Neighborhood Environment and Poor Maternal Glycemic Control-Associated Complications of Gestational Diabetes Mellitus.

Introduction: Risk of complications due to gestational diabetes mellitus is increasing in the U.S., particularly among individuals from racial minorities. Research has focused largely on clinical interventions to prevent complications, rarely on individuals' residential environments. This retrospective cohort study aims to examine the association between individuals' neighborhoods and complications of gestational diabetes mellitus. Methods: Demographic and clinical data were extracted from electronic health records and linked to American Community Survey data from the U.S. Census Bureau for 2,047 individuals who had 2,164 deliveries in 2014-2018. Data were analyzed in 2021-2022 using Wilcoxon rank sum test and chi-square test for bivariate analyses and logistic regression for analysis of independent effects. All census tract-based variables used in the model were dichotomized at the median. Results: Bivariate analysis showed that the average percentage of adults earning <$35,000 was higher in neighborhoods where individuals with complications were living than in neighborhoods where individuals without complications were living (30.40%±12.05 vs 28.94%±11.71, p=0.0145). Individuals who lived in areas with ≥8.9% of residents aged >25 years with less than high school diploma had a higher likelihood of complications than those who lived in areas with <8.9% of such residents (33.43% vs 29.02%, p=0.0272). Individuals who lived in neighborhoods that had ≥1.8% of households receiving public assistance were more likely to have complications than those who lived in areas where <1.8% of households received public assistance (33.33% vs 28.97%, p=0.0287). Logistic regression revealed that the odds of deliveries with complications were 44% higher for individuals with obesity (OR=1.44; 95% CI=1.17, 1.77), 35% greater for individuals residing in neighborhoods with higher percentages of households living below the poverty level (OR=1.35; 95% CI=1.09, 1.66), and 28% lower for individuals from neighborhoods where a higher percentage of households had no vehicles available for transportation to work (OR=0.72; 95% CI=0.59, 0.89). Conclusions: Clinical interventions in concert with environmental changes could contribute to preventing maternal and neonatal complications of gestational diabetes mellitus.

Telemedicine and health disparities: Association between the area deprivation index and primary care telemedicine utilization during the COVID-19 pandemic.

Introduction: The rapid implementation of telemedicine during the COVID-19 pandemic may have exacerbated the existing health disparities. This study investigated the association between the area deprivation index (ADI), which serves as a measure of socioeconomic deprivation within a geographic area, and the utilization of telemedicine in primary care. Methods: The study data source was electronic health records. The study population consisted of patients with at least one primary care visit between March 2020 and December 2021. The primary outcome of interest was the visit modality (office, phone, and video). The exposure of interest was the ADI score grouped into quartiles (one to four, with one being the least deprived). The confounders included patient sociodemographic characteristics (e.g., age, gender, race, ethnicity, insurance coverage, marital status). We utilized generalized estimating equations to compare the utilization of telemedicine visits with office visits, as well as phone visits with video visits. Results: The study population included 41,583 patients with 127,165 office visits, 39,484 phone visits, and 20,268 video visits. Compared to patients in less disadvantaged neighborhoods (ADI quartile = one), patients in more disadvantaged neighborhoods (ADI = two, three, or four) had higher odds of using phone visits vs office visits, lower odds of using video visits vs office visits, and higher odds of using phone visits vs video visits. Conclusions: Patients who resided in socioeconomically disadvantaged neighborhoods mainly relied on phone consultations for telemedicine visits with their primary care provider. Patient-level interventions are essential for achieving equitable access to digital healthcare, particularly for low-income individuals.

Association between lack of health insurance and risk of death and ESRD: results from the Kidney Early Evaluation Program (KEEP).

