Characteristics and outcomes of medically managed patients with non-ST-segment elevation acute coronary syndromes: Insights from the multinational EPICOR Asia study.

BACKGROUND: Many patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) are medically managed without coronary revascularization. The reasons vary and may impact prognosis. METHODS: EPICOR Asia (NCT01361386) is a prospective study of hospital survivors post-ACS enrolled in 218 hospitals from 8 countries/regions in Asia (06/2011-05/2012). All medically managed NSTE-ACS patients were classified into 3 groups: 1) no coronary angiography (CAG-); 2) non-significant coronary artery disease (CAD) on angiogram (CAG+ CAD-); and 3) significant CAD (CAG+ CAD+). We compared baseline differences between patients medically managed and patients undergoing revascularization, and also between the medically managed groups. Adverse events were reported and compared up to 2years. RESULTS: Of 6163 NSTE-ACS patients, 2272 (37%) were medically managed, with 1339 (59%), 254 (11%), and 679 (30%) in the CAG-, CAG+ CAD-, and CAG+ CAD+ groups, respectively. There were marked differences in the proportion of medically managed patients among the 8 countries/regions (13-81%). Medically managed patients had higher mortality at 2years compared with revascularization (8.7% vs. 3.0%, p<0.001). Among medically managed patients, CAG- patients were older, more likely to have pre-existing cardiovascular disease, and had the highest 2-year mortality (10.5% vs. 4.3% [CAG+ CAD-] and 6.6% [CAG+ CAD+], p<0.001). Mortality differences persisted after adjusting for other patient risk factors. CONCLUSIONS: Medically managed NSTE-ACS patients are a heterogeneous group with different risk stratification and variable prognosis. Identification of reasons underlying different management strategies, and key factors adversely influencing long-term prognosis, may improve outcomes.

Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document.

Endpoint selection is a critically important step in clinical trial design. It poses major challenges for investigators, regulators, and study sponsors, and it also has important clinical and practical implications for physicians and patients. Clinical outcomes of interest in heart failure trials include all-cause mortality, cause-specific mortality, relevant non-fatal morbidity (e.g., all-cause and cause-specific hospitalization), composites capturing both morbidity and mortality, safety, symptoms, functional capacity, and patient-reported outcomes. Each of these endpoints has strengths and weaknesses that create controversies regarding which is most appropriate in terms of clinical importance, sensitivity, reliability, and consistency. Not surprisingly, a lack of consensus exists within the scientific community regarding the optimal endpoint(s) for both acute and chronic heart failure trials. In an effort to address these issues, the Heart Failure Association of the European Society of Cardiology (HFA-ESC) convened a group of expert heart failure clinical investigators, biostatisticians, regulators, and pharmaceutical industry scientists (Nice, France, 12-13 February 2012) to evaluate the challenges of defining heart failure endpoints in clinical trials and to develop a consensus framework. This report summarizes the group's recommendations for achieving common views on heart failure endpoints in clinical trials.

Temas de actualidad en cardiología clínica y extrahospitalaria. Un nuevo proyecto: enfermedad cardiovascular en la mujer / Current Topics (2005) in Clinical Cardiology: Cardiovascular Disease in Women

De acuerdo con los objetivos de las monografías de Temas de Actualidad en Cardiología, y en lo que se refiere a avances en estimulación cardíaca durante el año 2005, conviene destacar para el clínico 3 aspectos de interés. El tratamiento coadyuvante en la insuficiencia cardíaca avanzada y refractaria mediante estimulación biventricular con marcapasos ha pasado a ser una indicación de tipo I, con lo que cabe esperar modificaciones en la práctica clínica. Por otra parte, la Sección de Estimulación Cardíaca, en nombre de la Sociedad Española de Cardiología, ha participado en la elaboración de un documento de consenso nacional sobre enfermedad del sueño donde quedan recogidas las diferentes alteraciones cardíacas relacionadas con el síndrome de apnea del sueño. Las enfermedades del ritmo cardíaco y, en especial, las bradiarritmias constituyen en la actualidad una línea novedosa de investigación para conocer la posibilidad de influir positivamente en la evolución de este síndrome mediante estimulación cardíaca permanente. Finalmente, se tratará sobre los sistemas diseñados para reducir la estimulación innecesaria en el ventrículo derecho que en muchas ocasiones se produce con las diversas modalidades de estimulación antibradicardia. Estos novedosos sistemas evitarán, en buena parte de los pacientes, los conocidos efectos perjudiciales que con frecuencia se observan durante la estimulación en el ápex de ventrículo derecho (AU)

Ischemic heart disease has mistakenly been considered of little relevance to women because it occurs infrequently during the fertile years. This is despite the fact that a larger percentage of women than men die from cardiovascular disease. There are differences in cardiovascular risk factors and disease between females and males, including differences in clinical presentation, disease course, diagnostic criteria, prognosis, and treatment. There is a need for increased information and education, earlier and more aggressive control of risk factors, and a more appropriate approach to diagnosis and treatment.The American Heart Association has published guidelines on the prevention of cardiovascular disease in women and the European Society of Cardiology is planning to (..) (AU)