The association between social determinants of health and patient-centred outcomes in adults with heart failure with reduced ejection fraction.

AIMS: To explore the associations between social determinants of health and patient-centred outcomes among adults with chronic heart failure with reduced ejection fraction. DESIGN: Cross-sectional online self-report survey. METHODS: A survey assessing social determinants of health (demographics, socio-economic position, affordability of care and social support) and patient-centred outcomes, including the Kansas City Cardiomyopathy Questionnaire-12 and validated measures of medication adherence, treatment satisfaction, treatment burden and mental health, was completed by 512 adults with chronic heart failure with a reduced ejection fraction between 06 March and 29 June 2020. Multivariable analyses included linear and logistic regression. RESULTS: Female gender, having a care partner, and being offered financial assistance with medications were associated with worse health status, while perceiving medication as affordable and being married were associated with better health status. Females and having Medicaid, dual Medicaid/Medicare or no medical insurance were associated with a higher likelihood of depression, and non-white race/ethnicity was associated with less depression. Medication adherence was lower in patients having a care partner and offered financial assistance. Patients being offered financial and medication management assistance were more likely to be overwhelmed by the treatment burden, whereas those having some college education were less so. CONCLUSIONS: Social determinants of health are associated with patients' disease-specific health status, mental health and treatment satisfaction and burden. These findings underscore the importance of assessing social determinants of health in clinical practice and the need for developing and testing novel strategies to determine whether they improve patients' health. IMPACT: The relationship between social determinants of health- and patient-centred outcomes was assessed; affordability of care and social support factors were most strongly associated with outcomes for patients with chronic heart failure and reduced ejection fraction, underscoring the importance of assessing social determinants of health in routine clinical care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Social determinants of health data could potentially inform care delivery for patients with heart failure and reduced ejection fraction by helping to identify those who require additional support to manage their symptoms, access care and adhere to treatment. Social support and affordability of treatment were associated with most patient-centred outcomes, suggesting these factors may provide clinicians with an indicator of a patient's level of general well-being that could be assessed during routine follow-up care. REPORTING METHOD: This research followed the STROBE checklist for cross-sectional studies. PATIENT OR PUBLIC CONTRIBUTION: Adults who have heart failure with reduced ejection fraction that consented to participate in the study provided the data used for all analyses reported on in the manuscript. Service users, caregivers or members of the public had no involvement in the study.

Patient-centered Outcomes in HFrEF Following a Worsening Heart Failure Event: A Survey Analysis.

BACKGROUND: Heart failure is a chronic disease punctuated by intermittent exacerbations that require hospitalization or intravenous diuretic therapy. The association of worsening heart failure events (WHFEs) with patient-centered outcomes in heart failure with reduced ejection fraction (HFrEF) remains unexplored. METHODS AND RESULTS: Patients with HFrEF completed an online survey assessing health status, medication adherence, treatment satisfaction, treatment burden, and medication costs and affordability. Patients with and without WHFEs were compared on all study variables, with adjustment for patient characteristics using linear or logistic regression. Overall, 512 patients (52.0% WHFEs) were included. Patients with WHFEs more commonly had depression (55.3% vs 24.0%), anxiety (46.2% vs 17.9%), and insomnia (77.8% vs 44.7%; P < 0.001 for all). Patients with WHFEs had lower adjusted mean Kansas City Cardiomyopathy Questionnaire values (52.9 vs 56.0) and Satisfaction with Medications Questionnaire values (70.5 vs 72.6) and higher Treatment Burden Questionnaire scores (51.1 vs 45.1; P < 0.001). Medication-related beliefs and long-term concerns were independently associated with nonadherence in patients with WHFE (adjusted odds ratios: 4.2 and 5.2, respectively; P < 0.01 for both). Patients with WHFE incurred 50.0% higher median monthly out-of-pocket HF prescription medication costs and less often perceived HF medications to be affordable. CONCLUSIONS: WHFE is associated with several adverse impacts on patients with HFrEF. Additional support is warranted to manage symptoms, comorbidities, and HF treatments to improve adherence and outcomes.

Enhancing Diversity and Inclusion in Clinical Trials.