BACKGROUND: Uninsured adults in the United States have poor access to health care services and worse health outcomes than insured adults. Little is known about the association between lack of insurance and chronic kidney disease (CKD) progression to end-stage renal disease (ESRD) or death in patients at high risk of kidney disease. We used 2000-2011 data from the National Kidney Foundation's Kidney Early Evaluation Program (KEEP) to examine this association. METHODS: The study population included KEEP participants younger than 65 years. Outcomes were time to ESRD (chronic kidney failure treated by renal replacement therapy) and time to death. Incident ESRD was ascertained by linkage to the US Renal Data System, and vital status, by linkage to the Social Security Administration Death Master File. We used Cox proportional hazard regression to examine the association between insurance and risk of death or ESRD after adjusting for demographic variables. RESULTS: Of 86,588 participants, 27.8% had no form of insurance, 10.3% had public insurance, and 61.9% had private insurance; 15.0% had CKD (defined as estimated glomerular filtration rate <60 mL/min/1.73 m(2) or urine albumin-creatinine ratio ≥ 30 mg/g), 63.3% had hypertension, and 27.7% had diabetes. Of participants with CKD, 29.3% had no health insurance. Participants without insurance were younger, more likely to be Hispanic and to have 12 or fewer years of education, and less likely to have seen a physician in the past year. After adjustment for demographic characteristics, uninsured KEEP participants were 82% more likely than privately insured participants to die (HR, 1.82; 95% CI, 1.56-2.12; P < 0.001) and 72% more likely to develop ESRD (HR, 1.72; 95% CI, 1.33-2.22; P < 0.001). The association between insurance and outcomes varied by CKD stage. CONCLUSIONS: Lack of insurance is an independent risk factor for early death and ESRD in this population at high risk of kidney disease. Considering the high morbidity and mortality and increasing cost associated with ESRD, access to appropriate health insurance coverage is warranted.

Association of physician care with mortality in Kidney Early Evaluation Program (KEEP) participants.

BACKGROUND: People with or at high risk of chronic kidney disease (CKD) are at increased risk of premature morbidity and mortality. We sought to examine the effect of care provided by a primary care physician (PCP) on survival for all participants in the National Kidney Foundation's Kidney Early Evaluation Program (KEEP) and the effect of care provided by a nephrologist on survival for KEEP participants with estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m(2). METHODS: Provision of care by a PCP (n = 138,331) or nephrologist (n = 10,797) was defined using self-report of seeing that provider within the past year. Survival was ascertained by linking KEEP data to the Social Security Administration Death Master File. Multivariable Cox proportional hazards models examining the relationship between primary care and nephrologist provider status adjusted for age, sex, race, smoking status, education, health insurance, diabetes, cardiovascular disease, hypertension, cancer, albuminuria, body mass index, baseline eGFR, and hemoglobin level, with nephrology models further adjusting for calcium, phosphorus, and parathyroid hormone levels. RESULTS: Of all participants, 70.9% (98,050 of 138,331) reported receiving PCP care; older age and female sex were associated with this care. During a median follow-up of 4.2 years, 4,836 deaths occurred. After multivariable adjustment, receiving PCP care and mortality were not associated (HR, 0.94; 95% CI, 0.86-1.03; P = 0.2). Of participants with eGFR <60 mL/min/1.73 m(2), 10.1% (1,095 of 10,797) reported receiving nephrology care; younger age and male sex were associated with receipt of nephrology care. During a mean follow-up of 2.2 years, 558 deaths occurred. After multivariable adjustment, nephrologist care was not associated with mortality (HR, 1.01; 95% CI, 0.75-1.36; P = 0.9). These associations were not modified by other specialist care (endocrinologist or cardiologist). CONCLUSIONS: For all KEEP participants, neither PCP nor nephrology care was associated with improved survival. These results highlight the need to explore the connection between access to health care and outcomes in persons at high risk of or with CKD.

Prepregnancy body mass index as an independent risk factor for pregnancy-induced hypertension.

BACKGROUND: Pregnancy-induced hypertension (PIH) plays a major role in the perinatal outcome for mother and neonate. With the rising prevalence of obesity, the role of prepregnancy body mass index (BMI) as an independent risk factor for PIH and a target for preconception care is important to explore. METHODS: We completed a retrospective cohort study of 16,582 women who received obstetrical care at a regional medical center and delivered a singleton pregnancy between 2003 and 2006. Clinical data were derived from the electronic medical record. Logistic regression was used to explore the association of demographic characteristics and medical risk factors with the outcome of PIH. RESULTS: Diagnoses of chronic hypertension, prepregnancy diabetes, and gestational diabetes were more likely in women with increasing prepregnancy maternal BMI (p < 0.0001). The odds of PIH also increased with BMI, ranging from an odds ratio (OR) of 1.99 (95% confidence interval [CI] 1.73-2.31) for overweight women through OR 4.26 (95% CI 3.37-5.38) for those with a BMI of ≥40 kg/m(2). Other risk factors for PIH included chronic hypertension (OR 6.57, 95% CI 5.43-7.95), nulliparity (OR 1.89, 95% CI 1.69-2.12), prepregnancy diabetes (OR 2.05, 95% CI 1.33-3.17), and gestational diabetes (OR 1.28, 95% CI 1.04-1.58). The presence of chronic hypertension modified the association between obesity and PIH; for women with chronic hypertension, obesity was not associated with PIH (adjusted OR [aOR] 1.39, 95% CI 0.77-2.50 for BMI 30-34.9; aOR 0.98, 95% CI 0.52-1.87 for BMI 35-39.9; and aOR 1.33, 95% CI 0.73-2.43 for BMI ≥40 kg/m(2)) compared with women with a BMI in the normal range. CONCLUSIONS: The risk of PIH rises with maternal prepregnancy BMI independent of other obesity-associated comorbidity. Women with chronic hypertension carry the greatest risk of PIH but incur no obesity-associated increase in risk.

