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A high percentage of total calories from ultra-processed foods has been associated with several cardiovascular disease risk factors. No study has examined the association between ultra-processed foods and heart age. This study examines the association between ultra-processed foods and excess heart age (difference between estimated heart age and chronological age) among U.S. adults.The National Health and Nutrition Examination Survey (2009-2016) data for participants aged 30-74 years without cardiovascular disease or stroke (n=12,640) was used. Ultra-processed food was assigned based on NOVA classification of food processing, with ultra-processed food being the highest level. This study estimated the usual percentage of calories from ultra-processed foods and used sex-specific Framingham heart age algorithms to calculate heart age. The multivariable linear or logistic regression was used to examine the association between ultra-processed foods and excess heart age or likelihood of excess heart age being ≥10 years. Data analyses were conducted in 2020.The median usual percentage of calories from ultra-processed foods was 54.5% (IQR=45.8%‒63.1%). Adjusted excess heart age increased from 7.0 years (95% CI=6.4, 7.6) in the lowest quintile (Q1) to 9.9 years (95% CI=9.2, 10.5) in the highest quintile (Q5) (p0.001). Compared with Q1, AORs for excess heart age of ≥10 years were 1.16 (95% CI=1.08, 1.25) in Q2, 1.29 (95% CI=1.14, 1.46) in Q3, 1.43 (95% CI=1.20, 1.71) in Q4, and 1.66 (95% CI=1.29, 2.14) in Q5 (p0.001). The pattern of association was largely consistent across subgroups.U.S. adults consumed more than half of total daily calories from ultra-processed foods. A higher percentage of calories from ultra-processed foods was associated with higher excess heart age and likelihood of excess heart age of ≥10 years.

Background Vascular endothelial growth factor (VEGF) gene is highly polymorphic, and single nucleotide polymorphisms (SNP) of VEGF gene are associate with cancer prognosis. This study aimed to analyze the correlation of VEGF gene polymorphisms with grade and prognosis of lung cancer. Methods A total of 458 Chinese patients with primary lung cancer were enrolled from September 2008 to October 2013. The genotypes of −2578C > A, −1154G > A, − 460 T > C, and + 405G > C were analyzed in white blood cells from patients using polymerase chain reaction based restriction fragment length polymorphism. Results Our data showed that –1154G > A polymorphism was significantly associated with tumor stages, but all four tested VEGF gene polymorphisms had no significant effect on survival. Conclusions VEGF polymorphisms may relate to stage of lung cancer in Chinese population.

This study is aimed to elucidate the mechanisms underlying the role of miR-485-5p in small cell lung cancer (SCLC). The expression of miR-485-5p were quantified with real time quantitative PCR and it was found that the level of miR-485-5p was lower in SCLC tissues than normal tissues. In cultured SCLC cell lines, overexpression of miR-485-5p reduced cell proliferation, migration, and invasion in vitro, whereas knockdown of miR-485-5p performed contrary. FLOT2 expression was obviously upregulated and negatively correlated with miR-485-5p expression level in SCLC tissues. Overexpression of miR-485-5p significantly inhibited the protein expression of flotillin-2 (FLOT2) in cultured SCLC cells. Luciferase reporter assay confirmed that FLOT2 was a direct target of miR-485-5p in SCLC cells. It is concluded that miR-485-5p, as a tumor suppressor, inhibits the growth and metastasis in SCLC by targeting FLOT2. Upregulation of miR-485-5p expression may be an attractive strategy for SCLC therapy.

Background Concern has been expressed by some that sodium reduction could lead to increased prevalence of hyponatremia and hyperkalemia for specific population subgroups. Current concentrations of serum sodium and potassium in the US population can help address this concern. Methods We used data from the National Health and Nutrition Examination Survey 2009–2016 to examine mean and selected percentiles of serum sodium and potassium by sex and age group among 25 520 US participants aged 12 years or older. Logistic regression models with predicted residuals were used to examine the age-adjusted prevalence of low serum sodium and high serum potassium among adults aged 20 or older by selected sociodemographic characteristics and by health conditions or medication use. Results The distributions of serum sodium and potassium concentrations were within normal reference intervals overall and across Dietary Reference Intake life-stage groups, with a few exceptions. Overall, 2% of US adults had low serum sodium (5 mmol/L). Prevalence of low serum sodium and high serum potassium was higher among adults aged 71 or older (4.7 and 2.0%, respectively) and among adults with chronic kidney disease (3.4 and 1.9%), diabetes (5.0 and 1.1%), or using certain medications (which varied by condition), adjusted for age; whereas, prevalence was Conclusions Most of the US population has normal serum sodium and potassium concentrations; these data describe population subgroups at higher risk of low serum sodium and high serum potassium and can inform clinical care.

Hypertension is an important modifiable risk factor for cardiovascular morbidity and mortality, and hypertension in adolescents and young adults is associated with long-term negative health effects (1,2).* In 2017, the American Academy of Pediatrics (AAP) released a new Clinical Practice Guideline (3), which updated 2004 pediatric hypertension guidance† with new thresholds and percentile references calculated from a healthy-weight population. To examine trends in youth hypertension and the impact of the new guideline on classification of hypertension status, CDC analyzed data from 12,004 participants aged 12-19 years in the 2001-2016 National Health and Nutrition Examination Survey (NHANES). During this time, prevalence of hypertension declined, using both the new (from 7.7% to 4.2%, p

Hypertension is an important modifiable risk factor for cardiovascular morbidity and mortality, and hypertension in adolescents and young adults is associated with long-term negative health effects (1,2).* In 2017, the American Academy of Pediatrics (AAP) released a new Clinical Practice Guideline (3), which updated 2004 pediatric hypertension guidance† with new thresholds and percentile references calculated from a healthy-weight population. To examine trends in youth hypertension and the impact of the new guideline on classification of hypertension status, CDC analyzed data from 12,004 participants aged 12-19 years in the 2001-2016 National Health and Nutrition Examination Survey (NHANES). During this time, prevalence of hypertension declined, using both the new (from 7.7% to 4.2%, p

No study examined and compared the association between intake of trans-fatty acids (TFAs) and risk of metabolic syndrome before and after significant reduction of TFA intakes in the US population. We hypothesized that the relationship might remain significant after substantial reduction of TFA intakes in the population. We used data on 1442 and 2233 adults aged ≥20 years from the National Health and Nutrition Examination Survey 1999-2000 and 2009-2010, respectively. Multivariable logistic regression analysis was used to assess the association between plasma TFA concentrations and metabolic syndrome, including each of its 5 components. The median plasma TFA concentrations were reduced from 79.8 μmol/L in 1999-2000 to 36.9 μmol/L in 2009-2010. The fully adjusted prevalence ratios comparing the highest vs the lowest quintile of plasma TFA concentrations in 1999-2000 were 3.43 (95% confidence interval, 2.39-4.92) for metabolic syndrome, 1.72 (1.38-2.14) for large waistline, 8.25 (6.34-10.74) for high triglycerides, 1.96 (1.46-2.62) for low high-density lipoprotein cholesterol, 1.14 (0.85-1.55) for high blood pressure, and 1.48 (1.19-1.85) for high fasting glucose, respectively. The corresponding prevalence ratios in 2009-2010 were 2.93 (2.41-3.54), 1.62 (1.39-1.89), 14.93 (9.28-24.02), 3.09 (2.18-4.37), 1.27 (1.11-1.46), and 1.24 (1.06-1.46), respectively. The pattern of association between TFAs and metabolic syndrome and its components did not differ by cycles. The observed associations were consistent across the subgroups examined. Despite a 54% decline in plasma TFA concentrations from 1999-2000 to 2009-2010, it was positively associated with risk of metabolic syndrome and its individual components except for blood pressure in 1999-2000. Our findings support Food and Drug Administration initiatives to remove TFAs from the industrially-produced foods.