Women and people from most racial and ethnic groups in the United States have historically been under-represented in clinical trials of investigational medical products. Inadequate representation of these groups may lead to an incomplete understanding of the safety and efficacy of new drugs, devices, biologics, and vaccines, and limit the generalizability of trial findings. As a result, new medical products may not be beneficial to all people who need them, and existing inequities in outcomes among various population groups may remain unchanged or worsen, or new disparities may arise. Although much work has focused on study-level strategies, research organizations must make systemic changes to how clinical trials are envisioned and implemented to achieve sustainable support for diversity and inclusion in clinical trials. The Clinical Trials Transformation Initiative (CTTI) conducted interviews with leaders at institutions that conduct clinical trials to explore perspectives on organizational-level practices that promote diversity and inclusion in clinical trials. Leaders described motivations, such as an ethical and moral imperative; organizational practices, such as staff investment and resource allocation; perceived return on investments, such as better science; and deterrents, such as cost and time. The CTTI also convened an expert meeting to discuss the interview findings and provide guidance. We present the interview findings and expert guidance in a framework that describes four key areas-commitment, partnerships, accountability, and resources-on sustaining organizational-level approaches for improving diversity and inclusion in clinical trials, with the ultimate goal of advancing health equity. Institutions who conduct and support clinical trials should implement organizational-level approaches to improve equitable access and diverse patient participation in clinical trials.

Increasing Diversity in Clinical Trials: Overcoming Critical Barriers.

Clinical trial results provide the critical evidence base for evaluating the safety and efficacy of new medicines and medical products. Efficacy and safety may differ among population subgroups depending on intrinsic/extrinsic factors, including sex, age, race, ethnicity, lifestyle, and genetic background. Racial and ethnic minorities continue to be underrepresented in cardiovascular and other clinical trials. Although barriers to diversity in trials are well recognized, sustainable solutions for overcoming them have proved elusive. We investigated barriers impacting minority patients' willingness to participate in trials and-based on literature review and evaluation, and input from key stakeholders, including minority patients, referring physicians, investigators who were minority-serving physicians, and trial coordinators-formulated potential solutions and tested them across stakeholder groups. We identified key themes from solutions that resonated with stakeholders using a transtheoretical model of behavior change and created a communications message map to support a multistakeholder approach for overcoming critical participant barriers.

US Cancer Centers of Excellence Strategies for Increased Inclusion of Racial and Ethnic Minorities in Clinical Trials.

PURPOSE: Participation of racial and ethnic minority groups (REMGs) in cancer trials is disproportionately low despite a high prevalence of certain cancers in REMG populations. We aimed to identify notable practices used by leading US cancer centers that facilitate REMG participation in cancer trials. METHODS: The National Minority Quality Forum and Sustainable Healthy Communities Diverse Cancer Communities Working Group developed criteria by which to identify eligible US cancer centers-REMGs comprise 10% or more of the catchment area; a 10% to 50% yearly accrual rate of REMGs in cancer trials; and the presence of formal community outreach and diversity enrollment programs. Cancer center leaders were interviewed to ascertain notable practices that facilitate REMG accrual in clinical trials. RESULTS: Eight cancer centers that met the Communities Working Group criteria were invited to participate in in-depth interviews. Notable strategies for increased REMG accrual to cancer trials were reported across five broad themes: commitment and center leadership, investigator training and mentoring, community engagement, patient engagement, and operational practices. Specific notable practices included increased engagement of health care professionals, the presence of formal processes for obtaining REMG patient/caregiver input on research projects, and engagement of community groups to drive REMG participation. Centers also reported an increase in the allocation of resources to improving health disparities and increased dedication of research staff to REMG engagement. CONCLUSION: We have identified notable practices that facilitate increased participation of REMGs in cancer trials. Wide implementation of such strategies across cancer centers is essential to ensure that all populations benefit from advances in an era of increasingly personalized treatment of cancer.

Low plasma RANTES levels are an independent predictor of cardiac mortality in patients referred for coronary angiography.

