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Thread on the reporting of hierarchical outcomes inspired by 1 of the only 2 #Impella RCTs.
A few months ago, @willsuh76 noted that rates of bleeding were not reported in PROTECT-II, a worry with any large bore percutaneous device.
This led me to look at the @FDA evaluation to see if they were reported there. I found it interesting that the FDA tables of outcomes/adverse events included all events, while the @CircAHA paper uses hierarchical for secondary outcomes.
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