Background Because family history is a known risk factor for heart disease, it is important to characterize its public health impact in terms of population prevalence of family history of heart disease, the burden of heart disease attributable to family history, and whether family history interacts with modifiable risk factors for heart disease. Methods and Results We used population data from NHANES (the National Health and Nutrition Examination Survey [2007–2014]) to measure the association of self‐reported family history of premature heart disease ( FHPHD ) with cardiovascular disease (n=19 253) and to examine the association between cardiovascular health metrics and FHPHD (n=16 248). Using logistic regression and multivariable adjustment, family history odds ratios were 5.91 (95% CI , 3.34–10.44) for ages 20 to 39, 3.02 (95% CI, 2.41–3.79) for ages 40 to 59, and 1.87 (95% CI , 1.54–2.28) for age ≥60 for cardiovascular disease. The prevalence of cardiovascular disease for the population with a FHPHD (15.72%; 95% CI , 13.81–17.64) was more than double the prevalence of cardiovascular disease for those without a family history (6.25%; 95% CI , 5.82–6.69). Compared with participants with optimum cardiovascular health, the prevalence ratio for FHPHD was 1.98 (95% CI , 1.40–2.79) for those with inadequate cardiovascular health. Conclusions Millions of people who are at high risk of having cardiovascular disease could be identified using FHPHD . FHPHD can become an important component of public health campaigns that address modifiable risk factors that plan to reduce the overall risk of heart disease.

Objective Associations of overall and regional body fat measured by dual-energy X-ray absorptiometry with total and cause-specific mortality in the National Health and Nutrition Examination Survey (NHANES) 1999-2006 were investigated. Methods This study included 9,471 participants (≥20 years) free of major chronic diseases at baseline. Death information was obtained from the National Death Index (mean follow-up duration: 8.8 years). Results A total of 682 participants died after 12 months since baseline, with 206 and 170 deaths attributed to cardiovascular diseases (CVD) and cancer, respectively. The second quartile of fat mass percentages (FM%) was used as the reference to account for potential nonlinearity. In the multivariate-adjusted model, participants in the highest quartile of total FM% had increased total mortality; hazard ratio (HR; 95% confidence interval, 95% CI) was 1.48 (1.07-2.04; P

Metastasis and recurrence are the challenges of cancer therapy. Recently, mounting evidence has suggested that cancer stem cells (CSCs) and epithelial-mesenchymal transition (EMT) are critical factors in tumor metastasis and recurrence. The oncogene, Bmi-1, promotes the development of hematologic malignancies and many solid tumors. The aim of the present study was to elucidate the mechanisms through which Bmi-1 promotes the invasion and migration of colon CSCs (CCSCs) using the HCT116 colon cancer cell line. Sphere formation medium and magnetic-activated cell sorting were used to enrich and screen the CCSCs. CD133 and CD44 were regarded as markers of CCSCs and they were found to be co-expressed in the HCT116 colon cancer cell line. Colony formation assay, cell proliferation assay and viability assay using the Cell Counting Kit-8, and transplantation assay using nude mice injected with CCSCs were used to examine the CCSCs. The CD133+CD44+ HCT116 cells exhibited greater cloning efficiency, an enhanced proliferative ability, increased cell viability and stronger tumorigenicity; these cells were used as the CCSCs for subsequent experiments. In addition, the invasive and migratory abilities of the CD133+CD44+ HCT116 cells were markedly decreased when Bmi-1 was silenced by small interfering RNA (siRNA). The results of RT-qPCR and western blot analysis suggested that Bmi-1 had a negative effect on E-cadherin expression. On the whole, our findings suggest that Bmi-1 promotes the invasion and migration of CCSCs through the downregulation of E-cadherin, possibly by inducing EMT. Our findings thus indicate that Bmi-1 may be a novel therapeutic target for the treatment of colon cancer.

BACKGROUND AND OBJECTIVES: Socioeconomic disparities in cardiovascular health among adults have been documented, but disparities during adolescence are less understood. In this study, we examined secular trends in 7 cardiovascular risk factors and disparities among US adolescents. METHODS: We analyzed NHANES data from 1999 to 2014, including 11 557 (4854 fasting) participants aged 12 to 19 years. To examine trends in cardiovascular risk factors, adolescents were stratified into 3 groups on the basis of family poverty-income ratio: low income (poverty-income ratio, RESULTS: From 1999 to 2014, the prevalence of obesity increased (16.5%–21.0%, P = .001) but only among low- and middle-income adolescents, with significant disparities in prevalence by income (21.7% vs 14.6% among low- versus high-income adolescents, respectively, in 2011–2014). In addition, there were significant and persistent disparities in the prevalence of smoking (20.8% vs 7.4% among low- versus high-income adolescents, respectively, in 2011–2014), low-quality diet (67.8% vs 49.0%), and physical inactivity (25.6% vs 17.0%). No significant disparities were observed in the prevalence of prediabetes and diabetes, hypertension, or hypercholesterolemia, although the prevalence of prediabetes and diabetes increased among low-income adolescents (21.4%–28.0%, P = .01). Overall, the prevalence of adolescents with 2 or more risk factors declined (48.3% to 37.1%, P CONCLUSIONS: Recent improvements in cardiovascular health have not been equally shared by US adolescents of varying socioeconomic status.

