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In the ACCORD trial, a mean of 3.7 years of intensive glucose lowering increased mortality and reduced nonfatal myocardial infarctions after 5 years of follow-up. The therapy cannot be recommended for high-risk patients with advanced type 2 diabetes. Type 2 diabetes mellitus is a strong, independent risk factor for cardiovascular disease and death, 1 and many epidemiologic analyses have identified a progressive relationship between hyperglycemia and these outcomes. 2 – 5 The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial was designed to determine whether a strategy of targeting normal glycated hemoglobin levels (i.e., <6.0%) would reduce the risk of serious cardiovascular events in middle-aged and elderly people with type 2 diabetes mellitus, glycated hemoglobin levels of 7.5% or more, and additional cardiovascular risk factors. 6 However, on the basis of a mean of 3.5 years' worth of data, the independent . . .

Atrial fibrillation (AF) is prevalent in patients with type 2 diabetes mellitus (DM) and is associated with markers of poor glycemic control; however, the impact of glycemic control on incident AF and outcomes is unknown. The aims of this study were to prospectively evaluate if intensive glycemic control in patients with DM affects incident AF and to evaluate morbidity and mortality in patients with DM and incident AF. A total of 10,082 patients with DM from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) cohort were studied in a randomized, double-blind fashion. Participants were randomized to an intensive therapeutic strategy targeting a glycated hemoglobin level of <6.0% or a standard strategy targeting a glycated hemoglobin level of 7.0% to 7.9%. Incident AF occurred in 159 patients (1.58%) over the follow-up period, at a rate of 5.9 per 1,000 patient-years in the intensive-therapy group and a rate of 6.37 per 1,000 patient-years in the standard-therapy group (p = 0.52). In a multivariate model, predictors of incident AF were age, weight, diastolic blood pressure, heart rate, and heart failure history. Patients with DM and new-onset AF had a hazard ratio of 2.65 for all-cause mortality (95% confidence interval 1.8 to 3.86, p <0.0001), a hazard ratio of 2.1 for myocardial infarction (95% confidence interval 1.33 to 3.31, p = 0.0015), and a hazard ratio of 3.80 for the development of heart failure (95% confidence interval 2.48 to 5.84, p <0.0001). In conclusion, intensive glycemic control did not affect the rate of new-onset AF. Patients with DM and incident AF had an increased risk for morbidity and mortality compared with those without AF. •Intensive glycemic control did not alter the rate of incident AF.•The investigators describe a number of predictors of AF in patients with diabetes.•Incident AF is associated with adverse outcomes in patients with diabetes.

Many cases of sudden death are caused by sustained ventricular tachyarrhythmias. Implantable cardioverter–defibrillators accurately detect and effectively terminate ventricular tachycardia or ventricular fibrillation in laboratory and clinical settings. 1 , 2 Observational studies document low rates of sudden death among patients treated with implanted defibrillators, 3 but only recently has a benefit in terms of overall mortality been demonstrated. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators report elsewhere in this issue of the Journal 4 that patients with previous cardiac arrest or sustained ventricular tachycardia have lower mortality rates when treated with implanted cardioverter–defibrillators than when treated with either amiodarone or sotalol. Patients who . . .

Primary prevention implantable cardioverter defibrillator (ICD) reduce all-cause mortality by reducing sudden cardiac death. There are conflicting data regarding whether patients with more advanced heart failure derive ICD benefit owing to the competing risk of nonsudden death. We performed a patient-level meta-analysis of New York Heart Association (NYHA) class II/III heart failure patients (left ventricular ejection fraction ≤35%) from 4 primary prevention ICD trials (MADIT-I, MADIT-II, DEFINITE, SCD-HeFT). Bayesian-Weibull survival regression models were used to assess the impact of NYHA class on the relationship between ICD use and mortality. Of the 2,763 patients who met study criteria, 68% (n=1,867) were NYHA II and 52% (n=1,435) were randomized to an ICD. In a multivariable model including all study patients, the ICD reduced mortality (hazard ratio [HR] 0.65, 95% posterior credibility interval [PCI]) 0.40-0.99). The interaction between NYHA class and the ICD on mortality was significant (posterior probability of no interaction=.036). In models including an interaction term for the NYHA class and ICD, the ICD reduced mortality among NYHA class II patients (HR 0.55, PCI 0.35-0.85), and the point estimate suggested reduced mortality in NYHA class III patients (HR 0.76, PCI 0.48-1.24), although this was not statistically significant. Primary prevention ICDs reduce mortality in NYHA class II patients and trend toward reducing mortality in the heterogeneous group of NYHA class III patients. Improved risk stratification tools are required to guide patient selection and shared decision making among NYHA class III primary prevention ICD candidates.

