Health status after treatment for coronary artery disease and type 2 diabetes mellitus in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial.

BACKGROUND: Health status is a key outcome for comparing treatments, particularly when mortality does not differ significantly. METHODS AND RESULTS: Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) randomized 2368 patients with type 2 diabetes mellitus and stable ischemic heart disease to (1) prompt revascularization versus medical therapy and (2) insulin sensitization versus insulin provision. Randomization was stratified by the intended method of revascularization, coronary artery bypass graft surgery or percutaneous coronary intervention. The Duke Activity Status Index and RAND Energy, Health Distress, and Self-Rated Health scales were assessed at study entry and annually thereafter; linear mixed models were used to evaluate the effect of randomized treatment on these measures. Health status improved significantly from baseline to 1 year (P<0.001) in each randomized treatment group. Compared with medical therapy, prompt revascularization was associated with significantly greater improvements in Duke Activity Status Index (1.32 points; P<0.001), Energy (1.36 points; P=0.02), and Self-rated Health (1.77 points; P=0.007) but not Health Distress (-0.47; P=0.46). These treatment effects were largely maintained over 4 years of follow-up. The effect of revascularization on the Duke Activity Status Index was significantly larger in the subgroup of patients intended for coronary artery bypass graft surgery compared with the subgroup intended for percutaneous coronary intervention. Health status did not differ significantly on any of the 4 measures between the insulin provision and insulin sensitization strategies. CONCLUSIONS: Prompt coronary revascularization was associated with small yet statistically significant improvements in health status compared with initial medical therapy among patients with diabetes mellitus and stable ischemic heart disease. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT00006305.

Economic outcomes of treatment strategies for type 2 diabetes mellitus and coronary artery disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial.

BACKGROUND: The economic outcomes of clinical management strategies are important in assessing their value to patients. METHODS AND RESULTS: Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) randomized patients with type 2 diabetes mellitus and angiographically documented, stable coronary disease to strategies of (1) prompt revascularization versus medical therapy with delayed revascularization as needed to relieve symptoms and (2) insulin sensitization versus insulin provision. Before randomization, the physician declared whether coronary artery bypass grafting or percutaneous coronary intervention would be used if the patient were assigned to revascularization. We followed 2005 patients for medical utilization and costs and assessed the cost-effectiveness of these management strategies. Medical costs were higher for revascularization than medical therapy, with a significant interaction with the intended method of revascularization (P<0.0001). In the coronary artery bypass grafting stratum, 4-year costs were $80 900 for revascularization versus $60 600 for medical therapy (P<0.0001). In the percutaneous coronary intervention stratum, costs were $73 400 for revascularization versus $67 800 for medical therapy (P<0.02). Costs also were higher for insulin sensitization ($71 300) versus insulin provision ($70 200). Other factors that significantly (P<0.05) and independently increased cost included insulin use and dose at baseline, female sex, white race, body mass index > or =30, and albuminuria. Cost-effectiveness based on 4-year data favored the strategy of medical therapy over prompt revascularization and the strategy of insulin provision over insulin sensitization. Lifetime projections of cost-effectiveness showed that medical therapy was cost-effective compared with revascularization in the percutaneous coronary intervention stratum ($600 per life-year added) with high confidence. Lifetime projections suggest that revascularization may be cost-effective in the coronary artery bypass grafting stratum ($47 000 per life-year added) but with lower confidence. CONCLUSIONS: Prompt coronary revascularization significantly increases costs among patients with type 2 diabetes mellitus and stable coronary disease. The strategy of medical therapy (with delayed revascularization as needed) appears to be cost-effective compared with the strategy of prompt coronary revascularization among patients identified a priori as suitable for percutaneous coronary intervention.

Economic evaluation of alternative strategies to treat patients with diabetes mellitus and coronary artery disease.

Diabetes mellitus and coronary artery disease (CAD) commonly coexist, and thus effective, cost-effective management strategies are needed. Intensive management of diabetes has been shown to increase medical costs while yielding better outcomes, with an acceptable cost-effectiveness ratio of <50,000 dollars per life-year added. On the basis of clinical trial findings in the 1970s and 1980s, coronary bypass surgery was cost-effective compared with medical therapy in the treatment of extensive CAD. Few trials have compared angioplasty with medical therapy, and its cost-effectiveness is not well established. The economic outcomes of contemporary coronary revascularization, especially angioplasty, compared with contemporary medical therapy must be evaluated. The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial will collect extensive economic data and examine the cost-effectiveness of alternative strategies to manage diabetes and CAD in patients with both disorders.

