FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

A correction has been published: N Engl J Med 1994;331(10):687.

A correction has been published: N Engl J Med 1994;331(19):1323.

Previous Volume 331:277-278 July 28, 1994 Number 4 Next

Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited Related Article Related Article Related Article by The GUSTO Investigators Related Article by The GUSTO Investigators

To the Editor: In September 1993 we reported on the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial, which involved 41,021 patients with acute myocardial infarction (Sept. 2 issue).¹ In that report, we erred in stating that there was a 99.9 percent level of completeness of "30-day mortality outcomes"; this should have read "in-hospital outcomes." Since our initial report, we have received complete data on outcomes at 30 days in all but 98 patients (0.2 percent) and there has been refinement in the data base for variables for which either data were missing or queries were pending. With the exception of one analysis, these represent only minor changes that have no substantive effect on the data or their interpretation. The final data have been deposited with the National Auxiliary Publications Service (^*).

There is one change, however, that deserves attention and is related to the analysis of the study groups according to the time to treatment. In the original report,¹ we found that the benefit of accelerated tissue plasminogen activator (t-PA) treatment as compared with streptokinase treatment was greater when the agent was administered early (within four hours) after the onset of symptoms (i.e., we found a significant interaction between the time to treatment and the reduction in mortality). Figure 1 shows the final data on the group given accelerated t-PA, as compared with the pooled groups given streptokinase (these data correspond to those in Figure 3 of the original paper¹). The interaction between the time to treatment and the reduction in mortality is no longer statistically significant (P = 0.38). The significant changes in the time-to-treatment data are attributed to the more extensive process involved in sorting this particular variable, for which data were frequently miscoded or initially left out. The data base was finalized in March 1994 with respect to 30-day outcomes, and no further changes are anticipated. It was independently reviewed by the Food and Drug Administration and its advisory panel in June 1994 before submission to the Journal.

View larger version (28K): [in this window] [in a new window]   Figure 1. Odds Ratios and 95 Percent Confidence Intervals (CI) for 30-Day Mortality in Subgroups Defined According to Time to Thrombolytic Therapy. The dashed line denotes the overall effect.

 

Eric J. Topol, M.D.
Cleveland Clinic Foundation
Cleveland, OH 44195

Robert M. Califf, M.D.
Kerry L. Lee, Ph.D.
Duke University
Durham, NC 27705

on behalf of the GUSTO Investigators

References

1. The GUSTO Investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med 1993;329:673-682. [Free Full Text]

^* See NAPS document no. 0512X for 19 pages of supplementary material. Order from NAPS c/o Microfiche Publications, P.O. Box 3513, Grand Central Station, New York, NY 10163-3513.

Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited Related Article Related Article Related Article by The GUSTO Investigators Related Article by The GUSTO Investigators

HOME  |  SUBSCRIBE  |  SEARCH  |  CURRENT ISSUE  |  PAST ISSUES  |  COLLECTIONS  |  PRIVACY  |  TERMS OF USE  |  HELP  |  beta.nejm.org Comments and questions? Please contact us. The New England Journal of Medicine is owned, published, and copyrighted © 2009 Massachusetts Medical Society. All rights reserved.