RE:RE:Highlights from Resverlogix Rodman and Renshaw 9/10G1945V,
I don't have enough information to form an opinion on the 3-point vs. 5-point MACE. On Thursday, Don said the the 3-point MACE would be comprised of death, non-fatal MI, and ischemic stroke. I don't know for sure waht the 5-point MACE included. In the ESC 2014 presentation, I see that the table lists death, myocardial infarction, coronary revascularization and "hospitalization for unstable angina or heart failure." I am assuming that these 2014 ESC presentation categories are what the post-hoc analysis for ASSURE/SUSTAIN are based on. If true, then I don't know why ischemic stroke wasn't listed. Perhaps no one in ASSURE/SUSTAIN had ischemic stroke during those 6-month studies. And I am not going to conjecture anything about the FDA. All I can say is that the obvious effect of focusing on 3-point serious MACE events and not also include more moderate MACE events woudl be expected to lower the overal incidence rate. "Is it wise?" you ask. I dunno. "Serious effects on the stats" I dunno. Like I said, I don't have enough information to form an opinion.
Bear