Medical costs and quality of life 10 to 12 years after randomization to angioplasty or bypass surgery for multivessel coronary artery disease.

BACKGROUND: Coronary bypass surgery (CABG) and angioplasty (PTCA) have been compared in several randomized trials, but data about long-term economic and quality-of-life outcomes are limited. METHODS AND RESULTS: Cost and quality-of-life data were collected prospectively from 934 patients who were randomized in the Bypass Angioplasty Revascularization Investigation (BARI) and followed up for 10 to 12 years. CABG had 53% higher costs initially, but the gap closed to <5% during the first 2 years; after 12 years, the mean cumulative cost of CABG patients was 123,000 dollars versus 120,750 dollars for PTCA, yielding a cost-effectiveness ratio of 14,300 dollars/life-year added. CABG patients experienced significantly greater improvement in their physical functioning for the first 3 years but not in later follow-up. Recurrent angina substantially reduced all quality-of-life measures throughout follow-up. Cumulative costs were significantly higher among patients with diabetes, heart failure, and comorbid conditions and among women; costs also were increased by angina, by the number of revascularization procedures, and among patients who died. CONCLUSIONS: Early differences between CABG and PTCA in costs and quality of life were no longer significant at 10 to 12 years of follow-up. CABG was cost-effective as compared with PTCA for multivessel disease.

Quality of life and time trade-off utility measures in patients with coronary artery disease.

BACKGROUND: Contemporary clinical trials commonly measure quality of life and medical costs to establish whether therapies are both effective and cost effective. Cost-effectiveness analysis, however, requires a measure of patient utility or preferences for various health states. Because utilities are not often measured directly, we sought to develop a method of translating standard quality-of-life scales into a patient utility measure. METHODS: Five hundred fifty-three patients enrolled in the Bypass Angioplasty Revascularization Investigation Study of Economics and Quality of Life completed a battery of quality-of-life measures and a time trade-off utility assessment an average of 7.3 years after random assignment. RESULTS: The mean time trade-off score was 8.54 (SD = 2.53) out of a maximum of 10; median score was 9.95. The distribution of scores was skewed, with 12% of patients at the highest possible score of 10. Patients with recurrent angina had significantly lower time trade-off scores than patients without angina (mean 7.03 vs 8.70, P <.05). Time trade-off scores were moderately correlated with each quality-of-life measure (Spearman coefficients 0.38-0.52). Time trade-off scores could be predicted by combinations of 4 (r2 = 0.29), 5 (r2 = 0.31), or 6 (r2 = 0.32) variables. CONCLUSIONS: Time trade-off utility scores can be inferred from commonly used quality-of-life measures. Angina significantly reduces patient utility scores.

Pregnancy outcomes in the super obese, stratified by weight gain above and below institute of medicine guidelines.

OBJECTIVE: To examine the association of antenatal weight gain above and below the 2009 Institute of Medicine (IOM) guidelines in the super-obese population (body mass index [BMI] of 50 or higher) on the maternal and neonatal morbidities of gestational hypertension or preeclampsia (pregnancy-induced hypertension), gestational diabetes mellitus, cesarean delivery, birth weight more than 4,000 g and more than 4,500 g, low birth weight, and preterm birth. METHODS: The effect of gestational weight gain was assessed in this retrospective cohort study using California birth certificate and patient discharge diagnosis data. Unconditional logistic regression was used to calculate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) as a function of antenatal weight gain. Weight gain within 2009 IOM guidelines (11-20 pounds) served as the reference group. RESULTS: The study population consisted of 1,034 women. Women gaining below, within, and above IOM guidelines accounted for 38.3, 23.5, and 38.2%, respectively. Weight gain below IOM guidelines was not associated with a statistically increased odds of preterm birth (OR 1.82, 95% CI 0.60-5.59) or low birth weight (OR 1.20, 95% CI 0.57-2.49); however, birth weight more than 4,000 g was significantly reduced (OR 0.50, 95% CI 0.32-0.77). Excessive weight gain statistically increased the odds of pregnancy-induced hypertension (OR 1.96, 95% CI 1.26-3.03) and cesarean delivery (OR 1.40, 95% CI 1.00-1.97) while not appearing to protect against the delivery of low-birth-weight neonates (OR 0.84, 95% CI 0.40-1.78). CONCLUSION: Weight gain below the current guidelines in the super-obese cohort is not associated with an increase in maternal or neonatal risk while decreasing the odds of delivering a macrosomic neonate. Women with BMIs of 50 or higher may warrant separate gestational weight gain recommendations.

