Cardiovascular Business invited representatives from the four major stent manufacturers to discuss the challenges and future outlook for drug-eluting stents (DES). Participants in the roundtable discussion are:
- Chuck Simonton, MD, chief medical officer at Abbott Vascular (XIENCE V)
- Keith Dawkins, MD, associate chief medical officer at Boston Scientific (PROMUS and TAXUS)
- Campbell Rogers, MD, chief technology officer at Cordis (CYPHER)
- Sean Salmon, general manager at Medtronic (Endeavor)
Moderator: C.P. Kaiser, Editor, Cardiovascular Business
The utilization of drug-eluting stents (DES) has been fluctuating in recent years. Do you think it will decrease, plateau or increase and why?
Sean Salmon, Medtronic: Since February of this year, we have seen in the U.S. market an increase in the use of DES from the low 60 percent range to the mid-60 percent range. The reason for the uptick is probably multi-factorial, but I believe the launch of Medtronic’s Endeavor DES in the U.S. market [February 2008] may have helped in some regard. I also think that physicians and patients have gained a general appreciation around the overall benefit that DES provide.
Campbell Rogers, MD, Cordis: I agree that an increased comfort level with DES in the marketplace is offsetting some of the perceived negative data that has come out over the previous 18 months. There also have been publications in the last few months demonstrating reassuring data—at least about CYPHER—regarding lower mortality rates compared to bare-metal stents (BMS). These studies have appeared in quality publications. In that setting, the news has been reassuring to practitioners.
Chuck Simonton, MD, Abbott Vascular: The data that have emerged more recently after extended follow-up show that the safety of DES is equal to, or even better than, non-drug-eluting stents. Also, some of the negative reverberations of the COURAGE trial are quieting down as we see that stable angina patients with documented ischemia who were treated medically are eventually finding their way back to the cath lab. Confidence in DES will continue to improve, particularly with the release of Endeavor and now with the XIENCE V [approved July 2008].
Keith Dawkins, MD, Boston Scientific: With the increased awareness of the data that has now been published from numerous trials and registries since the concerns that were initially brought up in 2006, physicians and referring clinicians are becoming more confident. We have seen a sustained increase in DES penetration and, indeed, in PCI penetration over the first half of this year. We anticipate it will get back to the 2006 levels within the next few months.
What can the industry do to neutralize sensational negative press coverage that contributed to the slide in DES utilization?
Salmon: This controversy has highlighted that there is a need for a better affinity group among interventionalists to define and protect the field. Our professional societies aren’t as mature or prominent as they need to be.
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.
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.