Percutaneous coronary intervention (PCI) represents an important treatment in the management of patients with ischemic heart disease. In the setting of an acute coronary syndrome, timely PCI reduces mortality and recurrent myocardial infarction.^1-3 However, for patients with stable ischemic heart disease, the clinical benefit of PCI is limited to symptom relief and improvements in health-related quality of life.^4-6 Furthermore, PCI is not without risk, with the potential for both peri-procedural complications and longer-term bleeding and stent thrombosis. Because nearly 500,000 patients undergo PCI annually in the United States at a cost of $8.5 billion,^7,8 it is important to ensure that the proper patients are selected for this procedure to minimize unnecessary risk while maximizing patient benefit.

Appropriate Use Criteria for PCI

The American College of Cardiology, in partnership with five other professional organizations, developed the Appropriate Use Criteria for Coronary Revascularization (AUC) to assess the quality of patient selection for coronary revascularization procedures.^9,10 The AUC was developed using a modified Delphi approach to achieve consensus on the appropriateness ratings for typical clinical scenarios in which PCI may be considered. In this approach, national cardiology societies nominated members to a panel that rated the appropriateness of PCI for clinical scenarios based on published trial evidence, practice guidelines, and their expert opinions using the following definition of appropriateness:

"Coronary revascularization is appropriate when the expected benefits, in terms of survival or health outcomes (symptoms, functional status, and/or quality of life) exceed the expected negative consequences of the procedure."

In the AUC, an "appropriate" rating represented clinical scenarios in which the expected benefits—in terms of survival, symptoms, or quality of life—exceeded the expected negative consequences of the procedure. An "uncertain" rating indicated that more research, patient information, or both was required to determine the anticipated balance of potential benefit and risk of revascularization for the clinical scenario. An "inappropriate" rating suggested that the risks were perceived to outweigh the benefits of coronary revascularization.

The AUC was intended to be a practical, quality improvement guide that applies published trial evidence and the generalized recommendations of practice guidelines to specific clinical scenarios likely to be encountered in everyday practice. The AUC is not intended to serve as an absolute mandate for or against treatment. Because unique patient factors and preferences are not captured in the AUC, there may be instances in which the AUC rating for PCI may be inappropriate but the clinician and patient believe PCI is justified. As such, the AUC is intended to examine and reduce practice patterns that deviate significantly from the norms of care (e.g., hospitals with higher rates of inappropriate PCI compared with national standards). Given concerns for the potential application of AUC to judge the appropriateness of individual procedures rather than practice patterns on the whole, the term "inappropriate" has been replaced with "rarely appropriate," and the term "uncertain" has been replaced with "may be appropriate" in later versions of the AUC.¹¹

Appropriateness of PCI in the United States

Application of the AUC to clinical practice has demonstrated gaps in the quality of patient selection for PCI. In a US national study of more than 500,000 PCIs from over 1,000 hospitals participating in the National Cardiovascular Data Registry® (NCDR) CathPCI Registry,¹⁶ PCIs performed in the acute setting (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and high-risk unstable angina) were almost uniformly classified as appropriate. However, among patients receiving PCI in nonacute settings, 50% of the procedures were classified as appropriate, 38% as uncertain, and 12% as inappropriate. The majority of patients who received inappropriate nonacute PCI had a low-risk stress test (72%), were asymptomatic (54%) at the time of their procedure, or had not received an adequate antianginal therapy (96%). Subsequent analyses of two other state-specific registries (Washington and New York) found similar rates of PCI for nonacute indications rated as inappropriate.^17,18 Additionally, all three studies showed a wide facility-level variation in the percentage of appropriate and inappropriate PCI for elective indications.

These studies also highlighted gaps in the assessment of patients prior to nonacute PCI. The anticipated benefit of PCI in this setting is related to patient symptom burden, adequacy of antianginal therapy, and ischemic risk as determined by noninvasive stress testing. However, 30-50% of patients undergo nonacute PCI without preprocedural stress testing.^16,17 Recently developed PCI performance measures attempt to address this gap by emphasizing the importance of adequate documentation of PCI indication (central to determination of appropriateness).¹⁹ This integration of procedural indication into a performance measure marks the first such occurrence in cardiology.

