROUND: The extent and consequences of ischemia in patients with chronic limb-threatening ischemia (CLTI) may change rapidly, and delays from diagnosis to revascularization may worsen outcomes. We sought to describe the association between time from diagnosis to endovascular lower extremity revascularization (diagnosis-to-limb revascularization [D2L] time) and clinical outcomes in outpatients with CLTI. METHODS AND RESULTS: In the CLIPPER cohort, comprising patients between 66 and 86 years old diagnosed with CLTI betweeen 2010 and 2019, we used Medicare claims data to identify patients who underwent outpatient endovascular revascularization within 180 days of diagnosis. We described the risk-adjusted association between D2L time and clinical outcomes. Among 1 130 065 patients aged between 66 and 86 years with CLTI, 99 221 (8.8%) underwent outpatient endovascular lower extremity revascularization within 180 days of their CLTI diagnosis. Among patients with D2L time <30 days, there was no association between D2L time and all-cause death or major lower extremity amputation. However, among patients with D2L time >30 days, each additional 10-day increase in D2L time was associated with a 2.5% greater risk of major amputation (hazard ratio, 1.025 [95% CI, 1.014-1.036]). There was no association between D2L time and all-cause death. CONCLUSIONS: A delay of >30 days from CLTI diagnosis to lower extremity endovascular revascularization was associated with an increased risk of major lower extremity amputation among patients undergoing outpatient endovascular revascularization. Improving systems of care to reduce D2L time could reduce amputations.

Racial, Ethnic, and Socioeconomic Inequities in Access to Left Atrial Appendage Occlusion.

Background Inequitable access to high-technology therapeutics may perpetuate inequities in care. We examined the characteristics of US hospitals that did and did not establish left atrial appendage occlusion (LAAO) programs, the patient populations those hospitals served, and the associations between zip code-level racial, ethnic, and socioeconomic composition and rates of LAAO among Medicare beneficiaries living within large metropolitan areas with LAAO programs. Methods and Results We conducted cross-sectional analyses of Medicare fee-for-service claims for beneficiaries aged 66 years or older between 2016 and 2019. We identified hospitals establishing LAAO programs during the study period. We used generalized linear mixed models to measure the association between zip code-level racial, ethnic, and socioeconomic composition and age-adjusted rates of LAAO in the most populous 25 metropolitan areas with LAAO sites. During the study period, 507 candidate hospitals started LAAO programs, and 745 candidate hospitals did not. Most new LAAO programs opened in metropolitan areas (97.4%). Compared with non-LAAO centers, LAAO centers treated patients with higher median household incomes (difference of $913 [95% CI, $197-$1629], P=0.01). Zip code-level rates of LAAO procedures per 100 000 Medicare beneficiaries in large metropolitan areas were 0.34% (95% CI, 0.33%-0.35%) lower for each $1000 zip code-level decrease in median household income. After adjustment for socioeconomic markers, age, and clinical comorbidities, LAAO rates were lower in zip codes with higher proportions of Black or Hispanic patients. Conclusions Growth in LAAO programs in the United States had been concentrated in metropolitan areas. LAAO centers treated wealthier patient populations in hospitals without LAAO programs. Within major metropolitan areas with LAAO programs, zip codes with higher proportions of Black and Hispanic patients and more patients experiencing socioeconomic disadvantage had lower age-adjusted rates of LAAO. Thus, geographic proximity alone may not ensure equitable access to LAAO. Unequal access to LAAO may reflect disparities in referral patterns, rates of diagnosis, and preferences for using novel therapies experienced by racial and ethnic minority groups and patients experiencing socioeconomic disadvantage.

Characteristics of Clinical Trial Sites for Novel Transcatheter Mitral and Tricuspid Valvular Therapies.

