BACKGROUND It is unknown whether warfarin or aspirin therapy is superior for patients with heart failure who are in sinus rhythm. METHODS We designed this trial to determine whether warfarin (with a target international normalized ratio of 2.0 to 3.5) or aspirin (at a dose of 325 mg per day) is a better treatment for patients in sinus rhythm who have a reduced left ventricular ejection fraction (LVEF). We followed 2305 patients for up to 6 years (mean [±SD], 3.5±1.8). The primary outcome was the time to the first event in a composite end point of ischemic stroke, intracerebral hemorrhage, or death from any cause. RESULTS The rates of the primary outcome were 7.47 events per 100 patient-years in the warfarin group and 7.93 in the aspirin group (hazard ratio with warfarin, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P = 0.40). Thus, there was no significant overall difference between the two treatments. In a time-varying analysis, the hazard ratio changed over time, slightly favoring warfarin over aspirin by the fourth year of follow-up, but this finding was only marginally significant (P = 0.046). Warfarin, as compared with aspirin, was associated with a significant reduction in the rate of ischemic stroke throughout the follow-up period (0.72 events per 100 patient-years vs. 1.36 per 100 patient-years; hazard ratio, 0.52; 95% CI, 0.33 to 0.82; P = 0.005). The rate of major hemorrhage was 1.78 events per 100 patient-years in the warfarin group as compared with 0.87 in the aspirin group (P<0.001). The rates of intracerebral and intracranial hemorrhage did not differ significantly between the two treatment groups (0.27 events per 100 patient-years with warfarin and 0.22 with aspirin, P = 0.82). CONCLUSIONS Among patients with reduced LVEF who were in sinus rhythm, there was no significant overall difference in the primary outcome between treatment with warfarin and treatment with aspirin. A reduced risk of ischemic stroke with warfarin was offset by an increased risk of major hemorrhage. The choice between warfarin and aspirin should be individualized.
Background: The emergence of the new severe acute respiratory syndrome coronavirus 2, which causes COVID-19 disease, has been a major public health challenge and an increase in the feeling of uncertainty of the population, who is also experiencing an increase in levels of anxiety and fear regarding the COVID-19 disease. Objective: The objective of the study was the construct and criterion validation of the Escala de evaluación de la Ansiedad y MIedo a COVID-19 (AMICO, for its acronym in Spanish) to measure both constructs in the general Spanish population Methods: Descriptive study of psychometric validation. A field study was carried out to execute univariate and bivariate analyses, in addition to the exploratory and confirmatory factorial analysis of the scale. For the criteria validity study, the State-Trait Anxiety Inventory ( STAI) and sensitivity and specificity values were calculated. Results: The study sample was composed of 1036 subjects over 18 years of age, who resided in Spain, where 56.3% were women with a mean age of 48.11 years (SD = 15.13). The study of construct validity reported two factors and 16 items, with a Cronbach's alpha value of 0.92. The scale was concurrently valid with the used gold standard and obtained sensitivity values of 90.48% and specificity values of 76%. Conclusions: The AMICO scale is valid and reliable for assessing the level of anxiety and fear of COVID-19 in the adult Spanish population and is highly sensitive.
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