Statistical versus clinical significance of the CURE study in acute coronary syndromes.
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Biomedical subjects
Publications and source records attributed to Marcus Flather.
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BACKGROUND: In patients with hypertrophic cardiomyopathy and obstruction of the left ventricular outflow tract, nonsurgical reduction of the septum is a treatment option when medical therapy has failed. We investigated the long-term effects of nonsurgical reduction of the septum on functional capacity and electrocardiographic and echocardiographic characteristics. METHODS: Sixty-four consecutive patients with hypertrophic cardiomyopathy and a mean (+/-SD) age of 48.5+/-17.2 years underwent nonsurgical reduction of the septum by injection of ethanol into the septal perforator branch of the left anterior descending coronary artery. These patients were assessed by exercise testing, electrocardiography, and resting and dobutamine (stress-induced) echocardiography after a mean period of 3.0+/-1.3 years. RESULTS: At follow-up, patients had significant improvements in New York Heart Association class, peak oxygen consumption (from 18.4+/-5.8 to 30.0+/-4.4 ml per kilogram of body weight per minute, P<0.001), and left ventricular outflow tract gradients (resting gradient, from 64+/-36 to 16+/-15 mm Hg; P<0.001; stress-induced gradient, from 132+/-34 to 45+/-19 mm Hg; P<0.001). Procedure-related complications included right bundle-branch block in all patients, complete heart block in 31 patients (48 percent), and significant increases in QRS and corrected QT intervals. Seventeen patients (27 percent) required permanent pacing. R-wave amplitude was significantly decreased (from 32+/-8 to 17+/-7 mV, P<0.001). The dimensions of the left ventricular cavity increased, and the interventricular septal thickness was reduced. CONCLUSIONS: Nonsurgical septal reduction leads to sustained improvements in both subjective and objective measures of exercise capacity in association with a persistent reduction in resting and stress-induced left ventricular outflow tract gradients. It is also associated with a high incidence of procedure-related complete heart block, however, often requiring permanent pacing.
BACKGROUND: The absence of electrocardiographic septal q wave is a recognized marker of left ventricular disease. We aimed to investigate the prognostic significance of absent septal q waves in elderly (age >65 years) patients with chronic heart failure. METHODS: A total of 110 patients (mean age 73 +/- 4 years) with New York Heart Association functional class II to IV and left ventricular ejection fraction of <45% were enrolled in the study. Standard 12-lead electrocardiograms were critically analyzed for the presence or absence of septal q waves in leads I, aVL, V5, and V6. Patient survival was determined from hospital and general practitioner records and National Statistics Registry at a mean follow-up of 4 years. RESULTS: Septal q waves were absent in 71 and present in 39 patients. The overall mortality rate was 47% (43 patients). The incidence of death was 49% (36 patients) in the group with no septal q waves and 18% (7 patients) in those who demonstrated septal q waves. On univariate analysis by Cox proportional hazard method, absence of septal q waves was found to be a strong marker of poor prognosis in CHF (P =.003, hazard ratio 1.40, 95% CI 1.10-1.67). Kaplan-Meier survival curves showed a significant difference in survival independent of age, New York Heart Association functional class, peak VO2, and QRS duration between these 2 groups. CONCLUSIONS: Absence of the normal septal q wave on 12-lead electrocardiography, which may indicate structural heart disease and myocardial fibrosis, is an independent predictor of poor prognosis in elderly patients with CHF.
BACKGROUND: Acute coronary syndrome continues to have significant long-term morbidity and mortality. This study sought to compare baseline characteristics, practice patterns and clinical outcomes for patients with non-ST elevation acute coronary syndrome from a broad range of low-, middle- and high-income countries. METHODS AND RESULTS: We compared the data from a prospective registry of patients with non-ST elevation acute coronary syndrome involving 4615 patients from 65 centers in 8 low and middle income countries (OASIS registry 2) with those obtained from 7987 patients from 95 centers in 6 middle and high income countries (OASIS registry 1). Patients in the OASIS registry 2 were younger, were more often males and smokers, presented later to the hospital after symptom onset and had a lower prevalence of diabetes at admission [with the exception of India, which had the highest age-adjusted prevalence (39.1%)]. There were marked variations in the angiography and intervention rates during the hospital stay, but the uses of proven pharmacological therapies were comparable. The two-year mortality rates adjusted for baseline covariates ranged from 6.9% to 15%. Patients from China had the lowest two-year mortality rate (6.9%) and patients from India had the highest rate (15%). Combining the two registries, the covariate-adjusted rate of death or myocardial infarction did not differ across countries with in-hospital angiographic rates of > or = 50% (17.1%), 25-49% (16.7%) or < 25% (16.5%). However, the covariate-adjusted rates for subsequent myocardial infarction (7.6%, 9.2% and 10.8% respectively, p < 0.0001), refractory angina (21.3%, 27.7% and 35.4% respectively, p < 0.0001) and the composite of death, myocardial infarction or refractory angina (34.9%, 40.7% and 46.8% respectively, p < 0.0001) differed depending on the angiographic rates. CONCLUSIONS: Among the participating countries there was a marked heterogeneity in patient characteristics, coronary interventions, resulting in differences in the two-year composite rates of death, myocardial infarction and refractory angina among patients admitted with non-ST elevation acute coronary syndrome.
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