Importance: Racial and ethnic minority and socioeconomically disadvantaged patients have been underrepresented in randomized clinical trials. Efforts have focused on enhancing inclusion of minority groups at sites participating at clinical trials; however, there may be differences in the patient populations of the sites that participate in clinical trials. Objective: To identify any differences in the racial, ethnic, and socioeconomic composition of patient populations among candidate sites in the US that did vs did not participate in trials for novel transcatheter therapies. Design, Setting, and Participants: This cross-sectional analysis used Medicare Provider Claims from 2019 for patients admitted to hospitals in the US. All clinical trials for transcatheter mitral and tricuspid valve therapies and the hospitals participating in each of the trials were identified using ClinicalTrials.gov. Hospitals with active cardiac surgical programs that did not participate in the trials were also identified. Data analysis was performed between July 2021 and July 2022. Exposures: Multivariable linear regression models were used to identify differences in racial, ethnic, and socioeconomic characteristics among patients undergoing cardiac surgery or transcatheter aortic valve replacement at trial vs nontrial hospitals. Main Outcome and Measures: The main outcome of the study was participation in a clinical trial for novel transcatheter mitral or tricuspid valve therapies. Results: A total of 1050 hospitals with cardiac surgery programs were identified, of which 121 (11.5%) participated in trials for transcatheter mitral or tricuspid therapies. Patients treated in trial hospitals had a higher median zip code-based household income (difference of $5261; 95% CI, $2986-$7537), a lower Distressed Communities Index score (difference of 5.37; 95% CI, 2.59-8.15), and no significant difference in the proportion of patients dual eligible for Medicaid (difference of 0.86; 95% CI, -2.38 to 0.66). After adjusting for each of the socioeconomic indicators separately, there was less than 1% difference in the proportion of Black and Hispanic patients cared for at hospitals participating vs not participating in clinical trials. Conclusions and Relevance: In this cohort study among candidate hospitals for clinical trials for transcatheter mitral or tricuspid valve therapies, trial hospitals took care of a more socioeconomically advantaged population than nontrial hospitals, with a similar proportion of Black and Hispanic patients. These data suggest that site selection efforts may improve enrollment of socioeconomically disadvantaged patients but may not improve the enrollment of Black and Hispanic patients.

Medicare Coverage and Out-of-Pocket Costs of Quadruple Drug Therapy for Heart Failure.

BACKGROUND: Beta-blockers, angiotensin receptor-neprilysin inhibitor (ARNI), mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 inhibitors (SGLT2i), known as quadruple therapy, are recommended for patients with heart failure with reduced ejection fraction (HFrEF). OBJECTIVES: This study sought to determine Medicare coverage and out-of-pocket (OOP) costs of quadruple therapy and regimens excluding ARNI or SGLT2i. METHODS: This study assessed cost sharing, prior authorization, and step therapy in all 4,068 Medicare prescription drug plans in 2020. OOP costs were determined during the standard coverage period and annually based on the Medicare Part D standard benefit, inclusive of deductible, standard coverage, coverage gap, and catastrophic coverage. RESULTS: Tier ≥3 cost sharing was required by 99.1% of plans for ARNI and 98.5% for at least 1 SGLT2i. Only ARNI required prior authorization (24.3% of plans), and step therapy was required only for SGLT2is (5.4%) and eplerenone (0.8%). The median 30-day standard coverage OOP cost of quadruple therapy was $94 (IQR: $84-$100), including $47 (IQR: $40-$47) for ARNI and $45 (IQR: $40-$47) for SGLT2i. The median annual OOP cost of quadruple therapy was $2,217 (IQR: $1,956-$2,579) compared with $1,319 (IQR: $1,067-$1,675) when excluding SGLT2i and $1,322 (IQR: $1,025-$1,588) when including SGLT2i and substituting an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for ARNI. The median 30-day OOP cost of generic regimens was $3 (IQR: $0-$9). CONCLUSIONS: Medicare drug plans restrict coverage of quadruple therapy through cost sharing, with OOP costs that are substantially higher than generic regimens. Quadruple therapy may be unaffordable for many Medicare patients with HFrEF unless medication prices and cost sharing are reduced.

Identifying Racial, Ethnic, and Socioeconomic Inequities in the Use of Novel P2Y12 Inhibitors After Percutaneous Coronary Intervention.

BACKGROUND: Novel P2Y12 inhibitors prasugrel and ticagrelor were approved for patients with acute coronary syndrome (ACS) in 2009 and 2011, respectively. We assessed the association of racial, ethnic, and socioeconomic factors with initiation of and adherence to novel P2Y12 inhibitors in a commercially insured population. METHODS: We performed a retrospective cohort analysis of adults undergoing percutaneous coronary intervention with placement of a drug-eluting stent, stratified by ACS status, between January 2008 and December 2016 using Clinformatics Data Mart (OptumInsight). We estimated multivariable logistic regression models to identify factors associated with the initiation of clopidogrel vs novel P2Y12 inhibitors as well as subsequent 6-month medication adherence, assessed via pharmacy records. RESULTS: A total of 55,664 patients were included in the analysis. Hispanic ethnicity was independently associated with the initiation of clopidogrel compared with novel P2Y12 inhibitors among ACS patients (odds ratio [OR], 1.19; 95% confidence interval [CI], 1.04-1.36; P<.01). ACS patients with an annual median household income of over $100,000 were less likely to be started on clopidogrel when compared with those who earned less than $40,000 (OR, 0.67; 95% CI, 0.61-0.75; P<.01). Black race, Hispanic ethnicity, and lower household income were each associated with significantly reduced odds of P2Y12 inhibitor adherence. CONCLUSION: Hispanic ethnicity and lower household income were associated with novel P2Y12 inhibitor initiation, and non-White race and ethnicity were associated with lower P2Y12 inhibitor adherence over 6-month follow-up. These findings highlight continued inequity of care, even in an insured population, and point to a need for new strategies to close these gaps.