Background Both excessive sodium intake and obesity are risk factors for hypertension and cardiovascular disease. The association between sodium intake and obesity is unclear, with few studies assessing sodium intake using 24-h urine collection. Objectives Our objective was to assess the association between usual 24-h sodium excretion and measures of adiposity among US adults. Methods Cross-sectional data were analyzed from a sample of 730 nonpregnant participants aged 20-69 y who provided up to 2 complete 24-h urine specimens in the NHANES 2014 and had data on overweight or obesity [body mass index (kg/m2) ≥25] and central adiposity [waist circumference (WC): >88 cm for women, >102 cm for men]. Measurement error models were used to estimate usual sodium excretion, and multiple linear and logistic regression models were used to assess its associations with measures of adiposity, adjusting for sociodemographic, health, and dietary variables [i.e., energy intake or sugar-sweetened beverage (SSB) intake]. All analyses accounted for the complex survey sample design. Results Unadjusted mean ± SE usual sodium excretion was 3727 ± 43.5 mg/d and 3145 ± 55.0 mg/d among participants with and without overweight/obesity and 3653 ± 58.1 mg/d and 3443 ± 35.3 mg/d among participants with or without central adiposity, respectively. A 1000-mg/d higher sodium excretion was significantly associated with 3.8-units higher BMI (95% CI: 2.8, 4.8) and a 9.2-cm greater WC (95% CI: 6.9, 11.5 cm) adjusted for covariates. Compared with participants in the lowest quartile of sodium excretion, the adjusted prevalence ratios in the highest quartile were 1.93 (95% CI: 1.69, 2.20) for overweight/obesity and 2.07 (95% CI: 1.74, 2.46) for central adiposity. The associations also were significant when adjusting for SSBs, instead of energy, in models. Conclusions Higher usual sodium excretion is associated with overweight/obesity and central adiposity among US adults.

Objectives Insufficient sleep negatively impacts the cardiovascular system. No study has examined the association between sleep duration and heart age (person's predicted vascular age based on cardiovascular disease [CVD] risk profile). This study examines association between sleep duration and excess heart age (EHA; difference between heart age and chronological age) among US adults. Design and participants Cross-sectional 2007-2014 National Health and Nutrition Examination Survey data for respondents aged 30-74 years without CVD or stroke (n = 12,775). Measurements Self-reported sleep duration was classified into 5 categories (≤5, 6, 7, 8, and ≥9 hours). We used sex-specific Framingham heart age algorithm to calculate heart age and multivariable linear regression to examine association between sleep duration and EHA. Results A total of 13.4% (95% confidence interval 12.5-14.3), 24.2% (23.1-25.2), 31.0% (29.8-32.3), 25.9% (25.0-26.9), and 5.5% (5.0-6.1) reported sleeping ≤5, 6, 7, 8, and ≥9 hours, respectively. We observed a nonlinear relationship between sleep duration and EHA using 7 hours as reference: EHA (adjusted for sociodemographics, body mass index, physical activity, Healthy Eating Index-2010, sleep disorder, and depression status) was 5.1 (4.8-5.8), 4.5 (3.9-5.1), 3.7 (3.3-4.0), 4.5 (4.1-5.0), and 4.1 (3.3-4.9) years for sleep durations of ≤5, 6, 7, 8 and ≥9 hours, respectively (P = .015 for quadratic trend). EHA was significantly higher among participants with lower education, lower income, and obesity. Conclusion Mean adjusted EHA was lowest among adults who reported sleeping 7 hours per night and increased as adults reported sleeping fewer or more hours. Discussing sleep duration in the context of EHA may be helpful for patients and clinicians.

Activating protein-4 (AP4) has been recently shown to regulate the cancer metastases in some cancers including non-small cell lung cancer (NSCLC). Specifically, AP4 regulates mTor/p21 and transforming growth factor β (TGFβ) receptor signaling pathway to increase an epithelial-mesenchymal transition process to augment cell invasiveness. Nevertheless, how AP4 is regulated in NSCLC has not been studied. Here, we showed that in the specimens from the NSCLC patients, the levels of miR-144 were significantly decreased and the levels of AP4 were significantly increased, compared to the paired non-tumor lung tissue. The levels of miR-144 and AP4 inversely correlated in patients’ specimens. Bioinformatics analyses revealed that miR-144 targeted the 3′-UTR of AP4 mRNA to inhibit its translation, confirmed by luciferase-reporter assay. Moreover, miR-144 overexpression inhibited AP4-mediated cell invasiveness, while miR-144 depletion increased AP4-mediated cell invasiveness in NSCLC cells. Together, our data suggest that miR-144 suppression may be the cause of the increased levels of AP4, as well as the augmented cancer metastases, in NSCLC.

The aim of the study is to study the correlation of genetic polymorphism of vascular endothelial growth factor (VEGF) gene with susceptibility to primary lung cancer. A total of 414 patients with primary lung cancer and 338 healthy volunteers were enrolled in this case-control study from September 2008 to October 2011. Gene identification with PCR-RFLP (polymerase chain reaction-based restriction fragment length polymorphism) was used to detect in white blood cells from the subjects the single-nucleotide polymorphisms (SNP) of VEGF gene, including +405G/C, -460 T/C, -1154G/A, -2578C/A sites. Association of genotypes or haplotypes with susceptibility of lung cancer was analyzed with unconditional logistic regression adjusted by gender and age. Smoking was significantly associated with increased risk of lung cancer. Gene phenotypic analysis demonstrated that C allele of +405G/C in VEGF gene was significantly associated increased risk of lung cancer in males (P=0.0094, odds ratio=1.634.3), as that with carrying GCTC haplotype (odds ratio=1.349), whereas carrying GACG had decreased risk for lung cancer (odds ratio=0.044). No relationship existed between 460 T/C, -1154G/A, -2578C/A alleles of VEGF gene and risk of lung cancer. VEGF gene polymorphism may have a role in the development of lung cancer.

associated with early development of cardiovascular disease and risk for premature death. High sodium intake and overweight/ obesity are recognized as risk factors for hypertension in children. WHAT THIS STUDY ADDS: These results show that usual sodium intake was positively associated with systolic blood pressure and risk for pre-high blood pressure and high blood pressure among US children. The data indicate a synergistic interaction between sodium intake and weight status on risk for high blood pressure. abstract To assess the association between usual dietary sodium intake and blood pressure among US children and adolescents, over- all and by weight status. METHODS: Children and adolescents aged 8 to 18 years (n = 6235) who participated in NHANES 2003-2008 comprised the sample. Subjects' usual sodium intake was estimated by using multiple 24-hour dietary recalls. Linear or logistic regression was used to examine association between sodium intake and blood pressure or risk for pre-high blood pressure and high blood pressure (pre-HBP/HPB). RESULTS: Study subjects consumed an average of 3387 mg/day of sodium, and 37% were overweight/obese. Each 1000 mg per day sodium intake was associated with an increased SD score of 0.097 (95% confidence interval (CI) 0.006-0.188, ∼1.0 mmHg) in systolic blood pressure (SBP) among all subjects and 0.141 (95% CI: -0.010 to 0.298, ∼1.5 mm Hg) increase among overweight/obese subjects. Mean adjusted SBP increased progressively with sodium intake quartile, from 106.2 mm Hg (95% CI: 105.1-107.3) to 108.8 mm Hg (95% CI: 107.5-110.1) overall (P = .010) and from 109.0 mm Hg (95% CI: 107.2-110.8) to 112.8 mm Hg (95% CI: 110.7-114.9; P = .037) among those overweight/obese. Adjusted odds ratios comparing risk for pre-HBP/HPB among subjects in the highest versus lowest sodium intake quartile were 2.0 (95% CI: 0.95-4.1, P = .062) overall and 3.5 (95% CI: 1.3-9.2, P = .013) among those overweight/obese. Sodium intake and weight status appeared to have synergistic effects on risk for pre-HBP/HPB (relative excess risk for interaction = 0.29 (95% CI: 0.01-0.90, P , .05). CONCLUSIONS: Sodium intake is positively associated with SBP and risk for pre-HBP/HPB among US children and adolescents, and this as- sociation may be stronger among those who are overweight/obese. Pediatrics 2012;130:611-619

