Hospitalization For Cardiovascular Causes Research Articles

Exploring The Obesity Paradox In Atrial Fibrillation. AFBAR (Atrial Fibrillation Barbanza Area) Registry Results.

Previous studies have described an inverse relationship between obesity and adverse events in a variety of conditions. Our aim was to investigate the relationship between obesity and prognosis in patients with atrial fibrillation. We studied 746 patients who were prospectively included, between January and April 2008, in the AFBAR (Atrial Fibrillation in BARbanza area) registry. Patients were categorized into 3 body mass index groups using baseline measurements: normal (< 25 kg/m2), overweight (25-30 kg/m2), and obese (≥30 kg/m2). Survival free from the composite endpoint hospitalization for cardiovascular causes or all-cause mortality was compared across the 3 body mass index groups. A multivariable Cox proportional hazard regression was also performed to determine the independent effect of obesity as well as overweight, with respect to normal body mass index as a reference category, regarding the study endpoint. Median follow-up time was 36 (28-36) months. 49.3% were obese and 38.2% had overweight. The composite endpoint rate was 70.9%, 67.5%, and 57.6% for obese, overweight, and normal weight patients, respectively (log rank test; p=0.02). An inverse association of obesity with a favorable prognosis persisted even after multivariable adjustment: hazard ratio 0.668; 95% confidence interval 0.449-0.995; p=0.047. Hazard ratio of overweight, however, was 0.741; 95% confidence interval: 0.500-1.098; p=0.096. Obesity, defined as a body mass index ≥ 30 kg/m2, is associated with better prognosis in a community-based cohort of patients with atrial fibrillation.

Sex differences in cardiovascular outcomes, pharmacological treatments and indicators of care in patients with newly diagnosed diabetes: Analyses on administrative database

BackgroundThe impact of diabetes on cardiovascular disease in both sexes is known, but the specifics have not been fully clarified. We investigated whether sex-related differences exist in terms of management and hospitalization in patients with newly diagnosed diabetes. MethodsWe examined the rates of hospitalization for cardiovascular causes, mortality, treatments and management of patients with diabetes compared to subjects without, from administrative database. Interaction between sex and diabetes on clinical outcomes were calculated using a Cox regression model. Pharmacological treatments and recommended examinations by sex were calculated using logistic regression. ResultsFrom 2002 to 2006, 158,426 patients with diabetes and 314,115 subjects without were identified and followed up for a mean of 33months (±17.5).Diabetes confers a higher risk for all clinical outcomes. Females with diabetes have a risk profile for hospitalization for coronary heart disease comparable to males without (4.6% and 5.3%). Interaction between sex and diabetes shows that females with diabetes had an added 19% higher risk of total death (95% CI 1.13–1.24). No differences were observed in hospitalizations, although females with diabetes were less likely to undergo revascularization after myocardial infarction. Females received cardiovascular prevention drugs less frequently than males and had a slight tendency to get fewer examinations. ConclusionDiabetes is linked to a higher increase of mortality in females relative to males. This might reflect sex differences in the use of revascularization procedures or therapeutic regimens. Closer attention and implementation of standard care for females are necessary from the onset of diabetes.

Usefulness of Tissue Doppler Imaging to Identify Low Risk Patients with Diagnosis of Hypertrophic Cardiomyopathy

Usefulness of Tissue Doppler Imaging to Identify Low Risk Patients with Diagnosis of Hypertrophic Cardiomyopathy Background Pulsed tissue Doppler imaging is a useful tool for the early detection of hypertrophic cardiomyopathy and the differential diagnosis of this disease from other secondary causes of hypertrophy. Objective The aim of the study was to determine the prognostic significance of preserved systolic tissue velocities in patients with diagnosis of hypertrophic cardiomyopathy. Methods One hundred and forty six patients with diagnosis of hypertrophic cardiomyopathy were prospectively included by means of a Doppler echocardiography study. Systolic tissue velocities were obtained from the averaged septal and lateral velocities. Patients with preserved systolic tissue velocities (Sa ≥ 8 cm/s; upper quartile) were compared with those presenting decreased velocities. The primary endpoint was defined as the presence of sudden death, stroke, heart failure, or hospitalization for cardiovascular causes at follow up. Results Twenty nine percent of patients (n = 43) presented preserved systolic tissue velocities in the tissue Doppler images, mostly in men (76.7% vs. 53.4%, p = 0.009) and with no age differences. Ventricular diameter and thickness were similar between the two groups while the atrial area was significantly lower (23.7 ± 6.7 vs. 28.8 ± 8, p <0.01). At follow up (median of 2.7 years), the number of events increased significantly as systolic pulsed tissue Doppler velocities decreased. No patient from the group with preserved systolic tissue velocities presented the combined endpoint, with significant differences with respect to the control group (0% vs. 21.6%, p = 0.001), and a negative predictive value of 100%. Conclusions In our population with hypertrophic cardiomyopathy, the presence of preserved systolic tissue velocities in pulsed tissue Doppler imaging identified low-risk patients with a very low number of events at follow up and high negative predictive value.

