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Replies to #38679 on Biotech Values
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iwfal

12/06/06 12:10 AM

#38682 RE: DewDiligence #38679

In general this article is extremely poorly written. It gives the immediate impression that DES are hazardous, but then gives no data that are even remotely compelling:

The lack of a significant difference in event rate -- 9.3% for drug-eluting stents versus 7.9% for bare metal stents -- was driven by a significantly lower target vessel revascularization rate for drug eluting stents (HR 0.52, 95% CI 0.33 to 0.85, P=0.009), the authors concluded.

First, the p value for the above difference in "event" rates is >0.5.

Second, what are these "events" given that later in the same sentence they say the DES had a lower rate? (And later yet they make it implicitly clear that these above mentioned "events" are not the late-thromb rate)

When these 16 late-thrombotic events are compared with the 49 other events that occurred after Plavix was stopped, a somewhat higher-but non-significant-cardiac mortality rate emerged but the rate of nonfatal MIs was significantly higher (19% versus 6%, P=<0.0001), they wrote.

This paragraph is more than a little unclear, but I think the point of it is that of all the (MACE???) events you can have, late-thrombitic events are the more likely to result in MI. Ok, yes, .... and the point is ... . Unless they give the relative difference of the DES late-thromb rate vs the BMS late-thromb rate it doesn't mean much.


It is possible something will come to light that DES, even with good treatment (e.g. Plavix), are more lethal. But so far the data are weak. The only other randomized studies I can find point the other way inre lethality.




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croumagnon

12/06/06 12:19 AM

#38683 RE: DewDiligence #38679

Re: Late Thrombosis Takes Off When Stent Patients Stop Plavix

I attended a dinner with a group of Cardiologists last week and we were talking about bare-metal stents Vs the Cypher stent and the latest litterature relating to Plavix and Cypher. All the cardiologists there were adament about the fact that they still much prefer the Cypher stent because the majority of problems with stents occur in the first 6 months, where the bare metal stents are quite inferior to the Cypher stent. They all felt that the difference in the rate of Thrombosis long term between the two was not appreciable enough to justify not using Cypher in most cases. Additionally, they felt that many of the pateients that are candidates for stents have other arteriosclerosis problems (PAD, etc...) and that taking Plavix long-term was generally advisable for that group of patients anyway...

As a side note, apparently by doing an angiogram a year or so after placing a stent, the Cardiac surgeon can tell whether or not a given stent has already been covered by the endothelial tissue of the patient or not, and this way they can tell which patient needs to stay on Plavix and which can discontinue. I guess the reason this is not done is because of the added screening risk and the prohibitive expense if done on all patients with a stent...