Younger women hospitalized with an acute myocardial infarction (MI) have a poorer prognosis than men. Whether this is true for patients with acute ST-segment elevation MI (STEMI) and non-STEMI (NSTEMI) is not extensively studied. Using the MarketScan 2004 to 2007 Commercial and Medicare supplemental admission databases, we assessed gender differences in in-hospital mortality according to age in 91,088 patients (35,899 with STEMI, 55,189 with NSTEMI) who were 18 to 89 years old and had acute MI as their primary diagnosis. Patients with STEMI had significantly higher in-hospital mortality than those with NSTEMI (4.35% vs 3.53%, p

It has not been clearly established whether percutaneous coronary intervention (PCI) can provide an incremental benefit in quality of life over that provided by optimal medical therapy among patients with chronic coronary artery disease.We randomly assigned 2287 patients with stable coronary disease to PCI plus optimal medical therapy or to optimal medical therapy alone. We assessed angina-specific health status (with the use of the Seattle Angina Questionnaire) and overall physical and mental function (with the use of the RAND 36-item health survey [RAND-36]).At baseline, 22% of the patients were free of angina. At 3 months, 53% of the patients in the PCI group and 42% in the medical-therapy group were angina-free (P0.001). Baseline mean (+/-SD) Seattle Angina Questionnaire scores (which range from 0 to 100, with higher scores indicating better health status) were 66+/-25 for physical limitations, 54+/-32 for angina stability, 69+/-26 for angina frequency, 87+/-16 for treatment satisfaction, and 51+/-25 for quality of life. By 3 months, these scores had increased in the PCI group, as compared with the medical-therapy group, to 76+/-24 versus 72+/-23 for physical limitation (P=0.004), 77+/-28 versus 73+/-27 for angina stability (P=0.002), 85+/-22 versus 80+/-23 for angina frequency (P0.001), 92+/-12 versus 90+/-14 for treatment satisfaction (P0.001), and 73+/-22 versus 68+/-23 for quality of life (P0.001). In general, patients had an incremental benefit from PCI for 6 to 24 months; patients with more severe angina had a greater benefit from PCI. Similar incremental benefits from PCI were seen in some but not all RAND-36 domains. By 36 months, there was no significant difference in health status between the treatment groups.Among patients with stable angina, both those treated with PCI and those treated with optimal medical therapy alone had marked improvements in health status during follow-up. The PCI group had small, but significant, incremental benefits that disappeared by 36 months. (ClinicalTrials.gov number, NCT00007657.)

ObjectiveWe sought to examine the comparative improvement in health status after primary mitral valve repair versus replacement in patients with mitral valve regurgitation in a longitudinal setting.MethodsWe prospectively followed 267 patients with mitral valve regurgitation who underwent primary mitral valve repair (n = 163) and replacement (n = 104) between January 2002 and January 2005. Health status was evaluated at baseline and 1, 3, and 12 months after surgery with the validated short-form 36 and analyzed using generalized estimating equations with adjustment for propensity scores.ResultsCompared with patients undergoing mitral valve replacement, patients requiring valve repair were younger and more likely to be male. The probability of postsurgical readmission because of cardiac events was low and similar between the two treatment groups. New York Heart Association functional class was significantly improved after both procedures, with better improvement achieved by mitral valve repair (P < .01). For both treatment groups, scores for most of the short-form 36 domains were depressed at 1 month; however, after 3- and 12-month lags, dramatic improvements were achieved in most of the domains. Adjusted changes in the physical component score were similar between the two arms at each follow-up. For the mental component score, patients who underwent repair showed significant improvements compared with patients who underwent replacement at both 3 months (difference: 4.84 points, P = .005) and 12 months (difference: 5.92 points, P < .001).ConclusionsOur study suggests that after mitral valve surgery, there is significant improvement in New York Heart Association functional class and health status, especially in patients undergoing mitral valve repair.

Background— In the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS), aldosterone blockade with eplerenone decreased mortality in patients with left ventricular systolic dysfunction and heart failure after acute myocardial infarction. The present study was performed to evaluate the cost-effectiveness of eplerenone compared with placebo in these patients. Methods and Results— A total of 6632 patients with left ventricular systolic dysfunction and heart failure after acute myocardial infarction were randomized to eplerenone or placebo and followed up for a mean of 16 months. The coprimary end points were all-cause mortality and the composite of cardiovascular mortality/cardiovascular hospitalization. The evaluation of resource use included hospitalizations, outpatient services, and medications. Eplerenone was priced at the average wholesale price, $3.60 per day. Survival beyond the trial period was estimated from data from the Framingham Heart Study, the Saskatchewan Health database, and the Worcester Heart Attack Registry. The incremental cost-effectiveness of eplerenone in cost per life-year and quality-adjusted life-year gained compared with placebo was estimated. The number of life-years gained with eplerenone was 0.1014 based on Framingham (95% CI, 0.0306 to 0.1740), 0.0636 with Saskatchewan (95% CI, 0.0229 to 0.1038), and 0.1337 with Worcester (95% CI, 0.0438 to 0.2252) data. Cost was $1391 higher over the trial period in the eplerenone arm (95% CI, 656 to 2165) because of drug cost. The incremental cost-effectiveness ratio was $13 718 per life-year gained with Framingham (96.7% under $50 000 per life-year gained), $21 876 with Saskatchewan, and $10 402 with Worcester. Conclusions— Eplerenone compared with placebo in the treatment of heart failure after acute myocardial infarction is effective in reducing mortality and is cost-effective in increasing years of life by commonly used criteria.

Information on the relative benefit of coronary artery bypass grafting (CABG) versus stent-assisted percutaneous coronary intervention (PCI) for improvement of cardiac-related health status in women and how it compares with men is limited. The Stent or Surgery trial compared randomly assigned CABG and stent-assisted PCI in 206 women and 782 men with multivessel disease. We examined longitudinal changes at 6 and 12 months from baseline by gender and treatment in 3 subscales of the Seattle Angina Questionnaire (SAQ): physical limitation, angina frequency, and quality of life. At the time of revascularization, women were older, more severely ill, and tended to have lower SAQ scores than men. At 6 months, SAQ scores after both procedures improved significantly in both genders, with greater improvement achieved with CABG. After adjustment for other factors, in men, CABG was associated with a 54.7% greater improvement in physical limitation compared with PCI, 31.3% greater improvement in angina frequency, and 18.3% greater improvement in quality of life. In women, these relative differences were 11.6%, 43.2%, and 39.3%, respectively. At 1 year, men continued to show greater improvement with CABG in all 3 dimensions (50.6%, 19.7%, and 15.3%, respectively), but in women the relative differences decreased substantially (1.6%, 11.1%, and 0.6%, respectively) due to a greater later improvement after PCI (p = 0.049 for the interaction among treatment, gender, and follow-up for the quality of life domain). Although CABG may be superior to PCI in men, in women, at 1 year after intervention, both procedures appear equally effective.