Racial and ethnic differences in albuminuria in individuals with estimated GFR greater than 60 mL/min/1.73 m(2): results from the Kidney Early Evaluation Program (KEEP).

BACKGROUND: Albuminuria is an important marker for chronic kidney disease and progression to end-stage renal disease in the general population; understanding racial and ethnic differences can help inform efforts to reduce health disparities. We sought to estimate independent associations of race/ethnicity with albuminuria to determine whether observed differences were attributable to known kidney disease risk factors. METHODS: This cross-sectional study included 64,161 Kidney Early Evaluation Program (KEEP) participants, 2000-2008, with estimated glomerular filtration rate > or = 60 mL/min/1.73 m(2), not on regular dialysis therapy, and without a previous kidney transplant. Albuminuria (urine albumin-creatinine ratio > or = 30 mg/g) was examined by self-reported race and ethnicity. Covariates were age, sex, educational level, body mass index, diabetes status or glucose level, hypertension status or blood pressure measurement, smoking status, health insurance status, and geographic region. RESULTS: Albuminuria prevalences were 8% (n = 2,303) in whites, 11% (n = 2,310) in African Americans, 9% (n = 730) in Hispanics, 10% (n = 381) in Asians, and 15% (n = 344) in American Indians/Alaska Natives. Compared with whites, odds of albuminuria were higher for all groups after multivariate adjustment. Odds were highest for American Indians/Alaska Natives (adjusted OR, 1.93; 95% CI, 1.70-2.20), then Asians (adjusted OR, 1.42; 95% CI, 1.26-1.61), African Americans (adjusted OR, 1.38; 95% CI, 1.29-1.47), and Hispanics (adjusted OR, 1.19; 95% CI, 1.08-1.31). CONCLUSIONS: In the KEEP study population, albuminuria prevalence was higher in African Americans, Hispanics, Asians, and American Indians/Alaska Natives than in non-Hispanic whites, suggesting a need for screening for early detection of kidney damage, especially in people at increased risk, in the community primary care setting.

Prevalence of CKD and comorbid illness in elderly patients in the United States: results from the Kidney Early Evaluation Program (KEEP).

BACKGROUND: Elderly individuals with chronic kidney disease (CKD) have high rates of comorbid conditions, including cardiovascular disease and its risk factors, and CKD-related complications. In individuals aged > or = 65 years, we sought to describe the prevalence of CKD determined from laboratory test results in the Kidney Early Evaluation Program (KEEP; n = 27,017) and National Health and Nutrition Examination Survey (NHANES) 1999-2006 (n = 5,538) and the prevalence of diagnosed CKD determined from billing codes in the Medicare 5% sample (n = 1,236,946). In all 3 data sources, we also explored comorbid conditions and CKD-related complications. METHODS: CKD was identified as decreased estimated glomerular filtration rate (<60 mL/min/1.73 m(2)) or increased albumin-creatinine ratio in KEEP and NHANES; CKD was identified using International Classification of Diseases, Ninth Revision, Clinical Modification codes in Medicare. Investigated comorbid conditions included diabetes, hypertension, high cholesterol level, coronary artery disease, congestive heart failure, cerebrovascular disease, peripheral vascular disease, and cancer, and CKD-related complications included anemia, hypocalcemia, hyperphosphatemia, and hyperparathyroidism. RESULTS: The prevalence of CKD was approximately 44% in both KEEP and NHANES participants, and the prevalence of diagnosed CKD was 7% in Medicare beneficiaries. In all 3 data sets, the prevalence of CKD or diagnosed CKD was higher in participants aged > or = 80 years and those with comorbid conditions. For KEEP and NHANES participants, the prevalence of most comorbid conditions and CKD complications increased with decreasing estimated glomerular filtration rate. For participants with CKD stages 3-5, a total of 29.2% (95% CI, 27.8-30.6) in KEEP and 19.9% (95% CI, 17.0-23.1) in NHANES had anemia, 0.7% (95% CI, 0.4-0.9) and 0.6% (95% CI, 0.3-1.3) had hypocalcemia, 5.4% (95% CI, 4.7-6.1) and 6.4% (95% CI, 5.1-8.0) had hyperphosphatemia, and 52.0% (95% CI, 50.4-53.6) and 30.0% (95% CI, 25.9-34.3) had hyperparathyroidism, respectively. CONCLUSIONS: CKD is common in the elderly population and is associated with high frequencies of concomitant comorbid conditions and biochemical abnormalities. Because CKD is not commonly diagnosed, greater emphasis on physician education may be beneficial.

