In Reply: We attempted to address most of the
issues raised by Dr Thiemann in our data analysis. First, as with any observational
study, it is impossible to identify and adjust for all differences between
patients who receive one therapy vs another. We agree that a randomized clinical
trial is the appropriate study design to determine treatment efficacy. However,
when data are lacking, as in the case of primary angioplasty in elderly patients,
careful observational studies can add important effectiveness data to the
debate about treatment choice. Observational studies have the additional benefit
of providing real-world data that may support randomized trial findings in
more select patients. This is best illustrated by Thiemann's observation of
time to treatment in the CCP cohort. Although times in the CCP were substantially
longer than the times reported in GUSTO-IIb,1
the longer time to treatment we reported in patients undergoing primary angioplasty
is consistent with treatment times reported in the National Registry of Myocardial
Infarction2 and is likely to be more representative
of community norms than inherent selection bias in the CCP cohort. Furthermore,
these longer times to treatment would likely create a bias to reduce the benefit
of primary angioplasty.
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