Drug-Eluting Stent Solutions: The Continuing Evolution of Drug-Eluting Stents

Mark A. Turco, MD, FACC, FSCAI is an interventional cardiologist who is the Director of the Center of Cardiac & Vascular Research at Washington Adventist Hospital, Takoma Park, Maryland. He has significant experience in clinical trial research, with areas of interest including acute coronary syndromes, interventional cardiology drugs and devices, and myocardial infarction. Dr. Turco is a Philadelphia native who received his undergraduate degree from the University of Pennsylvania. He received his medical degree and internal medicine training at the George Washington University in Washington, DC. His cardiology and interventional cardiology training were received at Temple University Hospital in Philadelphia, PA. Dr. Turco is board-certified in internal medicine, cardiology and interventional cardiology. It seems most clinical data coming out today addresses high-risk and complex lesions. Can you talk about how frequent those lesions are in your everyday practice? Often, the difficulty of a case is attributable to lesion complexity “ longer lesions, smaller vessels, more diffuse disease “ and we are treating a lot more of this anatomy in our everyday practice. In addition, patients frequently present with angulation, tortuosity and calcium, which can make a case challenging. A good illustration of the ever-increasing complexity of today’s patient population is the ARRIVE 2 Registry, which includes a high percentage of complex lesions (approximately 65 percent). What approach do you take in treating these challenging cases? When approaching complex lesions, it is important to have good guide catheter support and supportive wires. Usually, I use longer stents to ensure coverage from a non-diseased area to another non-diseased area. In addition, intravascular ultrasound is certainly an important technology in the treatment of these lesions, as it is critical to ensure you are treating from a normal segment to a normal segment and that the stents are well-apposed. Clearly, there is still no consensus on the best way to treat bifurcation disease. Although we have made strides with our current techniques, we are awaiting a dedicated or provisional bifurcation stenting technology. With the advent of more deliverable stenting technologies “ and given the complex nature of disease we’re treating (more heavily calcified vessels and more diffuse disease) “ we may see a re-emergence of plaque modification devices like the Cutting Balloon® Device and rotational atherectomy to prepare the vessel. The TAXUS ATLAS data was recently announced at the Paris Course on Revascularization (PCR). Can you describe the study and what the results indicate? The TAXUS ATLAS trial is a non-inferiority study that evaluated the TAXUS® Liberte© Stent compared to an historical control. The control was a matched patient set from TAXUS IV and V de novo. It is the first global trial to evaluate a second-generation TAXUS Stent. The TAXUS ATLAS trial met its primary endpoint of target vessel revascularization (TVR) at nine months. An interesting observation is that the TAXUS ATLAS treatment arm had statistically significantly more complex baseline lesion characteristics by angiography than the control. In addition, the procedure times in the TAXUS ATLAS treatment arm were significantly shorter than those of the control arm (47.8 ± 25.5 minutes vs. 53.0 ± 49.5 minutes, p = 0.0052). What can we learn from non-inferiority studies and how they complement randomized clinical trials (RCTs) and registries? Non-inferiority studies “ like the TAXUS ATLAS trial “ allow for more rapid device introduction because of their faster enrollment times, and they can provide a more realistic snapshot of current practice trends (i.e., randomizing against a bare metal control does not mirror real-life practices where we primarily use DES in the lab). We need well-designed trials with good endpoints and reasonable sample sizes that allow us to rapidly obtain safety and efficacy data for new technologies so they can be more quickly available to physicians for the treatment of their patients. How does the volume of clinical data available affect your treatment decisions? It gives us some confirmation that we have a certain level of confidence in treating complex lesions. Data from registries such as ARRIVE 2, the STENT Registry and the REWARD registries, which all had large numbers of patients and included lesion subsets that are frequently excluded from randomized trials, showed good results and relatively low MACE rates. The increasing complexity of these trials has contributed to our confidence to treat more complex lesions with DES. How has the introduction of DES changed your approach to treating complex lesions? Do you stent in situations that you may have previously sent to surgery? Many patients who were previously sent to surgery in a non-DES world are now being treated in the cath lab. I think the results of trials such as SYNTAX, FREEDOM and the upcoming COMBAT that are studying the use of DES vs. CABG in multi-vessel disease will indicate whether DES is the treatment of choice compared to a surgical approach. The reason we’re encouraged by the trials’ objectives is that we see more multi-vessel disease in our cath labs every day. For complete results of the TAXUS ATLAS trial, visit www.bostonscientific.com. From there, click on the following links: About Boston Scientific Research and Development Clinical Trials TAXUS Liberte© and Cutting Balloon are trademarks of Boston Scientific Corporation. CAUTION: Investigational device. Limited by federal law to investigation use. The TAXUS Liberte© Stent is not approved for sale in the United States and the safety and effectiveness of this device have not been established. TAXUS ATLAS 9-month results, presented by Mark A. Turco, EuroPCR 2006. Sponsored by Boston Scientific.

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