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February 11, 2004

"Cooling-Off" vs Immediate Revascularization for Patients With Acute Coronary Syndromes—Reply

Author Affiliations

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2004;291(6):691-692. doi:10.1001/jama.291.6.691-b

In Reply: In response to Dr Goodman, we convened an independent blinded end point committee to ensure unbiased assessment of events, as we stated in our article. Goodman is concerned about the differentiation between index infarctions that justified inclusion in the study and infarctions that subsequently occur as a complication. Indeed, this a problem in any study that includes patients with non–ST-elevation myocardial infarction and that concerns infarctions occurring within the first 8 hours after study entry. In our study, myocardial infarction within 8 hours from randomization occurred in 5 patients in the early intervention group and 6 patients in the prolonged pretreatment group. If anything, these infarctions may have blunted the principal finding of our study. If we exclude them from the analysis, the disadvantage of the prolonged pretreatment becomes even more pronounced (relative risk, 2.5 [95% confidence interval, 1.1-6.0]).