Prevalence of diabetic peripheral neuropathy and relation to glycemic control therapies at baseline in the BARI 2D cohort

Abstract   We evaluated the associations between glycemic therapies and prevalence of diabetic peripheral neuropathy (DPN) at baseline among participants in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial on medical and revascularization therapies for coronary artery disease (CAD) and on insulin-sensitizing vs. insulin-providing treatments for diabetes. A total of 2,368 patients with type 2 diabetes and CAD was evaluated. DPN was defined as clinical examination score >2 using the Michigan Neuropathy Screening Instrument (MNSI). DPN odds ratios across different groups of glycemic therapy were evaluated by multiple logistic regression adjusted for multiple covariates including age, sex, hemoglobin A1c (HbA1c), and diabetes duration. Fifty-one percent of BARI 2D subjects with valid baseline characteristics and MNSI scores had DPN. After adjusting for all variables, use of insulin was significantly associated with DPN (OR = 1.57, 95% CI: 1.15–2.13). Patients on sulfonylurea (SU) or combination of SU/metformin (Met)/thiazolidinediones (TZD) had marginally higher rates of DPN than the Met/TZD group. This cross-sectional study in a cohort of patients with type 2 diabetes and CAD showed association of insulin use with higher DPN prevalence, independent of disease duration, glycemic control, and other characteristics. The causality between a glycemic control strategy and DPN cannot be evaluated in this cross-sectional study, but continued assessment of DPN and randomized therapies in BARI 2D trial may provide further explanations on the development of DPN.     

Effects of heart failure and diabetes mellitus on long-term mortality after coronary revascularization (from the BARI Trial)

This study evaluated the effect of heart failure (HF) and ejection fraction (EF) at baseline on long-term cardiac mortality in patients undergoing coronary revascularization and investigated the effect of diabetes mellitus (DM) on mortality. We evaluated long-term outcomes of patients without HF, HF and a preserved EF, and HF and a decreased EF who underwent revascularization with percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery after enrollment in the Bypass Angioplasty Revascularization Investigation (BARI) trial. Ten years after initial revascularization, cumulative rates of freedom from cardiac death were 90% in patients without HF, 75% in patients with HF and a preserved EF, and 59% in patients with HF and a decreased EF (p <0.001, 3-way comparison). In diabetic patients with HF and a preserved EF, there was a significant increase in cardiac mortality compared with patients without HF (p <0.001); however, this relation was not seen in patients without DM. In conclusion, patients with HF and a preserved EF have increased mortality over 10 years compared with those without HF. Only in patients with DM did HF with preserved EF confer additional risk.     

The impact of body mass index on short- and long-term outcomes inpatients undergoing coronary revascularization. Insights from the bypass angioplasty revascularization investigation (BARI)

OBJECTIVES: We sought to investigate the impact of body mass index (BMI) on short- and long-term outcomes after initial revascularization with percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft surgery (CABG). BACKGROUND: Equivocal results exist on the impact of BMI on the risk of in-hospital complications after PTCA or CABG, and no long-term mortality data exist from a large series of revascularized patients. METHODS: From the randomized series and observational registry of the Bypass Angioplasty Revascularization Investigation (BARI), 2,108 patients who had PTCA and 1,526 patients who had CABG were evaluated by taking their BMI at study entry. They were classified as follows: low (< 20 kg/m(2)), normal (20 to 24.9 kg/m(2)), overweight (25 to 29.9 kg/m(2)), class I obese (30 to 34.9 kg/m(2)) and class II/III obese (greater-than-or-equal 35 kg/m(2)). In-hospital complications and short- and long-term mortalities were compared between levels of BMI within each mode of initial revascularization. RESULTS: Among patients who had PTCA, each unit increase in BMI was associated with a 5.5% lower adjusted risk of a major in-hospital event (death, myocardial infarction, stroke, coma); among patients who had CABG, no difference in the in-hospital outcome was observed according to BMI. In contrast, BMI was not associated with five-year mortality in the PTCA group; among the CABG group, adjusted relative risks of five-year cardiac mortality according to levels of BMI were 0.0 (low), 1.0 (normal), 2.02 (overweight), 3.16 (class I obese) and 4.85 (class II/III obese) (linear p < 0.001).CONCLUSIONS: Body mass index appears to have a differential impact on short- and long-term outcomes after coronary revascularization. These results underscore the need for further research to identify factors responsible for the apparent short-term protective effect of a higher BMI in patients undergoing PTCA and to study the impact of weight reduction on the long-term survival of obese patients undergoing CABG.     

Presentation in patients with angiographically documented coronary artery disease and type II diabetes mellitus (from the BARI 2D Clinical Trial)

Clinically stable patients with type 2 diabetes mellitus and coronary artery disease are not often thought to present with the symptom of typical angina. The aims of this study were to enumerate the proportion of patients presenting with typical angina or other cardiac symptoms and to elucidate what important clinical variables are associated with the presence of typical angina in patients with type 2 diabetes mellitus and angiographically documented coronary artery disease. Symptoms of angina, anginal equivalents, or an absence of symptoms were obtained using baseline data from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial (n = 2,319). A bivariate analysis stratified by the presence or absence of previous revascularization and logistic regression modeling with a stepwise covariate selection was used. Eighty-two percent of patients had symptoms, while 18% presented asymptomatically. This was further divided approximately into typical angina (1/5), anginal equivalents (1/5), combination (2/5), and asymptomatic (1/5). A history of previous revascularization was a determinant of the type of symptom presentation with regard to the variables gender, age, current insulin use, myocardial jeopardy index score, and use of β blockers. In the multivariate logistic regression analysis, of the available candidate variables, only a history of β-blocker use (odds ratio 1.53, 95% confidence interval 1.24 to 1.94, p <0.0001) and previous percutaneous coronary intervention (odds ratio 1.55, 95% confidence interval 1.24 to 1.94, p <0.0001) had higher odds of an association with typical angina. In conclusion, a large proportion of patients with type 2 diabetes mellitus and coronary artery disease indeed have symptoms. Future studies of long-term outcomes associated with these symptoms are needed.