Although the AUC is grounded in randomized trials and practice guidelines, critiques have been leveled against the criteria for the consensus method by which they are developed and the lack of prospective validation of the criteria, particularly as they pertain to patients with stable ischemic heart disease.^12,13 However, a recent observational analysis and a post hoc analysis of the randomized COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial support the validity of the AUC.^14,15 In both studies, the benefit of PCI was limited to patients with clinical scenarios rated as appropriate, with little to no benefit in patients with clinical scenarios rated as inappropriate. These findings support the validity of the AUC and provide greater credibility for its dissemination in routine care.

Impact of the AUC

In 2011, hospitals participating in the NCDR CathPCI registry began receiving information about their performance on PCI appropriateness, benchmarked against other participating hospitals. Similarly, approaches to reduce inappropriate use of PCI were incorporated in regional quality-improvement programs for coronary revascularization.²⁰ Simultaneously, insurers began to incorporate measures of PCI appropriateness into pay-for-performance programs and decisions on reimbursement.^21,22

Recent analyses have evaluated the changes in PCI practice following introduction of the AUC in 2009 and subsequent efforts to reduce inappropriate use of PCI.^20,23 In a national analysis from the NCDR CathPCI registry of patients undergoing PCI between 2009 and 2014 (5 years after dissemination of the AUC for PCI),²³ the volumes of nonacute PCIs has declined from 89,704 in 2010 to 59,375 in 2014, and the volume of acute PCIs has remained stable, from 377,540 in 2010 to 374,543 in 2014. In addition, the proportion of nonacute PCIs classified as inappropriate has been cut in half from 26.2% in 2009 to 13.3% in 2014. However, hospital-level variation in the rate of inappropriate PCIs persists, with an interquartile range of 5.9-22.9% in 2014. Similar reductions in the volume of nonacute PCI and inappropriate PCI were observed in a statewide analysis from the Clinical Outcome Assessment Program in Washington State.²⁰ Collectively, these findings suggest that the practice of interventional cardiology has evolved toward more appropriate selection of patients for nonacute PCI since the introduction of AUC in 2009.

As documentation of procedural indication and resultant appropriateness assessment become part of routine care delivery, concerns about "gaming" of appropriateness ratings become more pertinent. Although no evidence has been published to document appropriateness gaming, it is possible to inflate the documented symptom burden or stress test findings and thereby overstate the apparent appropriateness of PCI. The incorporation of validated, patient-centered health status questionnaires along with data audit programs has been proposed as a potential measure to prevent this type of abuse. Furthermore, as reimbursement structures increasingly seek to encourage high-value care delivery that improves patient outcomes at lower cost, incorporation of patient-reported health-status measures may protect against underutilization of PCI for patients who are most likely to benefit.

Summary

It is clear that the introduction of AUC for coronary revascularization several years ago has already impacted clinical practice and patient selection for PCI with resultant lower use of the procedure in settings where minimal or no patient benefit is expected. Opportunities remain to address hospital-level variation in rates of inappropriate use by 1) identifying processes associated with better patient selection at hospitals with low rates of inappropriate use and 2) implementing these processes at hospitals with higher rates of inappropriate PCI as determined by application of the AUC. Further, as the evidence base that informs the AUC continues to evolve, it will be imperative to ensure that the AUC reflects best evidence and continues to encourage optimal patient selection to minimize unnecessary risk while maximizing patient benefit.