Experimental evidence suggests that autonomic markers such as heart-rate variability and baroreflex sensitivity (BRS) may contribute to post-infarction risk stratification. There are clinical data to support this concept for heart-rate variability. The main objective of the ATRAMI study was to provide prospective data on the additional and independent prognostic value for cardiac mortality of heart-rate variability and BRS in patients after myocardial infarction in whom left-ventricular ejection fraction (LVEF) and ventricular arrhythmias were known. This multicentre international prospective study enrolled 1284 patients with a recent (<28 days) myocardial infarction. 24 h Holter recording was done to quantify heart-rate variability (measured as standard deviation of normal to normal RR intervals [SDNN]) and ventricular arrhythmias. BRS was calculated from measurement of the rate-pressure response to intravenous phenylephrine. During 21 (SD 8) months of follow-up, the primary endpoint, cardiac mortality, included 44 cardiac deaths and five non-fatal cardiac arrests. Low values of either heart-rate variability (SDNN <70 ms) or BRS (<3·0 ms per mm Hg) carried a significant multivariate risk of cardiac mortality (3·2 [95% CI 1·42–7·36] and 2·8 [1·24–6·16], respectively). The association of low SDNN and BRS further increased risk; the 2-year mortality was 17% when both were below the cut-offs and 2% (p < 0·0001) when both were well preserved (SDNN >105 ms, BRS >6·1 ms per mm Hg). The association of low SDNN or BRS with LVEF below 35% carried a relative risk of 6·7 (3·1–14·6) or 8·7 (4·3–17·6), respectively, compared with patients with LVEF above 35% and less compromised SDNN (≥70 ms) and BRS (≥3 ms per mm Hg). ATRAMI provides clinical evidence that after myocardial infarction the analysis of vagal reflexes has significant prognostic value independently of LVEF and of ventricular arrhythmias and that it significantly adds to the prognostic value of heart-rate variability.

In a randomized trial, 4733 patients with type 2 diabetes mellitus who were at high risk for cardiovascular events received treatment aimed at a target systolic blood pressure of less than 120 mm Hg or less than 140 mm Hg. At a mean follow-up of 4.7 years, the rates of the primary end point (nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death) were not significantly different between the two trial groups. Patients with type 2 diabetes mellitus who were at high risk for cardiovascular events received treatment aimed at a target systolic blood pressure of less than 120 mm Hg or less than 140 mm Hg. At a mean follow-up of 4.7 years, the rates of the primary end point were not significantly different between the two groups. Diabetes mellitus increases the risk of cardiovascular disease by a factor of two to three at every level of systolic blood pressure. 1 Because cardiovascular risk in patients with diabetes is graded and continuous across the entire range of levels of systolic blood pressure, even at prehypertensive levels, the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommended beginning drug treatment in patients with diabetes who have systolic blood pressures of 130 mm Hg or higher, with a treatment goal of reducing systolic blood pressure to below 130 mm Hg. . . .

In a randomized trial, 5518 patients with type 2 diabetes mellitus who were at high risk for cardiovascular events were all treated with simvastatin and assigned to receive either fenofibrate or placebo. At a mean follow-up of 4.7 years, the rates of the primary outcome (nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death) did not differ significantly between the two study groups. Patients with type 2 diabetes mellitus who were at high risk for cardiovascular events were all treated with simvastatin and either fenofibrate or placebo. At a mean follow-up of 4.7 years, the rates of the primary outcome did not differ significantly between the two groups. Patients with type 2 diabetes mellitus have an increased incidence of atherosclerotic cardiovascular disease. 1 – 4 This increase is attributable, in part, to associated risk factors, including hypertension and dyslipidemia. The latter is characterized by elevated plasma triglyceride levels, low levels of high-density lipoprotein (HDL) cholesterol, and small, dense low-density lipoprotein (LDL) particles. 5 , 6 The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study was designed to test the effect of intensive treatment of blood glucose and either blood pressure or plasma lipids on cardiovascular outcomes in 10,251 patients with type 2 diabetes who were at high risk for cardiovascular disease. . . .