Racial, Ethnic, and Socioeconomic Disparities in Access to Transcatheter Aortic Valve Replacement Within Major Metropolitan Areas.

Importance: Despite the benefits of high-technology therapeutics, inequitable access to these technologies may generate disparities in care. Objective: To examine the association between zip code-level racial, ethnic, and socioeconomic composition and rates of transcatheter aortic valve replacement (TAVR) among Medicare patients living within large metropolitan areas with TAVR programs. Design, Setting, and Participants: This multicenter, nationwide cross-sectional analysis of Medicare claims data between January 1, 2012, and December 31, 2018, included beneficiaries of fee-for-service Medicare who were 66 years or older living in the 25 largest metropolitan core-based statistical areas. Exposure: Receipt of TAVR. Main Outcomes and Measures: The association between zip code-level racial, ethnic, and socioeconomic composition and rates of TAVR per 100 000 Medicare beneficiaries. Results: Within the studied metropolitan areas, there were 7590 individual zip codes. The mean (SD) age of Medicare beneficiaries within these areas was 71.4 (2.0) years, a mean (SD) of 47.6% (5.8%) of beneficiaries were men, and a mean (SD) of 4.0% (7.0%) were Asian, 11.1% (18.9%) were Black, 8.0% (12.9%) were Hispanic, and 73.8% (24.9%) were White. The mean number of TAVRs per 100 000 Medicare beneficiaries by zip code was 249 (IQR, 0-429). For each $1000 decrease in median household income, the number of TAVR procedures performed per 100 000 Medicare beneficiaries was 0.2% (95% CI, 0.1%-0.4%) lower (P = .002). For each 1% increase in the proportion of patients who were dually eligible for Medicaid services, the number of TAVR procedures performed per 100 000 Medicare beneficiaries was 2.1% (95% CI, 1.3%-2.9%) lower (P < .001). For each 1-unit increase in the Distressed Communities Index score, the number of TAVR procedures performed per 100 000 Medicare beneficiaries was 0.4% (95% CI, 0.2%-0.5%) lower (P < .001). Rates of TAVR were lower in zip codes with higher proportions of patients of Black race and Hispanic ethnicity, despite adjusting for socioeconomic markers, age, and clinical comorbidities. Conclusions and Relevance: Within major metropolitan areas in the US with TAVR programs, zip codes with higher proportions of Black and Hispanic patients and those with greater socioeconomic disadvantages had lower rates of TAVR, adjusting for age and clinical comorbidities. Whether this reflects a different burden of symptomatic aortic stenosis by race and socioeconomic status or disparities in use of TAVR requires further study.

Socioeconomic and Geographic Characteristics of Hospitals Establishing Transcatheter Aortic Valve Replacement Programs, 2012-2018.

BACKGROUND: Despite the benefits of novel therapeutics, inequitable diffusion of new technologies may generate disparities. We examined the growth of transcatheter aortic valve replacement (TAVR) in the United States to understand the characteristics of hospitals that developed TAVR programs and the socioeconomic status of patients these hospitals served. METHODS: We identified fee-for-service Medicare beneficiaries aged 66 years or older who underwent TAVR between January 1, 2012, and December 31, 2018, and hospitals that developed TAVR programs (defined as performing ≥10 TAVRs over the study period). We used linear regression models to compare socioeconomic characteristics of patients treated at hospitals that did and did not establish TAVR programs and described the association between core-based statistical area level markers of socioeconomic status and TAVR rates. RESULTS: Between 2012 and 2018, 583 hospitals developed new TAVR programs, including 572 (98.1%) in metropolitan areas, and 293 (50.3%) in metropolitan areas with preexisting TAVR programs. Compared with hospitals that did not start TAVR programs, hospitals that did start TAVR programs treated fewer patients with dual eligibility for Medicaid (difference of -2.83% [95% CI, -3.78% to -1.89%], P≤0.01), higher median household incomes (difference $2447 [95% CI, $1348-$3547], P=0.03), and from areas with lower distressed communities index scores (difference -4.02 units [95% CI, -5.43 to -2.61], P≤0.01). After adjusting for the age, clinical comorbidities, race and ethnicity and socioeconomic status, areas with TAVR programs had higher rates of TAVR and TAVR rates per 100 000 Medicare beneficiaries were higher in core-based statistical areas with fewer dual eligible patients, higher median income, and lower distressed communities index scores. CONCLUSIONS: During the initial growth phase of TAVR programs in the United States, hospitals serving wealthier patients were more likely to start programs. This pattern of growth has led to inequities in the dispersion of TAVR, with lower rates in poorer communities.

Association of Health Insurance Payer Type and Outcomes After Durable Left Ventricular Assist Device Implantation: An Analysis of the STS-INTERMACS Registry.