OBJECTIVE: Our objective was to evaluate the prognostic value of baseline plasma RANTES levels in patients with known or suspected coronary artery disease. RANTES is a chemokine produced by a variety of cell types including platelets that has been implicated in atherosclerosis. METHODS AND RESULTS: Baseline plasma RANTES levels were measured in 389 male patients undergoing coronary angiography at a Veterans Affairs Medical Center. The patients were followed-up prospectively for the occurrence of cardiac mortality and myocardial infarction. Follow-up data at 24 months were available for 97% of patients. In the entire cohort of patients, low baseline RANTES levels were an independent predictor of cardiac mortality. For cardiac death at 24 months, the survival rate was 87.3% in the lowest tertile of RANTES values, compared with 94% in the upper 2 tertiles combined (P=0.0298 by log rank test). Furthermore, when patients were risk-stratified into those with and without an acute coronary syndrome, RANTES was an independent predictor of both cardiac mortality and myocardial infarction in those without an acute coronary syndrome. Finally, RANTES was also an independent predictor of cardiac mortality in the diabetic subset. CONCLUSIONS: In a cohort of male patients undergoing coronary angiography, low baseline plasma RANTES levels are an independent predictor of cardiac mortality.

Home blood pressure monitoring in an ethnically diverse inner-city cardiology practice.

OBJECTIVES: To evaluate home blood pressure monitoring (HBPM) in an inner city cardiology practice. DESIGN: Retrospective study. SETTING: Inner city cardiology practice. PATIENTS: Consecutive patients were evaluated for hypertension and had > or = 8 home blood pressure recordings during 2-4 weeks while clinically stable on a medical regimen. MAIN OUTCOME MEASURES: Blood pressure differences, blood pressure load, defined as %HBPM systolic blood pressure readings > 140 and/or diastolic blood pressure readings > 90 mm Hg. RESULTS: 55 patients, (33 female, age 62 +/- 12.5 years). Office systolic, diastolic and mean BPs were higher than HBPM values (147 +/- 19 mmHg vs 139 +/- 17 mmHg, P = < .0001), (86 +/- 10 mm Hg vs 79 +/- 10 mm Hg, P < .0001), and (106 +/- 11 mm Hg vs 99 +/- 10 mmHg, P < .0001) respectively. Office and home pulse pressure (PPs) were similar (61 +/- 17 mm Hg vs 60 +/- 17 mm Hg, P = .42). Office and home PPs were more strongly correlated (r = .78, P < .0001) than were systolic (r = .51, P < .0001), diastolic (r = .51, P < .0001). Blood pressure load increased in a step-wise manner with increasing office blood pressure, 7.5% for patients with office blood pressure < 120/80 mm Hg to 73.5% in patients with office blood pressure > 160/100 mm Hg (P = .02). Office BPs showed 10/55 patients were normal or controlled (blood pressure < 140/ 90 mmHg) and 45 were high or uncontrolled (blood pressure > or = 140/90 mmHg). HBPM reclassified 2/10 patients as high/uncontrolled whereas 17/45 patients became normal/controlled. CONCLUSIONS: Office systolic and diastolic BPs are 7-8 mm Hg higher than home recordings in ethnically diverse patients. Office and home PPs are more strongly correlated than systolic, diastolic or mean arterial BPs. Blood pressure load is related to office BPs. HBPM reclassified approximately one third of the patients. HBPM appears useful in managing minority populations with hypertension.

Impact of completeness of percutaneous coronary intervention revascularization on long-term outcomes in the stent era.

BACKGROUND: The importance of completeness of revascularization by percutaneous coronary intervention in patients with multivessel disease is unclear in that there is little information on the impact of incomplete revascularization outside of randomized trials. The objective of this study is to compare long-term mortality and subsequent revascularization for percutaneous coronary intervention patients receiving stents who were completely revascularized (CR) with those who were incompletely revascularized (IR). METHODS AND RESULTS: Patients from New York State's Percutaneous Coronary Interventions Reporting System were subdivided into patients who were CR and IR. Then subsets of IR patients were contrasted with CR patients. Differences in long-term survival and subsequent revascularization for CR and IR patients were compared after adjustment for differences in preprocedural risk. A total of 68.9% of all stent patients with multivessel disease who were studied were IR, and 30.1% of all patients had total occlusions and/or > or =2 IR vessels. At baseline, the following patients were at higher risk: those who were older and those with more comorbid conditions, worse ejection fraction, and more renal disease and stroke. After adjustment for these baseline differences, IR patients were significantly more likely to die at any time (adjusted hazard ratio=1.15; 95% confidence interval, 1.01 to 1.30) than CR patients. IR patients with total occlusions and a total of > or =2 IR vessels were at the highest risk compared with CR patients (hazard ratio=1.36; 95% confidence interval, 1.12 to 1.66). CONCLUSIONS: IR with stenting is associated with an adverse impact on long-term mortality, and consideration should be given to either achieving CR, opting for surgery, or monitoring percutaneous coronary intervention patients with IR more closely after discharge.

