Cardiovascular Business - September/October 2008 - (Page 9) u Dawkins TAXUS, paclitaxel-eluting stent Boston Scientific Keith Dawkins, MD, associate chief medical officer at Boston Scientific (PROMUS and TAXUS) events altogether. Our research strategy is two-fold. The first is the use of a bioabsorbable polymer on our next-generation devices, the Conor platform, which is being evaluated in two clinical trials outside the U.S. and soon to be tested in this country. The second is the ability to add additional drugs, which will lessen the rate of thrombosis even compared to BMS. The Conor platform enables us to do that, to add antithrombotic or antiplatelet drugs. u Dawkins: As Dr. Simonton mentioned, we have been tasked by the FDA, working through AdvaMed, to address this issue and have had a number of meetings as an industry group to develop a trial to answer the important questions of how much antiplatelet therapy is needed and which groups of patients need the therapy for extended periods. All of the industry is interested in reducing that need in all patients. We are working on programs to reduce the dose of drug, reduce the polymer load, and therefore hope to mimic, if you will, the duration of dual-antiplatelet therapy that is required for BMS, which is 30 days. We have two programs developing biodegradable stents, which we hope will allow us to dispense with the need for dualantiplatelet therapy in many patients after a very short period of time. n Salmon: I think it’s more on the seven- to 10-year range, if at all. There are numerous trade-offs to these devices. You have to ask yourself, what problem are you trying to solve. For fully resorbable stents in the coronary circulation, I am circumspect that there is a need. Maybe for other vascular beds there is a clearer case. I do see, within five years, stents that have resorbable carriers through the polymers themselves, resorbably leaving behind the bare-metal stent or some basement membranes as well. s Rogers: One of the advantages of Cordis is we have partners within Johnson & Johnson. We have within our Ethicon franchise, a polymer expertise group called the Center for Biomaterials and Advanced Technology. In collaboration with them, we are working on an internal program for a bioabsorbable stent. I will tell you there is a fair amount of skepticism in the overall assessment of the market, especially in the coronary space. And to borrow Mr. Salmon’s phrase, what problem are we solving? For other vasculature beds, there may well be more merit. In terms of bioabsorbable carriers on BMS, that’s the area where our focus is with the Conor platform. We have two ongoing trials. It’s not five years away, it’s happening now. : When can we expect fully dissolvable stents? l Simonton: Based on the current FDA guidelines for DES that have either a new metallic platform, new drug, or new polymer, the development cycle is going to be five to seven years. Abbott just completed its first in-man pilot with a bioabsorbable everolimus stent, which was published in The Lancet earlier this year. We anticipate the two-year outcomes in those patients will be presented at the TCT conference in October. u Dawkins: We have access to two fully biodegradable stents and are working in that field. There are challenges in relation to completely biodegradable stents, and I think Dr. Simonton’s assessment of five to seven years is appropriate. : Some data suggest that no significant differences in deaths or myocardial infarctions exist between groups receiving either the DES or BMS. Why, then, should interventional cardiologists use the more expensive DES? s Rogers: I would quibble with your premise. As we look at increasingly robust data sets from increasingly complex patients, there are clear differences in the pattern of adverse events that are falling out between the different DES. The Western Denmark Heart Registry, for example, presented similar outcomes for DES versus BMS, consistent with the premise you just put forward. However, when the investigators broke out the two different DES, CYPHER and TAXUS, there were dramatically different patterns. CYPHER performed as well or better than BMS for rates of death CardiovascularBusiness.com Cardiovascular Business 9 http://CardiovascularBusiness.com
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