Both systolic blood pressure and low-density lipoprotein (LDL) cholesterol are associated with cardiovascular disease. The authors hypothesize that a strategy of broad population-based primary prevention treatment of LDL cholesterol and blood pressure could be effective at preventing cardiovascular disease. They conducted a multicenter, long-term, international, double-blind, randomized, placebo-controlled trial by randomly assigning participants at intermediate risk (defined as no cardiovascular disease and at least one additional risk factor besides age) in 2 by 2 fashion to rosuvastatin 10mg per day or placebo, candesartan (16 mg per day) plus hydrochlorothiazide (12.5 mg per day), both rosuvastatin and candesartan/hydrochlorothiazide in one pill, or placebo. The primary outcome was composite of death from cardiovascular causes, nonfatal myocardial infarction or nonfatal stroke. Secondary outcomes were heart failure, cardiac arrest, or revascularization. The authors found that the primary outcome occurred in 113 participants (3.6%) in the combined-therapy group and in 157 (5.0%) in the dual-placebo group (HR, 0.71; 95% CI, 0.56 to 0.90; p=0.005). With respect to the secondary outcome, it occurred in 136 participants (4.3%) in the combined-therapy group and in 187 participants (5.9%) in the dual-placebo group (HR, 0.72; 95% CI, 0.57 to 0.89; p=0.003). Medical discontinuation was similar in the two groups. The number needed to treat for 5.6 years to prevent one event of the first primary outcome was 72, and the number needed to treat to prevent one event of the second primary outcome was 63. Therefore, the results of this study provide evidence that in patients with intermediate cardiovascular risk and hypertension but no prior cardiovascular disease, the combination of a statin and 2 antihypertensives was associated with a significantly lower rate of cardiovascular events.
Previous studies have shown similar survival rates with transcatheter aortic-valve replacement (TAVR) compared to surgical replacement in high-risk patients. The authors incorporated two parallel prospective multicenter randomized trials to compare the two procedures in a total of 2032 intermediate-risk patients (intermediate risk was based on a model that estimated the risk of death at 30 days after surgery between 4% and 8% from the Society of Thoracic Surgeons). The primary end point was death from any cause or disabling stroke at 2 years. The authors found the primary outcome was similar in the TAVR group compared to the surgery group (p=0.001 for noninferiority). At the two-year follow-up the Kaplan–Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% CI, 0.73 to 1.09; p=0.25). In terms of side-effects, TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation. Those who underwent surgery experienced fewer major vascular complications and less paravalvular aortic regurgitation. Therefore, the results of this study provide evidence that in intermediate-risk patients undergoing TAVR compared to surgical aortic valve replacement, there were no difference in terms of death or stroke.
Depression is a major cause of morbidity and mortality, however there is lacking research data on universal prevention of depression in adults. The purpose of this multicenter, cluster randomized trial was to evaluate the effectiveness of an intervention to prevent major depression. The primary outcome was new cases of major depression at 18-month follow-up. The authors recruited two primary care physicians (PCPs) who developed a psychosocial program tailored to these patients by measuring each patient’s individual risk for major depression, identifying specific risk factors for depression in each patient that were amenable to change, and helping the patient use this information to improve knowledge and alter behavior. They recruited 3326 patients randomly sampled from 10 primary care centers in Spain. The authors found at 18 months that 7.39% of patients in the intervention group developed major depression compared with 9.40% in the control (usual care) group (absolute difference, 2.01 percentage points [CI, 4.18 to 0.16 percentage points]; p = 0.070). The intervention did not result in a statistically significant reduction in the incidence of major depression at 18 months. However, the authors did prospectively measure anxiety symptoms because of its close association with depression and found that the intervention resulted in a statistically significant reduction in the incidence of anxiety at 18 months.
The long-term risk of infection in late preterm infants and in low birth weight infants is unknown. The purpose of this population-based, data-linkage study was to determine whether the rates of infection-related admissions to hospital for children in Western Australia were associated with age, gestational age, birth weight, and birth length. The authors longitudinally followed 719,311 live born singletons from hospital discharge at birth to age 18 years, death, or end of 2010. They found that infection-related rates of admissions to hospital increased by 12% for each week reduction in gestational age less than 39–40 weeks (RR 1.12, 95% CI 1.12–1.13), by 19% for each 500 g reduction in birth weight less than 3000–3500 g (1.19, 1.18–1.21), and by 41% for each 5 cm reduction in birth length less than 45–50 cm (1.41, 1.38–1.45). Specifically, age-specific and sex-specific birth weight Z scores lower than the 25th to 50th percentile and birth length Z scores lower than the 10th to 25th percentile were associated with increased rates of infection-related admissions to hospital. The results of this study provide evidence that individuals born with certain risk factors such as reduced gestational age, birth weight and birth length have increased risk of admission to hospital for infections in the future, until the age of 18. This result has both health promotion and health economic implications.
The purpose of this open-label, randomized, parallel-group, multicenter study was to determine whether catheter ablation is superior to amiodarone for the treatment of persistent atrial fibrillation (AF) in patients with a dual chamber ICD and known heart failure. Patients were randomly assigned to undergo ablation or receive amiodarone. The primary outcome was recurrence of AF at 24 months. The secondary outcome was all-cause mortality and unplanned hospitalization. At follow-up, 71 patients who underwent ablation were recurrence-free after average 1.4 procedures as compared to 34 who received amiodarone (p <0.001). Specifically for ablation, success rate in the different centers after a single procedure ranged from 29% to 61%. Patients assigned to amiodarone, after adjusting for covariates in the multivariable model, were found to be significantly more likely to fail (HR 2.5; p <0.001). In terms of the secondary outcomes, the rate of unplanned hospitalization was 31% in patients who underwent ablation and 57% in receiving amiodarone (p <0.001; 45% RR reduction). In addition, a significantly lower mortality was observed with ablation (p=0.037). Overall, the results of this study provide evidence that catheter ablation is superior to amiodarone in preventing recurrence, reducing hospitalization and mortality in patients with heart failure and persistent AF.
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