Sunday, March 29, 2009


I have been keeping an eye on the electronic media reports of the happenings in ACC 2009 at Orlando. Well, one of the earliest late breaking trials presented on 28th March, was the "Genius-STEMI" trial, a study of the use of the GENOUS EPC capture stent in STEMI patients.
The Genous stent is a rather unique stent. It is strictly not a DES. The stent platform is basically stainless steel, coated with a layer of monoclonal antibodies that can capture the EPC ( endothelial progenitor cell ), which promotes healing ( supposedly natural healing ). On this premise, we feel that it should have less stent thrombosis ( since it is lined by natural endothelial cells ), and also probably less scar tissue ( less restenosis ) since it is clinically promoted healing.
This Genous stent is also unique because, although the inventor of this concept stent is American, the owner of the stent company ( Orbus Niche ) is Chinese. Mr Teddy Chen is a very rich Chinese gentleman who owns the company. He is a philantrophist and has helped in many ways to advance interventional cardiology in the Asian Pacific region. Many of the senior management staff in Orbus Niche are also good friends of mine from the "early days ".
The third uniqueness of the Genous stent is that it has not attracted the attention of the interventional hot-shots in Washington. I was rather surprised. To get to the big market ( and USA is probably the biggest market presently, while we await the awakening of the Chinese market ), Orbus Niche must certainly want to get to the CRF fellows involved along the way?
Anyway, while reviewing the ACC 2009 late breaking trials, I saw that Dr Cervinka from the Czech republic had presented the data from the Genius-STEMI trial. A study of 100 STEMI patients with STEMI, half of which received the Genous stent and the other half a standard cobalt chromium stent. Lo and behold, the Genous stent came out worse than the bare cobalt chromium stent. After 6 months, the Genous stent had more stent thrombosis and also more repeat target vessel re-vascularisation. The authors concluded that the study was too small, and we will need larger trials to be sure. So we should wait for more data. It also show that the bare cobalt chromium stent is a very good stent.
So all the nice concepts and pictorials that came with any presentation of the Genous stent, was not supported by clinical trial data. There was an earlier clinical trial on the Genous stent, that was presented in the Japanese Circulation society meeting with showed some better results, but that was a non-randomised group, with some degree of patient bias.
Basically, the Genous stent looks like is not quite ready for clinical use. I understand that some Singapore medical centers are using them, on a clinical trial basis. Locally, I have always kept shy of it. I have told Mr Teddy Chen and his senior management staff that I do need more data. Some of my colleagues have been implanting them with impunity. Suffice to say that the Genous stent is NOT FDA approved and may carry some dangers, if the data from the Genius-STEMI, is to be believed.
Alas, nice pictorials and nice concept video taped and showed to the public is just that, nice pictures. We will need more clinical trials to tell us that Genous stent is safe and good. We should all wait for more data.

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