CLEVELAND – Against the background of recent debate surrounding drug-eluting stents (DES) and their proper place within the cardiovascular arsenal, a panel convened here at the InterContinental Hotel and Conference Center on the campus of Cleveland Clinic unpacked its crystal ball to determine the future for these devices over the next five years.

Titled “DES Utilization in 2012,” the panel took a long look at DES technology and concluded: DES devices not only will still be around in five years, but they’ll also continue to account for the majority of stent use vs. their recently resurging forebears, bare metal stent (BMS).

Deepak Bhatt, MD, associate director of the Cleveland Clinic’s Cardiovascular Coordinating Center, said that later generations of DES will do a much better job of delivering on the promise of this technology. And he predicted that there soon may be a biodegradable stent on the market that is completely absorbed by the body, perhaps eliminating the threat of in-stent restenosis. (The “no stent left behind” program, perhaps?)

Despite recent studies showing BMS and DES comparable in terms of preventing myocardial infarction or extending life, Bhatt said, “I think by 2012, bare metal stents will have sort of gone the way of plain old balloon angioplasty. That is, there will be a rare indication where it may be utilized, but it won’t be the default strategy.

“I think by 2012, all of the kinks will have been ironed out [for DES] and it’ll be some sort of stent-based technology that will supersede the current generation of bare metal stents and for that matter current drug-eluting stents.”

Bhatt said that he believes that with continued innovation and improved technology, the cost of DES also will decrease.

John Capek, PhD, VP medical devices at Abbott Laboratories (Abbott Park, Illinois), said that DES exists due to the very real need to treat intimal hyperplasia, a problem not being addressed adequately with BMS, and to reduce the numbers of reinterventions that condition caused.

“It is the primary goal of drug-eluting stents to improve efficacy, albeit it to do so without increasing any safety issues to the equation,” Capek said.

Capek said he has confidence in the newer generation DES as improved technology. To illustrate, he compared the current DES market to the early days of BMS. “We’re now more than 10 years into the evolution of bare metal stents and we’ve evolved the technology, which is far superior to what we had 10 or 15 years ago.”

And he emphasized the need to visualize “where the technology may be headed over the course of time, to not prematurely make a decision which prevents that technology from evolving as we have seen in virtually all the greatest cardiovascular technologies over the last 30 years.”

Abbott, of course, has a horse in the 2.0 stent race, currently poised to come out of this sector’s pipeline. The company learned last month that the FDA will schedule a panel meeting later this year to review the Xience DES (Medical Device Daily, Sept. 13, 2007), acquired from Guidant as an SEC requirement for Guidant’s acquisition by Boston Scientific (Natick, Massachusetts).

Bhatt speculated that, in the future, off-label use of DES will be limited and that the Centers for Medicare and Medicaid Services will no longer reimburse these types of DES procedures, confident in reducing healthcare costs. This will “almost force the industry to provide clinical data in situations where there may not be any required right now,” he said.

Another issue discussed by panelists is the marginal clinical differences found between rival companies’ DES products and their tendency to magnify these variations, trumpeting them as major differentiators.

Sidney Cohen, MD, PhD, VP of clinical research at Conor Medsystems (Menlo Park, California), a unit of Cordis (Miami Lakes, Florida), said it is difficult to differentiate the data and communicate it both to physicians and the media. And as a practicing physician, he acknowledged the difficulty of looking at data with a nuanced judgment.

“We can’t give you the perspective and show you whether it’s just a little different or a huge difference,” he said.

LeRoy Lenarz, MD, VP of medical affairs at Medtronic Vascular (Minneapolis), whose company also is preparing to go before an FDA panel for its Endeavor DES later this month, said the company is in the process of determining the appropriate surrogate data to present to physicians and the public.

“We will separate in our next-generation platform our angiography studies from our clinical studies, and in the clinical studies you will know the actual clinically driven TLR, and you will know death and MI.”

The issue of adoption for DES came up for discussion, not surprising given the recent clinical trial data questioning their utility.

Capek said that in 2006, DES accounted for 88% of all stents used globally, the remainder BMS.

In 3Q07, that number dropped to 67% for DES.

Bhatt said the COURAGE Trial — which tended to rank medical therapy as just as good as stent use — was largely responsible for the dramatic drop in DES use worldwide.

And he said that he believes European countries are using the “ambiguous” safety data concerning DES to eliminate DES from their repertoire, as a cost-cutting strategy. Most notably, the UK’s National Institute for Health and Clinical Excellence (NICE) in August reported that it was evaluating a decision to no longer fund DES use (MDD, Aug. 29, 2007).

Bhatt said the game changer over the next five years could be the marriage of interventional technology to other areas of science, including stem cell and gene therapies. And he challenged the captains of this industry, including those on the panel, “to really look at the big picture question — which patients really would benefit from revascularization?”

Best of all, he said, would be good head-to-head studies between the different DES products, and well-constructed data analysis, to assist him in making the most appropriate decisions for his patients.