Thursday, May 17, 2012


Paris is the focus of attention this week, with the searing in of the new French President, Hollande. Not only that, it is also the venue of EuroPCR 2012. EuroPCR which started in Paris, shifted to Barcelona, is now back in Paris.
Well, one of the papers presented was a comparison of the Biolimus Norbori stent against the market leading Xience V. Remember that the Xience V has a permanent polymer and the drug is everolimus, while the Norbori ( sister of Biomatrix ) has a bioerodable polymer and the drug is Biolimus A9. There are both 2nd generation DES. Some claim that the Biomatrix and Norbori is 3rd generation. Let us sa y that Xience V is DES 2.1 and Norbori is DES 2.2, I think. The study is the called COMPARE II and it is a non-inferiority study on a 2:1 design, meaning that for every patient with Xience V, there were two patients with Norbori. 2707 patients were enrolled and followed up for 12 months. The primary end point was cardiac death, MI and repeat TLR.
Well, at the end of 12 months follow-up, there was no difference in the composite primary end points. Norbori is non-inferior to Xience V.
There was also no difference in the secondary end point of stent thrombosis at 1 year. But realy, this is nice to know but rather meaningless. The benefit of the bioerodable polymer on the Norbori, will be to reduce late stent thrombosis, usually after 2-3 years, so we are still early yet.
I suppose this is another piece of useful information, as DES companies battle one another for market share, and Xience V is now leading the market, with the Xience V / Promus stents so well used in the USA. This study also is the first to compare two good second generation DES. Initially, the traditional partner in stent trial was the Taxus stent, which seemed easy to better. Then  they took on the Cypher ( sirolimus eluting DES ). That was difficult to better but had problems with late stent thrombosis. Now they are challenging the Xience V, and this will prove challenging, as Xience V is a very good stent. I suppose, it is fair to say that all DES 2.0 stents are good. They differ in decimal points, especially in late stent thrombosis. Then i suppose, for the practitioner, the cost factor kicks in.
I am quite convinced that the second generation DES are all equally good.
We await the arrival of the disappearing DES, ABSORB, or what Abbott Vascular calls the bio-degradable vascular scaffolding device, to our shores probably in the 4th quarter. There again, what will it cost, to have a good stent that can disappear at 6 months, knowing that those DES that does not disappear are so good, and does not require replacement.

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