Correspondence

Correction

More on the GUSTO Trial

N Engl J Med 1994; 331:277-278July 28, 1994

Article

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 (NAPS).

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 1Figure 1Odds Ratios and 95 Percent Confidence Intervals (CI) for 30-Day Mortality in Subgroups Defined According to Time to Thrombolytic Therapy. 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.

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

NAPS 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.

1 References

1. 1

   The GUSTO Investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med 1993;329:673-682
   Full Text | Web of Science | Medline

Citing Articles (6)

Citing Articles

1. 1

   Christopher P. Cannon, Assaad J. Sayah, Ron M. Walls. (1999) Prehospital thrombolysis: An idea whose time has come. Clinical Cardiology 22:S4, 10-19
   CrossRef

2. 2

   Deborah J. Cook, Paul C. Hebert, Daren K. Heyland, Gordon H. Guyatt, Christian Brun-Buisson, John C. Marshall, James Russell, Jean-Louis Vincent, Charles L. Sprung, Frank Rutledge. (1997) How to use an article on therapy or prevention. Critical Care Medicine 25:9, 1502-1513
   CrossRef

3. 3

   L. Kristin Newby, Wolfgang R. Rutsch, Robert M. Califf, Maarten L. Simoons, Philip E. Aylward, Paul W. Armstrong, Lynn H. Woodlief, Kerry L. Lee, Eric J. Topol, Frans Van de Werf. (1996) Time from symptom onset to treatment and outcomes after thrombolytic therapy. Journal of the American College of Cardiology 27:7, 1646-1655
   CrossRef

4. 4

   Charles H. Hennekens, Christopher J. O'Donnell, Paul M. Ridker, Victor J. Marder. (1995) Current issues concerning thrombolytic therapy for acute myocardial infarction. Journal of the American College of Cardiology 25:7, S18-S22
   CrossRef

5. 5

   Susan C. Kalish, Jerry H. Gurwitz, Harlan M. Krumholz, Jerry Avorn. (1995) A cost-effectiveness model of thrombolytic therapy for acute myocardial infarction. Journal of General Internal Medicine 10:6, 321-330
   CrossRef

6. 6

   Christopher P. Cannon, Elliott M. Antman, Ron Walls, Eugene Braunwald. (1994) Time as an adjunctive agent to thrombolytic therapy. Journal of Thrombosis and Thrombolysis 1:1, 27-33
   CrossRef