A recent report by a nonprofit clinical watchdog group is drawing fire from cardiologists, in part because the organization alleged that 1 in 5 stents placed in Medicare recipients with stable coronary artery disease (CAD) over a 3-year period were considered "overuse."
The Lown Institute report looked at percutaneous coronary interventions (PCIs) — primarily stent placements — using Medicare claims data from 2019 to 2021; the first 2 years included Medicare Advantage, but those data were not available for 2021.
A stent placement was defined as "overuse" if it was in a patient with stable CAD — that is, if the patient had a diagnosis of ischemic heart disease for at least 6 months before the procedure. Patients with unstable angina or myocardial infarction (MI) within the prior 2 weeks were excluded, as were those who had visited the emergency room in the past 2 weeks.
The report is part of the Lown Institute's focus on what it calls low-value care.
"Anybody who is concerned about healthcare in the US — its quality, its safety, its affordability — should be interested in these issues," Lown President Vikas Saini, MD, told theheart.org | Medscape Cardiology.
The report concludes that hospitals performed more than 229,000 unnecessary stent placements (20% of the total placed) and that Medicare spent as much as $2.4 billion on that overuse from 2019 to 2021. Saini said that overuse could be equated with "inappropriate."
Among the hospitals that had the highest volumes of stent procedures, the institute further delineated those with the highest and lowest rates of overuse.
Number four on the highest-overuse list was the UW Medical Center-Montlake, a Seattle-based hospital that is part of an 810-bed campus. Lown reported that 713 of Montlake's 1544 stent placements or 46.18% could be tagged as overuse.
James M. McCabe, MD, section chief of interventional cardiology at the UW Medicine Heart Institute, said that while the question of stent appropriateness is a valid and worthy undertaking, "I take great umbrage with the label overuse."
"Overuse as a term is a signifier and that signifier is easily manipulated," McCabe told Medscape Medical News.
The cardiologist acknowledged that UW has proportionately more patients receiving stents in the context of stable angina than perhaps other facilities. However, he noted that UW generally does not have many "good old-fashioned non-ST elevation MI patients." Instead, it receives many local and national referrals for complex coronary disease, he said. "I guess that's how we have ended up on this list," said McCabe.
But he said that stent appropriateness does not get overlooked. The UW system adheres to the 2017 appropriate use criteria for percutaneous coronary angioplasty issued by the American College of Cardiology (ACC), American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions (SCAI), Society of Cardiovascular Computed Tomography, and Society of Thoracic Surgeons.
Washington is also a certificate of need state, which means UW must publicly report on various measures, and the system belongs to registries such as the National Cardiovascular Device Registry (NCDR), said McCabe. "We feel actually that we do a fantastic job tracking this," he said.
Questioning Definition of Overuse
George D. Dangas, MD, PhD, president of the SCAI, said the Lown criteria for overuse ignore the appropriate use criteria and other guidelines published by professional societies.
"Their invented, new definition of overuse is something that belongs to them," Dangas, professor of medicine and surgery at Icahn School of Medicine at Mount Sinai in New York City, told theheart.org | Medscape Cardiology. The overuse definition "doesn't have validity or generalizable utilization by anyone except for themselves," he said.
Lown "used an extremely liberal definition of overuse," said Wayne Batchelor, MD, FACC, chair of the Interventional Council at the ACC, noting that overuse covered any stent placed during a nonemergency.
"We don't just do procedures to try to save lives in very acute situations," he said. "We also do procedures to try to improve symptoms and quality of life," said Batchelor, director of Interventional Cardiology at the Inova Schar Heart and Vascular Institute in Fairfax, Virginia.
Batchelor said that drawing conclusions from claims data alone in this report is improper because "it's devoid of all the clinical information that a doctor and patient would want to discuss to make a decision as to whether or not a stent would provide a meaningful benefit to the patient."
That would include the number of medications a patient was already taking, severity of angina symptoms, and whether symptoms are interfering with quality of life. "None of that information was gathered for this analysis," said Batchelor, adding that if the Lown report was submitted for peer review, "there would be a lot of concerns about methodology."
Saini counters that the algorithm Lown used for its calculations has been published, and that its methodology for the report is based in part on a 2014 investigation in JAMA looking at low-value care in Medicare and a 2021 paper on overuse of medical tests in JAMA Network Open. The Institute further explains its methods in a 2023 White Paper.
He also said that "the plurality of cases had no angina whatsoever," that is, they were not coded for angina, which he called "shocking."
Saini said many trials over the last 15 years — including COURAGE, BARI 2D, ISCHEMIA, ORBITA, and ORBITA-2 — have demonstrated that PCI is equal to or inferior to medical management combined with diet and lifestyle modifications, which do not present the potential for harm from an invasive intervention.
UW's McCabe, however, said that ORBITA-2 results contradict the Lown report.
The trial, just presented at the American Heart Association Scientific Sessions in November, showed that PCI in patients with stable CAD reduced angina frequency, increased exercise capacity, and improved quality of life, but that almost two thirds of those who had a stent placed still had angina symptoms.
The bottom line, said Batchelor, is that the Lown definition is "extremely simplistic and far overestimates the degree of inappropriateness."
"It's just not consistent with reality, nor does it take into account the multiple factors that go into decision-making for implanting stents that patients and physicians must take into account," he said.
Faulty 'Clogged Pipe' Hypothesis?
Stent use is driven in part by clinicians and patients who buy into the notion that stents can "unclog a pipe" and get blood flowing again, said Saini, who called this a flawed hypothesis.
David L. Brown, MD, clinical professor of medicine at the University of Southern California's Keck School of Medicine, agreed, calling it a 19th- or 20th-century disease model for chronic stable obstructive disease.
"Unfortunately, human anatomy is much more complicated than that, and the science really doesn't support that model," said Brown, during a briefing with reporters when the Lown report was released.
But Batchelor said it "is not a very good analogy," adding that stenting does not reduce future MI risk. Even doctors sometimes "get this wrong," when explaining the benefits in stable disease, Batchelor said.
In stable disease, "there are only two reasons to implant a stent — to relieve symptoms and improve quality of life," he said.
Brown, however, said he believes that stent overuse was driven by "financial conflict of interest and preconceived biases."
Assessing Appropriateness
The cardiologists who spoke to theheart.org | Medscape Cardiology pointed out that PCI appropriateness, including assessing data from the NCDR, is constantly evaluated at their facilities as part of a quality improvement feedback loop.
Even so, "we need to be very clear that this is a space where there are problems," said McCabe.
While overuse exists, "it's grossly exaggerated by the Lown report," said Batchelor.
"The fact that it's there still means that we should be addressing it and should be discussing it," he said.
The report raised awareness and may stimulate discussion, but "the way that the Lown report addressed this was unfortunately insufficient to really provide useful conclusions," he added.
"It's a great opportunity to actually turn our attention to the existing, much more sophisticated and in my opinion, accurate methods for assessing appropriateness," Batchelor concludes.
Batchelor reports that he has worked as a consultant for Abbott, Boston Scientific, and Medtronic. McCabe reports that he has consulted with and done new product development for Boston Scientific, Medtronic, and Shock Wave, all in valvular heart disease.
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