Friday, February 08, 2013


The SORT OUT V result was published in the Jan 29th issue of Lancet. In a rather unusual twist, the authors reported that the Nobori DES was inferior to Cypher. Now, that is rather unusual. The Nobori is a second generation drug eluting stent with abluminal coating of a biodegradable polymer. Theorectically, it should be easily better the first generation, old fashion Cypher with a tri-layer permanent polymer. This was easily established in the COMPARE II study and also the Leaders trial. So Dr Evald Christiansen ( PI of SORT OUT V ) of Aarthus Denmark, has confused us a little. SORT OUT V studied 2568 pts, with about half receiving the Nobori stent and half the cypher stent. At 9 months FU, the MACE was 4.1% for Nobori cohort and 3.1% for the Cypher cohort, and at 12 months FU, the MACE was 5.4% for Nobori and 4.4% for the Cypher stent. Both results showing that Cypher was better, although by just a little. What was even more disturbing was the fact that most of the differences was in the initial 1 month, and may be due to the higher rate of definite stent thrombosis. Now this is even more confusing, because, the use of a biodegradable polymer was to mitigate against the dangers of stent thrombosis. We thought that the permanent polymer coating of the Cypher was the reason for stent thrombosis and the HooHa of Barcelona 2006.
Now now now, this is against the trend. Why? Is it the Nobori stent, or could there be other explannation?
Suspicious me thinks there may be. I recall, that SORT OUT IV comparng the Endeavor Sprint stent against the Cyper also did badly, in this Scandinavian cohort. This was also an outlier.
Could it be that the Scandinavian interventionist were more use to implanting Cyphers ( and they seemed to be getting good results with Cyphers ), then the newer generation DES. Interesting.
Whatever it may be the reason, Nobori must look into it carefully, as it will impact on its marketing. And by extension also, Biomatrix ( Biosensors ), as they share the drug ( Biolimus A9 ), and bio-degradable technology.
I believe that SORT OUT V maybe an outlier, due to technical procedural factors.

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