Cardiovascular Business - September/October 2008 - (Page 10) s Rogers CYPHER sirolimus-eluting stent Cordis Campbell Rogers, MD, chief technology officer at Cordis (CYPHER) and MI, while TAXUS performed worse. Additionally, the rate of re-intervention is clearly lower with CYPHER than with TAXUS. l Simonton: I agree with many of the comments Dr. Rogers made, but much of the data he mentions are from large registries. Regarding the XIENCE V, our data from large randomized trials, the SPIRIT III trail, for instance, show very interesting outcomes in relation to death and MI at one year, particularly with periprocedural MI, which are trending lower for the second-generation stents. Deliverability is part of the problem with the first-generation stents and maintaining that benefit over time is important. Regarding DES versus BMS, there will be the largest pooled analysis of registries coming out of the Cardiovascular Research Foundation by Dr. Ajay Kirtane. It will show that the mortality rate actually favors DES. u Dawkins: It’s clear beyond doubt that DES reduce the need for repeat procedures by reducing target lesion and target vessel revascularization. The only open question was the issue of late stent thrombosis. At ACC 2008, Dr. Gregg Stone presented a mega-trial incorporating all the available DES data from randomized trials and registries. It shows that DES are efficacious, essentially halving the chance a patient will come back for a repeat procedure. In the more complex patients, the off-label patients who are frequently treated in everyday practice, the evidence shows a reduction in hard end-points including mortality. Patients who have BMS also suffer from stent thrombosis and they may have an MI associated with repeat procedures. That risk associated with BMS is offset by DES. From the point of view of cost differentials between BMS and DES, the patient clearly prefers not to have to come back for a re-do procedure. Therefore, we would favor DES for the majority of patients. s Rogers: Our current shelf life in the U.S. is three months and outside the U.S. it is up to 12 months in some parts of the globe. l Simonton: The XIENCE V stent is currently approved for one-year shelf life and Abbott is in the process of putting through all of the applications necessary to extend that to 18 months. u Dawkins: The shelf life for the TAXUS stent in the U.S. is 18 months, and for the PROMUS stent 12 months. : What are you doing to measure and improve the safety of the next generation of stents? u Dawkins: We are looking at ways of reducing the drug load, reducing the polymer load and switching from durable to biodegradable polymers, as well as looking at unidirectional delivery of the drug. Everybody in the field accepts that these measures will be beneficial for the patient. The area of potential difficulty is to work out whether doing so improves the function of the device compared to the devices we have now. n Salmon: The most important thing to figure out is whether there is a safety issue that needs improvement. We do have ongoing trials, half enrolled toward their 8,800 patients, randomized with a primary endpoint of ARC-defined definite and probable stent thrombosis at three years with an active control. They will prove definitively whether this device has an issue that needs to be fixed. We also are always interested in continuously improving the technologies and we are accomplishing that in a couple of ways. We have an active polymer library, where we create highly biocompatible durable polymers that degrade without creating acid that induces inf lammation. We also have completely non-polymeric stents with a nanoporous surface. s Rogers: We are looking at improving upon what we think are fairly similar patterns over time with CYPHER and BMS : What will the shelf life be of the newer DES? n Salmon: The shelf life we have for the Endeavor stent in the U.S. is 12 months. We just received approval for 18 months in mid-July and it is 24 months outside the U.S. 10 Cardiovascular Business September/October 2008
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