BACKGROUND: Due to the high cost of left ventricular assist device (LVAD) therapy, payer type may be an important factor in determining eligibility. How payer type influences outcomes after LVAD implantation is unclear. We, therefore, aimed to study the association of health insurance payer type with outcomes after durable LVAD implantation. METHODS: Using STS-INTERMACS (Society of Thoracic Surgeons-Interagency Registry for Mechanically Assisted Circulatory Support), we studied nonelderly adults receiving a durable LVAD from 2016 to 2018 and compared all-cause mortality and postindex hospitalization adverse event episode rate by payer type. Multivariable Fine-Gray and generalized linear models were used to compare the outcomes. RESULTS: Of the 3251 patients included, 26.0% had Medicaid, 24.9% had Medicare alone, and 49.1% had commercial insurance. Compared with commercially insured patients, mortality did not differ for patients with Medicaid (subdistribution hazard ratio, 1.00 [95% CI, 0.75-1.34], P=0.99) or Medicare (subdistribution hazard ratio, 1.09 [95% CI, 0.84-1.41], P=0.52). Medicaid was associated with a significantly lower adjusted incidence rate (incidence rate ratio, 0.88 [95% CI, 0.78-0.99], P=0.041), and Medicare was associated with a significantly higher adjusted incidence rate (incidence rate ratio, 1.16 [95% CI, 1.03-1.30], P=0.011) of adverse event episodes compared with commercially insured patients. CONCLUSIONS: All-cause mortality after durable LVAD implantation did not differ significantly by payer type. Payer type was associated with the rate of adverse events, with Medicaid associated with a significantly lower rate, and Medicare with a significantly higher rate of adverse event episodes compared with commercially insured patients.

Association of Race/Ethnicity, Gender, and Socioeconomic Status With Sodium-Glucose Cotransporter 2 Inhibitor Use Among Patients With Diabetes in the US.

Importance: Sodium-glucose cotransporter 2 (SGLT2) inhibitors significantly reduce deaths from cardiovascular conditions, hospitalizations for heart failure, and progression of kidney disease among patients with type 2 diabetes. Black individuals have a disproportionate burden of cardiovascular and chronic kidney disease (CKD). Adoption of novel therapeutics has been slower among Black and female patients and among patients with low socioeconomic status than among White or male patients or patients with higher socioeconomic status. Objective: To assess whether inequities based on race/ethnicity, gender, and socioeconomic status exist in SGLT2 inhibitor use among patients with type 2 diabetes in the US. Design, Setting, and Participants: This retrospective cohort study of commercially insured patients in the US was performed from October 1, 2015, to June 30, 2019, using the Optum Clinformatics Data Mart. Adult patients with a diagnosis of type 2 diabetes, including those with heart failure with reduced ejection fraction (HFrEF), atherosclerotic cardiovascular disease (ASCVD), or CKD, were evaluated in the analysis. Main Outcomes and Measures: Prescription of an SGLT2 inhibitor. Multivariable logistic regression models were used to assess the association of race/ethnicity, gender, and socioeconomic status with SGLT2 inhibitor use. Results: Of 934 737 patients with type 2 diabetes (mean [SD] age, 65.4 [12.9] years; 50.7% female; 57.6% White), 81 007 (8.7%) were treated with an SGLT2 inhibitor during the study period. Between 2015 and 2019, the percentage of patients with type 2 diabetes treated with an SGLT2 inhibitor increased from 3.8% to 11.9%. Among patients with type 2 diabetes and cardiovascular or kidney disease, the rate of SGLT2 inhibitor use increased but was lower than that among all patients with type 2 diabetes (HFrEF: 1.9% to 7.6%; ASCVD: 3.0% to 9.8%; CKD: 2.1% to 7.5%). In multivariable analyses, Black race (adjusted odds ratio [aOR], 0.83; 95% CI, 0.81-0.85), Asian race (aOR, 0.94; 95% CI, 0.90-0.98), and female gender (aOR, 0.84; 95% CI, 0.82-0.85) were associated with lower rates of SGLT2 inhibitor use, whereas higher median household income (≥$100 000: aOR, 1.08 [95% CI, 1.05-1.10]; $50 000-$99 999: aOR, 1.05 [95% CI, 1.03-1.07] vs <$50 000) was associated with a higher rate of SGLT2 inhibitor use. These results were similar among patients with HFrEF, ASCVD, and CKD. Conclusions and Relevance: In this cohort study, use of an SGLT2 inhibitor treatment increased among patients with type 2 diabetes from 2015 to 2019 but remained low, particularly among patients with HFrEF, CKD, and ASCVD. Black and female patients and patients with low socioeconomic status were less likely to receive an SGLT2 inhibitor, suggesting that interventions to ensure more equitable use are essential to prevent worsening of well-documented disparities in cardiovascular and kidney outcomes in the US.