Background— Functional status and quality of life are important outcomes in the evaluation of revascularization approaches for symptomatic coronary artery disease. Few data are available regarding the comparative improvement in disease-specific health status after CABG versus percutaneous coronary intervention (PCI) in the era of coronary stenting. Methods and Results— Cardiac-specific health status was evaluated at baseline and at 6 and 12 months after intervention with the Seattle Angina Questionnaire (SAQ) in patients randomized to stent-assisted PCI (n=488) versus CABG (n=500) in the Stent or Surgery trial. Scores for physical limitation, angina frequency, and quality of life improved significantly for both treatment groups at 6 months (range of improvement from 13.6 to 34.7 points) and 12 months (14.3 to 38.2 points; all P Conclusions— Both CABG and stent-assisted PCI dramatically improved cardiac-related health status in patients with multivessel disease at 6- and 12-month follow-up. During the first postprocedure year, patients’ angina burden and physical limitations were alleviated to a greater extent with CABG.

OBJECTIVE To determine whether macronutrient intake differs by awareness of glycemic status among people with diabetes and prediabetes. RESEARCH DESIGN AND METHODS We used 24-h dietary recall and other data from 3,725 nonpregnant adults with diabetes or prediabetes aged ≥20 years from the morning fasting sample of the 2005–2010 National Health and Nutrition Examination Survey. Diabetes and prediabetes awareness were self-reported; those unaware of diabetes and prediabetes were defined by fasting plasma glucose (FPG) ≥126 mg/dL or HbA1c ≥6.5% and FPG 100–125 mg/dL or HbA1c of 5.7%–6.4%, respectively. Components of nutrient intake on a given day assessed were total calories, sugar, carbohydrates, fiber, protein, fat, and total cholesterol, stratified by sex and glycemic status awareness. Estimates of nutrient intake were adjusted for age, race/ethnicity, education level, BMI, smoking status, and family history of diabetes. RESULTS Men with diagnosed diabetes consumed less sugar (mean 86.8 vs. 116.8 g) and carbohydrates (mean 235.0 vs. 262.1 g) and more protein (mean 92.3 vs. 89.7 g) than men with undiagnosed diabetes. Similarly, women with diagnosed diabetes consumed less sugar (mean 79.1 vs. 95.7 g) and more protein (mean 67.4 vs. 56.6 g) than women with undiagnosed diabetes. No significant differences in macronutrient intake were found by awareness of prediabetes. All participants, regardless of sex or glycemic status, consumed on average less than the American Diabetes Association recommendations for fiber intake (i.e., 14 g/1,000 kcal) and slightly more saturated fat than recommended (>10% of total kcal). CONCLUSIONS Screening and subsequent knowledge of glycemic status may favorably affect some dietary patterns for people with diabetes.

Purpose Although studies suggest that higher consumption of added sugars is associated with cardiovascular risk factors in adolescents, none have adjusted for measurement errors or examined its association with the risk of dyslipidemia. Methods We analyzed data of 4,047 adolescents aged 12–19 years from the 2005–2010 National Health and Nutrition Examination Survey, a nationally representative, cross-sectional survey. We estimated the usual percentage of calories (%kcal) from added sugars using up to two 24-hour dietary recalls and the National Cancer Institute method to account for measurement error. Results The average usual %kcal from added sugars was 16.0%. Most adolescents (88.0%) had usual intake of ≥10% of total energy, and 5.5% had usual intake of ≥25% of total energy. After adjustment for potential confounders, usual %kcal from added sugars was inversely associated with high-density lipoprotein (HDL) and positively associated with triglycerides (TGs), TG-to-HDL ratio, and total cholesterol (TC) to HDL ratio. Comparing the lowest and highest quintiles of intake, HDLs were 49.5 (95% confidence interval [CI], 47.4–51.6) and 46.4 mg/dL (95% CI, 45.2–47.6; p = .009), TGs were 85.6 (95% CI, 75.5–95.6) and 101.2 mg/dL (95% CI, 88.7–113.8; p = .037), TG to HDL ratios were 2.28 (95% CI, 1.84–2.70) and 2.73 (95% CI, 2.11–3.32; p = .017), and TC to HDL ratios were 3.41 (95% CI, 3.03–3.79) and 3.70 (95% CI, 3.24–4.15; p = .028), respectively. Comparing the highest and lowest quintiles of intake, adjusted odds ratio of dyslipidemia was 1.41 (95% CI, 1.01–1.95). The patterns were consistent across sex, race/ethnicity, and body mass index subgroups. No association was found for TC, low-density lipoprotein, and non-HDL cholesterol. Conclusions Most U.S. adolescents consumed more added sugars than recommended for heart health. Usual intake of added sugars was significantly associated with several measures of lipid profiles.

Objectives Studies indicate high sodium and low potassium intake can increase blood pressure suggesting the ratio of sodium-to-potassium may be informative. Yet, limited studies examine the association of the sodium-to-potassium ratio with blood pressure and hypertension. Methods We analyzed data on 10,563 participants aged ≥20 years in the 2005–2010 National Health and Nutrition Examination Survey who were neither taking anti-hypertensive medication nor on a low sodium diet. We used measurement error models to estimate usual intakes, multivariable linear regression to assess their associations with blood pressure, and logistic regression to assess their associations with hypertension. Results The average usual intakes of sodium, potassium and sodium-to-potassium ratio were 3,569 mg/d, 2,745 mg/d, and 1.41, respectively. All three measures were significantly associated with systolic blood pressure, with an increase of 1.04 mmHg (95% CI, 0.27–1.82) and a decrease of 1.24 mmHg (95% CI, 0.31–2.70) per 1,000 mg/d increase in sodium or potassium intake, respectively, and an increase of 1.05 mmHg (95% CI, 0.12–1.98) per 0.5 unit increase in sodium-to-potassium ratio. The adjusted odds ratios for hypertension were 1.40 (95% CI, 1.07–1.83), 0.72 (95% CI, 0.53–0.97) and 1.30 (95% CI, 1.05–1.61), respectively, comparing the highest and lowest quartiles of usual intake of sodium, potassium or sodium-to-potassium ratio. Conclusions Our results provide population-based evidence that concurrent higher sodium and lower potassium consumption are associated with hypertension.

