Aim
The globalization of clinical trials has highlighted geographic differences in patient characteristics, treatments, and outcomes. We examined these differences in PARADISE‐MI.
Methods and results
...Overall, 23.0% were randomized in Eastern Europe/Russia, 17.5% in Western Europe, 12.2% in Southern Europe, 10.1% in Northern Europe, 12.0% in Latin America (LA), 9.3% in North America (NA), 10.0% in East/South‐East Asia and 5.8% in South Asia (SA). Those from Asia, particularly SA, were different from patients enrolled in the other regions, being younger and thinner. They also differed in terms of comorbidities (high prevalence of diabetes and low prevalence of atrial fibrillation), type of myocardial infarction (more often ST‐elevation myocardial infarction), and treatment (low rate of primary percutaneous coronary intervention). By contrast, patients from LA did not differ meaningfully from those randomized in Europe or NA. Use of angiotensin‐converting enzyme inhibitors/angiotensin receptor blockers (34.8%) and beta‐blockers (65.5%) was low in SA, whereas mineralocorticoid receptor antagonist use was lowest in NA (22%) and highest in Eastern Europe/Russia (53%). Rates of the primary composite outcome of cardiovascular death or incident heart failure varied two‐fold among regions, with the lowest rate in SA (4.6/100 person‐years) and the highest in LA (9.2/100 person‐years). Rates of incident heart failure varied almost six‐fold among regions, with the lowest rate in SA (1.0/100 person‐years) and the highest in Northern Europe (5.9/100 person‐years). The effect of sacubitril/valsartan was not modified by region.
Conclusion
In PARADISE‐MI, there were substantial regional differences in patient characteristics, treatments and outcomes. Although the generalizability of these findings to a ‘real‐world’ unselected population may be limited, these findings underscore the importance of considering both regional and within‐region differences when designing global clinical trials.
The left panel shows geographic regions according to the United Nations classification. The right panel shows the correlation between the rate of all‐cause mortality and the rate of incident heart failure according to region. AMI, acute myocardial infarction; LVEF, left ventricular ejection. fraction.
Background: Chronic kidney disease is a disorder of epidemic proportions that impairs cardiac function. Cardiovascular diseases are the leading cause of death in hemodialysis patients, and the ...understanding of new nontraditional predictors of mortality could improve their outcomes. Right ventricular systolic dysfunction (RVSD) has recently been recognized as a predictor of cardiovascular death in heart failure and hemodialysis patients. However, the factors contributing to RVSD in hemodialysis patients remain unknown. The aim of this study was to evaluate the clinical and echocardiographic factors associated with RVSD in hemodialysis patients. Methods: A cross-sectional study was conducted in which 100 outpatients with end-stage renal disease on chronic hemodialysis were evaluated. A transthoracic echocardiographic examination was performed at optimal dry weight. Right ventricular systolic function was evaluated using tricuspid annular plane systolic excursion (TAPSE). Clinical and echocardiographic data were recorded for each patient. A multivariate linear logistic regression was created using RVSD (TAPSE <14 mm) as the dependent variable. Results: Fifteen patients with RVSD and 85 patients without RVSD were analyzed. TAPSE had a positive correlation with left ventricular ejection fraction (LVEF) and myocardial relaxation velocity. Independent contributors to RVSD were LVEF (OR 1.14, 95% CI 1.05-1.26), left ventricular mass index (OR 1.02, 95% CI 1.00-1.04), and myocardial relaxation velocity (OR 1.81, 95% CI 1.18-3.19). Conclusions: Echocardiographic factors were significant contributors to RVSD. These measurements could be included as part of the routine workup in all end-stage renal disease patients on hemodialysis.
La terapia celular en la cardiopatía isquémica Escobedo-Uribe, Carlos David; Monsiváis-Urenda, Adriana Elizabeth; López-Quijano, Juan Manuel ...
Archivos de cardiología de México,
7/2012, Letnik:
82, Številka:
3
Journal Article
Cell therapy for ischemic heart disease Escobedo-Uribe, Carlos David; Monsiváis-Urenda, Adriana Elizabeth; López-Quijano, Juan Manuel ...
Archivos de cardiología de México,
2012 Jul-Sep, Letnik:
82, Številka:
3
Journal Article
Recenzirano
Ischemic heart disease is the leading cause of death and heart failure worldwide. That is why it is important to develop new therapeutic modalities to decrease mortality and long-term complications ...in these patients. One of the main lines of research worldwide is myocardial regeneration, using progenitor cells in order to improve systolic and diastolic function in patients with ischemic heart disease, as well as to increase their survival. There have been carried out, with great enthusiasm worldwide, human and animal studies to define the usefulness of stem cells in the management of patients with ischemic heart disease. Today, regenerative therapy in ischemic heart disease is considered a novel therapeutic tool, with substantial theoretical benefits and few side effects. Here we present the scientific principles that support the use of this therapy, discuss the current clinical evidence available; and point out the controversial issues still not clarified on its use and usefulness in the short and long term.
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