Cardiovascular Business - September/October 2008 - (Page 8) l Simonton XIENCE V everolimus-eluting stent Abbott Vascular Chuck Simonton, MD, Chief medical officer at Abbott Vascular (XIENCE V) protect the field. Our professional societies aren’t as mature or prominent as they need to be. u Dawkins: We’ve been working as an industry with AdvaMed [Advanced Medical Technology Association] to deal with some of these issues. Sometimes it is better if we share our communication with the press as an industry group rather than as companies. The way we will be judged as successful or not will be based on clinical science. At Boston Scientific, we have the TAXUS program, now with more than 45,000 patients studied. We continue to look for clinical science to provide us with the answers. s Rogers: All of us have been part of the peer-review process on both sides and we have incredible faith in those mechanisms. What happened with DES in the past several years was the data came out in forums that were not peer-reviewed medical journals, such as at meetings. An additional side to this is that we have to continue to undertake rigorous well-designed clinical studies that answer clinically important questions, which is a slightly different approach than having clinical studies purely to get a specific device approved. For example, all four DES manufacturers, as well as two of the manufacturers of antiplatelet medications, are part of an ongoing constructive collaboration under AdvaMed. We are in the beginning stages of designing a trial with approved devices aimed at identifying the best way to manage patients with antiplatelet therapies for optimal long-term outcomes. related to the procedure with thinner struts, polymers that are bioabsorbable and lower doses of anti-proliferative medicine. Abbott is specifically interested in—and is probably the furthest along in its development—a fully bioabsorbable DES, which has the potential to shorten the time a patient might have to continue Plavix for the concern of late stent thrombosis. This stent not only has a polymer that bioabsorbs on the surface of the metallic stent, but the whole stent would actually bioabsorb over about 18 to 24 months. n Salmon: There is another point of view here that the antiplatelet drugs that are used adjunctively with stents also prevent further atherosclerotic events, whether in the carotid circulation or other places in the coronary tree. The avoidance of further atherothrombotic cardiovascular events might make these drugs cost-effective. That premise needs to be further evaluated in clinical trials. With regards to device development, the available data so far on the Endeavor stent suggest that we don’t see an excess rate of stent thrombosis, particularly from one year and beyond. Those data are being evaluated in a prospective randomized trial with an active control. Like everyone else, we have been working on resorbable stent technology, but even with those you will induce some inflammation, which has been implicated in both thrombosis and restenosis. We feel comfortable that we have a device right now that doesn’t seem to have problems that existed in the early iterations. s Rogers: Antiplatelet therapy is an area where there is ongoing pharmaceutical innovation such as with the Eli Lilly drug Prasugrel. Also, there are mechanisms for patients who cannot afford these medicines long term. Johnson & Johnson, of which Cordis is a subsidiary, is a member, for example, of Together Rx, which provides discounts to prescription medicines for people without health insurance. In terms of our CYPHER stent, we don’t see a difference in late thrombotic events compared with BMS as we gather data from more patients over longer periods of time. We need to take it to the next step: to find ways to prevent thrombotic : What is being done to reduce the cost of dual-antiplatelet therapy? Are you developing coatings and polymers that will help reduce the duration of therapy? l Simonton: The FDA-mandated AdvaMed study, as mentioned earlier, will deliver more clinical data to help us determine the optimal length of dual-antiplatelet therapy and help us determine variables in patient selection that make a difference. Regarding making stents safer, we all have ideas in the pipeline. One immediate way is to reduce the acute injury 8 Cardiovascular Business September/October 2008
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