DRUG-ELUTING STENT SOLUTIONS: DELIVERABILITY IN DES

Dr. Hermiller received his undergraduate degree from Miami University in Oxford, Ohio, and earned his MD from Ohio State University School of Medicine in Columbus, Ohio. He did his internship and residency in internal medicine at the National Naval Medical Center in Bethesda, Maryland. He completed his cardiology fellowship at Duke University Medical Center in Durham, North Carolina, and his interventional cardiology fellowship at Nasser, Smith & Pinkerton Cardiology in Indianapolis, Indiana. Currently, Dr. Hermiller is the Director of the Cardiac Catheterization Labs for The Care Group at St. Vincent Hospital in Indianapolis, Indiana. He is also the Director of the Interventional Fellowship Program at St. Vincent Hospital. He is heavily involved in Cardiac Research for St. Vincent Hospital and The Heart Center of Indiana. He is a member of the American College of Cardiology, the American Medical Association, American College of Physicians and the Society for Cardiac Angiography and Intervention. What were some of the interesting data points relative to drug-eluting stents (DES) that came out of the October 2005 Transcatheter Cardiovascular Therapeutics (TCT) meeting this year? We saw a lot of data regarding the long-term sustained efficacy of drug-eluting stents. The TAXUS IV Trial three-year data demonstrated a sustained benefit of the TAXUS Stent compared to the bare metal control arm in target lesion revascularization (TLR). What we have seen in both the TAXUS II Trial and TAXUS IV Trial is sustained efficacy and safety. Likewise, with respect to the SIRIUS data, we have seen similar sustained results. The data is reassuring and suggests no significant catch-up phenomenon for either drug-eluting stent currently on the market, which is something we did observe following intracoronary brachytherapy. It is exciting as an interventionalist to see that the impact of DES is both robust and lasting. In comparing DES available on the market today, what were some of the highlights from TCT? The STENT Registry was a considerable highlight at TCT. What is important about the STENT Registry is that it is a large, multi-center U.S. registry that was conducted comparing both the Cypher Stent and TAXUS Stent in over 3,000 patients. Risk-adjusted multivariable analysis for major adverse cardiac events (MACE) and target vessel revascularization (TVR) shows no significant differences between the TAXUS Stent and the Cypher Stent. The TVR for the Cypher Stent was 4.2 percent and the TVR for the TAXUS Stent was 3.4 percent. The conclusion of this registry was that in U.S. real-world practice, TAXUS and Cypher Stents seem to have comparable clinical and safety outcomes. Another interesting registry presented at TCT was the ARRIVE Registry one-year results. The ARRIVE Registry is another U.S.-based multi-center registry that showed low re-intervention rates of 5.4 percent overall using the TAXUS Stent in 2,458 patients. The most interesting point of this registry was the all-comers design, which included chronic total occlusions, saphenous vein grafts, bifurcations, diabetics, acute myocardial infarction (MI) and other challenging subsets. The ARRIVE Registry will continue to provide interesting information about the performance of TAXUS in these patient subsets. What value does registry data bring to your practice? I believe that a well-designed registry can provide useful information into the performance of the device outside the realm of tightly-controlled clinical studies and can also give insight into whether or not the performance of the device in the real world departs from that in a clinical study. Although registries are more susceptible to confounding and bias, they can provide additional data regarding a wide range of lesion and or patient subsets. Also, registries avoid the bias of mandatory angiographic follow-up and the consequent oculo-stenotic reflex-driven repeat revascularization. It is helpful as an interventionalist to have both registry and randomized trial data to guide one™s practice. What is most important to you in selecting a DES? The calculus of DES selection is complex. Today it is important to first consider who should not get a DES. The data has shown that compliance with antiplatelet therapy post-operatively is extremely important; therefore, if compliance with aspirin and clopidogrel may be an issue, reasonable alternatives and or treatment strategies may need to be considered. It is clear that both the Cypher and TAXUS Stents are good choices. Since both are very effective and safe, decisions about which DES to select often come down to issues of availability, deliverability, cost, and vendor relationships. At this juncture, it is difficult to argue that one stent or the other should be chosen because of an unequivocal clinical superiority. Sponsored by Boston Scientific Corporation Cypher is a Trademark of Cordis Corporation

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