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Re: zz1 post# 148552

Tuesday, 10/09/2018 10:11:28 AM

Tuesday, October 09, 2018 10:11:28 AM

Post# of 426402
ZZ - Thanks. I think we have to remember that V works via multiple mechanisms, so results for death reduction in prior non-EPA trials are of questionable utility in predicting what the SEs will show. JELIS showed directionally lower death (and similar RRR to the primary outcome IIRC) but was not significant due to the small sample size. Given the high risk and large sample, I think R-It will have a sufficient sample size of deaths to be nominally significant (p<.05) if the RRR is in the same range as the primary MACE outcome. That plus JT's statements regarding robustness "across multiple SEs" make me certain that hard MACE will be significant (SE #1), and so will CV death+nonfatal MI composite (#2), and fatal/nonfatal MI (#3). CV death is the 4th SE tested, and my guess is that this will likely be significant too (because it is also captured in SE #2). Only reason that it might not be is that if the coronary revascularization SE is not significant, they would not be able to test CV death. Based on some things I have seen in other articles, this is a possibility.
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