Cost effectiveness of enoxaparin in acute ST-segment elevation myocardial infarction: the ExTRACT-TIMI 25 (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction 25) study.

OBJECTIVES: We used a U.S. model of health care costs to examine the cost effectiveness of enoxaparin compared with unfractionated heparin (UFH) as adjunctive therapy for fibrinolysis in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: The ExTRACT-TIMI 25 (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction 25) study, a large, randomized, multinational trial, demonstrated a reduction in death or nonfatal myocardial infarction when enoxaparin was used instead of UFH as adjunctive therapy for fibrinolysis in patients with STEMI. METHODS: We used patient-level clinical outcomes and resource use from the ExTRACT-TIMI 25 trial and estimates of life expectancy gains as a result of the prevention of the clinical events on the basis of the Framingham Heart Study. RESULTS: Index hospitalization costs trended lower by $126 in the enoxaparin group (95% confidence interval [CI]: -$295 to $49). Thirty-day costs trended higher by $102 for enoxaparin (95% CI: $108 to $314). Patients receiving enoxaparin gained an average of 0.12 life-years relative to patients given UFH. Estimated total lifetime costs were $1,207 higher in the enoxaparin group (95% CI: $491 to $1,923). The incremental cost-effectiveness ratio of enoxaparin compared with UFH was $5,700 per life-year gained, with 99.9% of bootstrap-derived estimates <$50,000 per life-year gained. Using a probabilistic sensitivity analysis, there is a 90% probability that enoxaparin is cost effective for lifetime, provided that the willingness-to-pay value exceeds $50,000. CONCLUSIONS: Based on a U.S. model of health care economics, the strategy of using enoxaparin instead of UFH as adjunctive therapy for fibrinolysis in patients with STEMI is cost effective according to commonly used benchmarks.

Quality of life in autosomal dominant polycystic kidney disease patients not yet on dialysis.

BACKGROUND AND OBJECTIVES: Autosomal dominant polycystic kidney disease (ADPKD) is an inherited progressive disorder associated with significant pain and discomfort affecting quality of life. This study determined the impact of pain medication use and other clinical, biochemical and genetic characteristics on the physical and mental well being of predialysis ADPKD patients using the Short Form 36 (SF-36) questionnaire. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The authors prospectively evaluated ADPKD patients in the Cohort Study, funded by the Polycystic Kidney Disease Foundation. Data on clinical, biochemical, and radiologic variables were collected in patients who were given the Short Form-36 questionnaire. Variables independently associated with the Physical Component Summary (PCS) and the Mental Component Summary (MCS) scores were identified. RESULTS: One hundred fifty-two patients had a mean PCS and MCS of 46.9 +/- 11.3 and 51.0 +/- 9.0, similar to the general population and better than the ESRD population. Eleven (7%) reported pain medication intake within 1 mo of evaluation and demonstrated lower PCS than those not taking pain medications. Patients with GFR >or= 80 ml/min/1.73 m(2) had greater PCS than those with GFR < 80 ml/min/1.73 m(2). Age, BMI, pulse pressure, pain medication use, and education level independently associate with PCS and account for 32% of the variability of the measurement. Pulse pressure correlated with MCS. CONCLUSIONS: Predialysis ADPKD patients assess their quality of life similar to the general population. Age, BMI, pulse pressure, pain medication intake, and education level link to their physical well-being.

