title: Frequency of inclusion of patients with cardiogenic shock in trials of thrombolytic therapy.
abstract: The purpose of this study was to determine the extent to which patients with cardiogenic shock have participated in trials of thrombolytic therapy, to examine factors associated with their exclusion from these trials, and to summarize data on the efficacy of thrombolysis in these patients. Previous publications were searched for all randomized, controlled studies involving the use of thrombolytic medications used in the treatment of acute myocardial infarction. Data were abstracted for year of trial publication, performance location, sample size, maximal allowable delay between symptom onset and treatment, and exclusion criteria. Of the 94 trials included in the analysis, 22% included patients with cardiogenic shock, 37% excluded them, and the remainder contained no information on their inclusion or exclusion. Only 2 trials provided data on the efficacy of thrombolytic therapy in patients with cardiogenic shock. Multivariate analysis revealed that studies conducted exclusively in the U.S. were significantly more likely to exclude patients in cardiogenic shock than those conducted outside of the U.S., as were studies that excluded patients with a previous myocardial infarction, studies published more recently, and smaller trials. Patients with cardiogenic shock have frequently been excluded from clinical trials of thrombolytic agents. As a result, data on the efficacy of thrombolytic agents in these patients is extremely limited.
authors.affiliation: Department of Medicine, University of Massachusetts Medical School, Worcester 01655.
authors.forename: N F
authors.initials: NF
authors.lastname: Col
authors.forename: J H
authors.initials: JH
authors.lastname: Gurwitz
authors.forename: J S
authors.initials: JS
authors.lastname: Alpert
authors.forename: R J
authors.initials: RJ
authors.lastname: Goldberg
mesh_terms: D006801:Humans; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000150:complications / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012770:Shock, Cardiogenic / Q000188:drug therapy* / Q000209:etiology; D015912:Thrombolytic Therapy / Q000706:statistics & numerical data*; D016896:Treatment Outcome