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Reconsidering the Gatekeeper Paradigm for Percutaneous Coronary Intervention in Stable Coronary Disease Management
Reconsidering the Gatekeeper Paradigm for Percutaneous Coronary Intervention in Stable Coronary Disease Management Major randomized clinical trials over the last decade support the role of optimal medical therapy for the initial management approach for patients with stable coronary artery disease (CAD), whereas percutaneous coronary intervention (PCI) ought to be reserved for patients with persistent symptoms despite optimal medical therapy. Likewise, several studies have continued to demonstrate the superiority of coronary artery bypass grafting surgery over PCI in many patients with extensive multivessel CAD, especially those with diabetes. Nevertheless, the decision-making paradigm for patients with stable CAD often continues to propagate the upfront use of “ad hoc PCI” and disadvantages alternative therapeutic approaches. In our editorial, we discuss how multiple systemic and interpersonal factors continue to favor early revascularization with PCI in stable patients. We discuss whether the interventional cardiologist can be an unbiased “gatekeeper” for the use of PCI or whether other physicians should also be involved with the patient in decision-making. Finally, we offer suggestions that can redefine the gatekeeper role to facilitate an evidence-based approach that embraces shared decision-making. A “gatekeeper” is defined as “a person who controls access” to something. In medicine, primary care physicians often serve as “gatekeepers”—the basic premise of which is that these doctors are best suited to determine appropriate treatment by virtue of their extensive relationships with patients and breadth of experience. By contrast, within cardiovascular medicine, this same principle is frequently inverted, with the subspecialist (i.e., interventional cardiologist) leading the decisionmaking process when obstructive coronary artery disease (CAD) is diagnosed by invasive angiography. This raises several concerns given recent scientific advances regarding the multiple effective management options for stable CAD. Furthermore, this predominant gatekeeper paradigm, in which important decisions often occur in the catheterization laboratory itself, appears especially inadequate given the present advocacy for shared clinical decision-making. Much of the tension over who should fill the gatekeeper role arises from the evolution and growth of interventional cardiology. The advent of percutaneous coronary intervention (PCI) and its demonstrable benefit in treating acute myocardial infarction (MI) leads many physicians to accept the broader (but unproven) premise that PCI would confer a similarly durable benefit (i.e., beyond symptom relief) in stable CAD. This assumption was seriously undermined by 2 major randomized control trials, the Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation and the Bypass Angioplasty Revascularization Investigation 2 Diabetes.1,2 Both trials provided support for an upfront trial of intensive pharmacotherapy and lifestyle intervention known in the aggregate as optimal medical therapy (OMT), with PCI deferred for persistently symptomatic patients. Importantly, as an initial management strategy in patients with stable CAD, PCI did not reduce the risk of death, MI, or other major car-
Manuscript received May 2, 2017; revised manuscript received and accepted July 10, 2017. See page 1451 for disclosure information. 0002-9149/$ - see front matter © 2017 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjcard.2017.07.021
diovascular events when added to OMT. Furthermore, although not explicitly studied in these trials, it is likely that deferring PCI also reduced rates of PCI-related adverse events (e.g., procedural complications, acute kidney injury). Nevertheless, it remains a common clinical practice that when a stable patient with CAD with angina or evidence of myocardial ischemia is referred for diagnostic angiography and is discovered to have obstructive CAD, a decision is made to proceed straightaway to PCI, which is performed as an ad hoc procedure immediately thereafter. Similarly, the relative ease and widespread use of ad hoc PCI has contributed to a concomitant decline in the use of coronary artery bypass graft (CABG) surgery. However, recent trials have continued to demonstrate the superiority of CABG compared with PCI for many patients with multivessel CAD, and thus further the need for an objective, unbiased gatekeeper role. For example, in