The limited effect of omega-3 polyunsaturated fatty acids on cardiovascular risk in patients with impaired glucose metabolism: A meta-analysis

ObjectivesThe impacts of marine-derived n−3 polyunsaturated fatty acids (n−3 PUFAs) on cardiovascular risk are not well known. We conducted this meta-analysis to determine the effects of n−3 PUFAs on cardiovascular outcomes and cardiovascular risk markers in patients with impaired glucose metabolism (IGM). Design and methodsWe searched PUBMED, EMBASE, The Cochrane Library and reference lists of relevant papers for high quality randomized controlled trials comparing dietary intake of n−3 PUFAs with placebo in IGM patients. Data was extracted and quality assessed independently by two reviewers. Authors were contacted for missing information. Overall estimates were calculated using a random-effects model or a fixed-effects model, and the possibility of publication bias was examined using a funnel plot. Subgroup analyses were conducted to explore the association between the risk markers and study characteristics. ResultsOur meta-analysis included 19 studies, 24,788 patients. Compared with placebo, n−3 PUFAs had no statistically significant reduce effect on cardiovascular mortality, major cardiovascular events, all-cause mortality or composite endpoint of all-cause mortality or hospitalization for cardiovascular cause, however it can significantly reduce the level of triglycerides (weighted mean difference [WMD] −0.25mmol/L; 95% CI −0.37 to −0.13: p<0.001; 12 trials, 13,921 patients). ConclusionMarine-derived n−3 polyunsaturated fatty acids have no protective effect on cardiovascular mortality, major cardiovascular events, all-cause mortality and composite endpoint of all-cause mortality or hospitalization for cardiovascular cause in IGM patients, but can reduce triglyceride level.

Cardiovascular morbidity and mortality in surgically treated hyperthyroidism – a nation‐wide cohort study with a long‐term follow‐up

Previous studies suggest that patients with hyperthyroidism remain at an increased risk of cardiovascular morbidity even after restoring euthyroidism. The mechanisms of the increased risk and its dependency on the different treatment modalities of hyperthyroidism remain unclear. The aim of this long-term follow-up study was to compare the rate of hospitalizations for cardiovascular causes and the mortality in hyperthyroid patients treated surgically with an age- and gender-matched reference population. A population-based cohort study was conducted among 4334 hyperthyroid patients (median age 46 years) treated with thyroidectomy in 1986-2007 in Finland and among 12,991 reference subjects. Firstly, the hospitalizations due to cardiovascular diseases (CVD) were analysed until thyroidectomy. Secondly, the hazard ratios for any new hospitalization due to CVDs after the thyroidectomy were calculated in Cox regression analysis adjusted with the prevalent CVDs at the time of thyroidectomy. The risk of hospitalization due to all CVDs started to increase already 5 years before the thyroidectomy, and by the time of the operation, it was 50% higher in the hyperthyroid patients compared to the controls (P < 0·001). After the thyroidectomy, the hospitalizations due to all CVDs (HR 1·15), hypertension (HR 1·23), heart failure (HR 1·17) and valvular diseases or cardiomyopathies (HR 1·55) remained more frequent among the patients than among the controls for 20 years after thyroidectomy. The increased morbidity was not clearly related to the aetiology of hyperthyroidism. Despite the increased CVD morbidity among the patients, there was no difference in cardiovascular mortality. The present study shows that hyperthyroidism increases the risk of hospitalization due to CVDs and the risk is sustained up to two decades after effective surgical treatment. However, there was no excess CVD mortality in the middle-aged patient cohort studied.

