Left ventricular ejection fraction may not be useful as an end point of thrombolytic therapy comparative trials.

Journal Article (Journal Article;Review)

In the era of comparative and adjunctive trials in reperfusion therapy, the need to develop alternative end points for mortality reduction is clear. Left ventricular ejection fraction, which has been commonly used as a surrogate, is problematic due to missing values, technically inadequate studies, and lack of correlation with mortality results in controlled reperfusion trials performed to date. In this paper, we present a composite clinical end point that includes, in order, severity of adverse outcome death, hemorrhagic stroke, nonhemorrhagic stroke, poor ejection fraction (less than 30%), reinfarction, heart failure, and pulmonary edema. Such a composite index may be useful to detect true therapeutic benefit in reperfusion trials without necessitating greater than 20-30,000 patient enrollment.

Full Text

Duke Authors

Cited Authors

  • Califf, RM; Harrelson-Woodlief, L; Topol, EJ

Published Date

  • November 1990

Published In

Volume / Issue

  • 82 / 5

Start / End Page

  • 1847 - 1853

PubMed ID

  • 2225381

International Standard Serial Number (ISSN)

  • 0009-7322

Digital Object Identifier (DOI)

  • 10.1161/01.cir.82.5.1847


  • eng

Conference Location

  • United States