Adoption of PCSK9 Inhibitors Among Patients With Atherosclerotic Disease.

Background PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors represent a promising class of lipid-lowering therapy, although their use has been limited by cost concerns. Methods and Results A retrospective cohort study was conducted using a nationwide commercial claims database comprising patients with atherosclerotic cardiovascular disease (ASCVD), aged 18 to 64 years. We identified the number of patients with ASCVD started on a PCSK9 inhibitor from the dates of US Food and Drug Administration approval in quarter 3 2015 through quarter 2 2019. Secondary objectives identified the proportions of patients started on a PCSK9 inhibitor in various ASCVD risk groups based on statin use and baseline low-density lipoprotein cholesterol. We identified 126 419 patients with ASCVD on either PCSK9 inhibitor or statin therapy. Among these patients, 1168 (0.9%) filled a prescription for a PCSK9 inhibitor. The number of patients initiating a PCSK9 inhibitor increased from 2 patients in quarter 3 2015 to 119 patients in quarter 2 2019, corresponding to an increase from 0.05% to 2.5% of patients with ASCVD already on statins who started PCSK9 inhibitor therapy. Of patients with ASCVD with high adherence to a high-intensity statin, 13 643 had low-density lipoprotein cholesterol ≥70 mg/dL, and in this subgroup, 119 (0.9%) patients initiated a PCSK9 inhibitor. Conclusions Few patients started PCSK9 inhibitors from 2015 through mid-2019, despite increasing trial evidence of efficacy, guidelines recommending PCSK9 inhibitors in high-risk patients with ASCVD, and price reductions during this period. The magnitude of price reductions may not yet be sufficient to influence use management strategies aimed to limit PCSK9 inhibitor use.

Trends in Coded Indications for Percutaneous Coronary Interventions in Medicare and the Veterans Affairs After Implementation of Hospital-Level Reporting of Appropriate Use Criteria.

BACKGROUND: In 2009, the American College of Cardiology and American Heart Association published Appropriate Use Criteria for Coronary Revascularization (AUC) to aid patient selection for percutaneous coronary intervention (PCI). The subsequent decline in inappropriate PCIs was interpreted as a success of AUC. However, there are concerns clinicians reclassify nonacute PCIs to acute indications to fulfill AUC. METHODS: A longitudinal, observational difference-in-differences analysis was performed using administrative claims from US Department of Veterans Affairs (VA) beneficiaries coenrolled in Medicare and from a national random sample of Medicare beneficiaries, undergoing PCI from September 30, 2009, to December 31, 2013. Non-VA hospitals participating in the American College of Cardiology CathPCI registry began receiving AUC reports in 2011, while VA hospitals did not receive reports, serving as quasiexperimental and control cohorts, respectively. We measured the proportion of PCIs coded for acute myocardial infarction, unstable angina, and nonacute coronary syndrome indications by quarter. RESULTS: There were 87 464 and 30 251 PCIs performed in the Medicare and VA cohorts, respectively. In Medicare, proportion of PCIs coded for acute myocardial infarction and unstable angina changed from 31.9% and 12.6% in quarter 4 2009 to 41.0% and 10.5% in quarter 4 2013, an associated 2.00% (95% CI, 1.56%-2.44%; P<0.001) increase per year in PCIs coded for acute coronary syndrome indications. In the VA, proportion of PCIs coded for acute myocardial infarction and unstable angina changed from 26.5% and 15.7% in quarter 4 2009 to 34.3% and 12.3% in quarter 4 2013, an associated 1.20% (95% CI, 0.56%-1.88%; P=0.001) increase per year in PCIs coded for acute coronary syndrome indications. Difference-in-differences modeling found no statistically significant change in PCI coded for acute indications between Medicare and VA, pre- and post-AUC reporting. CONCLUSIONS: After introduction of AUC assessments and reporting, we observed comparable increases in coding for acute myocardial infarction and corresponding decreases in coding for unstable angina and nonacute coronary syndrome indications among national cohorts of Medicare and VA enrollees. The provision of appropriate use reporting did not appear to have a substantial impact on the proportion of PCIs coded for acute indications during this study period.

Association Between County-Level Change in Economic Prosperity and Change in Cardiovascular Mortality Among Middle-aged US Adults.