Determining the in-hospital cost of bleeding in patients undergoing percutaneous coronary intervention.

BACKGROUND: The economic impact of bleeding in the setting of nonemergent percutaneous coronary intervention (PCI) is poorly understood and complicated by the variety of bleeding definitions currently employed. This retrospective analysis examines and contrasts the in-hospital cost of bleeding associated with this procedure using six bleeding definitions employed in recent clinical trials. METHODS: All nonemergent PCI cases at Christiana Care Health System not requiring a subsequent coronary artery bypass were identified between January 2003 and March 2006. Bleeding events were identified by chart review, registry, laboratory, and administrative data. A microcosting strategy was applied utilizing hospital charges converted to costs using departmental level direct cost-to-charge ratios. The independent contributions of bleeding, both major and minor, to cost were determined by multiple regression. Bootstrap methods were employed to obtain estimates of regression parameters and their standard errors. RESULTS: A total of 6,008 cases were evaluated. By GUSTO definitions there were 65 (1.1%) severe, 52 (0.9%) moderate, and 321 (5.3%) mild bleeding episodes with estimated bleeding costs of $14,006; $6,980; and $4,037, respectively. When applying TIMI definitions there were 91 (1.5%) major and 178 (3.0%) minor bleeding episodes with estimated costs of $8,794 and $4,310, respectively. In general, the four additional trial-specific definitions identified more bleeding events, provided lower estimates of major bleeding cost, and similar estimates of minor bleeding costs. CONCLUSIONS: Bleeding is associated with considerable cost over and above interventional procedures; however, the choice of bleeding definition impacts significantly on both the incidence and economic consequences of these events.

CKD and cardiovascular disease in screened high-risk volunteer and general populations: the Kidney Early Evaluation Program (KEEP) and National Health and Nutrition Examination Survey (NHANES) 1999-2004.

BACKGROUND: Chronic kidney disease (CKD) is recognized as an independent cardiovascular disease risk state. The relationship between CKD and cardiovascular disease in volunteer and general populations has not been explored. METHODS: The National Kidney Foundation Kidney Early Evaluation Program (KEEP) is a community-based health-screening program to raise kidney disease awareness and detect CKD for early disease intervention in individuals 18 years or older with diabetes, hypertension, or family history of kidney disease, diabetes, or hypertension. KEEP volunteers completed surveys and underwent blood pressure and laboratory testing. Estimated glomerular filtration rate (eGFR) was computed, and urine albumin-creatinine ratio (ACR) was measured. In KEEP, CKD was defined as eGFR less than 60 mL/min/1.73 m(2) or ACR of 30 mg/g or greater. Cardiovascular disease was defined as self-reported myocardial infarction or stroke. Data were compared with National Health and Nutrition Examination Survey (NHANES) 1999-2004 data for prevalence of cardiovascular disease risk factors and cardiovascular outcomes. RESULTS: Of 69,244 KEEP participants, mean age was 53.4 +/- 15.7 years, 68.3% were women, 33.0% were African American, and 27.6% had diabetes. Of 17,061 NHANES participants, mean age was 45.1 +/- 0.27 years, 52% were women, 11.2% were African American, and 6.7% had diabetes. In KEEP, 26.8% had CKD, and in NHANES, 15.3%. ACR was the dominant positive screening test for younger age groups, and eGFR, for older age groups, for both populations. Prevalences of myocardial infarction or stroke were 16.5% in KEEP and 15.1% in NHANES (P < 0.001) and 7.8% in KEEP and 3.7% in NHANES (P < 0.001) for individuals with and without CKD, respectively. In adjusted analysis of both KEEP and NHANES data, CKD was associated with a significantly increased risk of prevalent myocardial infarction or stroke (odds ratio, 1.34; 95% confidence interval, 1.25 to 1.43; odds ratio, 1.37; 95% confidence interval, 1.10 to 1.70, respectively). In KEEP, short-term mortality was greater in individuals with CKD (1.52 versus 0.33 events/1,000 patient-years). CONCLUSIONS: CKD is independently associated with myocardial infarction or stroke in participants in a voluntary screening program and a randomly selected survey population. Heightened concerns regarding risks in volunteers yielded greater cardiovascular disease prevalence in KEEP, which was associated with increased short-term mortality.

