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Boston Scientific Corporation Message Board

  • jokerswild41s jokerswild41s Mar 13, 2004 12:49 PM Flag

    size matters

    It is my understanding that BSX was approved by the FDA to sell more sizes than JNJ. How many more sizes? Why didn't JNJ get approved for all sizes?

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    • "How many patients and what percent of overlap occured in Taxus 4?"

      I would hope that it was zero. That would have been out of protocol.

      I thought Taxus 5 was for overlap.

    • Wrong again. No significant difference in sizes approved. Only real difference is that the 3.0 and 3.5 mm Taxus stents should not have been approved based on statistical analysis from Taxus 4 showing that Taxus was statistically the SAME as a bare Express stent in 3.0 mm and larger vessels (not enough drug as stent is expanded to 3.0 mm or larger, very narrow therapeutic window with this toxic drug). If it is not better than the lousy bare Express (see prior posts) in 3.0 and 3.5 sizes why would any Doctor use it in those sizes ?? Interesting that the 6 month TLR in Taxus 2 with Express with Taxol in a very low risk group (10 mm long lesions 2.9 mm vessels) was 4.6% (identical to the BARE Bx Velocity in the VENUS Study). That gives you and idea of the power of Taxol. i.e., same as bare Bx in taxus 2 in lower risk population than in the VENUS study (Taxus 2 had only 10.4% diabetics vs 24% in VENUS study!!). BSX data in Taxus 4 is therefore highly suspect (at best). Unfortunately doctors and patients will learn the hard way if they think they can substitute Taxus for Cypher (with real world experiences in labs across the country of <1% TLR in all comers so far with Cypher!). Poor patients that get this Taxus crap. Class action suits against BSX and their hyped distortion of results (very low angio follow-up etc.) now nearly inevitable as many Taxus patients reblock with diffuse in stent lesions.

      • 1 Reply to leagueeag324
      • The Taxus results on the 3.0 and larger vessels actually had excellant results, a TLR of 2.5! It is just the control arm also had a very good result, thus did not give statistical significance. The other stuff you threw out there is right from the JNJ spin machine "(not enough drug as stent is expanded to 3.0 mm or larger, very narrow therapeutic window with this toxic drug)" and this is not correct. Look at the result, a 2.5 TLR versus the control of I think around 6.7 (estimate). That is the distort. As far as the previous post by Just (a good post by the way, the type I personnally do like) I believe some of your numbers were wrong, and I will not dwell on it except to say the Victory was a randomized study, not a registry, and I think it had more like 1100 patients, but my lab was not in the study. Would you like to compare the control arms of the Sirius versus taxus?

 
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