A comparison of mortality, myocardial infarction, and repeated revascularization for sirolimus-eluting and paclitaxel-eluting coronary stents.

BACKGROUND: Drug-eluting stents are now used in most percutaneous coronary interventions. There are only 2 approved devices: sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). Only a few population-based studies have compared their patient outcomes. METHODS: All New York State patients undergoing SES or PES in nonfederal hospitals in the state between April 1 and December 31, 2004, except those with a previous revascularization, left main coronary artery disease, or a recent myocardial infarction (MI) or shock (4867 patients with PES and 6914 with SES) were followed up through the end of 2005. We compared SES and PES with respect to inhospital and 18-month mortality, 18-month mortality/MI, and subsequent target vessel and target lesion revascularization (TVR and TLR) after adjusting for differences in patient risk factors. RESULTS: By 18 months after receiving a PES, 4.0% of the patients died compared with 4.1% for SES patients, 5.9% of PES patients experienced mortality/MI compared with 6.3% of SES patients, 6.8% of the PES patients had a subsequent TVR within 18 months compared with 7.8% for SES patients, and 4.5% of the PES patients had a subsequent TLR within 18 months compared with 5.3% for SES patients. The respective adjusted hazards ratios (PES/SES) for these adverse outcomes were 1.02 (95% CI 0.82-1.26, P = .86), 0.94 (95% CI 0.78-1.13, P = .52), 0.89 (95% CI 0.75-1.06, P = .20), and 0.86 (95% CI 0.70-1.05, P = .14). CONCLUSIONS: Patients receiving PES and SES do not have significantly different 18-month mortality, mortality/MI, subsequent TVR, or subsequent TLR rates.

Differences in utilization of drug-eluting stents by race and payer.

Numerous disparities in access to health care by race and gender have been identified in the literature. This study examines differences in the use of drug-eluting stents (DES) versus bare-metal stents (BMS) by race, payer, and income level. Data from New York State's Percutaneous Coronary Intervention Reporting System from July 2003 to December 2004 were used to examine use of DES (20,165 patients) relative to BMS (4,547 patients) by race, payer, and annual income level, controlling for a variety of patient and hospital characteristics. African-Americans were found to be less likely to receive DES than other races between July 2003 and March 2004 (adjusted odds ratio [OR] 0.56, 95% confidence interval [CI] 0.50 to 0.65) and between April 2004 and December 2004 (adjusted OR 0.74, 95% CI 0.61 to 0.90). These disparities were reduced (respective adjusted ORs 0.67, 95% CI 0.58 to 0.77 and 0.81, 95% CI 0.66 to 0.91) when controlling for admitting hospital and hospital volume, but were still significant. Medicaid/self-pay patients, and patients living in zip codes with median annual incomes between $20,000 and $30,000 were also less likely to receive DES in the first time period (adjusted respective ORs 0.80, 95% CI 0.68 to 0.93) and 0.85, 95% CI 0.75 to 0.96). In conclusion, African-Americans and low income groups receive DES less frequently than their counterparts compared with BMS. This is related to the hospitals where they are admitted, but not entirely.

Usefulness of the serum complement component C4 as a predictor of stroke in patients with known or suspected coronary artery disease referred for coronary angiography.

The complement system has been implicated in the pathogenesis of atherosclerosis. In addition, complement activation and complement-mediated brain injury have been found in a variety of central nervous system diseases, including stroke. However, there are limited data about the value of complement components for prediction of stroke. Complement C3 and C4 levels, in addition to a variety of established biomarkers, were measured in 389 men with known or suspected coronary artery disease referred for coronary angiography for a variety of indications at a Veterans Affairs Medical Center. Patients were followed prospectively for the development of stroke, which was defined and classified according to criteria of the Trial of Org 10172 in Acute Stroke Treatment (TOAST). All strokes were confirmed with magnetic resonance imaging or computed tomography. For the 97% of patients in whom 24-month follow-up data were available, there were 23 strokes (5.9%). By multivariate Cox proportional hazard analysis, complement C4 was an independent predictor of stroke, with a hazard ratio of 1.57 (95% confidence interval 1.03 to 2.39, p = 0.0358). The 24-month stroke-free survival rate for the patients whose complement C4 levels were equal to or below the median value for the entire cohort was 96.1% compared with 90.1% for patients whose complement C4 levels were above the median value, p = 0.0127 by log rank test). In conclusion, in a cohort of men across a spectrum of risk referred for coronary angiography, a single baseline determination of serum complement C4 level is an independent predictor of the future development of stroke.