Importance: After a decline in cardiovascular mortality for nonelderly US adults, recent stagnation has occurred alongside rising income inequality. Whether this is associated with underlying economic trends is unclear. Objective: To assess the association between changes in economic prosperity and trends in cardiovascular mortality in middle-aged US adults. Design, Setting, and Participants: Retrospective analysis of the association between change in 7 markers of economic prosperity in 3123 US counties and county-level cardiovascular mortality among 40- to 64-year-old adults (102 660 852 individuals in 2010). Exposures: Mean rank for change in 7 markers of economic prosperity between 2 time periods (baseline: 2007-2011 and follow-up: 2012-2016). A higher mean rank indicates a greater relative increase or lower relative decrease in prosperity (range, 5 to 92; mean [SD], 50 [14]). Main Outcomes and Measures: Mean annual percentage change (APC) in age-adjusted cardiovascular mortality rates. Generalized linear mixed-effects models were used to estimate the additional APC associated with a change in prosperity. Results: Among 102 660 852 residents aged 40 to 64 years living in these counties in 2010 (51% women), 979 228 cardiovascular deaths occurred between 2010 and 2017. Age-adjusted cardiovascular mortality rates did not change significantly between 2010 and 2017 in counties in the lowest tertile for change in economic prosperity (mean [SD], 114.1 [47.9] to 116.1 [52.7] deaths per 100 000 individuals; APC, 0.2% [95% CI, -0.3% to 0.7%]). Mortality decreased significantly in the intermediate tertile (mean [SD], 104.7 [38.8] to 101.9 [41.5] deaths per 100 000 individuals; APC, -0.4% [95% CI, -0.8% to -0.1%]) and highest tertile for change in prosperity (100.0 [37.9] to 95.1 [39.1] deaths per 100 000 individuals; APC, -0.5% [95% CI, -0.9% to -0.1%]). After accounting for baseline prosperity and demographic and health care-related variables, a 10-point higher mean rank for change in economic prosperity was associated with 0.4% (95% CI, 0.2% to 0.6%) additional decrease in mortality per year. Conclusions and Relevance: In this retrospective study of US county-level mortality data from 2010 to 2017, a relative increase in county-level economic prosperity was significantly associated with a small relative decrease in cardiovascular mortality among middle-aged adults. Individual-level inferences are limited by the ecological nature of the study.

Racial, Ethnic, and Socioeconomic Inequities in Glucagon-Like Peptide-1 Receptor Agonist Use Among Patients With Diabetes in the US.

Importance: Randomized clinical trials have shown that glucagon-like peptide-1 receptor agonists (GLP-1 RAs) cause significant weight loss and reduce cardiovascular events in patients with type 2 diabetes (T2D). Black patients have a disproportionate burden of obesity and cardiovascular disease and have a higher rate of cardiovascular-related mortality. Racial and ethnic disparities in health outcomes are largely attributable to the pervasiveness of structural racism, and patients who are marginalized by racism have less access to novel therapeutics. Objectives: To evaluate GLP-1 RA uptake among a commercially insured population of patients with T2D; identify associations of race, ethnicity, sex, and socioeconomic status with GLP-1 RA use; and specifically examine its use among the subgroup of patients with atherosclerotic cardiovascular disease (ASCVD) because of the known benefit of GLP-1 RA use for this population. Design Setting and Participants: This was a retrospective cohort analysis using data from OptumInsight Clinformatics Data Mart of commercially insured adult patients with T2D (with or without ASCVD) in the US. Data from October 1, 2015, to June 31, 2019, were included, and the analyses were performed in July 2020. We estimated multivariable logistic regression models to identify the association of race, ethnicity, sex, and socioeconomic status with GLP-1 RA use. Main Outcome and Measure: A prescription for a GLP-1 RA. Results: Of the 1 180 260 patients with T2D (median [IQR] age, 69 [59-76] years; 50.3% female; 57.7% White), 90 934 (7.7%) were treated with GLP-1 RA during the study period. From 2015 to 2019, the percentage of T2D patients treated with an GLP-1 RA increased from 3.2% to 10.7%. Among patients with T2D and ASCVD, use also increased but remained low (2.8%-9.4%). In multivariable analyses, lower rates of GLP-1 RA use were found among Asian (aOR, 0.59; 95% CI, 0.56-0.62), Black (adjusted odds ratio [aOR] 0.81; 95% CI, 0.79-0.83), and Hispanic (aOR, 0.91; 95% CI, 0.88-0.93) patients with T2D. Female sex (aOR, 1.22; 95% CI, 1.20-1.24) and higher zip code-linked median household incomes (>$100 000 [OR, 1.13; 95% CI, 1.11-1.16] and $50 000-$99 999 [OR, 1.07; 95% CI, 1.05-1.09] vs <$50 000) were associated with higher GLP-1 RA use. These results were similar to those found among patients with ASCVD. Conclusions and Relevance: In this cohort study of US patients with T2D, GLP-1 RA use increased, but remained low overall for treatment of T2D, particularly among patients with ASCVD who are likely to derive the most benefit. Asian, Black, and Hispanic patients and those with low income were less likely to receive treatment with a GLP-1 RA. Strategies to lower barriers to GLP-1 RA use, such as lower cost, are needed to prevent the widening of well-documented inequities in cardiovascular disease outcomes in the US.