Abstract 9337: Zofenopril is Cost Effective for Treatment of Patients With Left Ventricular Systolic Dysfunction After Acute Myocardial Infarction: A Post- Hoc Analysis of the SMILE-4 Study

Background and objective: in the Survival of Myocardial Infarction Long-term Evaluation 4 Study (SMILE-4) zofenopril associated with ASA was superior to ramipril plus ASA in reducing the occurrence of major cardiovascular events, in patients with left ventricular dysfunction (LVD) following acute myocardial infarction (AMI). The present post-hoc analysis was performed to evaluate cost-effectiveness of zofenopril compared to ramipril. Methods: a total of 771 patients with LVD and AMI were randomized double-blind to zofenopril 60 mg/day (n=389) or ramipril 10 mg/day (n=382) plus ASA 100 mg/day and followed-up for 1 year. The primary study end-point was 1-year combined occurrence of death or hospitalization for cardiovascular causes. The economic analysis was based on the evaluation of cost of medications and hospitalizations and was applied to the intention-to-treat population (n=716). Cost data were drawn from the National Health Service databases of the European countries participating into the study. The incremental cost-effectiveness ratio (ICER) was used to quantify the cost per event prevented with zofenopril vs. ramipril. Results: zofenopril significantly (p=0.028) reduced the risk of the primary study end-point by 30% as compared to ramipril (95% confidence interval: 49%, 4%). The number needed to treat to prevent a major cardiovascular event with zofenopril was 13 less than with ramipril. The cost of drug therapies was higher with zofenopril (328.78 Euros per patient per year, n=365) than with ramipril (165.12 Euros per patient per year, n=351). The cost related to the occurrence of major cardiovascular events requiring hospitalization, averaged 4983.64 Euros for zofenopril and 4850.01 Euros for ramipril. The ICER of zofenopril vs. ramipril was 2125.45 Euros per event prevented (worst- and best-case scenario in the sensitivity analysis: 3590.09 and 3243.96 Euros, respectively). Conclusions: zofenopril is a viable and cost-effective treatment for managing patients with LVD after AMI.

Zofenopril is a cost-effective treatment for patients with left ventricular systolic dysfunction following acute myocardial infarction: a pharmacoeconomic analysis of the SMILE-4 study

Objective: The Survival of Myocardial Infarction Long-term Evaluation 4 Study (SMILE-4) showed the superiority of Zofenopril (Z) associated with Acetylsalicylic Acid (ASA) as respect to Ramipril (R) plus ASA in reducing the occurrence of major cardiovascular events, in patients with left ventricular dysfunction (LVD) following Acute Myocardial Infarction (AMI). The objective of this retrospective analysis was the evaluation of cost-effectiveness of Z compared to R. Methods: 771 patients with LVD and AMI were randomized, double-blind to Z 60 mg/day (n=389) or R 10 mg/day (n=382) plus ASA 100 mg/day and followed-up for 1 year. The primary study end-point was 1-year combined occurrence of death or hospitalization for cardiovascular causes. The economic analysis was based on the evaluation of cost of medications and hospitalizations and was applied to the intention-to-treat population (n=716). Cost data were drawn from the database of the Italian National Health Service. The Incremental Cost-Effectiveness Ratio (ICER) was used to quantify the cost per event prevented with Z vs. R. Results: Z significantly (p=0.028) reduced the risk of the primary study end-point by 30% as compared to ramipril (95% confidence interval: 49%, 4%). The number needed to treat to prevent a major cardiovascular event with Z was 13 less than with R. The cost of drug therapies was higher with Z (313.90 Euros per patient per year, n=365) than with R (160.60 Euros per patient per year, n=351). The cost related to the occurrence of major cardiovascular events requiring hospitalization, averaged 3195.47 Euros for Z and 3071.37 Euros for R. The ICER of Z vs. R was 1990.88 Euros per event prevented. Conclusions: Z is a viable and cost-effective treatment for managing patients with LVD after AMI.

Vitamin D serum levels are associated with cardiovascular outcome in coronary artery disease

