Three Years Later: The PCI Appropriate Use Criteria in Review
With rising health care costs, the use of percutaneous coronary intervention (PCI) in patients with stable angina has come under scrutiny. Coronary artery disease (CAD) is increasing in prevalence, PCI costs are high, and there is a substantial amount of geographic variability in the use of PCI across the United States.
Appropriate Use Criteria (AUC) were first published in the Journal of the American College of Cardiology (JACC) in 2009 to guide use of PCI in a wide variety of scenarios. Recently, almost three years after the publication of the AUC, JACC Cardiovascular Interventions featured two editorials—“Percutaneous Coronary Intervention Use in the United States”1 by Steven Marso, MD, and Aaron Grantham, MD, and colleagues, and “Progress Toward Doing the Right Thing”2 by James Blankenship, MD—discussing the guidelines, methods used to report appropriateness, and implications for clinical practice. While Marso et al. suggest changes to address perceived flaws in the guidelines, Dr. Blankenship argues that guidelines will never sufficiently prescribe an appropriate course of action for every patient.
Dr. Marso and colleagues—a group of leading interventional cardiologists from across the United States—criticize the AUC guidelines for their lack of concordance with the views of the clinical cardiology community, pointing out that the AUC Technical Panel of 17 members included only four interventional cardiologists. They write that while the AUC committee “purposefully limited involvement from the interventional community” in order to prevent bias from a group whose “livelihood is tied to the technology under study,” the skewed composition of the group may have led to a failure to recognize some important benefits of PCI.
The 2009 AUC address the appropriate use of PCI in 68 clinical scenarios. The use of revascularization is considered “appropriate,” “inappropriate,” or “uncertain” in each scenario based on its likelihood of improving patients’ health outcomes or survival. Of particular concern to the editorialists was scenario 12B—patients with one- or two-vessel disease, no proximal LAD artery involvement or prior coronary artery bypass graft, class I or II symptoms, low-risk noninvasive findings, and no or minimal medications. This category was the most common reason for PCI to be categorized as inappropriate by the AUC Technical Panel, whereas 85 cardiologists in a survey-based study judged this scenario to be uncertain. The AUC panel may have “got[ten] this one wrong,” Marso and coauthors wrote in their editorial.
They also disagree with the “inappropriate” classification of PCI use in Canadian Cardiovascular Society (CCS) class II patients—those who experience angina with moderate activity—who have not received anti-anginal medications to improve their symptoms. They propose that class II patients have significant angina that can be effectively managed by PCI—and cite evidence of its superiority over medical therapy in terms of effectiveness and lifetime costs.
The Marso paper advocates not only the reclassification of some clinical scenarios, but also revisions in the process by which an appropriateness score is assigned. Risk assessment for PCI candidates usually requires knowledge of pre-procedural stress test findings. The authors highlight the lack of specific criteria for interpreting these test results, the inability to link these test results to coronary anatomy, and the problems with requiring patients to undergo stress testing. They emphasize the need for standard operating procedures to avoid hospital variation when documenting stress test risk, rather than relying on data abstractors to assign a risk category based on vague guidelines. They draw attention to the need for a strategy to link stress test results with the extent of vessel occlusion. And they argue that stress tests in some patients are not appropriate to begin with and are, in fact, highly unreliable and costly.
While the authors deem pre-procedural stress testing to be inappropriate in determining risk in some patients, they call attention to a variable that should have been used but wasn’t: the status of grafts from previous bypass surgery. PCI performed in the proximal LAD of patients who had not undergone prior bypass surgery was always considered appropriate by the AUC, but several procedures in patients with prior bypass surgery were classified as inappropriate without taking into consideration the patency of the graft. Dr. Marso and colleagues emphasize the importance of collecting graft status to determine the appropriate use of revascularization in these patients.