The Kidney Early Evaluation Program (KEEP): program design and demographic characteristics of the population.

BACKGROUND: Chronic kidney disease (CKD) recently was identified as a public health problem requiring a public health prevention approach. The National Kidney Foundation Kidney Early Evaluation Program (KEEP), initiated in 2000, meets the definition of a public health program, offering surveillance and early detection of CKD. This report aims to detail demographic characteristics of KEEP participants and compare them with characteristics of participants in the National Health and Nutrition Examination (NHANES) 1999-2004. METHODS: KEEP is a CKD screening program enrolling individuals 18 years and older with a family history of kidney disease or personal or family history of diabetes or hypertension. Simple descriptive statistics were used in the analysis. For comparison, the NHANES sample was restricted to participants with hypertension or diabetes or a family history of hypertension or diabetes. RESULTS: The number of KEEP participants grew exponentially over time. Most participants were aged 46 to 60 years. KEEP enrolled twice as many women as men (68.4% versus 31.5%). Minorities were well represented (33.4% African American, 12.3% Hispanic). Almost 58% of participants had some college or more education, and close to 85.0% had a physician. Compared with NHANES, the KEEP population was older and included a larger proportion of women and African Americans. Self-reported hypertension, self-reported diabetes, obesity, and CKD were higher in KEEP (52.9% versus 38.5%, 26.6% versus 9.9%, 43.6% versus 35.5%, and 22.8% versus 17.6%, respectively). CONCLUSIONS: KEEP has been successful in enrolling individuals at risk of kidney disease, evidenced by the high levels of self-reported hypertension and diabetes.

Cost-effectiveness of percutaneous coronary intervention in optimally treated stable coronary patients.

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.

Reduced 6-month resource use and costs associated with cilostazol in patients after successful coronary stent implantation: results from the Cilostazol for RESTenosis (CREST) trial.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Cost and cost-effectiveness of an early invasive vs conservative strategy for the treatment of unstable angina and non-ST-segment elevation myocardial infarction.

CONTEXT: In the Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy (TACTICS)-Thrombolysis in Myocardial Infarction (TIMI) 18 trial, patients with either unstable angina or non-ST-segment elevation myocardial infarction (UA/NSTEMI) treated with the platelet glycoprotein (Gp IIb/IIIa) inhibitor tirofiban had a significantly reduced rate of major cardiac events at 6 months with an early invasive vs a conservative strategy. OBJECTIVE: To examine total 6-month costs and long-term cost-effectiveness of an invasive vs a conservative strategy. DESIGN: Randomized controlled trial including a priori economic end points. SETTING: Hospitalization for UA/NSTEMI with 6-month follow-up period. PATIENTS: A total of 2220 patients with UA/NSTEMI; economic data from 1722 patients at US-non-VA hospitals. INTERVENTION: Early invasive strategy with routine catheterization and revascularization as appropriate vs a conservative strategy with catheterization performed only for recurrent ischemia or a positive stress test. MAIN OUTCOME MEASURE: Total 6-month costs and incremental cost-effectiveness ratio. RESULTS: The average initial hospitalization costs among those in the invasive strategy group were $15714 vs $14047 among those in the conservative strategy group, a difference of $1667 (95% confidence interval [CI], $387-3091). The in-hospital costs were offset significantly at the 6-month follow-up, with an average cost in the invasive group of $6098 vs $7180 in the conservative group, a difference of $1082 (95% CI, -$2051 to $76). The average total costs at 6 months, including productivity costs, for the invasive group was $21 813 vs $21 227 for the conservative group, a $586 difference (95% CI, -$1087 to $2486). The average 6-month costs excluding productivity costs in the invasive group was $19 780 vs $19 111 in the conservative group, a difference of $670, 95% CI; (-$1035 to $2321). Estimated cost per year of life gained for the invasive strategy, based on projected life expectancy, was $12739 for the base case, and ranged from $8371 to $25769, based on model assumptions. CONCLUSIONS: In patients with UA/NSTEMI treated with the Gp IIb/IIIa inhibitor tirofiban, the clinical benefit of an early invasive strategy was achieved with a small increase in cost, yielding favorable projected estimates of cost per year of life gained. These results support the broader use of an early invasive strategy in these patients.