Potential Association of the ISCHEMIA Trial With the Appropriate Use Criteria Ratings for Percutaneous Coronary Intervention in Stable Ischemic Heart Disease | Cardiology | JAMA Internal Medicine | JAMA Network
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Figure 1.  Analytical Cohort Selection and Breakdown of Patients Who Were Unclassified by Current and Modified Appropriate Use Criteria (AUC)
Analytical Cohort Selection and Breakdown of Patients Who Were Unclassified by Current and Modified Appropriate Use Criteria (AUC)

Criteria defined previously.1 ACS indicates acute coronary syndrome; CAD, coronary artery disease; LV, left ventricular; PCI, percutaneous coronary intervention; SIHD, stable ischemic heart disease; SYNTAX, synergy between PCI with taxus and cardiac surgery.

Figure 2.  Rates of Percutaneous Coronary Intervention (PCI) Appropriateness Using Current and Modified Appropriate Use Criteria (AUC)
Rates of Percutaneous Coronary Intervention (PCI) Appropriateness Using Current and Modified Appropriate Use Criteria (AUC)
1.
Patel  MR, Dehmer  GJ, Hirshfeld  JW, Smith  PK, Spertus  JA; 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; Heart Failure Society of America; Society of Cardiovascular Computed Tomography.  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(6):530-553. doi:10.1016/j.jacc.2008.10.005PubMedGoogle ScholarCrossref
2.
Maron  DJ, Hochman  JS, Reynolds  HR,  et al; ISCHEMIA Research Group.  Initial invasive or conservative strategy for stable coronary disease.   N Engl J Med. 2020;382(15):1395-1407. doi:10.1056/NEJMoa1915922 PubMedGoogle ScholarCrossref
3.
Spertus  JA, Jones  PG, Maron  DJ,  et al; ISCHEMIA Research Group.  Health-status outcomes with invasive or conservative care in coronary disease.   N Engl J Med. 2020;382(15):1408-1419. doi:10.1056/NEJMoa1916370 PubMedGoogle ScholarCrossref
4.
Brindis  RG, Fitzgerald  S, Anderson  HV, Shaw  RE, Weintraub  WS, Williams  JF.  The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR): building a national clinical data repository.   J Am Coll Cardiol. 2001;37(8):2240-2245. doi:10.1016/S0735-1097(01)01372-9 PubMedGoogle ScholarCrossref
5.
Boden  WE, O’Rourke  RA, Teo  KK,  et al; COURAGE Trial Research Group.  Optimal medical therapy with or without PCI for stable coronary disease.   N Engl J Med. 2007;356(15):1503-1516. doi:10.1056/NEJMoa070829 PubMedGoogle ScholarCrossref
6.
Schwartz  AL, Landon  BE, Elshaug  AG, Chernew  ME, McWilliams  JM.  Measuring low-value care in Medicare.   JAMA Intern Med. 2014;174(7):1067-1076. doi:10.1001/jamainternmed.2014.1541 PubMedGoogle ScholarCrossref
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    Research Letter
    Less Is More
    September 21, 2020

    Potential Association of the ISCHEMIA Trial With the Appropriate Use Criteria Ratings for Percutaneous Coronary Intervention in Stable Ischemic Heart Disease

    Author Affiliations
    • 1St Luke’s Mid America Heart Institute, Kansas City, Missouri
    • 2Duke University, School of Medicine, Durham, North Carolina
    • 3Virginia Tech Carilion School of Medicine, Roanoke, Virginia
    JAMA Intern Med. 2020;180(11):1540-1542. doi:10.1001/jamainternmed.2020.3181

    Decreasing the risk for major adverse cardiovascular events (eg, myocardial infarction and death) and alleviating symptoms are primary therapeutic goals of percutaneous coronary intervention (PCI) in patients with stable ischemic heart disease (SIHD). Current appropriate use criteria (AUC) developed by national cardiovascular societies classify PCIs as appropriate, maybe appropriate, or rarely appropriate.1 Recently, the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial reported that coronary revascularization did not lower cardiovascular event rates among patients with SIHD2 but did improve the disease-specific health status of patients if they had angina.3 We sought to understand the potential implications of the ISCHEMIA trial on the appropriateness of PCI in a contemporary cohort of patients with SIHD.

    Methods

    The National Cardiovascular Data Registry CathPCI registry is a multicenter nationally representative sample of patients undergoing PCI in the US.4 We included patients who were enrolled in the CathPCI registry between April 1, 2018, and June 30, 2019, and excluded patients with PCIs for acute coronary syndromes (529 391 [57%]), staged revascularization procedures, and those presenting with cardiac arrest or shock (Figure 1). Of the remaining patients with SIHD, the number and proportion of PCIs classified as appropriate, maybe appropriate, and rarely appropriate based on current AUC definitions were compared with modified AUC ratings that, based on the ISCHEMIA trial,2 recategorized all PCIs performed for asymptomatic patients (defined by the current AUC as those with no symptoms or nonanginal chest pain) without left main coronary artery disease and/or left ventricular dysfunction (defined as an ejection fraction <35%) as rarely appropriate. Institutional review board approval was waived by Saint Luke’s Hospital because the study used deidentified data. Analyses were conducted using SAS, version 9.1 (SAS Institute).

