Yes, lots of secondary outcome measures for BETonMACE including those listed on ClinicalTrials.gov as well as the rosuvastatin vs. atorvastatin sub-groups. I do not know for sure if just missing the primary outcome is a killer for not. Definitely not good, but potentially not a killer. I found this NEJM article interesting. I've seen some recent CVOT trials sneak by with a p=0.04. EMPA-REG (empagliflozin, SGLT2 inhibitor) sneaked by with a p=0.04 for a 14% RRR for 3-point MACE but showed much greater effects for reduction for one particular component of the 3-point MACE, cardiovascular death 38% RRR (p<0.001). SGLT2 inhibts are all the rage now. Hopefully we won't be on the fence of p=0.05 but will have a more decisive win to take away any doubt. And if we truly are achieving ~30% RRR, and if the SSRA serves its purpose to strengthen the trial (if necessary) in order to get that significance, then all should be good. Wishful thinking. DYODD.
The Primary Outcome Fails — What Next?
