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This paper tackles several statistical controversies that are commonly faced when reporting a major clinical trial. Topics covered include: multiplicity of data, interpreting secondary endpoints and composite endpoints, the value of covariate adjustment, the traumas of subgroup analysis, assessing individual benefits and risks, alternatives to analysis by intention to treat, interpreting surprise findings (good and bad), and the overall quality of clinical trial reports. All is put in the context of topical cardiology trial examples and is geared to help trialists steer a wise course in their statistical reporting, thereby giving readers a balanced account of trial findings. [ABSTRACT FROM AUTHOR]

Background: In survivors of myocardial infarction (MI), new left bundle branch block (LBBB) is associated with adverse outcomes, but its impact is not well described in post-MI patients with left ventricular (LV) systolic dysfunction and/or heart failure (HF).Objectives: The aim of this study was to determine if new LBBB is an independent predictor of long-term fatal and nonfatal outcomes in high-risk survivors of MI by reviewing data from the VALsartan In Acute myocardial iNfarcTion (VALIANT) trial.Methods: In VALIANT, 14,703 patients with LV systolic dysfunction and/or HF were randomized to valsartan, captopril, or both a mean of 5 days after MI. Baseline ECG data were available from 14,259 patients. We assessed the predictive value of new LBBB for death and major cardiovascular outcomes after 3 years, adjusting for multiple baseline covariates including LV ejection fraction.Results: At follow-up, patients with new LBBB (608 [4.2%]) compared with patients without new LBBB had more comorbidities and increased adjusted risk of death (hazard ratio [HR] 1.3, 95% confidence interval [CI] 1.2-1.6), cardiovascular death (HR 1.4, 95% CI 1.2-1.7), HF (HR 1.3, 95% CI 1.1-1.6), MI (HR 1.5, 95% CI 1.2-1.9), and the composite of death, HF, or MI (HR 1.4, 95% CI 1.2-1.6).Conclusion: In post-MI survivors with LV systolic dysfunction and/or HF, new LBBB was an independent predictor of all major adverse cardiovascular outcomes during long-term follow-up. This readily available ECG marker should be considered a major risk factor for long-term cardiovascular complications in high-risk patients after MI. [ABSTRACT FROM AUTHOR]

Summary Although heart failure is common, disabling, and deadly, there are now many effective treatments, at least for patients with low left-ventricular ejection fraction. For all, angiotensin-converting-enzyme inhibitors and β blockers are the essential disease-modifying treatments, improving symptoms, reducing hospital admissions, and increasing survival. Implantable cardioverter defibrillators also improve survival. For patients with persistent symptoms, angiotensin-receptor blockers and aldosterone antagonists have additional benefits. These treatments are now preferred to digoxin, although this drug can still be useful at an earlier stage in patients with atrial fibrillation. In some patients with persistently severe symptoms and a wide QRS on the electrocardiogram, cardiac resynchronisation therapy also reduces mortality and morbidity. The role of other markers of ventricular dys-synchrony is under investigation. There is growing evidence that left-ventricular assist devices are indicated in some patients with end-stage heart failure. Organised delivery of care also improves outcome. However, there is still no firmly evidence-based treatment for heart failure with preserved ejection fraction. Many new pharmacological, device, and surgical treatments for heart failure are currently under evaluation in clinical trials, and other approaches, including stem-cell treatment, are at an earlier stage of investigation. [ABSTRACT FROM AUTHOR]

Objectives: The goal of this study was to identify potentially novel laboratory markers of risk in chronic heart failure patients. Background: Although a variety of prognostic markers have been described in heart failure, a systematic assessment of routine laboratory values has not been reported. Methods: All 2,679 symptomatic chronic heart failure patients from the North American CHARM (Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity) program had a wide range of laboratory measures performed at a core facility, enabling us to assess the relationship between routine blood tests and outcomes using a Cox proportional hazards model. We then replicated our findings in a cohort of 2,140 heart failure patients from the Duke Databank. Results: Among 36 laboratory values considered in the CHARM program, higher red cell distribution width (RDW) showed the greatest association with morbidity and mortality (adjusted hazard ratio 1.17 per 1-SD increase, p < 0.001). Higher RDW was among the most powerful overall predictors, with only age and cardiomegaly showing a better independent association with outcome. This finding was replicated in the Duke Databank, in which higher RDW was strongly associated with all-cause mortality (adjusted hazard ratio 1.29 per 1 SD, p < 0.001), second only to age as a predictor of outcome. Conclusions: In 2 large contemporary heart failure populations, RDW was found to be a very strong independent predictor of morbidity and mortality. Understanding how and why this marker is associated with outcome may provide novel insights into heart failure pathophysiology. [Copyright &y& Elsevier]