    Results

    The analytical cohort comprised 352 376 patients with SIHD. The mean (SD) age was 68.0 (10.7) years, 40 171 patients (11.4%) were persons of color, and 106 065 (30.1%) were women. Comorbidities were common, with 152 907 (43.4%) having diabetes, 201 417 (57.2%) being current or recent smokers, and 58 295 (16.5%) having chronic lung disease. Overall, 61 651 (17.5%) were asymptomatic or had nonanginal chest pain at the time of PCI. The current AUC classified 120 058 PCIs (56.2%) as appropriate, 86 547 (40.5%) as maybe appropriate, and 7148 (3.3%) as rarely appropriate. Using the modified AUC ratings, 120 044 PCIs (50.8%) were classified as appropriate, 63 648 (26.9%) as maybe appropriate, and 52 590 (22.3%) as rarely appropriate (Figure 2). Appropriateness ratings could not be assigned to 138 623 PCIs (39.3%) using the current AUC and 116 094 PCIs(32.9%) using the modified AUC. Lack of stress testing results or missing stress test results accounted for 112 555 of unclassified PCIs (81.2%) in the current AUC and 86 779 of unclassified PCIs (74.7%) in the modified AUC (Figure 1).

    The large increase in the number of rarely appropriate PCIs came from reclassification of 45 442 asymptomatic patients whose PCIs were initially categorized as maybe appropriate (22 899 [50.4%]), unable to be classified (22 529 [49.6%]), or appropriate (14 [0.03%]) to a rating of rarely appropriate. As a sensitivity analysis, excluding patients with left main coronary artery disease and left ventricular dysfunction (to align with ISCHEMIA trial criteria) had a minimal association with the proportion of patients with PCIs classified as appropriate, maybe appropriate, and rarely appropriate.

    Discussion

    In a national registry of patients undergoing nonacute PCI, we found that approximately 1 in 6 patients were asymptomatic at the time of PCI. If the AUC were modified to incorporate randomized clinical trials, such as COURAGE5 and the recent ISCHEMIA trial,2 and considered these PCIs to be rarely appropriate for SIHD, the rates of rarely appropriate PCI may be nearly 7-fold higher compared with current AUC ratings. Given that we were unable to assess whether optimal antianginal therapy had failed before PCI in the current or modified AUC, the proportion of patients with PCIs classified as rarely appropriate with either AUC could be even higher than we estimate. As PCIs in patients with SIHD are estimated to cost $2.8 billion annually6 and are associated with risks for bleeding, infection, and death, these findings underscore the importance of updating clinical guidelines and AUC to be consistent with the robust evidence base.

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    Article Information

    Accepted for Publication: June 6, 2020.

    Corresponding Author: Paul S. Chan, MD, MSc, St Luke’s Mid America Heart Institute, 4401 Wornall Rd, 9th Floor, Kansas City, MO 64111 (paulchan.mahi@gmail.com).

    Published Online: September 21, 2020. doi:10.1001/jamainternmed.2020.3181

    Author Contributions: Drs Malik and Chan had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

    Concept and design: Malik, Spertus, Dehmer, Chan.

    Acquisition, analysis, or interpretation of data: Malik, Spertus, Patel, Kennedy, Chan.

    Drafting of the manuscript: Malik, Chan.

    Critical revision of the manuscript for important intellectual content: All authors.

    Statistical analysis: Malik, Kennedy.

    Obtained funding: Spertus.

    Administrative, technical, or material support: Malik, Patel.

    Supervision: Spertus, Chan.

    Conflict of Interest Disclosures: Dr Malik reported grants from the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health during the conduct of the study. Dr Spertus reported personal fees from Janssen, Amgen, Novartis, Bayer, Merck, United Healthcare, and Blue Cross Blue Shield of Kansas City outside the submitted work, had a patent for the copyright to the SAQ with royalties paid, and equity in Health Outcomes Sciences. Dr Patel reported grants and personal fees from Bayer, Janssen, and Heartflow and grants from the NHBLI outside the submitted work. Dr Chan reported grants from the NHLBI and American Heart Association during the conduct of the study and personal fees from Optum outside the submitted work. No other disclosures were reported.

    References
    1.
    Patel  MR, Dehmer  GJ, Hirshfeld  JW, Smith  PK, Spertus  JA; 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; Heart Failure Society of America; Society of Cardiovascular Computed Tomography.  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(6):530-553. doi:10.1016/j.jacc.2008.10.005PubMedGoogle ScholarCrossref
    2.
    Maron  DJ, Hochman  JS, Reynolds  HR,  et al; ISCHEMIA Research Group.  Initial invasive or conservative strategy for stable coronary disease.   N Engl J Med. 2020;382(15):1395-1407. doi:10.1056/NEJMoa1915922 PubMedGoogle ScholarCrossref
    3.
    Spertus  JA, Jones  PG, Maron  DJ,  et al; ISCHEMIA Research Group.  Health-status outcomes with invasive or conservative care in coronary disease.   N Engl J Med. 2020;382(15):1408-1419. doi:10.1056/NEJMoa1916370 PubMedGoogle ScholarCrossref
    4.
    Brindis  RG, Fitzgerald  S, Anderson  HV, Shaw  RE, Weintraub  WS, Williams  JF.  The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR): building a national clinical data repository.   J Am Coll Cardiol. 2001;37(8):2240-2245. doi:10.1016/S0735-1097(01)01372-9 PubMedGoogle ScholarCrossref
    5.
    Boden  WE, O’Rourke  RA, Teo  KK,  et al; COURAGE Trial Research Group.  Optimal medical therapy with or without PCI for stable coronary disease.   N Engl J Med. 2007;356(15):1503-1516. doi:10.1056/NEJMoa070829 PubMedGoogle ScholarCrossref
    6.
    Schwartz  AL, Landon  BE, Elshaug  AG, Chernew  ME, McWilliams  JM.  Measuring low-value care in Medicare.   JAMA Intern Med. 2014;174(7):1067-1076. doi:10.1001/jamainternmed.2014.1541 PubMedGoogle ScholarCrossref
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