Purpose: The role of vitamin D in coronary artery disease is under question recently. We study the diagnostic and prognostic significance of vitamin D status in coronary artery disease (CAD) patients. Methods: In this cohort study we included 252 CAD patients (mean aged 62±11 years) followed-up for 3 to 36 (median 15) months. The extent of CAD (1 vessel disease (1VD), 2VD and 3VD) was determined by coronary angiography and severity of CAD was evaluated by Gensini score. Measures for vitamin D were performed using Liquid Chromatography Mass Spectrometry technology. Subjects with vitamin D levels above and below 30ng/ml were characterized as having sufficiency and deficiency respectively. The primary end point was the composite of death from cardiovascular causes, cardiovascular events and hospitalization for cardiovascular causes. Results: From the study population 222 (88%) were categorized as having vitamin D deficiency and 30 subjects as having vitamin D sufficiency (12%). There was no difference between subjects with deficiency and sufficiency in baseline characteristics. There was no association of Vitamin D levels with Gensini score (rho=0.06, p=0.36) and with the extent of CAD [17.75 (11.37-23.53) vs. 18.40 (13.65-23.53) vs. 16.90 (12.97-26.50) ng/ml, p=0.96, for 1VD, 2VD and 3VD respectively]. During the follow up period the primary end point occurred in 24% of the subjects with vitamin D deficiency and in 7% of the subjects with vitamin D sufficiency. Cox-regression analysis after adjustment for multiple confounders such as age, gender, creatinine clearance, gensini score, the presence of dyslipidemia, arterial hypertension, diabetes mellitus, smoking habits and obesity revealed that subjects with vitamin D deficiency have seven times increased hazard (HR=7.24, p=0.05) for the occurrence of primary end point compared to subjects with vitamin D sufficiency. Conclusion: Vitamin D deficiency is highly prevalent in CAD patients. Importantly, vitamin D deficiency is associated with adverse cardiovascular outcome in this high risk population a finding that must be further evaluated by interventional studies.

Longer interdialytic interval and cause-specific hospitalization in children receiving chronic dialysis

Previous studies have demonstrated a relationship between longer interdialytic intervals and hospitalization for cardiovascular causes in adults maintained on hemodialysis (HD). This association has not been previously demonstrated in children. We hypothesized that the risk of hospitalization for hypertension (HTN), fluid overload or electrolyte abnormalities would be increased on the days following a longer interdialytic interval in children. We queried the Pediatric Hospital Information System for all admissions of patients with chronic kidney disease stage V or V-D who received dialysis during the hospitalization. Admissions were divided into two categories: admissions for HTN, fluid overload or electrolyte abnormalities and admissions for all other causes. We assumed that HD patients did not receive dialysis on weekends, and therefore any admission on Monday occurred following a longer interval from the last dialysis. We assumed that all peritoneal dialysis (PD) patients received dialysis on a daily basis. We used mixed effects logistic regression, clustering by patient within each hospital, to assess the increased odds for cause-specific admission on Monday versus other days of the week. We stratified the analysis by dialysis modality, HD or PD. Among HD patients, the odds ratio of admission for HTN, fluid overload or electrolyte abnormalities was 2.6 (95% CI = 1.4-4.7, P = 0.003) if the admission occurred on a Monday versus other days of the week. The odds of cause-specific admission among PD patients was not significantly different on Monday compared with other days of the week (95% CI =0.5-1.3, P = 0.8). Children receiving chronic HD are more likely to be hospitalized for HTN, fluid overload or electrolyte abnormalities following a longer interdialytic interval. Changes to the frequency of outpatient dialysis treatments may decrease admissions in this population and decrease resource utilization in this high-risk population.

Cost-effectiveness of zofenopril in patients with left ventricular systolic dysfunction after acute myocardial infarction: a post hoc analysis of SMILE-4

BackgroundIn SMILE-4 (the Survival of Myocardial Infarction Long-term Evaluation 4 study), zofenopril + acetylsalicylic acid (ASA) was superior to ramipril + ASA in reducing the occurrence of major cardiovascular events in patients with left ventricular dysfunction following acute myocardial infarction. The present post hoc analysis was performed to compare the cost-effectiveness of zofenopril and ramipril.MethodsIn total, 771 patients with left ventricular dysfunction and acute myocardial infarction were randomized in a double-blind manner to receive zofenopril 60 mg/day (n = 389) or ramipril 10 mg/day (n = 382) + ASA 100 mg/day and were followed up for one year. The primary study endpoint was the one-year combined occurrence of death or hospitalization for cardiovascular causes. The economic analysis was based on evaluation of cost of medications and hospitalizations and was applied to the intention-to-treat population (n = 716). Cost data were drawn from the National Health Service databases of the European countries participating in the study. The incremental cost-effectiveness ratio was used to quantify the cost per event prevented with zofenopril versus ramipril.ResultsZofenopril significantly (P = 0.028) reduced the risk of the primary study endpoint by 30% as compared with ramipril (95% confidence interval, 4%–49%). The number needed to treat to prevent a major cardiovascular event with zofenopril was 13 less than with ramipril. The cost of drug therapies was higher with zofenopril (328.78 Euros per patient per year, n = 365) than with ramipril (165.12 Euros per patient per year, n = 351). The cost related to the occurrence of major cardiovascular events requiring hospitalization averaged 4983.64 Euros for zofenopril and 4850.01 Euros for ramipril. The incremental cost-effectiveness ratio for zofenopril versus ramipril was 2125.45 Euros per event prevented (worst and best case scenario in the sensitivity analysis was 3590.09 and 3243.96 Euros, respectively).ConclusionZofenopril is a viable and cost-effective treatment for managing patients with left ventricular dysfunction after acute myocardial infarction.