The purpose of this analysis was to determine whether there is an association between type of emergency medical services (EMS) medical direction and local EMS agency practices and characteristics specifically related to emergency response for acute cardiovascular events.We surveyed 1,292 EMS agencies in nine states. For each cardiovascular prehospital procedure or practice, we compared the proportion of agencies that employed paid (full- or part-time) medical directors with the proportion of agencies that employed volunteer medical directors. We also compared the proportion of EMS agencies who reported direct interaction between emergency medical technicians (EMTs) and their medical director within the previous four weeks with the proportion of agencies who reported no direct interaction. Chi-square tests were used to assess statistical differences in proportion of agencies with a specific procedure by medical director employment status and medical director interaction. We repeated these comparisons using t-tests to evaluate mean differences in call volume.The EMS agencies with prehospital cardiovascular response policies were more likely to report employment of a paid medical director and less likely to report employment of a volunteer medical director. Similarly, agencies with prehospital cardiovascular response practices were more likely to report recent medical director interaction and less likely to report absence of recent medical director interaction. Mean call volumes for chest pain, cardiac arrest, and stroke were higher among agencies having paid medical directors (compared with agencies having volunteer medical directors) and agencies having recent medical director interaction (compared with agencies not having recent medical director interaction).Our study demonstrated that EMS agencies with a paid medical director and agencies with medical director interaction with EMTs in the previous four weeks were more likely to have prehospital cardiovascular procedures in place. Given the strong relationship that both employment status and direct interaction have with the presence of these practices, agencies with limited resources to provide a paid medical director or a medical director that can be actively involved with EMTs should be supported through partnerships and other interventions to ensure that they receive the necessary levels of medical director oversight.

Ischemic heart disease (IHD) is both the most common and the most costly form of cardiovascular disease (CVD) in the United States (US).1-2 In 2010, the estimated prevalence of IHD among American adults aged ≥20 years was 7.9% (9.1% in men and 7.0% in women),1 and the aging of the US population should drive prevalence even higher in the future. Fortunately, the IHD death rate has declined in recent decades, but it remains the leading cause of hospital admissions and the single largest killer of American men and women, causing 1 of every 6 deaths.1-3 Not surprisingly, spending to treat IHD has increased more than 40% over the past 25 years.4 For 2010, the total economic burden of IHD was estimated to be $177 billion, $96 billion in direct medical costs and $81 billion in indirect costs. Well over half of the direct costs ($57 billion) were for inpatient care.1 Thus, information on the costs of hospitalizations involving IHD may be helpful in developing strategies to contain the growth in the disease’s economic burden. To date, researchers have used a variety of approaches in investigating the health care costs of IHD.4-15 For example, in the US, Hodgson and Cohen used a prevalence-based approach to demonstrate that IHD accounted for just over one half of health care expenditures for heart disease in 1995 ($38.7 billion of $75.9 billion.)5 Russell et al., using a variety of data sources and a Markov model, estimated incidence-based first-year treatment costs of IHD in the US for that same year at $5.54 billion.6 More recently, Menzin and coworkers estimated the average cost (in 2005 dollars) of initial hospitalization for acute coronary syndromes to be $22,921, and their estimate for re-hospitalization for IHD was $28,637.7 In other industrialized countries, the economic burden of IHD has also been very high. For example, in the United Kingdom (UK), Liu and associates estimated the total 1-year cost (1999) of IHD to be £7.06 billion, the highest of any disease in the UK. The total direct health care costs of IHD were £1.73 billion, of which £917 million (53%) was for inpatient care.8 Unfortunately, these earlier studies either did not use detailed diagnostic codes for IHD, did not address diagnostic status and issues of comorbidity, or focused exclusively on older population. Thus, their results have limited implications for deciding how to allocate resources and, similarly, for evaluating the costeffectiveness of prevention programs at the community level. To address these gaps, we used a large administrative dataset to explore the cost of hospitalization for patients with IHD; to make this a valuable exercise we classified the

The EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure and Survival Study) showed that the use of aldosterone blockade with eplerenone decreased mortality in patients with heart failure after acute myocardial infarction, and a subsequent analysis showed eplerenone to be highly cost effective in this population.To assess the cost effectiveness of eplerenone in an EPHESUS subgroup population who were taking both ACE inhibitors and beta-blockers (beta-adrenoceptor antagonists) at baseline. In the EPHESUS, a total of 6632 patients were randomized to receive eplerenone 25-50 mg/day (n = 3319) or placebo (n = 3313) concurrently with standard therapy and were followed for up to 2.5 years. Of these, 4265 (64.3%) patients (eplerenone: n = 2113; placebo: n = 2152) were taking both ACE inhibitors and beta-blockers at baseline.Resource use after the initial hospitalization included additional hospitalizations, outpatient services, emergency room visits, and medications. Eplerenone was priced at an average wholesale price of $US3.60 per day (year 2004 value). Bootstrap methods were used to estimate the fraction of the joint distribution of the cost and effectiveness. A net-benefit regression model was used to derive the propensity score-adjusted cost-effectiveness curve. The incremental cost effectiveness of eplerenone in cost per life-year gained (LYG) and cost per quality-adjusted life-year (QALY) gained beyond the trial period was estimated using data from the Framingham Heart Study, the Saskatchewan Health database, and the Worcester Heart Attack Registry. Both costs and effectiveness were discounted at 3%. Although not all resource use could be accounted for, the overall perspective was societal.As in the overall EPHESUS population, the total direct treatment costs were higher in the eplerenone arm than the placebo arm for patients who were taking both ACE inhibitors and beta-blockers ($US14,563 vs $US12,850, difference = $US1713; 95% CI 721, 2684). The number of LYGs with eplerenone compared with placebo was 0.1665 based on the Framingham data, 0.0979 using the Saskatchewan data, and 0.2172 using the Worcester data. The incremental cost-effectiveness ratio (ICER) was $US10,288/LYG with the Framingham data, $US17,506/LYG with the Saskatchewan data, and $US7888/LYG with the Worcester data (99%$US50,000/LYG for all three sources). The ICERs were systematically higher when calculated as the cost per QALY gained ($US14,926, $US25,447, and $US11,393, respectively) as the utilities were below 1 with no difference between the treatment arms.As for the overall EPHESUS population, aldosterone blockade with eplerenone is effective in reducing mortality and is cost effective in increasing years of life for the EPHESUS subgroup of patients who were taking both ACE inhibitors and beta-blockers.

Background— The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluations) trial compared the effect of percutaneous coronary intervention (PCI) plus optimal medical therapy with optimal medical therapy alone on cardiovascular events in 2287 patients with stable coronary disease. After 4.6 years, there was no difference in the primary end point of death or myocardial infarction, although PCI improved quality of life. The present study evaluated the relative cost and cost-effectiveness of PCI in the COURAGE trial. Methods and Results— Resource use was assessed by diagnosis-related group for hospitalizations and by current procedural terminology code for outpatient visits and tests and then converted to costs by use of 2004 Medicare payments. Medication costs were assessed with the Red Book average wholesale price. Life expectancy beyond the trial was estimated from Framingham survival data. Utilities were assessed by the standard gamble method. The incremental cost-effectiveness ratio was expressed as cost per life-year and cost per quality-adjusted life-year gained. The added cost of PCI was approximately $10 000, without significant gain in life-years or quality-adjusted life-years. The incremental cost-effectiveness ratio varied from just over $168 000 to just under $300 000 per life-year or quality-adjusted life-year gained with PCI. A large minority of the distributions found that medical therapy alone offered better outcome at lower cost. The costs per patient for a significant improvement in angina frequency, physical limitation, and quality of life were $154 580, $112 876, and $124 233, respectively. Conclusions— The COURAGE trial did not find the addition of PCI to optimal medical therapy to be a cost-effective initial management strategy for symptomatic, chronic coronary artery disease.

