Minor updates to analysis of ARISE blended results vs historicals:
a) Confirmed that it is definitively true that DES provide no ongoing advantage in MACE after 1 year. Confirmed this for both PES and SES stents. (Tricky to do since, for example, there is no paper which published out year MACE rates for PES - so you have to string multiple papers together.) Note that DES maintain some advantage in TLR, but TLR is such a small part of MACE after 12 months it disappears. So my assumptions are correct inre >12 mo DES vs BMS.
b) Very likely that there were rapid protocol changes putting DES into much smaller/trickier lesions than was the case in PROVE-IT. (vs performing CABG) So this will increase revasc rate.
c) ARISE does not need any efficacy whatsoever in first 12 months if worst case HR for the period after 12 months is correct in the post to which this post is a reply. Reasoning - event rate for first 12 months is 9.5% (=580 events), leaving 410 events after 12 months. 410 events with HR=0.6 gives 444 total events in 1067 arm and 546 in SoC arm which is HR=.81 (any measured HR<~0.86 is stat sig per company guidance and my own checks).
Question - AGIX started closeout Aug 1? Will events after that still be counted? How long afterwards??? (Anyone have any idea how closeouts work?)
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