More on the GUSTO Trial

IN RESPONSE: Before our article was published [1], the GUSTO data were updated to reflect the most current and complete information available from the trial. The updated rates of coronary bypass surgery were 9.0% for accelerated tPA and 8.3% for streptokinase, rather than 9.5% and 8.5%, respectively. We regret that Ridker and colleagues were not provided with this latest information before its publication. However, even with the rates that Ridker and colleagues had available to them, their statement that the actual difference in rates of bypass surgery was larger than any reported mortality difference in the trial [2] was inaccurate. A 1% difference in coronary artery bypass surgery rates, albeit as large, was not larger than the 1% mortality difference between accelerated tPA and streptokinase. To augment the information in our letter published in the June 1 issue of Annals, which reported the rates in the accelerated tPA arm and the streptokinase arms within the first day after randomization [3], we provide (Table 1). Through the first week after randomization (by which time the mortality differences between streptokinase and tPA were fully established), no differences were seen between the two thrombolytic agents regarding the rates of coronary artery bypass surgery. Table 1. Coronary Artery Bypass Surgery Rates within 30 Days of Randomization We thank Dr. Lomaestro for his interesting commentary on the variability of tPA dosing in his institution. It appears that it has been difficult to achieve a standardized dosing protocol at many hospitals and that significant treatment is often substantially delayed. We fully agree that the administration of the drug needs to be optimized, and the accelerated tPA dosing regimen tested in GUSTO clearly showed a reduction in patient mortality. We also emphasize the importance of shortening the time to treatment. To this end, we agree with Dr. Lomaestro that it is appropriate for institutions to investigate the way they administer accelerated tPA. The changes in data referred to by Dr. Lee and colleagues were made by them in their article in the proof stage at the last possible minute before closure of the issue with the printer. Allowing such a change was particularly inappropriate in the context of an In the Balance exchange. I apologize to Dr. Ridker and colleagues for whatever embarrassment this incident may have caused them.The Editor