the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery, mean 5-year outcomes of major adverse cardiac or cerebrovascular events favored CABG, and causes of death were more likely to be cardiac in patients undergoing PCI than in those undergoing CABG.3,4 The benefit of CABG is accentuated in patients with diabetes, as demonstrated in a recent patientlevel pooled analysis of 5,034 subjects with CAD and diabetes. The authors found that CABG + OMT was superior to PCI + OMT or OMT alone for the composite of death, MI, or stroke as well as most of the individual end points, whereas there was no significant difference between PCI + OMT and OMT.5 Thus, there is compelling evidence from clinical trials that stable patients with mild to moderate CAD do not need to undergo urgent ad hoc PCI, whereas patients with extensive, multivessel CAD should often be considered for CABG. Although such evidence has been incorporated into practice guidelines and appropriate use criteria,6,7 all too often these important concepts are neither translated into clinical practice nor effectively communicated to patients. Rather, preangiography discussions tend to set the scene for ad hoc www.ajconline.org
Editorial/Gatekeeper Role in PCI Decision-Making
PCI if anatomic stenoses deemed suitable for intervention are encountered, regardless of symptom severity, extent of ischemia, or an adequate initial trial of OMT. On the surface, such a procedural approach appears intuitive to many patients. Yet the downside may be the lost opportunity to consider all therapeutic options. Many other factors contribute to a pathway favoring ad hoc PCI. Despite the lack of conclusive evidence of any PCI benefit other than modest improvement in short-term angina, a widespread belief persists in the superiority of (and need for) revascularization to treat ischemia. There is often an understandable fear of leaving visually obstructive coronary stenoses untreated, whether out of clinical or medicolegal concern. There is frequently a perceived need to accommodate referring physicians by performing a therapeutic procedure. Similarly, there may be an understandable desire to satisfy patients who wish to be immediately “fixed,” even if such requests are based on an incomplete or inadequate understanding of PCI’s risks and effectiveness. Finally, when a patient with stable CAD is already “on the table” with coronary stenoses amenable to intervention, ad hoc PCI seems both “convenient” and readily achievable. In the aggregate, these considerations argue for an alternative gatekeeper model, specifically one that involves the referring cardiologist or even primary care provider. Such clinicians are ostensibly more impartial regarding choice of therapeutic strategy and often have a more established and nuanced physician-patient relationship. In addition, these clinicians often serve as the initial de facto gatekeeper for the referral to diagnostic angiography itself, and are thus better positioned to facilitate a discussion of all treatment options. However, numerous studies have demonstrated that clinical cardiologists are not necessarily comprehensive or unbiased in the precatheterization informed consent process or discussing all available treatment options.8,9 This preprocedural gatekeeper role is further complicated by the contingency planning required when considering what may be discovered with the diagnostic angiogram. The sum of these factors contributes to a tendency to defer to the “expert.” How then might we develop a better gatekeeper paradigm for the use of PCI in patients with stable CAD? We offer a few potential suggestions. First, before referral for cardiac catheterization, OMT (including lifestyle modification) should be prescribed as the foundational standard of care, with emphasis that this is not an “inferior” treatment. For patients who remain symptomatic or have other highrisk clinical features (e.g., left ventricular dysfunction), the judicious use of noninvasive anatomic imaging may be considered to identify very high-risk anatomic subsets (e.g., left main disease) that could benefit from earlier revascularization. Before invasive coronary angiography, a structured informed consent process, perhaps augmented with visual decision aids, can be employed to set more accurate and realistic patient expectations. After obstructive CAD is diagnosed by angiography (with appropriate use of functional techniques such as fractional flow reserve or instantaneous free wave ratio), it may be worthwhile to employ a multidisciplinary “Heart Team” approach and call a “time out” to ensure that all therapeutic options (OMT, PCI, or CABG) are fully and transparently discussed. Such an approach could even be facilitated through the use of tele-consultation in-