Usefulness of baseline plasma myeloperoxidase levels as an independent predictor of myocardial infarction at two years in patients presenting with acute coronary syndrome.

Baseline plasma myeloperoxidase (MPO) levels have been shown to independently predict the early risk of myocardial infarction (MI) in patients presenting with chest pain. In addition, baseline MPO levels have been demonstrated to predict the development of adverse cardiac events up to 6 months after an acute coronary syndrome (ACS). However, in contrast to other biomarkers, there are no data about the long-term independent predictive value of baseline MPO values in patients with ACS. The present study investigated the long-term prognostic significance of baseline MPO levels in a well-characterized cohort of 193 men with ACS who were referred for coronary angiography at a Veterans Administration Medical Center. All patients were followed prospectively for the development of death and MI, and follow-up data were available for all patients at 24 months. After controlling for different baseline clinical, laboratory, and angiographic variables, baseline plasma MPO values were a strong and independent predictor of MI at 24 months by multivariate analysis. Using the median MPO value of the entire cohort of patients (i.e., 20.34 ng/ml) as a prespecified cutoff, the MI-free survival at 24 months for the group whose baseline MPO values were < or =20.34 ng/ml was 88% compared with 74% in those whose values were >20.34 ng/ml (p = 0.0249 by log-rank test). In conclusion, these data demonstrate that baseline MPO levels independently predict MI at 2 years in patients with ACS.

Metabolic syndrome in African Americans: implications for preventing coronary heart disease.

The metabolic syndrome represents a specific clustering of cardiovascular risk factors in the same individual (abdominal obesity, atherogenic dyslipidemia, elevated blood pressure, insulin resistance, a prothrombotic state, and a proinflammatory state). Almost 50 million American adults (about one in four) have the metabolic syndrome, which puts them at increased risk for the development of diabetes mellitus and cardiovascular disease. African Americans, especially African-American women, have a high prevalence of the metabolic syndrome. This is attributable mainly to the disproportionate occurrence in African Americans of elevated blood pressure, obesity, and diabetes. Management of the metabolic syndrome consists primarily of modification or reversal of the root causes (overweight/obesity and physical inactivity) and therapy to reduce or control the risk factors. Although all components of the metabolic syndrome should be addressed, optimal control of atherogenic dyslipidemia and elevated blood pressure may reduce cardiovascular risk by more than 80%.

Bedside ultrasound diagnosis of aortic dissection in a cocaine abuser.

Aortic dissection and myocardial infarction are two well-known and well-reported complications of cocaine abuse. This case report describes a patient with cocaine-induced myocardial infarction who was also found to have a type A aortic dissection. Interestingly, this potentially fatal complication was detected by a bedside 2D echocardiogram.

Volume-outcome relationships for percutaneous coronary interventions in the stent era.

BACKGROUND: Most studies that are the basis of recommended volume thresholds for percutaneous coronary interventions (PCIs) predate the routine use of stent placement. METHODS AND RESULTS: Data from New York's Percutaneous Coronary Interventions Reporting System in 1998 to 2000 (n=107 713) were used to examine the impact of annual hospital volume and annual operator volume on in-hospital mortality, same-day coronary artery bypass graft (CABG) surgery, and same-stay CABG surgery after adjustment for differences in patients' severity of illness. For a hospital-volume threshold of 400, the odds ratios for low-volume hospitals versus high-volume hospitals were 1.98 (95% CI, 1.17, 3.35) for in-hospital mortality, 2.07 (95% CI, 1.36, 3.15) for same-day CABG surgery, and 1.51 (95% CI, 1.03, 2.21) for same-stay CABG surgery. For an operator-volume threshold of 75, the odds ratios for low-volume versus high-volume operators were 1.65 (95% CI, 1.05, 2.60) for same-day CABG surgery and 1.55 (95% CI, 1.10, 2.18) for same-stay CABG surgery. Operator volume was not significantly associated with mortality. Also, for hospital volumes below 400 and operator volumes below 75, the respective odds of mortality, same-day CABG surgery, and same-stay CABG surgery were 5.92, 4.02, and 3.92 times the odds for hospital volumes of 400 or higher and operator volumes of 75 or higher. CONCLUSIONS: Higher-volume operators and hospitals continue to experience lower risk-adjusted PCI outcome rates.

