Ann: Mesoblast Phase 3 Chronic Heart Failure Results, page-621

Hm... I can see why investors are confused, like others, the 'top-line' result isn't very clear. Hoping someone can shine some light into this:
The primary outcome is:
"Time to recurrent non-fatal decompensated heart failure major adverse cardiac events (HF-MACE) that occur prior to the first terminal cardiac event (TCE). [ Time Frame: 6 Month minimum ]"
This means: the 1st HF-MACE is not counted? the time it takes to the 2nd (thus recurrent) HF-MACE is then recorded? This result is recorded in days/months (eg: treated group: 10 months vs placebo 9 months)

Also, the caveat of this is that If a patient died without an HF-MACE or died after the 1st HF-MACE without a recurrent one, then this patient data cannot be accounted for in the Primary result? The placebo group (especially Class III) is likely to die without a recurrent MACE!!! I wonder how many patients fall into this category.

I find today's announcement also very confusing: "Significant reduction in the incidence of non-fatal ischemic major adverse cardiac events (MACE) due to a heart attack (myocardial infarction, MI) or stroke (cerebrovascular accident,CVA) by 60% relative to controls in the total population of 537 patients (p=0.002); reduction in MACE was seen consistently across both New York Heart Association (NYHA) class II or III populations and irrespective of whether the underlying cause of heart failure was ischemic or non-ischemic"

I would interpret this as the total number of MACE events recorded between different groups, irrespective of 1st or recurrent (2nd), but only counting those caused by 1) heart attack or 2) stroke (eg: treatment group 40 events vs placebo 100 events), BUT since there is a survival benefit in Class II patients, the more survivors = increase the chances of having more MACEs, yet we are still seeing a difference between the treated vs the placebo group. Why wasn't this chosen as a primary end-point? of course, hindsight is always 20/20