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Activity Number:
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458
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 1, 2007 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309036 |
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Title:
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A Noninferiority Trial Utilizing a Closed Hierarchical Testing Procedure
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Author(s):
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Peggy Pereda*+ and Eric Bass and Peter Lam
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Companies:
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Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation
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Address:
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1 Scimed Place, Maple Grove, MN, 55311,
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Keywords:
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Non-Inferiority Trial ; Margin ; Hierarchical Testing
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Abstract:
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The goal of the current trial is to assess the optimal revascularization treatment for patients with three-vessel (3VD) or left main (LM) CAD by randomizing them to PCI with DES or CABG. The primary endpoint is 12-month MACCE; the DES group will be assessed for non-inferiority to the CABG group. A closed hierarchical testing procedure will be performed on three populations of interest: all patients, 3VD only, and LM. The primary analysis will be performed on the overall population pooling 3VD and LM. For each population, if the upper one-sided 95% confidence bound for the difference is less than ?, PCI with DES will be considered to be non-inferior to CABG. The order of testing will be: overall, 3VD only and LM. Each test will be performed at a significance level of 5%; the overall family-wise error rate will be controlled at 5% based on the closed hierarchical procedure being used.
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