Although left ventricular ejection fraction (LVEF) is the primary determinant for sudden cardiac death (SCD) risk stratification, in isolation, LVEF is a sub-optimal risk stratifier. We assessed whether a multi-marker strategy would provide more robust SCD risk stratification than LVEF alone. We collected patient-level data (n = 3355) from 6 studies assessing the prognostic utility of microvolt T-wave alternans (MTWA) testing. Two thirds of the group was used for derivation (n = 2242) and one-third for validation (n = 1113). The discriminative capacity of the multivariable model was assessed using the area under the receiver-operating characteristic curve (c-index). The primary endpoint was SCD at 24 months. In the derivation cohort, 59 patients experienced SCD by 24 months. Stepwise selection suggested that a model based on 3 parameters (LVEF, coronary artery disease and MTWA status) provided optimal SCD risk prediction. In the derivation cohort, the c-index of the model was 0.817, which was significantly better than LVEF used as a single variable (0.637, P < .001). In the validation cohort, 36 patients experienced SCD by 24 months. The c-index of the model for predicting the primary endpoint was again significantly better than LVEF alone (0.774 vs 0.671, P = .020). A multivariable model based on presence of coronary artery disease, LVEF and MTWA status provides significantly more robust SCD risk prediction than LVEF as a single risk marker. These findings suggest that multi-marker strategies based on different aspects of the electro-anatomic substrate may be capable of improving primary prevention implantable cardioverter-defibrillator treatment algorithms.

Intensive glucose lowering targeting glycated hemoglobin levels of less than 6.0% was unexpectedly associated with an increase in overall mortality in high-risk patients with type 2 diabetes in the ACCORD trial. The findings identify a previously unrecognized risk of intensive glucose lowering in such patients. Intensive glucose lowering targeting glycated hemoglobin levels to less than 6.0% was unexpectedly associated with an increase in overall mortality in high-risk patients with type 2 diabetes. Type 2 diabetes mellitus is a metabolic disease that is diagnosed on the basis of sustained hyperglycemia. People with type 2 diabetes are at elevated risk for a number of serious health problems, including cardiovascular disease, premature death, blindness, kidney failure, amputations, fractures, frailty, depression, and cognitive decline. 1 In prospective epidemiologic studies, the incidence of many of these outcomes is directly associated with the degree of hyperglycemia, as measured by the plasma glucose or the glycated hemoglobin level, a measure of the mean blood glucose level during the previous 2 to 3 months. Thus, after adjustment for other risk factors, . . .

ABSTRACT BACKGROUND Hispanics in the United States represent diverse racial, ethnic, and socioeconomic groups, and manifest heterogeneous cardiovascular risks including diabetes. It is not known if there are residual differences in the control of diabetes among Hispanic groups given uniform access to diabetes care. OBJECTIVE To evaluate glucose control differences among Mexicans, Puerto Ricans, and Dominicans receiving substantial diabetes care and support in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. DESIGN Secondary analysis of data from a randomized trial comparing two treatment strategies: intensive, targeting glycated hemoglobin below 6.0 %, and standard, targeting glycated hemoglobin between 7.0 % and 7.9 %. PARTICIPANTS Seven hundred and sixteen Hispanic and 6066 non-Hispanic white participants were recruited from 77 clinical sites across the United States and Canada. There were 243 Mexicans, 199 Puerto Ricans, and 150 Dominicans; and 135 of these Hispanic groups were born in the United States. MAIN MEASURE Glycated hemoglobin RESULTS Compared to Puerto Ricans, Mexicans were more likely (HR = 1.38, CI:0.90–2.10) and Dominicans as likely (HR = 1.01, CI:0.66–1.54) to achieve glycated hemoglobin goal in the intensive arm. Participants born in the United States achieved glycated hemoglobin goal at a higher rate than those born elsewhere (HR = 1.57, CI:0.99–2.51 in the intensive arm, HR = 1.51, CI:0.95–2.43 in the standard arm). These differences were not statistically significant. In the intensive arm, Puerto Ricans (OR = 0.47, CI:0.31–0.71), and Dominicans (OR = 0.41, CI:0.26–0.66) were less likely than non-Hispanic whites to achieve glycated hemoglobin goal, whereas the difference between non-Hispanic whites and Mexicans was not statistically significant, (OR = 0.66, CI:0.43–1.02). CONCLUSIONS Hispanic groups, given access to comprehensive diabetes care, differed from each other non-significantly and had a variable divergence from non-Hispanic whites in achieving intensive glycated hemoglobin goal. These differences, if confirmed, could be due to such factors as variable acculturation and functional health literacy levels that were not measured in the ACCORD trial, but should be further explored in future studies.