THE GENOUS STENT. IS THIS THE END?

About 1 year ago, I wrote that the TRIAS 1 results on the Genous ( EPC capture stent ), was poor when compared to the first generation drug eluting stent.
Well Dr Margo Klomp, from the University of Amsterdam, Netherlands, has just published their 1 year followup of their study, comparing the Genous stent with the commercially available DES ( a mixture ), and showed that the Genous stent had double the rate of re-stenosis when compared with commercially available DES, not even comparable with the second generation DES. The 304 patients that were in Dr Margo's study was part of the enrollees for the TRIAS HR study, which was still enrolling patients.
Probably as a result of Dr Margo's publication, the TRIAS HR study was discontinued prematurely.
When I were introduced to the Genous stent almost 10 years ago now, I was quite impressed with the concept that you could use monoclonal antibodies to turn on Epithelial Progenitor cells and have them coat your stent. What a smart idea, and wow, the video pictorials were captivating. Cells were floating all over, and selected ones were sticking to the stents. The impression then were " We are not a Drug Eluting Stent " we are a new concept, cellular stent. I have always argued at international meetings that when you turn on a cellular reaction, you often do not get one straight answer, as the body cells are complicated structures. More so the vascular endothelium. It is not exactly a simple computer bit/byte response. If the EPC concept is straight forward, we should at least see less stent thrombosis. This is also not so. I remember the earlier days when the University of Singapore doctors were doing a trail to show that this EPC capture stent, when placed in patients following an acute heart attacks ( these are the patients with high risk of stent thrombosis ), had less stent thrombosis. That did not work out, so Singapore Uni had given up on that. We tried to sound the alarm bells, but of course being an Asian Chinese, nobody listens to you. ( The white man knows best, right ). This was despite the fact that the company that first discovered this stent ( Orbus Niche ) was a Chinaman own company based in Hong Kong with factory in Shenzhen.
Anyway, when eHealing registry came out almost 1-2 years ago ( my memory is slipping ), their big marketing guy came out to convince me that the eHealing registry data of over 5,000 patients was great. I took a look at the data, and was trying to convince him, on his own data, that it was not. Of course, at the end of that meeting, we agreed to disagree.
Well, we have just seen the publication of the select 1640 patients from the eHealing refistry with 1 year follow-up ( that previous 5,000 patients was with 5 year follow-up ), showed that at best the Genous stent, was no worse or no better then the first generation Taxus stent in terms of MACCE events and TLR. This latest publication on the select eHealing registry, was authored by Dr Robbert de Winter from the University of Amsterdam, Netherlands.

	Genous (n = 304)	DES (n = 318)
TLFa	17.4%	7.0%
Cardiac Death	2.0%	1.0%
MI	4.3%	1.3%
TLR	15.2%	5.7%
Stent Thrombosis	2.7%	1.0%

What I also failed to understand is that there is one private medical center that uses almost exclusively the Genous stent, knowing the poor performance. That really stumps me. In the light of all the data now available, how can you justify using a Genous stent when you have, easily available, at reasonable cost, a second generation DES? How can you justify to your patients? maybe there are some non-medical reasons for doing so, and I do not wish to speculate.

Is this the end of Genous, now that TRIAS HR has been called off? Perhaps not, I am also aware, and have seen the preliminary data on a combo Genous + sirolimus eluting stent. Now JnJ Cordis had teamed up with Orbus Niche, to produce a stent that is coated one side with the EPC capture monoclonal antibody, and the abluminal surface with sirolimus, hoping to reduce intimal hyperplasia with sirolimus and reduce stent thrombosis with EPC capture. The early data looks promising, like many else. Lets wait and see. The problem is JnJ Cordis, the prime mover of this stent, is now no longer in the stent business. By December 2011, they would have closed the division. I had written about this earlier. So is this the end of Genous? I really do not know.

Well, I would not be surprise, if the company is not looking for a buyer. The sad thing is that, I do have some friends ( I hope they still consider me one, after all that I have written ), in Orbus Niche. No, I think that when you try to fine tune God's handiwork in the vascular endothelium, I suppose also any of the other body cells, you have to think as smart as God, and few of us can.