Zofenopril and ramipril and acetylsalicylic acid in postmyocardial infarction patients with left ventricular systolic dysfunction

Antecedent hypertension represents a risk factor for adverse outcomes in survivors of acute myocardial infarction (AMI). Prognosis of such patients might be greatly improved by drugs enhancing blood pressure control. In the present retrospective analysis of the randomized, double-blind, parallel-group, SMILE-4 study we compared the efficacy of zofenopril 60 mg and acetylsalicylic acid (ASA) 100 mg versus ramipril 10 mg and ASA in patients with AMI complicated by left ventricular dysfunction, classified according to a history of hypertension. The primary study end-point was 1-year combined occurrence of death or hospitalization for cardiovascular causes. Hypertension was defined according to medical history and current blood pressure values at entry and could be determined in 682 of 716 patients of the intention-to-treat analysis. One hundred and fifty-seven patients (23%) were normotensives and 525 (77%) hypertensives. In the normotensive population the primary end-point occurred in 19 of 76 zofenopril-treated patients (25%) and in 23 of 81 ramipril-treated patients (28%) [odds ratio (95% confidence interval): 0.84 (0.41-1.71), P = 0.631]. In the hypertensive population, major cardiovascular outcomes were reported in 84 of 273 zofenopril-treated patients (31%) and in 99 of 252 ramipril-treated patients (39%), with a 31% significantly (P = 0.041) lower risk with zofenopril [0.69 (0.48-0.99)]. The superiority of zofenopril versus ramipril was particularly evident in patients with isolated systolic hypertension [n = 131, 0.48 (0.23-0.99), P = 0.045]. This retrospective analysis of the SMILE-4 study confirmed the good efficacy of zofenopril and ASA in the prevention of long-term cardiovascular outcomes also in the subgroup of patients with hypertension.

Abstract 9643: Effect of Partial Fatty Acids Oxidation Inhibition With Trimetazidine on Survival in Heart Failure: Results From an International Multicentre Retrospective Cohort Study

Background: Trimetazidine (TMZ) shifts myocardial energy production from free fatty acids to glucose oxidation, a more efficient metabolic pathway. Previous small studies in patients with chronic heart failure (CHF) have shown that TMZ can improve contractile left ventricular function, exercise capacity and NYHA class compared to placebo. However, no data on the effects of TMZ on survival in patients with CHF have ever been produced. Methods: In this international multicentre retrospective cohort study 669 patients (521 post-ischaemic) from the CHF clinics of our institutions were recruited. 362 patients (288 post-ischaemic) were on TMZ (20 mg tid or 35 mg bid) due to symptoms persistence (dyspnoea on exertion, fatigue, orthopnoea, oedema, alone or in combination) despite up titration of optimal CHF medical therapy, while the remaining patients continued conventional CHF therapy alone. Effects of TMZ administration were evaluated by Kaplan-Meier survival analysis and Cox-Regression survival analysis. Obtained results were corrected with propensity score (PS) in order to minimize selection bias. The protocol has been registered in the Italian Pharmaceutical Agency (AIFA) - Italian Ministry of Health, on the observational studies registry, ID number 458. Results: Kaplan-Meier analysis for global mortality showed 11•3% improved global survival (p=0•015) and 8•5% improved survival for death from cardiovascular disease (CVD) causes (p=0•050) in the TMZ group. Cox regression analysis for global mortality showed a significant risk reduction for TMZ treated patients with a PS-corrected hazard ratio (HR)= 0•189 (confidence interval - CI 95%: 0•079-0•454; p=0•0002). TMZ also showed a good risk reduction profile for CVD death causes (PS-adjusted HR=0•072, CI 95%: 0•019-0•268, p=0•0001). The rate of hospitalization for cardiovascular causes was reduced by 10.4% at 5 years (p &lt; 0•0005) with increased hospitalization-free survival of •8 months. Conclusions: TMZ is effective in reducing both global and cardiovascular mortality and event-free survival in patients with CHF. The addition of TMZ on top of optimal medical therapy improves long-term survival in CHF patients.