The impact of change in pregnancy body mass index on cesarean delivery.

OBJECTIVE: To examine the impact of pregnancy changes in body mass index (BMI) on the incidence of cesarean delivery. METHODS: This is a retrospective cohort study using linked birth certificate and discharge diagnosis data from the year 2007. Adjusted odds ratios (aOR) were calculated for the outcome of cesarean delivery, as a function of a categorical change in pregnancy BMI (kg/m(2)): BMI loss (BMI change<-0.5), no change (-0.5 to 0.5), minimal (0.6 to 5), moderate (5.1 to 10) and excessive (>10). The impact of pregnancy change in BMI was determined for the entire cohort and then stratified by prepregnancy BMI category. RESULTS: The study population consisted of 436 414 women with singleton gestations. When compared to women with no net change in BMI, women with excessive BMI changes collectively had a 80% increased incidence of cesarean delivery (aOR = 1.78). By prepregnancy obesity class, the aOR for cesarean delivery in women with excessive BMI change were: normal weight (aOR = 2.25), overweight (aOR = 2.39), obese class I (aOR = 2.23), obese class II (aOR = 2.56) and obese class III (aOR = 2.08). CONCLUSIONS: The odds of cesarean delivery were uniformly increased in all prepregnancy BMI categories as net BMI change increased. These data illustrate that all women, not just the overweight and obese, are at significantly increased risk of cesarean delivery with excessive BMI change during pregnancy.

The impact of change in pregnancy body mass index on macrosomia.

OBJECTIVE: To examine the impact of change in body mass index (BMI) during pregnancy on the incidence of macrosomia. METHODS: This is a retrospective cohort study using 2007 linked birth certificate and discharge diagnosis data from the state of California. Adjusted odds ratios (aOR) with 95% confidence intervals (CI) were calculated for the outcome of macrosomia, as a function of a categorical change in pregnancy BMI: BMI loss (<-0.5), no change (-0.5 to 0.5), minimal (0.6 to 5), moderate (5.1 to 10), and excessive (>10). The impact of pregnancy change in BMI was determined for the entire cohort and then stratified by prepregnancy BMI category. Minimal BMI change served as the reference group. RESULTS: The study population consisted of 436,414 women. Overall, women with moderate and excessive BMI changes had aORs of 1.66 and 3.21, respectively, for macrosomia, when compared with women with minimal BMI change. When stratified by prepregnancy BMI, normal (aOR 3.85) and overweight women (aOR 2.96) with antenatal BMI change greater than 10 had the highest odds of macrosomia. CONCLUSIONS: Excessive change in pregnancy BMI results in an increased odds of macrosomia. This finding was most pronounced in the normal and overweight women.

Increasing pre-pregnancy body mass index is predictive of a progressive escalation in adverse pregnancy outcomes.

OBJECTIVE: To evaluate the association between pre-pregnancy body mass index (BMI) and adverse pregnancy outcomes using a large administrative database. METHODS: Retrospective cohort study of California women delivering singletons in 2007. The association between pre-pregnancy BMI category and adverse outcomes were evaluated using multivariate logistic regression. RESULTS: Among 436,414 women, increasing BMI was associated with increasing odds of adverse outcomes. Obese women (BMI=30-39.9) were nearly 3 x more likely to have gestational diabetes (OR=2.83, 95% CI=2.74-2.92) and gestational hypertension/preeclampsia (2.68, 2.59-2.77) and nearly twice as likely to undergo cesarean (1.82, 1.78-1.87), when compared to normal BMI women (BMI=18.5-24.9). Morbidly obese women (BMI ≥ 40) were 4x more likely to have gestational diabetes (4.72, 4.46-4.99) and gestational hypertension/preeclampsia (4.22, 3.97-4.49) and nearly 3 x as likely to undergo cesarean (2.60, 2.46-2.74). CONCLUSION: There is a strong association between increasing maternal BMI and adverse pregnancy outcomes. This information is important for counseling women regarding the risks of obesity in pregnancy.