Angel Gonzàlez-Medina

BACKGROUND: Clinical trials in heart failure have focused on the improvement in symptoms or decreases in the risk of death and other cardiovascular events. Little is known about the effect of drugs on the risk of clinical deterioration in surviving patients. METHODS AND RESULTS: We compared the angiotensin-neprilysin inhibitor LCZ696 (400 mg daily) with the angiotensin-converting enzyme inhibitor enalapril (20 mg daily) in 8399 patients with heart failure and reduced ejection fraction in a double-blind trial. The analyses focused on prespecified measures of nonfatal clinical deterioration. In comparison with the enalapril group, fewer LCZ696-treated patients required intensification of medical treatment for heart failure (520 versus 604; hazard ratio, 0.84; 95% confidence interval, 0.74-0.94; P=0.003) or an emergency department visit for worsening heart failure (hazard ratio, 0.66; 95% confidence interval, 0.52-0.85; P=0.001). The patients in the LCZ696 group had 23% fewer hospitalizations for worsening heart failure (851 versus 1079; P<0.001) and were less likely to require intensive care (768 versus 879; 18% rate reduction, P=0.005), to receive intravenous positive inotropic agents (31% risk reduction, P<0.001), and to have implantation of a heart failure device or cardiac transplantation (22% risk reduction, P=0.07). The reduction in heart failure hospitalization with LCZ696 was evident within the first 30 days after randomization. Worsening of symptom scores in surviving patients was consistently more common in the enalapril group. LCZ696 led to an early and sustained reduction in biomarkers of myocardial wall stress and injury (N-terminal pro-B-type natriuretic peptide and troponin) versus enalapril. CONCLUSIONS: Angiotensin-neprilysin inhibition prevents the clinical progression of surviving patients with heart failure more effectively than angiotensin-converting enzyme inhibition. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035255.

Introduction: Cardiovascular diseases are the leading cause of death and morbidity worldwide, with a significantly higher burden in low- and middle-income countries. Hypertension, a major risk factor for cardiovascular morbidity and mortality, remains under-diagnosed and poorly controlled, especially in regions such as Latin America. The HOPE-4 study demonstrated that the involvement of non-physician health workers (NPHWs), the use of standardized treatment algorithms, the provision of free antihypertensive drugs and home follow-up can significantly improve hypertension control and reduce cardiovascular risk, as demonstrated in Colombia and Malaysia. On this basis, the COTRACO study aims to address the barriers to hypertension treatment in low- and middle-income countries by implementing a similar standardized treatment approach delivered by non-specialist health workers. Methodology: The COTRACO study is a quasi-experimental, parallel-group, non-randomized, before-and-after study. A community-based model will be implemented in 600 patients in Colombia and the Dominican Republic, involving NPHWs to: 1) apply standardized treatment algorithms, 2) promote adherence to healthy lifestyles, and 3) provide standardized pharmacological treatment. Propensity Score Matching will be used to select 300 patients in Chile and 1200 in Spain for comparison with standard care in these populations. Expected outcomes: The primary outcome at 12 months of follow-up is the percentage of patients achieving controlled hypertension (defined as systolic BP < 140 mmHg and diastolic BP < 90 mmHg, or < 130 mmHg, and diastolic BP < 80 mmHg for diabetic patients), ensuring it is not inferior to that achieved in the control countries. Secondary outcomes include changes in BP levels, cholesterol levels, BMI, handgrip strength, waist-to-hip ratio, smoking status, Interheart risk score, diet, and physical activity at 6 and 12 months. Recommendations: If this model demonstrates superior outcomes compared to usual care, it is recommended that health authorities in low- and middle-income regions adopt and implement this approach. Using non-medical health professionals, standardized treatment algorithms and free access to antihypertensive medications, these regions can significantly improve awareness, diagnosis and management of hypertension. This strategy has the potential to reduce cardiovascular morbidity and mortality, thereby improving overall public health outcomes.