Tissue inhibitor of metalloproteinase-1 (TIMP-1) is an independent predictor of all-cause mortality, cardiac mortality, and myocardial infarction.

BACKGROUND: Matrix metalloproteinases and their inhibitors have been implicated in both vascular and ventricular remodeling, and in atherosclerotic plaque rupture. The prognostic value of plasma tissue inhibitor of metalloproteinase-1 (TIMP-1) levels in patients with established or suspected coronary artery disease is unknown. METHODS: Tissue inhibitor of metalloproteinase-1 and matrix metalloproteinase-9 (MMP-9) levels, along with a number of other established biomarkers, were measured in 389 male patients undergoing coronary angiography at a Veterans Administration Medical Center. The patients were then followed prospectively for the occurrence of all-cause mortality, cardiac mortality, and myocardial infarction (MI). RESULTS: Follow-up data at 24 months were available for 97% of the patients. For the entire cohort of patients, TIMP-1 was the only biomarker to independently predict all-cause mortality and MI. In addition, the ratio of TIMP-1 to matrix metalloproteinase-9 was independently predictive of cardiac mortality at 24 months. The 24-month survival rates for patients in the lower quartile (< 66.5 ng/mL), interquartile (66.5-100 ng/mL), and upper quartile (> 100 ng/mL) of plasma TIMP-1 values were 95.3%, 89.3%, and 72.2%, respectively (P < .001). Furthermore, when patients with chest pain were risk stratified into those with and without an acute coronary syndrome, TIMP-1 remained an independent predictor of all-cause mortality in both subgroups. CONCLUSIONS: In a cohort of male patients undergoing coronary angiography, a single baseline determination of plasma TIMP-1 is independently predictive of the subsequent risk of death and MI.

Usefulness of anemia in men as an independent predictor of two-year cardiovascular outcome in patients presenting with acute coronary syndrome.

Anemia has been shown to be an independent risk factor for the development of adverse cardiovascular outcomes in a variety of patient populations. In the case of patients presenting with acute coronary syndrome (ACS), anemia has been demonstrated to be a powerful and independent predictor of 30-day outcomes. However, there are limited and conflicting data about the long-term independent predictive value of anemia in patients with ACS. This is in contrast to non-ACS populations in which anemia has been shown to be an independent predictor of long-term outcomes. The present study investigated the long-term prognostic significance of anemia in a well-characterized cohort of 193 men with ACS who were referred for coronary angiography at a Veterans Affairs Medical Center. All patients were followed prospectively for the development of death or acute myocardial infarction (AMI), and follow-up data were available for all patients at 24 months. After controlling for a variety of baseline clinical, laboratory, and angiographic variables, hemoglobin (analyzed as a continuous variable and as a categorical variable using the World Health Organization cutoff of 13 g/dl for men) was a strong and independent predictor of the composite end point of death or AMI at 24 months when using a Cox proportional hazards model. At 24 months, the event-free survival was 64% in the group with a hemoglobin level < 13 g/dl compared with 81% in the group with a hemoglobin level > or = 13 g/dl (p = 0.0065 by log-rank test). In conclusion, these data demonstrate that baseline anemia is a strong and independent predictor of death or AMI at 2 years in patients with ACS.

Usefulness of the white blood cell count as a predictor of angiographic findings in an unselected population referred for coronary angiography.

