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Message: Patient Years & MACE rate Question

"Based on my spreadsheet sensitivity analysis, the MACE rate for the placebo is the most important figure.  The trial seems to have been designed at 7 for the placebo and 5 for RVX208.  But based on the various scribblings of Tundup and others, the 7 seems too low.  I read/heard somewhere that some of these patients were getting repeated MACE events.  If we raise the MACE rate to 8, then the RRR just explodes higher."

Only the first 3-point MACE event counts towards the primary endpoint in BETonMACE. So the relevant event rate is the rate to first 3-point MACE event. You can't use subsequent events to "pad" the event rate for the primary endpoint in BETonMACE. Subsequent MACE events are important and are surely being adjudicated and tracked and likely reported in a subsequent total event analysis. However, these will not be used in the analysis of the BETonMACE primary endpoint. 

Check out the total event analysis for EXAMINE. While most patients only experience just one 3-point MACE event during the ~18 median month follow up, some patients experienced 2, 3, 4, 5, 6, or more 3-point MACE events!!!



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