Oral anticoagulant use in patients with atrial fibrillation and mitral valve repair.

BACKGROUND: Patients with atrial fibrillation (AF) who have undergone mitral valve repair are at risk for thromboembolic strokes. Prior to 2019, only vitamin K antagonists were recommended for patients with AF who had undergone mitral valve repair despite the introduction of direct oral anticoagulants (DOAC) in 2010. OBJECTIVE: To characterize the use of anticoagulants in patients with AF who underwent surgical mitral valve repair (sMVR) or transcatheter mitral valve repair (tMVR). METHODS: We performed a retrospective cohort analysis of patients with AF undergoing sMVR or tMVR between 04/2014 and 12/2018 using Optum's de-identified Clinformatics® Data Mart Database. We identified anticoagulants prescribed within 90 days of discharge from hospitalization. RESULTS: Overall, 1997 patients with AF underwent valve repair: 1560 underwent sMVR, and 437 underwent tMVR. The mean CHA2DS2-VASc score among all patients was 4.1 (SD 1.9). The overall use of anticoagulation was unchanged between 2014 (72.2%) and 2018 (70.0%) (P = .49). Among patients who underwent sMVR or tMVR between April 2014 and December 2018, the use of VKA therapy decreased from 62.9% to 32.1% (P < .01 for trend) and the use of DOACs increased from 12.4% to 37.3% (P < .01 for trend). CONCLUSIONS: Among patients with AF who underwent sMVR or tMVR between 2014 and 2018, roughly 30% of patients were not treated with any anticoagulant within 90 days of discharge, despite an elevated stroke risk in the cohort. The rate of DOAC use increased steadily over the study period but did not significantly increase the rate of overall anticoagulant use in this high-risk cohort.

Association Between 90-Minute Door-to-Balloon Time, Selective Exclusion of Myocardial Infarction Cases, and Access Site Choice: Insights From the Cardiac Care Outcomes Assessment Program (COAP) in Washington State.

BACKGROUND: For patients presenting with ST-segment-elevation myocardial infarction, national quality initiatives monitor hospitals' proportion of cases with door-to-balloon (D2B) time under 90 minutes. Hospitals are allowed to exclude patients from reporting and may modify behavior to improve performance. We sought to identify whether there is a discontinuity in the number of cases included in the D2B time metric at 90 minutes and whether operators were increasingly likely to pursue femoral access in patients with less time to meet the 90-minute quality metric. METHODS: Adult patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention from 2011 to 2018 were identified from the Cardiac Care Outcomes Assessment Program, a quality improvement registry in Washington state. We used the regression discontinuity framework to test for discontinuity at 90 minutes among the included cases. We defined a novel variable, remaining D2B as 90 minutes minus the time between hospital arrival and catheterization laboratory arrival. We estimated multivariable logistic regression models to assess the relationship between remaining D2B time and access site. RESULTS: A total of 19 348 patients underwent primary percutaneous coronary intervention and were included in the analysis. Overall, 7436 (38.4%) were excluded from the metric. There appeared to be a visual discontinuity in included cases around 90 minutes; however, local quadratic regression around the 90-minute cutoff did not reveal evidence of a significant discontinuity (P=0.66). Multivariable analysis showed no significant relationship between remaining D2B time and the odds of undergoing femoral access (P=0.73). CONCLUSIONS: Among patients undergoing percutaneous coronary intervention for ST-segment-elevation myocardial infarction, we did not find evidence of a statistically significant discontinuity in the frequency of included cases around 90 minutes or an increased preference for femoral access correlated with decreasing time to meet the 90-minute D2B time quality metric. Together, these findings indicate no evidence of widespread inappropriate methods to improve performance on D2B time metrics.

Federal Payments for Coronary Revascularization Procedures Among Dual Enrollees in Medicare Advantage and the Veterans Affairs Health Care System.