BACKGROUND: We estimated the hospitalization costs associated with hypertension as a secondary diagnosis among insured adults aged 18-64 years by using data from 2005 MarketScan Commercial Claims and Encounters (CCAE) inpatient admissions. METHODS: We analyzed costs for four patient groups (N = 455,944): (i) all selected patients; (ii) patients with the primary diagnosis of ischemic heart disease (IHD); (iii) patients with the primary diagnosis of cerebrovascular disease; and (iv) patients with neither IHD nor cerebrovascular disease as the primary diagnosis. We conducted propensity score matching to control possible bias in cost estimates due to sample selections and estimated the costs of hypertension by using a regression model on the matched populations that controlled for subjects' age, sex, length of hospital stay, Charlson comorbidity index (CCI), region of residence, and urbanization of residence. RESULTS: For all patients with hypertension as a secondary diagnosis, the estimated average annual hospitalization cost per patient was $21,094, of which $2,734 (13%; P < 0.01) was associated with hypertension. The estimated average costs were $31,106 for patients with a primary diagnosis of IHD, $17,298 for those with a primary diagnosis of cerebrovascular disease, and $18,693 for those without a primary diagnosis of IHD or cerebrovascular disease; hypertension-associated costs for these patients were $3,540 (11.4%; P < 0.01), $1,133 (6.5%; P < 0.01), and $2,254 (12.1%; P < 0.01), respectively. CONCLUSIONS: Hypertension-associated hospitalization costs are substantial among insured US patients aged 18-64 years with hypertension as a secondary diagnosis and suggest a need for cost-effective programs to prevent, manage, and control hypertension.

Background— Although a variety of prognostic tools have been shown to predict rehospitalization and mortality in heart failure patients, their utility in assessing future costs is less clear. We assessed whether health status assessment with the Kansas City Cardiomyopathy Questionnaire (KCCQ) predicts future costs in stable heart failure outpatients with left ventricular dysfunction after myocardial infarction. Methods and Results— We evaluated 12-month cost utilization data from 1516 heart failure outpatients enrolled in the Quality-of-Life Substudy of the Eplerenone Post–Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS). Multivariable hierarchical models assessed whether the KCCQ (categorized as 0 to P P =0.0002). Conclusion— Health status assessment predicts resource use and costs over the next year in stable heart failure outpatients with left ventricular dysfunction after myocardial infarction.

ObjectivesFor economic evaluations of chronic heart failure (CHF) management strategies, utilities are not currently available for disease proxies commonly used in Markov models. Our objective was to estimate utilities for New York Heart Association (NYHA) classification and number of cardiovascular rehospitalizations.MethodsEuroQol 5D data from the Eplerenone Post-acute Myocardial Infarction Heart Failure Efficacy and Survival Study trial were used to estimate utilities as a function of NYHA classification and number of cardiovascular rehospitalizations.ResultsIn multivariate regression analyses adjusted for age (60 years), female sex and absence of further comorbidities, utilities for NYHA classes I–IV were 0.90, 0.83, 0.74, and 0.60 (P-value < 0.001 for trend). For cardiovascular rehospitalizations 0, 1, 2 and ≥3, the associated utilities were 0.88, 0.85, 0.84, and 0.82 (P-value < 0.001 for trend).ConclusionsNYHA class and number of cardiovascular rehospitalizations are established proxies for CHF progression and can be linked to utilities when used as health states in a Markov model. NYHA class should be used when feasible.

Background The COMMIT trial demonstrated that clopidogrel produced a 9% relative reduction in death, reinfarction or stroke (9.2% vs. 10.1%, 95% CI: 0.86–0.97) in ST-elevated myocardial infarction (STEMI) patients. Methods Between 08/1999 and 05/2005, 45,852 STEMI patients were randomized to clopidogrel ( n =22,961) or matching placebo ( n =22,891) in addition to aspirin. The rate of initial hospitalizations for death, non-fatal myocardial infarction with/without major complications and PCI within 28 days was calculated based on the COMMIT clinical paper. Three CURE papers, concerning non-STEMI patients, were used to estimate the event rates between 29 days and 1 year. Hospitalizations were assigned a diagnosis-related group (DRG). Costs for each DRG were estimated from the Medicare reimbursement rate. Clopidogrel was assumed to be given for 1 year, priced at $4.22/day. Life expectancy gain as a result of the prevention of death, myocardial infarction, and stroke was estimated using Framingham data. Results Within 28 days, adding clopidogrel to aspirin is likely a dominant strategy, lowering the event rate (9.2% vs. 10.1%) without an increase in cost ($7791 vs. $7797). Over a lifetime, treating for 1 year with clopidogrel-plus-aspirin produced a gain of 0.1187 life years at an incremental cost of $1269 compared to aspirin alone, resulting in an incremental cost-effectiveness ratio (ICER) of $10,691/life year gained. Sensitivity analyses showed that ICERs for clopidogrel are well below the common benchmark ceiling ratio of $50,000/life year gained. Conclusions Addition of clopidogrel to aspirin, given up to 1 year, in the setting of STEMI is a highly cost-effective strategy.

The ACUTE II study demonstrated that transesophageal echocardiographically guided cardioversion with enoxaparin in patients with atrial fibrillation was associated with shorter initial hospital stay, more normal sinus rhythm at 5 weeks, and no significant differences in stroke, bleeding, or death compared with unfractionated heparin (UFH). The present study evaluated resource use and costs in enoxaparin (n = 76) and UFH (n = 79) during 5-week follow-up. Resources included initial and subsequent hospitalizations, study drugs, outpatient services, and emergency room visits. Two costing approaches were employed for the hospitalization costing. The first approach was based on the UB-92 formulation of hospital bill and diagnosis-related group. The second approach was based on UB-92 and imputation using multivariable linear regression. Costs for outpatient and emergency room visits were determined from the Medicare fee schedule. Sensitivity analysis was performed to assess the robustness of the results. A bootstrap resample approach was used to obtain the confidence interval (CI) for the cost differences. Costs of initial and subsequent hospitalizations, outpatient procedures, and emergency room visits were lower in the enoxaparin group. Average total costs remained significantly lower for the enoxaparin group for the 2 costing approaches ($5,800 vs $8,167, difference $2,367, 95% CI 855 to 4,388, for the first approach; $7,942 vs $10,076, difference $2,134, 95% CI 437 to 4,207, for the second approach). Sensitivity analysis showed that cost differences between strategies are robust to variation of drug costs. In conclusion, the use of enoxaparin as a bridging therapy is a cost-saving strategy (similar clinical outcomes and lower costs) for atrial fibrillation.

