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STICH: Surprising results?

Posted Mar 29, 2009 at 01:30 PM, EDT by Eric Topol

Simultaneously presented by Bob Jones here at ACC and in the NEJM, the STICH trial results show that no major cardiovascular surgical repair work should be undertaken during open heart surgery. Are you surprised by these findings? In light of the negative nature of the trial, should we revisit how government finances clinical trials?
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I look forward to a rigorous debate as to what the real meaning of this trial should be as appears to suggest that left ventricular volume no longer important. If CABG despite reducing the SVI by on average only 6% achieves the same result, then implies that ESVI > 60 is no longer an indicator of worse outcome in the surgical patient, and presumably the non surgical patient. The suggestion that diastolic dysfunction can/is an issue is true and I am sure you have seen this, probably especially with over reduction in the most dilated ventricles. I don’t believe though that CABG alone for instance with the isolated LAD infarct can be the answer and does not explain why they should receive any benefit of revascularisation alone. My concerns would reflect the relatively open enrolment albeit with relatively small group accepting randomisation. A large percentage had 3 vessel disease which would make viability assessment crucial, and a large percentage had anginal symptoms – were pts with hibernating myocardium being enrolled? The relatively short extra pump run time as evident by the usage of a patch in only 60% of cases (in my experience it is unusual to not need a patch closure). The availability of volumes in just under a 1/3 of patients who had SVR should raise concerns as to whether in fact these ventricles were being remodelled ie is the lack of differential due to the operation or the surgeon and case selection. My equal concern will be that in cases where there are clear clinical benefits these patients will no longer be put forward for the appropriate operation such is the power of the “RCT”. I believe the accompanying commentary that SVR should be put on hold is excessive based on the results of this trial alone as mortality alone was not increased nor outcomes worsened. Surely this study in fact highlights that more ongoing study of these patients is required, that viability assessment is not an exact science nor understood equally in all parts of the world and that these are complex patients. My patient with the single occluded LAD, in NYHA class IV heart failure before surgery, yet after CABG/SVR at 6 months has his EF doubled to 50%, remains in SR, having been in AF for 3 yrs despite having no arrhythmia surgery and in NYHA class I is still a triumph of this operation regardless of what a RCT tells us. Perhaps the real take home message should be that it is nigh impossible to account for all variables in a surgical RCT. One has concerns as to what the results of the Hypothesis 1 group will also be.(whether CABG is indeed better than medical therapy which would equally be a nonsense outcome)
Posted by Dr Alison, Mar 31, 2009 Publié le Dr Alison, 03.31.2009
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I prefer to intereprete that surgical correction of big heart is not the way to address the heart failure problem. Time and time again, data have shown that the left ventricular dilatation results in worse prognosis. Only neurohumoral inhibitions, RAAS and adrenergic inhibition, have consistently improve ventricular remodeling and reduce heart size. Remodelling seems to be an neurohumoral process by the evidence we've seen now. The surgical reduction of dilated heart may not be the answer to the whole process. 


Posted by Dr. Yang, Mar 31, 2009 Publié le Dr. Yang, 03.31.2009
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Eric  Sorry for entering this forum I looked unsucessfully for another alternative to contact you...I was just @ CTIA in Las Vegas where I heard your Keynote.. I am very impressed with what you are involved with in the area of Wirless medical (monitoring) systems...That said  I was hoping to get a copy of your presentation.

 

 

 

 

 

 


Posted by CTIA 2009, Apr 05, 2009 Publié le CTIA 2009, 04.05.2009
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The trial answered a relevant question. And again, a treatment with biological plausibility didn't show any benefit when considering relevant end-points and not surrogate end-points.

That is the beauty of a RCT! 

And this kind of research has to depend on public money since the hyphotesis doesn't attract pharmaceutical companies.

In my opinion, we have to discuss how to make these kind of studies (done with government's money) more frequently. 

 

 

 


Posted by Juarez Braga, Apr 08, 2009 Publié le Juarez Braga, 04.08.2009
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Agree fully with Dr Topol's comments--as a surgeon, this concept never resonated with me.  Important to stress that this is not in any way related to the proven and reproducible benefits of LV Aneurysmectomy.  We should maintain our aggressive and beneficial operative strategies in ischemic patients with occlusive disease and LV Aneurysms, but concentrate on isolated efficient and complete surgical revascularization in ischemics with LV dysfunction and no isolated dyskinetic areas... 
Posted by P Murphy MD, Apr 15, 2009 Publié le P Murphy MD, 04.15.2009
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Bob Jones study is fascinating!

Surgeons have embarked on untested hypothesis and clinicians have made it possible that more intervention is better when it comes to dilated ventricle,dyskinetic or akinetic segments and mitral regurgitation.

Quick,efficient,effective ,complete and durable revascularisation may be the answer1 


Posted by sriram sudarshan, Apr 15, 2009 Publié le sriram sudarshan, 04.15.2009
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This comment is a reply to sriram sudarshan (Apr 16, 2009)

 

do you think that quick and efficent and effective revascularisation can change a trasmural scar in very efficent contractile myocardium?


Posted by l.menicanti, Apr 16, 2009 Publié le l.menicanti, 04.16.2009
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Eric J Topol MD
Director, Scripps Translational Science Institute
The Gary and Mary West Chair of Innovative Medicine
Chief Academic Officer, Scripps Health
La Jolla, CA