References

1. Weaver WD, Simes RJ, Betriu A, et al. Comparison of primary coronary angioplasty and intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review. JAMA 1997;278:2093-8.
2. Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet 2003;361:13-20.
3. Fox KA, Clayton TC, Damman P, et al. Long-term outcome of a routine versus selective invasive strategy in patients with non-ST-segment elevation acute coronary syndrome a meta-analysis of individual patient data. J Am Coll Cardiol 2010;55:2435-45.
4. Boden WE, O'Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 2007;356:1503-16.
5. Boden WE, O'Rourke RA, Teo KK, et al. Impact of optimal medical therapy with or without percutaneous coronary intervention on long-term cardiovascular end points in patients with stable coronary artery disease (from the COURAGE Trial). Am J Cardiol 2009;104:1-4.
6. Weintraub WS, Spertus JA, Kolm P, et al. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J Med 2008;359:677-87.
7. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation 2016;133:e38-e360.
8. Healthcare Cost and Utilization Project (Agency for Healthcare Research and Quality website). 2011. Available at: http://www.ahrq.gov/research/data/hcup/index.html. Accessed 02/14/2016.
9. Patel MR, Dehmer GJ, Hirshfeld JW, et al. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization: a report by the American College of Cardiology Foundation Appropriateness Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, and the American Society of Nuclear Cardiology Endorsed by the American Society of Echocardiography, the Heart Failure Society of America, and the Society of Cardiovascular Computed Tomography. J Am Coll Cardiol 2009;53:530-53.
10. Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA. ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 Appropriate use criteria for coronary revascularization focused update: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, and the Society of Cardiovascular Computed Tomography. J Am Coll Cardiol 2012;59:857-81.
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12. Marso SP, Teirstein PS, Kereiakes DJ, Moses J, Lasala J, Grantham JA. Percutaneous coronary intervention use in the United States: defining measures of appropriateness. JACC Cardiovasc Interv 2012;5:229-35.
13. Kereiakes DJ, Stone GW. Appropriate use criteria to reduce underuse and overuse of revascularization. J Am Coll Cardiol 2013;61:2024.
14. Ko DT, Guo H, Wijeysundera HC, et al. Assessing the association of appropriateness of coronary revascularization and clinical outcomes for patients with stable coronary artery disease. J Am Coll Cardiol 2012;60:1876-84.
15. Bradley SM, Chan PS, Hartigan PM, et al. Validation of the appropriate use criteria for percutaneous coronary intervention in patients with stable coronary artery disease (from the COURAGE trial). Am J Cardiol 2015;116:167-73.
16. Chan PS, Patel MR, Klein LW, et al. Appropriateness of percutaneous coronary intervention. JAMA 2011;306:53-61.
17. Bradley SM, Maynard C, Bryson CL. Appropriateness of percutaneous coronary interventions in Washington State. Circ Cardiovasc Qual Outcomes 2012;5:445-53.
18. Hannan EL, Cozzens K, Samadashvili Z, et al. Appropriateness of coronary revascularization for patients without acute coronary syndromes. J Am Coll Cardiol 2012;59:1870-6.
19. Nallamothu BK, Tommaso CL, Anderson HV, et al. ACC/AHA/SCAI/AMA-Convened PCPI/NCQA 2013 performance measures for adults undergoing percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures, the Society for Cardiovascular Angiography and Interventions, the American Medical Association-Convened Physician Consortium for Performance Improvement, and the National Committee for Quality Assurance. J Am Coll Cardiol 2014;63:722-45.
20. Bradley SM, Bohn CM, Malenka DJ, et al. Temporal Trends in Percutaneous Coronary Intervention Appropriateness: Insights From the Clinical Outcomes Assessment Program. Circulation 2015;132:20-6.
21. Hospital Pay-for-Performance Program (Blue Cross Blue Shield of Michigan website). 2014. Available at: http://www.bcbsm.com/content/dam/public/Providers/Documents/value/2015-hospital-pay-performance-program.pdf. Accessed 02/14/2016.
22. New York State Medicaid Update: Percutaneous Coronary Intervention Coverage Guidelines (New York State Department of Health website). 2013. https://www.health.ny.gov/health_care/medicaid/program/update/2013/2013-06.htm#ous. Accessed 02/14/2016.
23. Desai NR, Bradley SM, Parzynski CS, et al. Appropriate Use Criteria for Coronary Revascularization and Trends in Utilization, Patient Selection, and Appropriateness of Percutaneous Coronary Intervention. JAMA 2015;314:2045-53.

Keywords: Acute Coronary Syndrome, Angina, Unstable, Area Under Curve, Coronary Artery Disease, Drug Evaluation, Exercise Test, Expert Testimony, Health Status, Insurance Carriers, Myocardial Infarction, Myocardial Ischemia, Patient Selection, Percutaneous Coronary Intervention, Quality Improvement, Quality of Life, Randomized Controlled Trials as Topic, Registries, Reimbursement, Incentive, Stents, Thrombosis, Angina, Stable

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