By MARK McCARTY
Medical Device Daily Washington Editor
The question of whether interventional cardiologists are implanting more drug-eluting stents (DES) than is necessary has resurfaced thanks to an article in the Archives of Internal Medicine, but the controversy may be no closer to resolution. The authors of the article state that DES are used in arteries at low risk of target vessel revascularization (TVR), and that a postulated reduction in DES usage would save more than $200 million a year. One of the problems with the analysis is that it includes data from 2004 and 2005, the years of peak DES penetration. The pullback after the stent thrombosis controversy at the European Society of Cardiology (Sophia Antipolis, France) meeting in Barcelona may invalidate the numbers somewhat, but a leading cardiologist says that the article does little more than affirm a view held by interventional cardiologists.
The authors of the article, titled "Use of Drug-Eluting Stents as a Function of Predicted Benefit," acknowledge that a 50% reduction of use of DES in vessels deemed unlikely to experience restenosis would boost TVR event rates by only 0.5%, and the savings cited in the article are said to account for the costs of these events. However, patients might not agree with the remark that a recurrence of stenosis which would prompt a second procedure is "a relatively benign condition in most patients."
The issue arose last year in an article appearing in the Journal of the American Medical Association, which documented a drop in DES usage after the 2006 controversy over late-stent thrombosis, with bare metal stents (BMS) filling in (Medical Device Daily, May 5, 2011). Later that year, Circulation featured an article suggesting that DES units could save more than $400 million a year when used "selectively" (MDD, Aug. 19, 2011).
The Archives article cites a "marked variation in physicians' use of DES," in a range of 2%-100%, and the use of DES was said to be "high across all predicted TVR risk categories." The authors also cited a "modest relationship between TVR risk and DES use."
Neal Kleiman, MD, an interventionalist at Methodist DeBakey Heart Center (Houston), spoke to Medical Device Daily on behalf of the American College of Cardiology (Washington). He said a recurrence of stenosis "is a big deal," noting that there are economic consequences of some note for those who are still employed and who would miss work for a second procedure. Still, Kleiman said "there are many worse things" than a second trip to the cath lab.
When asked whether the authors' estimate of a recurrence of restenosis was overly conservative, Kleiman said, "I don't think they're low-balling it. This kind of analysis has been done before," he remarked, adding that in one study of registry data that sorted out the numbers pre- and post-Barcelona, "what happened is the DES use went down from the low 90s to the mid 70s" in terms of percentages, "and the restenosis went up by about 1%."
Kleiman remarked, "I think [the article] reinforces what we know" but he added that despite the DES draw-down since 2006, "we could probably be a bit more judicious." He also remarked that the study "looked at the early days of DES use," adding that he searched for some sort of adjustment to the drop-off in DES usage in the article. "It may be in there but I didn't see it," he said.
The economics of such dilemmas is not lost on physicians, Kleiman mused. "Over time we're getting smarter about getting more bang for the buck," he said, but he indicated he was wary of any notion that a 50% reduction was either appropriate or likely to happen.
Susan Pisano, VP for communication for America's Health Insurance Plans (AHIP; Washington), told Medical Device Daily, that insurers are aware of such dilemmas, but that they have a somewhat limited set of tools to deal with overuse of DES units.
"I think one principal that we believe is that it's important to have comparative effectiveness studies to build the evidence base," she said. Pisano remarked that insurers for the most part "think its important that as the system evolves that practice changes, but also that there be an option for a patient" to get one device vs. another based on a physician's advice.
Insurers "tend to rely" on specialty society guidelines to keep doctors from stampeding to a device, Pisano remarked, explaining that the insurance industry would engage in an audit effort to keep usage to sensible levels only "in pretty limited circumstances," which includes "well documented abuse or overuse." She added that insurers "rely more today on decision support tools and information" to aid in this effort than in the past.
When asked about prior approval, Pisano quipped, "I don't think pre-authorization is popular in the provider community" and "insurers tend to be sparing in its use," she said, although it "comes into play for documented abuse." She explained it has been used "for high-tech imaging because there has been documented misuse and a growing realization that there's a potential harm for patients" where ionizing radiation is concerned.
Pisano offered as a 40,000-foot observation. "What we say is quality trumps cost."
Judy Rosenbloom of JR Associates (Reseda, California) told MDD that insurers are indeed "very reluctant to tell physicians how to treat" their patients, but she noted that the accountable care organization will elevate already-existing price pressures on DES and other devices beyond anything that could be imposed by articles such the Archives entry.
"In general, the selection of treatment is still left to physicians," Rosenbloom remarked, pointing out that payers "would still look to the specialty societies and appropriateness criteria" as to when one type of stent is used.
Rosenbloom said the Archives report will not likely provoke a patella-tendon reaction. "I think initially it will be status quo" with regard to DES usage, she said, but she cited the possibility of "a natural progression that people will pay attention to it" from both clinical and financial sides of the equation.
"There will be price pressures regardless" of any journal articles "just because of the negotiating that will happen between ACOs and payers," Rosenbloom said, predicting further that such pressures will arrive "regardless of how this plays out."
Published July 13, 2012