Left ventricular ejection fraction may not be useful as an end point of thrombolytic therapy comparative trials.
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.
Califf
R M
RM
Department of Medicine, Duke University Medical Center, Durham, North Carolina.
Harrelson-Woodlief
L
L
Topol
E J
EJ
D002561:Cerebrovascular Disorders / Q000453:epidemiology; D002986:Clinical Trials as Topic; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006333:Heart Failure / Q000453:epidemiology; D006801:Humans; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000453:epidemiology; D015425:Myocardial Reperfusion; D011654:Pulmonary Edema / Q000453:epidemiology; D013318:Stroke Volume; D015912:Thrombolytic Therapy
D005343:Fibrinolytic Agents