In Reply: Drs Rubin and Warner are concerned that no cardiac biomarkers were used to assess time delay to presentation for the patients with acute STEMI included in the BRAVE-2 trial. The goal of the BRAVE 2 trial was to assess whether an invasive strategy is associated with reduction of infarct size in patients with STEMI presenting more than 12 hours after symptom onset. The study was based on symptoms and unequivocal electrocardiographic changes to define acute MI, and on the interval from symptom onset to define time to presentation.
Pivotal studies assessing optimal treatment strategies for patients with acute MI have used interval from symptom onset rather than enzymatic criteria to define early1 or late2 - 3 presentation. In 1 of these trials,3 biomarker evidence subsequent to randomization was sought only in case of equivocal electrocardiographic changes. Also, guidelines on treatment of acute MI4 used interval from symptom onset, not enzymatic criteria, to define the cutoff point of 12 hours beyond which reperfusion treatment was discouraged. Even enzymatic curves after acute MI have been constructed on the basis of the interval between blood sampling and symptom onset.5 The applicability of the results of the BRAVE-2 trial would have been jeopardized had we used a time delay definition different from that applied in previous studies and current guidelines. Patients included in our study had not only symptoms and electrocardiographic signs of acute MI, but also increased enzyme levels with a median creatine kinase-MB activity of 77 U/L (interquartile range, 47-147 U/L) and a normal range of less than 24 U/L.
Drs Kanna and Almadi question the potential effect of the glycoprotein IIb/IIIa inhibitor abciximab on clinical outcome in the patients in the invasive group. An additional effect of abciximab beyond that of the intervention is very difficult to isolate in our study. Although we cannot exclude this effect, another study found no benefit of the glycoprotein IIb/IIIa inhibitor tirofiban in patients considered ineligible for reperfusion.6 The absence of a significant clinical benefit with the invasive strategy up to 3 months after enrollment despite the significant infarct size reduction might be related to insufficient power of the BRAVE-2 trial to assess clinical outcomes.
Finally, the criteria used for the diagnosis of recurrent MI in the BRAVE-2 trial were typical for studies on PCIs and may differ from those used in studies on fibrinolysis.7 The differences in these criteria may be less relevant because the BRAVE-2 trial had scintigraphic infarct size as the primary end point.
Financial Disclosures: None reported.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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