The authors make a case for several changes in the composition of the AUC Technical Panel, the appropriateness rating of clinical scenarios, and the methods used to score these scenarios—but their most compelling criticism may be the lack of quality control in the data used to monitor appropriate use. They criticize an appropriate use paper (“Appropriateness of Percutaneous Coro¬nary Intervention”3) published in the Journal of the American Medical Association (JAMA) last year from the National Cardiovascular Data Registry (NCDR®) that highlighted a large number of inappropriate PCI procedures and a great degree of variability among institutions.
Marso and his coauthors denounce the NCDR data for being entirely self-reported, minimally monitored, and potentially biased. Interestingly, Drs. Marso and Grantham (first and senior authors of the JACC PCI paper) and two authors of the JAMA paper (Paul Chan, MD, and John Spertus, MD) are all from the same institution—Saint Luke’s Mid America Heart Institute in Kansas City, Missouri. That should make for some interesting hallway conversation.
Drs. Marso and Grantham reveal that, through personal communication with Dr. Chan, they came to know of inaccurate data used in several “inappropriate” cases of PCI. They go on to state that 56% of the cases classified as inappropriate at their institution “were misclassified due to incorrectly coding CCS class status, not documenting angina equivalents, or inaccurate documentation of the noninvasive risk assessment findings.” Dr. Marso and colleagues suggest that the AUC committee should refrain from approving clinical studies until participating NCDR sites have been properly educated on the appropriate collection of AUC-specific data elements. The authors conclude that, given the imprecise methods used to develop the AUC and the inaccuracy of the data collected to assess appropriate use, a “zero tolerance” policy for inappropriate use of PCI is not realistic. What is an “acceptable threshold?” they ask.
Drs. Marso and Blankenship concur that there is a great deal of uncertainty when mapping complex clinical scenarios. But while Dr. Marso’s team focus on flaws in the guidelines and the need for revision, Dr. Blankenship contends that such efforts to improve existing guidelines and recommendations will always be “doomed to imperfection.”
“Guidelines and AUC codify what experts consider to be best practices. To use these to make good decisions for the individual patient, one must also cut through misperceptions commonly held by patients and physicians, educate the patient, and honor the patient’s preferences,” Dr. Blankenship told CardioSource WorldNews. He added that some patients will have extenuating circumstances that will require treatment that differs from that recommended by the AUC guidelines, and the AUC appropriateness ratings fail to take patients’ perceptions and preferences into account.
In his editorial “Progress Toward Doing the Right Thing,” Dr. Blankenship addresses the misperceptions of both patients and physicians when deciding upon PCI as a treatment option. Patients overestimate the benefits and underestimate the risks of PCI, while underestimating the efficacy of medical therapy. At the same time, physicians may favor PCI due to lack of awareness of recent research and guidelines, malpractice concerns, and their perception of action being preferable to inaction. These factors contribute to an increased risk of making non– evidence-based treatment decisions.
AUC Here to Stay
The 2012 update to the AUC for coronary revascularization was released last month.4 The revised guideline expands upon the original list of clinical scenarios and incorporates some new indications in keeping with evidence from recently completed clinical studies. Still, Dr. Marso notes some areas where the criteria are lacking. “While we are pleased to see that the AUC were updated, the criteria still do not address many of the systematic limitations articulated in our recent Viewpoint article,” CardioSource WorldNews.
Determining the treatment decision that will offer an individual patient the best health outcome is often a complicated, multifaceted issue—and with the shift towards accountable care, guidelines determining what constitutes an “appropriate” treatment decision will be of paramount importance. “AUC will serve as the method for the cardiology professional to participate and improve the care of our patients for years to come,” Manesh Patel, MD, chair of the Coronary Revascularization Writing Group, told CardioSource WorldNews. The AUC will be used as the basis for treatment options and shared decision making, as well as for the development of reimbursement strategies.
Clinicians, payers, and patients all have a vested interest in making the “right” treatment decision—but who decides what the best course of action is, and what values guide their decision, will ultimately leave some feeling like the designated criteria are “inappropriate” in some circumstances. If left to their own devices, would physicians and patients choose the most necessary, beneficial, and cost-effective treatment? It depends who you ask. —by Kaitlyn L. Nemani
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