There are limited data about the relative importance of the many different but inter-related inflammatory markers with respect to their ability to independently predict the presence and extent of coronary artery disease (CAD). In addition, studies demonstrating such associations have often been conducted in well-defined populations and have excluded patients with or not adjusted for co-morbidities associated with CAD. In a cohort of 389 men who underwent coronary angiography for a variety of clinical indications and across a spectrum of risk, the following inflammatory markers were measured at baseline to determine their relative abilities to predict angiographic outcomes: C-reactive protein, myeloperoxidase, tissue inhibitor of metalloproteinase-1, erythrocyte sedimentation rate, and white blood cell (WBC) count. This analysis was done in the context of traditional CAD risk factors and other co-morbidities associated with CAD (such as morbid obesity, renal dysfunction, heart failure, and so forth). WBC count was the only marker that was independently associated with angiographically documented CAD (p = 0.0184). Further, WBC count (odds ratio 1.31, 95% confidence interval 1.05 to 1.64, p = 0.0157) and plasma myeloperoxidase (odds ratio 1.35, 95% confidence interval 1.08 to 1.69, p = 0.0090) were the only inflammatory markers that were independently predictive of the presence of multivessel disease on coronary angiography. In conclusion, these data demonstrate that a simple baseline WBC count is independently associated with angiographic CAD, and that it can predict the presence of multivessel disease, even in the context of clinical CAD risk factors and other established inflammatory markers.

Comparison of efficacy and safety of rosuvastatin versus atorvastatin in African-American patients in a six-week trial.

The lipid-modifying effects of statin therapy in hypercholesterolemic African-Americans have not been well characterized. This study compared the efficacy and safety of rosuvastatin and atorvastatin treatment for 6 weeks in hypercholesterolemic African-American adults. In the African American Rosuvastatin Investigation of Efficacy and Safety (ARIES) trial (4522US/0002), 774 adult African-Americans with low-density lipoprotein cholesterol > or = 160 and < or = 300 mg/dl and triglycerides < 400 mg/dl were randomized to receive open-label rosuvastatin 10 or 20 mg or atorvastatin 10 or 20 mg for 6 weeks. At week 6, significantly greater reductions in low-density lipoprotein cholesterol, total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B concentrations, as well as lipoprotein and apolipoprotein ratios, were seen with rosuvastatin versus milligram-equivalent atorvastatin doses (analysis of variance with Bonferroni-adjusted critical p < 0.017 for all comparisons). Rosuvastatin 10 mg also increased high-density lipoprotein cholesterol significantly more than atorvastatin 20 mg (p < 0.017). Although statistical comparisons were not performed, larger proportions of rosuvastatin-treated patients than atorvastatin-treated patients achieved National Cholesterol Education Program Adult Treatment Panel III low-density lipoprotein cholesterol goals. The median high-sensitivity C-reactive protein levels were significantly reduced statistically from baseline with rosuvastatin 20 mg and atorvastatin 20 mg among all patients and with rosuvastatin 10 and 20 mg and atorvastatin 20 mg in those patients with a baseline C-reactive protein level > 2.0 mg/L. The 2 study medications were well tolerated during the 6-week study period. In conclusion, rosuvastatin 10 and 20 mg improved the overall lipid profile of hypercholesterolemic African-Americans better than did milligram-equivalent doses of atorvastatin.

Ethnic differences in achievement of cholesterol treatment goals. Results from the National Cholesterol Education Program Evaluation Project Utilizing Novel E-Technology II.

BACKGROUND: African Americans (AA) have the highest coronary heart disease mortality rate of any ethnic group in the United States. Data from the National Cholesterol Education Program Evaluation ProjecT Utilizing Novel E-Technology (NEPTUNE) II survey were used to assess ethnic differences in low-density lipoprotein cholesterol (LDL-C) goal achievement. METHODS: NEPTUNE II surveyed patients with treated dyslipidemia to assess achievement of treatment goals established by the Adult Treatment Panel III of the National Cholesterol Education Program. United States physicians working in primary care or relevant subspecialties enrolled 10 to 20 consecutive patients (May to September 2003), and patient data were recorded in Personal Digital Assistants and uploaded to a central database via the internet. RESULTS: Among 4,885 patients receiving treatment for dyslipidemia, 79.7% were non-Hispanic white (NHW) and 8.4% were AA. Non-Hispanic white and AA patients had significantly different frequencies of treatment success, with 69.0% and 53.7%, respectively, having achieved their LDL-C goal (P<.001). African-American patients were more likely to be in the highest risk category, and less likely to be using lipid drug therapy, taking high-efficacy statins, and receiving care from a subspecialist, but the difference in goal achievement remained significant (P<.001) after adjustment for these and other predictors of treatment success. CONCLUSIONS: The frequency of treatment success in dyslipidemia management was significantly lower in AA than NHW patients. Additional research is needed to elucidate reasons for this disparity and to evaluate strategies for improving goal achievement among AA patients receiving therapy for dyslipidemia.