Effect of partial fatty acid oxidation inhibition with trimetazidine on mortality and morbidity in heart failure: Results from an international multicentre retrospective cohort study

ObjectivesThe aim of this cohort study was to retrospectively evaluate, in patients with chronic heart failure (CHF), the long term effect of trimetazidine (TMZ) on morbidity and mortality. BackgroundPrevious small studies in patients with CHF have shown that TMZ can improve left ventricular function, exercise capacity and NYHA class compared to placebo. However, no data on the effects of TMZ on survival in patients with CHF have ever been produced. MethodsIn this international multicentre retrospective cohort study data from 669 patients were analyzed. 362 patients were on TMZ due to symptom persistence despite up-titration of optimal CHF therapy, while the remaining patients continued conventional CHF therapy alone. Propensity score analysis was performed in order to minimize selection bias between the two groups. ResultsKaplan–Meier analysis for global mortality showed 11.3% improved global survival (p=0.015) and 8.5% improved survival for cardiovascular (CVD) death (p=0.050) in the TMZ group. Cox regression analysis for global mortality showed a significant risk reduction for TMZ treated patients with a hazard ratio (HR)=0.189 (confidence interval — CI 95%: 0.017–0.454; p=0.0002). TMZ also showed a good risk reduction profile for CVD death causes (HR=0.072, CI 95%: 0.019–0.268, p=0.0001). The rate of hospitalization for cardiovascular causes was reduced by 10.4% at 5years (p<0.0005) with increased hospitalization-free survival of 7.8months. ConclusionTMZ is effective in reducing mortality and event-free survival in patients with CHF. The addition of TMZ on top of optimal medical therapy improves long term survival in CHF patients.

Association Between the Part D Coverage Gap and Adverse Health Outcomes

To determine whether Part D coverage gap entry is associated with risk of death or hospitalization for cardiovascular outcomes. Prospective cohort study. Beneficiaries entered the study upon reaching the coverage gap spending threshold and were observed until an outcome reaching the threshold for catastrophic coverage occurred or year's end. Nine thousand four hundred thirty-six exposed individuals (those who were responsible for drug costs in the gap) were compared with 9,436 unexposed individuals (those who received financial assistance) based on propensity score (PS) or high-dimensional propensity score (hdPS). Medicare Part D drug insurance. Three hundred three thousand nine hundred seventy-eight Medicare beneficiaries aged 65 and older in 2006 and 2007 with linked prescription and medical claims who enrolled in stand-alone Part D or retiree drug plans and reached the gap spending threshold. Rates of death and hospitalization for any of five cardiovascular outcomes, including acute coronary syndrome with revascularization (ACS), after reaching the coverage gap spending threshold were compared using Cox proportional hazards models. In PS-matched analyses, exposed beneficiaries had higher, albeit not significantly so, hazard of death (hazard ratio (HR) = 1.25, 95% confidence interval (CI) = 0.98-1.59) and ACS (HR = 1.16, 95% CI = 0.83-1.62) than unexposed beneficiaries. hdPS-matched analyses minimized residual confounding and confirmed results (death: HR = 0.99, 95% CI = 0.78-1.24; ACS: HR = 1.07, 95% CI = 0.81-1.41). Exposed beneficiaries were no more or less likely to experience other outcomes than were those who were unexposed. During the short-term coverage gap period, having no financial assistance to pay for drugs was not associated with greater risk of death or hospitalization for cardiovascular causes, although long-term health consequences remain unclear.

Comparison Between Zofenopril and Ramipril in Combination With Acetylsalicylic Acid in Patients With Left Ventricular Systolic Dysfunction After Acute Myocardial Infarction: Results of a Randomized, Double‐Blind, Parallel‐Group, Multicenter, European Study (SMILE‐4)

Angiotensin-converting enzyme inhibitors (ACEIs) are largely employed for treating patients with left ventricular dysfunction (LVD), but their efficacy may be negatively affected by concomitant administration of acetylsalicylic acid (ASA), with some difference among the different compounds. The interaction between ASA and the two ACEIs zofenopril and ramipril may result in a different impact on survival of cardiac patients, due to differences in the pharmacological properties of the two ACEIs. This phase IIIb, randomized, double-blind, parallel-group, multicenter, European study compared the safety and efficacy of zofenopril (60 mg/day) and ramipril (10 mg/day) plus ASA (100 mg/day), in 771 patients with LVD (clinical signs of heart failure or a left ventricular ejection fraction <45%) following acute myocardial infarction (AMI). The primary study end point was 1-year combined occurrence of death or hospitalization for cardiovascular causes. In the intention-to-treat population, the primary outcome was significantly reduced by zofenopril (n = 365) vs ramipril (n = 351) (odds ratio [OR]: 0.70, and 95% confidence interval [CI]: 0.51-0.96; P = 0.028) as a result of a decrease in cardiovascular hospitalization (OR: 0.64,95% CI: 0.46-0.88; P = 0.006). Mortality rate was not significantly different between the 2 treatments (OR: 1.51, 95% CI: 0.70-3.27; P = 0.293). Blood pressure values did not significantly change during the 1-year follow-up. N-terminal pro-brain natriuretic peptide levels were progressively reduced during the study, with no statistically significant between-treatment differences. Proportion of patients with deterioration of renal function during the study was similar between the 2 groups. Drug safety profile was comparable between treatments. In patients with LVD following AMI, the efficacy of zofenopril associated with ASA was superior to that of ramipril plus ASA, indicating some important clinical implications for the future use of ACEIs in patients with LVD or overt heart failure.