Objective: The EPHESUS study demonstrated that aldosterone blockade with eplerenone decreased mortality in patients with left ventricular systolic dysfunction (LVSD) and heart failure after acute myocardial infarction (AMI). The EPHESUS pharmacoeconomic analysis was performed to evaluate the cost-effectiveness of eplerenone in the Swiss setting. Materials and methods: A total of 6,632 patients with LVSD and heart failure after AMI were randomized to eplerenone or placebo and followed for a mean of 16months. The co-primary endpoints were all-cause death and the composite of cardiovascular death/cardiovascular hospitalization. The evaluation of resource use included hospitalizations, outpatient services, and medications. Survival beyond the trial period was estimated using data from the Framingham Heart Study, the Saskatchewan Health database, and the Worcester Heart Attack Registry. The incremental cost-effectiveness of eplerenone in cost per life-year and quality-adjusted life-year gained was estimated. The perspective of the Swiss third party payers was used. Daily treatment costs of eplerenone were set at CHF 3.88. All other resources were valued on the basis of official tariffs. Discounting of the results was performed at a rate of 3%. Results: The number of life-years gained with eplerenone was 0.1083 based on Framingham, 0.0661 with Saskatchewan and 0.1518 with Worcester survival estimates. Total costs were CHF 1,028 higher over the trial period in the eplerenone arm, due to drug cost. The incremental cost-effectiveness ratio was CHF 10,145 per life-year gained with Framingham, CHF 16,178 with Saskatchewan, and CHF 7,693 with Worcester survival estimates. The corresponding costs per QALY were CHF 15,219, CHF 23,965 and CHF 11,337, respectively. Conclusion: Eplerenone is effective in reducing mortality and, in Switzerland, is also cost-effective in increasing years of life for patients with LVSD after AMI

The CREST trial demonstrated that after successful coronary stent implantation, the 6-month rate of target vessel revascularization (TVR) was similar (15.4% vs 16%, P = .90) for the 2 treatment groups, but restenosis rate was lower (22.0% vs 34.5%, P = .002) in cilostazol-treated patients. We sought to evaluate resource use, cost, and cost-effectiveness of cilostazol in CREST.A total of 705 patients were randomized to cilostazol 100 mg twice daily (n = 354) versus placebo (n = 351) for 6 months. Resources included rehospitalizations, medications, and outpatient services. Costs were determined from the Medicare fee schedule. Cilostazol was priced at 1.64 dollars a day. Base-case cost and cost-effectiveness analysis was performed for the entire population using TVR as a measure of effectiveness. Sensitivity analysis was conducted among 526 patients because restenosis data were available only for this patient population. A bootstrap resample approach (5000 samples) was used to obtain confidence intervals for cost differences.For the entire population, costs of rehospitalizations, concomitant medications, outpatient tests, and physician or emergency department visits were lower during follow-up for cilostazol-treated patients. Overall, total 6-month follow-up costs remained 447 dollars lower for cilostazol (4178 dollars vs 4625 dollars), although this difference did not reach significance (95% CI -1458 dollars to 515 dollars). Cilostazol is likely a cost-saving strategy (similar rate of TVR and lower costs). Sensitivity analysis showed that cilostazol is likely a dominant strategy (lower restenosis rate and costs, 85% dominant, 88.9%1000 dollars per restenosis averted).Treatment with cilostazol is likely a cost-saving or dominant strategy in patients with successful coronary bare metal stent implantation. Cilostazol may offer a low-cost alternative to restenosis prevention in patients who do not receive drug-eluting stents.

Data are limited regarding the impact of acute coronary syndromes (ACSs) on the relative benefits of coronary artery bypass grafting (CABG) versus stent-assisted percutaneous coronary intervention (PCI).The SoS trial compared patients with multivessel disease who were randomly assigned to CABG (n = 500) or stent-assisted PCI (n = 488). The impact of treatment on 1-year outcomes was compared in ACS (n = 126, CABG; n = 116, PCI) and non-ACS (n = 374, CABG; n = 372, PCI) subgroups.Baseline characteristics were similar between treatment groups within ACS and non-ACS groups, as was the 1-year composite incidence of mortality and myocardial infarction (ACS, 5.2% for PCI vs 5.6% for CABG, P = .89; non-ACS, 7.0% vs 8.3%, P = .50). The need for repeat revascularizations was higher after PCI versus CABG within each subgroup (ACS, 15.5% vs 7.1%, P = .04; non-ACS, 18.0% vs 3.2%, P.001). At 6 and 12 months, scores on the Seattle Angina Questionnaire improved significantly in patients with and without ACS. In patients without ACS, CABG was associated with greater improvement in physical limitation, angina frequency, and quality of life at 6 and 12 months. In patients with ACS, there was only a nonsignificant slight trend toward greater improvement with CABG at 1 year. The total 1-year costs for PCI and CABG in patients without ACS were 5760 pound sterling and 8509 pound sterling (Delta = 2749 pound sterling, 95% CI 1890 pound sterling - 3409 pound sterling), and in patients with ACS, 8014 pound sterling and 10080 pound sterling (Delta = 2066 pound sterling, 95% CI -690 pound sterling to 3487 pound sterling).In patients with and without ACS, CABG had similar clinical outcomes, less need for repeat revascularization and higher costs compared to PCI. The benefit of CABG relative to PCI in improving patients' health status tended to be greater in patients without ACS than in patients with ACS.

To compare initial and one year costs of coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in the stent or surgery trial.Prospective, unblinded, randomised trial.Multicentre study.988 patients with multivessel disease.CABG and stent assisted PCI.Initial hospitalisation and one year follow up costs.At one year mortality was 2.5% in the PCI arm and 0.8% in the CABG arm (p = 0.05). There was no difference in the composite of death or Q wave myocardial infarction (6.9% for PCI v 8.1% for CABG, p = 0.49). There were more repeat revascularisations with PCI (17.2% v 4.2% for CABG). There was no significant difference in utility between arms at six months or at one year. Quality adjusted life years were similar 0.6938 for PCI v 0.6954 for PCI, Delta = 0.00154, 95% confidence interval (CI) -0.0242 to 0.0273). Initial length of stay was longer with CABG (12.2 v 5.4 days with PCI, p0.0001) and initial hospitalisation costs were higher (7321 pounds sterling v 3884 pounds sterling for PCI, Delta = 3437 pounds sterling, 95% CI 3040 pounds sterling to 3848 pounds sterling). At one year the cost difference narrowed but costs remained higher for CABG (8905 pounds sterling v 6296 pounds sterling for PCI, Delta = 2609 pounds sterling, 95% CI 1769 pounds sterling to 3314 pounds sterling).Over one year, CABG was more expensive and offered greater survival than PCI but little added benefit in terms of quality adjusted life years. The additional cost of CABG can be justified only if it offers continuing benefit at no further increase in cost relative to PCI over several years.