Endoscopic sclerotherapy compared with no specific treatment for the primary prevention of bleeding from esophageal varices. A randomized controlled multicentre trial [ISRCTN03215899]

BACKGROUND: Since esophageal variceal bleeding is associated with a high mortality rate, prevention of bleeding might be expected to result in improved survival. The first trials to evaluate prophylactic sclerotherapy found a marked beneficial effect of prophylactic treatment. These results, however, were not generally accepted because of methodological aspects and because the reported incidence of bleeding in control subjects was considered unusually high. The objective of this study was to compare endoscopic sclerotherapy (ES) with nonactive treatment for the primary prophylaxis of esophageal variceal bleeding in patients with cirrhosis. METHODS: 166 patients with esophageal varices grade II, III of IV according to Paquet's classification, with evidence of active or progressive liver disease and without prior variceal bleeding, were randomized to groups receiving ES (n = 84) or no specific treatment (n = 82). Primary end-points were incidence of bleeding and mortality; secondary end-points were complications and costs. RESULTS: During a mean follow-up of 32 months variceal bleeding occurred in 25% of the patients of the ES group and in 28% of the control group. The incidence of variceal bleeding for the ES and control group was 16% and 16% at 1 year and 33% and 29% at 3 years, respectively. The 1-year survival rate was 87% for the ES group and 84% for the control group; the 3-year survival rate was 62% for each group. In the ES group one death occurred as a direct consequence of variceal bleeding compared to 9 in the other group (p = 0.01, log-rank test). Complications were comparable for the two groups. Health care costs for patients assigned to ES were estimated to be higher. Meta-analysis of a large number of trials showed that the effect of prophylactic sclerotherapy is significantly related to the baseline bleeding risk. CONCLUSION: In the present trial, prophylactic sclerotherapy did not reduce the incidence of bleeding from varices in patients with liver cirrhosis and a low to moderate bleeding risk. Although sclerotherapy lowered mortality attributable to variceal bleeding, overall survival was not affected. The effect of prophylactic sclerotherapy seems dependent on the underlying bleeding risk. A beneficial effect can only be expected for patients with a high risk for bleeding

A Measure of Mortality Risk for Elderly Patients With Acute Myocardial Infarction.

The objective of this study was to derive and validate a simple scoring system that predicts risk of short-term mortality in elderly patients hospitalized with acute myocardial infarction (AMI) and to compare this derived score with the MedisGroups admission severity score. A myocardial infarction severity score (MISS) was derived from a database of clinical information abstracted using MedisGroups and follow-up information on 30-day mortality status. The MISS was validated and compared with the MedisGroups Admission Severity Groups (ASGs) in a separate database. The derivation set included 2,037 Medicare patients 65 years old or older with confirmed AMI who were randomly selected from patients discharged from hospitals in seven states during 1985. The validation set consisted of 6,323 patients from the 1988 MedisGroups comparative database who were at least 65 years of age and had confirmed AMI. Multivariate logistic regression analysis found a set of nine abnormal patient characteristics that independently predict 30-day mortality. There was good agreement between mortality rates predicted by the logistic model and observed mortality rates in the validation population. This regression model was then simplified to an additive score where eight of the characteristics were weighted as one point and one characteristic was weighted as two points. The MISS is the sum of the points for each patient. In the validation dataset, the 1,373 patients with the lowest MISS scores had a mortality rate of 4.6% and the 400 patients with the highest MISS scores had a mortality rate of 64%.(ABSTRACT TRUNCATED AT 250 WORDS