A Generation 2.5 Drug-Eluting Stent?
Stephen G. Ellis, MD
Cleveland Clinic
JACC: Cardiovascular Interventions, Vol. 2, No. 10, 2009: 986-988

"Approximately 8,000 patients total are required for an 80% power, assuming stent A has a thrombosis risk of 2% and stent B has a risk of 3%."

The 1,800 patients at the Maasstad hospital reported in the Wall Street Journal has too few patients to draw any real conclusions, and the period of time was only one year, too short to be taken seriously.

Dr. Ellis also mentions low risk patients being used to evaluate initial DES trials. In other words, large, open patient trials need to be used early on. Without doing this, you create bias against a stent that works well in high risk patients.

The reason Boston Scientific is sitting tight with Taxus is because the large Swedish registry study with 19,000 patients showed Taxus superior to olimus stents at two years. The latest 1,800 Maasstad hospital study is the propaganda of the day, and the large head to head study data comparing Taxus and everolimus remains to be seen.

In addition there are differences in the polymer between Taxus stents and Promus/Xience. Dr. Ellis describes this difference in his commentary. There is room for improvement in both platforms.

I think Boston Scientific is holding on to Taxus for a good reason, it is most likely as good or better than everolimus. If there are polymer artifacts that create respective problems, these have nothing to do with the molecule but still have to be addressed for both stent platforms.

The answer of the potential benefit of combining the two molecules for a combinatorial effect remains unanswered. Probably for reasons of profit? I guess the companies know the general public is too busy trying to put food on the table to actually get their head in the game and start asking questions about the stents they are having implanted? i.e. They could be screwing the public for a profit?

For now, physicians seem to be running from pillar to post with whatever the latest study finds regardless of study size or integrity. Would not want to get sued I guess. After the Swedish registry data was released, Taxus had a bump. Now that another study is pumping everolimus, Abbott is getting more business I suppose?

The Zilver PTX stent may be hard to beat, but I am unsure about delivery rate. I am sure Cook Medical did their homework. PAD will be a new area for competition for Taxus. I would like to know more about Cook's 100% polymer free delivery. This is very exciting if the delivery rate is similar to the polymers. This could really make Taxus shine.