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Re: DewDiligence post# 802

Friday, 12/08/2006 8:59:57 AM

Friday, December 08, 2006 8:59:57 AM

Post# of 2446
Just a closing summary - from the FDA write-up:

Whether DES are associated with an overall long-term increased rate of death or MI is an area of uncertainty. Meta-analyses based on published literature suggest an increased death or MI risk associated with the CYPHER stent. In contrast, meta-analyses based upon patient level data bases from the DES manufacturers have not shown an increased risk in either CYPHER or TAXUS stents. Reconcilliation of the results of these meta-analyses is needed.

[Note that, as per the above, one of the two meta-analyses did show excess mortality/MI for Cypher, the other did not. But inre the one that did not it was pointed out that the non-cardiac death rate was substantially higher in the Cypher stent (due to cancer - for which there was no explanation other than bad luck). This begs the question as to whether the excess mortality/MI seen in the one positive meta-analysis was due to non-cardiac causes since they undoubtedly use many of the same underlying trials. The size of the effect would be about right - about 2%.]

They also say that it is clear that DES does cause more MI and death in more complex lesion usage. But that there is no comparison data for BMS so it is completely unknown whether DES is adding risk.

All in all I'd choose TAXUS stent, but even more importantly I'd make sure I really needed a stent since it is clear that US docs do too many stents. I'd also take anti=platelet therapy for 18 months or so. Note that it might be true that I'd need to go off meds for some other surgery, but those numbers are subsumed in the trial data (i.e. undoubtedly some of them went off surgery as well).

So I think Dew and I just see the same data differently.
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