About refudiate and the noninferiority of MACCE

The study I just reviewed (SYNTAX 3 Analysis) had a couple of words that I would like to talk to you about.

The first one is "noninferiority".

In the age of "refudiate", it should be no surprise that new words arrive every now and then, but "noninferiority"?  In SYNTAX it refers to an attempt to prove that in this study, occasionally Stenting (PCI) is as effective as Coronary Artery Bypass surgery (CABG) in the treatment of symptomatic Coronary Artery Disease (CAD). Look, I am doing it as well. It is so easy to get carried away by Acronyms, even if these are well established enough to make it into the Lay Press (LP)!

I assume "noninferiority" means the same as "equal", but why design a study (and spend the resources) to prove that a new procedure is good enough to be "equal" to another one? Now in its third year of follow-up, SYNTAX confirms Coronary Bypass surgery more and more  as the front runner it has always been.

It is one thing for a procedure to be "equal" if there are other benefits. SYNTAX as well as many other studies comparing PCI with CABG, only proves that in a small subset of patients Stenting is equal to Bypass surgery, albeit only for a short period of time. With another two years to go, the differences will only become more pronounced.

I wouldn't be surprised therefore, if this will generate other words trying to make chicken pie out of chicken You Know What ("YKW"), which brings me to the other words, "MACE" or "MACCE".

"MACE” arrived on the scene in year one of SYNTAX, but in year three has gained another C and expanded into "MACCE".

This is what they stand for:

  • MACE = Major Adverse Cardiovascular Event, defined as a compound Risk Factor of mortality, myocardial infarction, stroke, or re-intervention for CABG compared with PCI.
  • MACCE = Major Adverse Cardiovascular and CerebroVascular Event, emphasizing stroke, because in year one of SYNTAX it was the only risk factor in which PCI out performed CABG. Now that year three has arrived, this difference is fast disappearing. It is therefore reasonable to expect MACCE will gain another letter or two in the years to come.
  • WTF = You figure it out.

I blogged about this before, but I strongly object to this new habit of lumping major risk factors together and see them as an attempt to disguise unwanted outcomes. Despite this, even with adding another C, MACCE failed to hide that CABG was the better procedure for the patients in this study, thus preparing the ground for another acronym in the hope that one will do better.

In my days you had “Death”, “Major” and “Minor Complications" to describe outcomes. While occasionally insufficient to describe complex situations, most often it worked well and better yet, everybody understood what it meant. In fairness to SYNTAX, the components of MACCE are analyzed separately, showing the same results as the compound risk factors. What a surprise!

In the end, with pain in my heart because it tells good things about the benefits of CABG over PCI, I can do nothing but refudiate this study, and, paraphrasing another recent public speaker, "what they're saying is unfactual". I may even have to "refute" SYNTAX! Where is Shakespeare?

Let me know what you think, I can't wait to play Scrabble - unlimited  possibilities!


Dr T



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