This systematic review examines the level and prevalence of spin in presenting findings that are not statistically significant in published reports of cardiovascular randomized clinical trials (RCTs).

Background Although sodium restriction is advised for patients with heart failure (HF), data on sodium restriction and HF outcomes are inconsistent. Objective We sought to evaluate the impact of sodium restriction on HF outcomes. Methods We analyzed data from the multi-hospital, Heart Failure Adherence and Retention Trial which enrolled 902 NYHA class II/III HF patients and followed them for a median of 36 months. Sodium intake was serially assessed by a food frequency questionnaire. Based on the mean daily sodium intake prior to the first event of death or HF hospitalization, patients were classified into sodium restricted (<2,500 mg/day) and unrestricted (≥2,500 mg/day) groups. Study groups were propensity score-matched according to plausible baseline confounders. The primary outcome was a composite of death or HF hospitalization. The secondary outcomes were cardiac death and HF hospitalization. Results Sodium intake data were available for 833 subjects (145 sodium restricted, 688 sodium unrestricted), of whom 260 were propensity-matched into sodium restricted (n=130) and sodium unrestricted (n=130) groups. Sodium restriction was associated with significantly higher risk of death or HF hospitalization (42.3% vs. 26.2%; hazard ratio [HR], 1.83; 95% confidence interval [CI], 1.21–2.84; P=0.004), derived from an increase in the rate of HF hospitalization (32.3% vs. 20.0%; HR, 1.82; CI, 1.11–2.96; P=0.015) and a non-significant increase in the rate of cardiac death (HR, 1.62; CI, 0.70–3.73; P=0.257) and all-cause mortality (P=0.074). Exploratory subgroup analyses suggested that sodium restriction was associated with increased risk of death or HF hospitalization in patients not receiving angiotensin converting-enzyme inhibitor or angiotensin receptor blocker (HR, 5.78; CI, 1.93–17.27; P=0.002). Conclusions In symptomatic patients with chronic HF, sodium restriction may have a detrimental impact on outcome. A randomized clinical trial is needed to definitively address the role of sodium restriction in HF management.

Background-Appropriate use criteria (AUC) have been developed to aid in the optimal use of single-photon emission computed tomography (SPECT)-myocardial perfusion imaging (MPI), a technique that is a mainstay of risk assessment for ischemic heart disease. The impact of appropriate use on the prognostic value of SPECT-MPI is unknown. Methods and Results-A prospective cohort study of 1511 consecutive patients undergoing outpatient, community-based SPECT-MPI was conducted. Subjects were stratified on the basis of the 2009 AUC for SPECT-MPI into an appropriate or uncertain appropriateness group and an inappropriate group. Patients were prospectively followed up for 27±10 months for major adverse cardiac events of death, death or myocardial infarction, and cardiac death or myocardial infarction. In the entire cohort, the 167 subjects (11%) with an abnormal scan experienced significantly higher rates of major adverse cardiac events and coronary revascularization than those with normal MPI. Among the 823 subjects (54.5%) whose MPIs were classified as appropriate (779, 51.6%) or uncertain (44, 2.9%), an abnormal scan predicted a multifold increase in the rates of death (9.2% versus 2.6%; hazard ratio, 3.1; P=0.004), death or myocardial infarction (11.8% versus 3.3%; hazard ratio, 3.3; P=0.001), cardiac death or myocardial infarction (6.7% versus 1.7%; hazard ratio, 3.7; P=0.006), and revascularization (24.7% versus 2.7%; hazard ratio, 11.4; P<0.001). Among the 688 subjects (45.5%) with MPI classified as inappropriate, an abnormal MPI failed to predict major adverse cardiac events, although it was associated with a high revascularization rate. Furthermore, appropriate MPI use provided incremental prognostic value beyond myocardial perfusion and ejection fraction data. Conclusions-When performed for appropriate indications, SPECT-MPI continues to demonstrate high prognostic value.However, inappropriate use lacks effectiveness for risk stratification, further emphasizing the need for optimal patient selection for cardiac testing. (Circulation. 2013;128:1634-1643.)