• Professional Stewardship and the More Selective Use of Drug-Eluting Stents

    October 31, 2012

    This content is from the Fall 2012 issue of SCAI News & Highlights.

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    By Robert W. Yeh, M.D., MSc, FSCAI

    In the current healthcare and economic climate, increasing the value of the care that we deliver is critical to ensuring that we can continue to better the lives of our patients. That healthcare costs are rising in an unsustainable fashion is undeniable, and we no longer have the luxury of making medical decisions in a bubble shielded from the economic consequences of our actions. While widespread cuts in reimbursement by payers are an obvious approach to bending the cost curve, they are crude solutions that address only the denominator of the value equation. Finding opportunities that improve the quality of our care while reducing costs is a more daunting, but potentially more rewarding, task.

    It was in this spirit that my colleagues and I embarked on an analysis examining practice patterns of drug-eluting stent use within the National Cardiovascular Data Registry (NCDR). We had previously developed and validated a model to predict the need for target vessel revascularization (TVR) at one year within a broad population of patients undergoing PCI in Massachusetts, and applied this prediction model to the more than 1.5 million patients who underwent PCI included in the NCDR between 2004 through 2010. We were able to classify 43 percent of these patients as being at low risk for TVR assuming treatment with a bare metal stent (<10% risk at 1 year), 44 percent as moderate risk (10-< 20% risk), and 13 percent as high risk (≥20% risk).

    It is a truism that patients at the highest risk for an adverse event stand to gain the most from a therapy that prevents that event. As such, patients at the highest risk for restenosis (i.e., those with diabetes, long lesions, and small vessel diameters) are likely the ones for whom treatment with drug-eluting stents offers the greatest benefit. Conversely, those at low risk for TVR have less to gain from drug-eluting stents; indeed, an
    475,000 low-risk patients receiving DES have done just as well with a bare-metal stent? Moreover, given the prolonged course of dual antiplatelet therapy currently recommended for drug-eluting stents, the challenges of managing unexpected surgeries and postponement of elective procedures, the out-of-pocket drug costs, and the fear of stent thrombosis with premature antiplatelet discontinuation, might they have even preferred a bare metal stent?

    We proposed exchanging half of the drug-eluting stents used in low-risk patients with bare metal stents, and modeled the economic and clinical consequences of this change. Such a change would have resulted in a yearly savings of more than $200 million, with a modest increase in the TVR rate by 0.5 percent. We purposefully modeled a 50 percent reduction as opposed to entirely eliminating drug-eluting stents for low-risk patients to preserve clinicians’ and patients’ abilities to exercise their judgment and preferences on a case-by-case basis while still working toward a goal that decreases PCI costs – an effort to maintain the sanctity of the clinician–patient relationship that no sweeping policy change can adequately acknowledge. But it should be said that this approach also allowed us to avoid peering directly at the uncomfortable truth that, at some point, we must be willing to allow for the possibility that a therapy, although beneficial, may not be worth its price tag in all cases – all while continuing to foster the spirit of innovation that has been the foundation of interventional cardiology. Ultimately, these difficult decisions will be better made with eyes wide open, informed by the collective wisdom and humanism of our profession.

    Since its publication in Archives of Internal Medicine, our study has been met with a diversity of responses in the medical community and the press. As some have pointed out, the results are admittedly bound by assumptions that may change as technology advances, new evidence is generated, and guidelines evolve. Others have used the results as a platform to criticize the interventional cardiology community, cited as further evidence of inappropriately done procedures for some implicit financial gain. Speaking on behalf of my co-authors, we unequivocally reject this mischaracterization of our study as addressing PCI appropriateness in any way. Among our author group are six practicing interventional cardiologists and active participants in SCAI. Through our patients, we have experienced first-hand the lifesaving wonder of primary PCI for myocardial infarction and the profound improvements in angina and quality of life of elective stenting. Collectively, we have implanted thousands of drug-eluting stents into patients who have avoided repeat procedures as a direct result of this important and evolving technology.

    However, these facts do not preclude the possibility that we can do better. As with any technology, drugeluting stents do not benefit everyone equivalently. While it is undoubtedly true that interventionalists are making attempts to assess risks and benefits to inform their decisions, our data suggest there may be room to improve how we act on these assessments. In challenging one another to ensure that we and our patients fully understand the risks and benefits of our procedural and technological decisions, in investing our energy into efforts that enhance the value of our care, I’m hopeful that we can continue to demonstrate the professional stewardship central to our Society’s mission.

    Dr. Yeh is an interventional cardiologist at the Massachusetts General Hospital and instructor in Medicine at Harvard Medical School. He also serves as the Medical Director of Trial Design for the Harvard Clinical Research Institute.

    SCAI thanks Hot Topics columnists for their work while noting the opinions and recommendations expressed are solely their own. Publication in Hot Topics does not constitute an endorsement by SCAI. To suggest a topic or volunteer to contribute a column, contact Kathy Boyd David at kbdavid@scai.org.