Importance: More than 1 million US veterans are dually enrolled in a Medicare Advantage (MA) plan and in the Veterans Affairs (VA) health care system. The federal government prepays private MA plans to cover veterans; if a dually enrolled veteran receives an MA-covered service at the VA, the government is making 2 payments for the same service. It is not clear what proportion of veterans dually enrolled in VA and MA are undergoing coronary revascularization at VA vs non-VA hospitals. Objective: To describe where veterans who are enrolled in both VA and MA undergo coronary revascularization and the associated costs. Design, Settings, and Participants: This is a cohort study consisting of US veterans dually enrolled in VA and MA from January 1, 2010, to December 31, 2013, who had at least 1 VA encounter and underwent coronary revascularization during the study period. Data were analyzed from April 2019 to September 2019. Main Outcomes and Measures: Number of coronary artery bypass graft (CABG) operations and percutaneous coronary interventions (PCIs) performed through the VA and through MA during years 2010 to 2013, and the associated VA costs of coronary revascularization. In addition, multivariable logistic regression was performed to assess patient factors associated with receiving care through the VA. Results: A total of 18 874 VA users with concurrent MA enrollment who underwent coronary revascularization during 2010 to 2013 were identified (mean [SD] age, 75.3 [8.8] years; 18 739 men [99.0%]). Enrollees were predominantly white (17 457 patients [92.0%]). Among patients, 4115 (22.0%) underwent either CABG or PCI through the VA only, 14 281 (75.0%) did so through MA only, and 478 (2.5%) underwent coronary revascularization procedures through both payers. From 2010 to 2013, these veterans underwent 4764 coronary revascularization procedures (721 CABGs and 3043 PCIs) that cost the VA $214.7 million ($115.8 million for CABGs and $99.0 million for PCIs). In multivariable analysis, nonwhite patients were more likely than white patients to undergo coronary revascularization through the VA (odds ratio, 1.73; 95% CI, 1.52-1.96; P < .001), and for each year of age, veterans were less likely to undergo coronary revascularization through the VA (odds ratio, 0.95; 95% CI, 0.94-0.95; P < .001). There was no statistically significant association between undergoing coronary vascularization through the VA and distance in miles to the nearest VA hospital (odds ratio, 1.00; 95% CI, 0.99-1.00; P = .30). Conclusions and Relevance: A substantial share of VA users concurrently enrolled in an MA plan underwent coronary revascularization procedures through the VA, incurring significant duplicative federal health care spending. Given the financial pressures facing both Medicare and the VA, government officials should consider policy solutions to mitigate redundant spending.

Performance of Hospitals When Assessing Disease-Based Mortality Compared With Procedural Mortality for Patients With Acute Myocardial Infarction.

Importance: Quality of percutaneous coronary intervention (PCI) is commonly assessed by risk-adjusted mortality. However, this metric may result in procedural risk aversion, especially for high-risk patients. Objective: To determine correlation and reclassification between hospital-level disease-specific mortality and PCI procedural mortality among patients with acute myocardial infarction (AMI). Design, Setting, and Participants: This hospital-level observational cross-sectional multicenter analysis included hospitals participating in the Chest Pain-MI Registry, which enrolled consecutive adult patients admitted with a diagnosis of type I non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI), and hospitals in the CathPCI Registry, which enrolled consecutive adult patients treated with PCI with an indication of NSTEMI or STEMI, between April 1, 2011, and December 31, 2017. Exposures: Inclusion into the National Cardiovascular Data Registry Chest Pain-MI and CathPCI registries. Main Outcomes and Measures: For each hospital in each registry, a disease-based excess mortality ratio (EMR-D) for AMI was calculated, which represents a risk-adjusted observed to expected rate of mortality for AMI as a disease using the Chest Pain-MI Registry, and a procedure-based excess mortality ratio (EMR-P) for PCI was calculated using the CathPCI Registry. Results: A subset of 625 sites participated in both registries, with a final count of 776 890 patients from the Chest Pain-MI Registry (509 576 men [65.6%]; 620 981 white [80.0%]; and median age, 64 years [interquartile range, 55-74 years]) and 853 386 patients from the CathPCI Registry (582 701 men [68.3%]; 691 236 white [81.0%]; and median age, 63 years [interquartile range, 54-73 years]). Among the 625 linked hospitals, the Spearman rank correlation coefficient between EMR-D and EMR-P produced a ρ of 0.53 (95% CI, 0.47-0.58), suggesting moderate correlation. Among the highest-performing tertile for disease-based risk-adjusted mortality, 90 of 208 sites (43.3%) were classified into a lower category for procedural risk-adjusted mortality. Among the lowest-performing tertile for disease-based risk-adjusted mortality, 92 of 208 sites (44.2%) were classified into a higher category for procedural risk-adjusted mortality. Bland-Altman plots for the overall linked cohort demonstrate a mean difference between EMR-P and EMR-D of 0.49% (95% CI, -1.61% to 2.58%; P < .001), with procedural mortality higher than disease-based mortality. However, among patients with AMI complicated by cardiogenic shock or cardiac arrest, the mean difference between EMR-P and EMR-D was -0.64% (95% CI, -4.41% to 3.12%; P < .001), with procedural mortality lower than disease-based mortality. Conclusions and Relevance: This study suggests that, for hospitals treating patients with AMI, there is only a moderate correlation between procedural outcomes and disease-based outcomes. Nearly half of hospitals in the highest tertile of performance for PCI performance were reclassified into a lower performance tertile when judged by disease-based metrics. Higher rates of mortality were observed when using disease-based metrics compared with procedural metrics when assessing patients with cardiogenic shock and/or cardiac arrest, signifying what appears to be potential risk avoidance among this highest-risk subset of 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.