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This seems like kind of a big deal. The patient brochure deliberately chooses one way of reporting outcomes for the Impella, but a different way of reporting them for IABP, in a way that (surprise) would systematically favor the Impella.
Key tweets that help illustrate this. The table from the manuscript with hierarchical outcomes:
The table from the FDA document with the non-hierarchical outcomes:
And the patient brochure:
For example, look at MI. Paper shows 10.9% for IABP vs 13.4% for Impella at 30 days. FDA doc shows 12.2% for IABP vs 17.8% for Impella at 30 days. Patient brochure uses the 12.2% (27/222) number for IABP (from FDA document) but 13.8% (31/225) for Impella even though...
...the corresponding call for Impella in the FDA document would be 17.8% (40 of 225).
