Saturday, 16 April 2011

RUNNING TO KEEP STILL

The results of an unprecedented number of trials involving cardiac surgical ops have been published recently. Most have been in the NEJM here, here and here. Many, including the results of the Partner Cohort A trial  were announced for the first time at the recent annual meeting of the American College of Cardiology. I have commented on the results of the Partner trial in my last post. Many of these trials have
something in common and that is they are powered to demonstrate non-inferiority of the non-surgical treatment with regard to the primary outcome. One effect of this is that the results are interpreted optimistically by those standing on both sides of the fence.  Incidentally, only trials of treatments administered by different specialists can polarise clinicians like this. As a surgeon, I sometimes think that such a design (to demonstrate the noninferiority of the non surgical treatment ) is inherently unfair to the surgical arm of the trial.  I do accept that such a perception is very subjective. Objectively, it is difficult to deny that as a treatment modality, surgery carries a lot of baggage that percutaneous intervention and even more so, tablets, just do not have. These include length of stay, wound infections, time to full mobility and associated costs associated with the delivery of surgical treatment. What this means in the health cost conscious world we live in, is that surgery has to be more effective in the primary outcome in order to be equivalent (so to speak).  I can see therefore the importance of demonstrating non inferiority on the non surgical arm and why interventional cardiologists see this as a 'victory'.   This emphasises the continuing never ending need for surgeons to develop innovative ways of minimising the 'baggage' associated with effective surgery such as development of minimally invasive approaches and enhanced recovery