Prospective study on clinical effects of renal replacement therapy in treatment-resistant congestive heart failure

Clinical outcome in cardiorenal syndrome (CRS) Type 2 and treatment with dialysis. Prospective observational non-randomized study. Twenty-three patients were included, mean age 66±21 years. Twelve (52%) patients were treated with peritoneal dialysis (PD) and 11 (48%) with intermittent haemodialysis (IHD). Median survival time after start of dialysis was 16 months. Hospitalizations for cardiovascular causes were reduced (1.4±0.6 pre-dialysis versus 0.4±0.6 days/patient/month post-dialysis, P=0.000), without significant changes in hospitalization for all causes (1.8±1.6 versus 2.1±2.9 days/patient/month). New York Heart Association (NYHA) class (3.8±0.4 at start versus 2.4±0.7 after 4 months, P=0.000, versus 2.7±0.9 after 8 months, P=0.001) and quality of life tended to improve (63±21 at start, versus 41±20 after 4 months, versus 51±25 after 8 months; P=0.056). Left ventricular ejection fraction did not change. The number of technical complications associated with dialysis therapy was relatively high in this population. After starting dialysis for CRS, hospitalizations for cardiovascular causes were reduced, but not hospitalizations for all causes. Functional NYHA class improved and quality of life tended to improve, without evidence for a change in cardiac function. In this small study, no differences between IHD and PD were observed.

Abstract 9163: Head-to-head Comparison Between the Prognostic Role of Two Functional Tests in a Population of Elderly Patients with Chronic Heart Failure

Background The six-minute walk test (6MWT) and the cardio-pulmonary exercise testing (CPx ) provide a valid assessment of functional performance in patients ( pts ) with HF but in elderly pts a comparison on prognostic validity of the 2 techniques has not been yet performed. Aims: We sought to compare the prognostic ability of the two functional tests in risk stratification of elderly CHF pts. Methods: We prospectively followed-up 170 stable HF outpatients on optimized medical therapy by using a thorough clinical, laboratory and instrumental evaluation, including the 6MWT and the CPX . The composite end-point was death or hospitalizations for cardiovascular causes. Results Mean age was 71±11 years, 28 % were female, 43% had ischemic heart disease, 18 % were in NYHA class III, 70% were on beta-blockers, 13% had an advanced diastolic disfunction, echocardiographic left ventricular ejection fraction ( LVEF ) was 44±13 %, mean BNP was 358±482 pg /ml . The mean distance covered during the 6MWT was 329±104 m. Peak workload was 71±11 watts, peak oxygen consumption (PVO2) was 13.2±4 ml/kg/min, the slope of the regression line relating ventilation to CO2 output, (VE/VCO2 slope) was 34±7 Exercise oscillatory breathing was found in 79 pts (46 %). During a median follow-up of 13 months, 18 patients died of cardiovascular causes and overall 51 met the combined end point of death or cardiovascular hospitalization. Distance walked correlated significantly to PVO2 (r=0.47, p&lt;.0001). By Cox multivariable analysis, independent predictors of outcome were mean distance covered during the 6MWT (HR 0.996, CI 95% 0.992-0.999), LVEF (HR 0.962, CI 95% 0.938 - 0.985) and PVO2 (HR 0.883, CI 95% 0.790-0.987). Conclusions: Among elderly CHF pts 6MWT is not only a simple and reliable first-line test for quantification of exercise intolerance but retains a prognostic value independent of CPX derived PVO2. This is a cornerstone in functional assessment because the 6MWT is widely diffused, safe and may be more feasible than CPX in a population of elderly HF pts.

