Monday, November 16, 2009

NEWS FROM ORLANDO : PEP-CAD - 3

There are some of us who no longer visit USA following the US response to 9/11. Anyway, the American Heart Association is meeting in Orlando, Florida, this week for their annual scientific meeting. So we should hear a few relevant updates on Interventional Cardiology, this week.
One of the earlier paper presented yesterday was PEP-CAD-3. For those of us in interventional cardiology, PEP-CAD will stand for " Paclitaxel-Eluting PTCA Balloon Catheter in CAD. This is the third trial in the series, and it compares the use of the paclitaxel-eluting balloon followed by placement of a bare-metal stent ( the BBruan Coroflex cobalt-chromium bare metal stent ), against the CYPHER ( sirolimus-eluting stent) in the treatment of CAD. The cohort of 609 included patients with stable or unstable angina pectoris, with documented ischemia, randomised into the DEB/BMS ( drug-eluting balloon / bare metal stent ) group Vs the CYPHER group, on a non-inferiority comparison. The end-point being angiographic follow-up with measurements of lumen late-loss ( LLL ) and target lesion revascularisation ( TLR ). The investigators were very brave to challenge CYPHER. I suppose when they compared their DEB ( drug-eluting balloon ) against the Taxus stent ( paclitaxel-eluting stent ), in PEP-CAD-2. they came out better, and preliminary animal work supports that the DEB/BMS combination will not be inferior to CYPHER.
Well, they were surprised. After 9 months follow-up, 542 of the cohort underwent coronary angiography and this should that the DEB/BMS combination was inferior to the CYPHER stent for treatment of ischemia proven CAD. The late loss was better with the chpher stent and the TLR was much less with the cypher stent.
I suppose, PEPCAD-3 only serves to show that the first generation cyper stent is still a very good stent. With in-segment late loss of 0.16mm and angiographic TLR of 4.7% after 9 months, is very good.
I was hoping ( I have been talking to my friend Dr Martin U who was doing this piece of work for BBruan ) that the DEB will come out good as it would mean that I do not have to use so much drug coated stents. But it is not too be. Presently, I do use the DEB to treat in-stent restenosis, so that I do not have to place a metal across another metal ( if I were to use a DES ).
We will have to think again as to why DEB/BMS failed to best cypher. Afterall, some of the second generation DES have already been pproven to be non-inferior to cypher.
I suppose, that is why we do clinical trials, so that we can see how ur theory pens out. Animal experiments are necessary, but clinical trial results, properly conducted is also indispensible.

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