CABG and Medical Therapy Perform Equally Well in Patients With Heart Failure

NEW ORLEANS—A trial of 2 treatment strategies for heart failure, one much more expensive and invasive, found that both provide the same degree of protection against death within about 5 years after initiating treatment. Such a finding suggests that cardiologists will opt for the cheaper and less invasive therapy, but that may not be the case. At issue is treatment of patients with coronary artery disease and left ventricular dysfunction. At the American College of Cardiology scientific session here in April, researchers compared the efficacy and safety of coronary artery bypass graft (CABG) surgery plus optimal medical therapy with medical therapy alone. The Surgical Treatment for Ischemic Heart Failure (STICH) trial included 1212 patients with left ventricular ejection fraction of 35% or less and coronary artery disease amenable to CABG, who were randomized to either treatment strategy. After a median follow-up of 56 months, 218 of 610 patients randomized to CABG plus medical therapy died compared with 244 of 602 patients randomized to medical therapy alone; CABG plus medical therapy reduced death rates by 14% compared with medical therapy alone, but the difference did not reach statistical significance (Velazquez EJ et al. N Engl J Med. 2011;364[17]:1607-1616). Those arguing that CABG should remain a viable treatment option for these patients point to secondary analyses showing that those who had the surgery had lower rates of hospitalization for cardiovascular causes or death. Robert O. Bonow, MD, a STICH coinvestigator and a professor of medicine at Northwestern University’s Feinberg School of Medicine in Chicago, pointed out that this is the first prospective randomized study of these types of patients and treatment options and that

Apixaban in Patients with Atrial Fibrillation

Vitamin K antagonists have been shown to prevent stroke in patients with atrial fibrillation. However, many patients are not suitable candidates for or are unwilling to receive vitamin K antagonist therapy, and these patients have a high risk of stroke. Apixaban, a novel factor Xa inhibitor, may be an alternative treatment for such patients. In a double-blind study, we randomly assigned 5599 patients with atrial fibrillation who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable to receive apixaban (at a dose of 5 mg twice daily) or aspirin (81 to 324 mg per day), to determine whether apixaban was superior. The mean follow up period was 1.1 years. The primary outcome was the occurrence of stroke or systemic embolism. Before enrollment, 40% of the patients had used a vitamin K antagonist. The data and safety monitoring board recommended early termination of the study because of a clear benefit in favor of apixaban. There were 51 primary outcome events (1.6% per year) among patients assigned to apixaban and 113 (3.7% per year) among those assigned to aspirin (hazard ratio with apixaban, 0.45; 95% confidence interval [CI], 0.32 to 0.62; P<0.001). The rates of death were 3.5% per year in the apixaban group and 4.4% per year in the aspirin group (hazard ratio, 0.79; 95% CI, 0.62 to 1.02; P=0.07). There were 44 cases of major bleeding (1.4% per year) in the apixaban group and 39 (1.2% per year) in the aspirin group (hazard ratio with apixaban, 1.13; 95% CI, 0.74 to 1.75; P=0.57); there were 11 cases of intracranial bleeding with apixaban and 13 with aspirin. The risk of a first hospitalization for cardiovascular causes was reduced with apixaban as compared with aspirin (12.6% per year vs. 15.9% per year, P<0.001). The treatment effects were consistent among important subgroups. In patients with atrial fibrillation for whom vitamin K antagonist therapy was unsuitable, apixaban reduced the risk of stroke or systemic embolism without significantly increasing the risk of major bleeding or intracranial hemorrhage. (Funded by Bristol-Myers Squibb and Pfizer; ClinicalTrials.gov number, NCT00496769.).

Hand-Carried Echocardiography in Heart Failure and Heart Failure Risk Population: A Community Based Prospective Study

The basic reservation concerning the use of hand-carried echocardiographic devices by general practitioners has been a lack of data demonstrating that they would provide clinically important information on patients' outcomes. One hundred seventy-five patients with heart failure and/or heart failure risk factors were selected from a general community outpatient clinic. They underwent simplified hand-carried echocardiography performed by an internist with basic echocardiographic experience and N-terminal pro-B-type natriuretic peptide measurements. Patients were followed for the occurrence of the combined end point, consisting of death or hospitalization for cardiovascular causes. Hand-carried echocardiographic results were abnormal in 90 patients (55%). During 48 ± 7 months of follow-up, the combined end point occurred in 41 patients (25%). On multivariate analysis, only abnormal echocardiography (hazard ratio, 5.55; 95% confidence interval, 2.04-14.28; P = .0004) was an independent predictor of outcomes. Hand-carried echocardiographic examinations performed by an internist with basic echocardiographic training can provide important prognostic information, independent of N-terminal pro-B-type natriuretic peptide levels.