1451
cluding real-time review of diagnostic findings. It is likely that structural changes in reimbursement would be needed to enable this kind of multidisciplinary consultation, although this may be worthwhile given the shift to valuebased care. Such an approach to clinical decision-making could potentially redefine the gatekeeper paradigm in stable patients with CAD into one that is more collaborative, evidence-based, and truly patient centered. Disclosures The authors have no conflicts of interest to disclose. Joshua Schulman-Marcus, MDa,* William S. Weintraub, MDb William E. Boden, MDc a Division of Cardiology Albany Medical Center Albany Medical College Albany, New York b Division of Cardiology Christiana Healthcare System Newark, Delaware c VA New England Healthcare System Massachusetts Veterans Epidemiology, Research, and Informatics Center (MAVERIC) Boston University School of Medicine Boston, Massachusetts *Corresponding author: Tel: 518-262-5076; fax: 518-262-5082. E-mail address: [email protected] (J. Schulman-Marcus). 1. Boden WE, O’Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 2007;356:1503–1516. 2. The BARI 2D Study Group. A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med 2009;360:2503– 2515. 3. Mohr FW, Morice MC, Kappetein AP, Feldman TE, Stahle E, Colombo A, Mack MJ, Holmes DR Jr, Morel MA, Van Dyck N, Houle VM, Dawkins KD, Serruys PW. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet 2013;381:629–638. 4. Milojevic M, Head SJ, Parasca CA, Serruys PW, Mohr FW, Morice MC, Mack MJ, Stahle E, Feldman TE, Dawkins KD, Colombo A, Kappetein AP, Holmes DR Jr. Causes of death following PCI versus CABG in complex CAD: 5-year follow-up of sYNTAX. J Am Coll Cardiol 2016;67:42–55. 5. Mancini GB, Farkouh ME, Brooks MM, Chaitman BR, Boden WE, Vlachos H, Hartigan PM, Siami FS, Sidhu MS, Bittner V, Frye R, Fuster V. Medical treatment and revascularization options in patients with type 2 diabetes and coronary disease. J Am Coll Cardiol 2016;68:985–995. 6. Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith CR Jr, Smith SC Jr, Spertus JA, Williams SV. 2012 ACCF/AHA/ACP/AATS/ PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses As-
1452
The American Journal of Cardiology (www.ajconline.org)
sociation, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2012;60:e44–e164. 7. Patel MR, Calhoon JH, Dehmer GJ, Grantham JA, Maddox TM, Maron DJ, Smith PK. ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 appropriate use criteria for coronary revascularization in patients with stable ischemic heart disease: a report of the American College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascu-
lar Computed Tomography, and Society of Thoracic Surgeons. J Am Coll Cardiol 2017;69:2212–2241. 8. Goff SL, Mazor KM, Ting HH, Kleppel R, Rothberg MB. How cardiologists present the benefits of percutaneous coronary interventions to patients with stable angina: a qualitative analysis. JAMA Intern Med 2014;174:1614–1621. 9. Rothberg MB, Sivalingam SK, Kleppel R, Schweiger M, Hu B, Sepucha KR. Informed decision making for percutaneous coronary intervention for stable coronary disease. JAMA Intern Med 2015;175:1199– 1206.
Manuscript received May 2, 2017; revised manuscript received and accepted July 10, 2017. See page 1451 for disclosure information. 0002-9149/$ - see front matter © 2017 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjcard.2017.07.021
diovascular events when added to OMT. Furthermore, although not explicitly studied in these trials, it is likely that deferring PCI also reduced rates of PCI-related adverse events (e.g., procedural complications, acute kidney injury). Nevertheless, it remains a common clinical practice that when a stable patient with CAD with angina or evidence of myocardial ischemia is referred for diagnostic angiography and is discovered to have obstructive CAD, a decision is made to proceed straightaway to PCI, which is performed as an ad hoc procedure immediately thereafter. Similarly, the relative ease and widespread use of ad hoc PCI has contributed to a concomitant decline in the use of coronary artery bypass graft (CABG) surgery. However, recent trials have continued to demonstrate the superiority of CABG compared with PCI for many patients with multivessel CAD, and thus further the need for an objective, unbiased gatekeeper role. For example, in the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery, mean 5-year outcomes of major adverse cardiac or cerebrovascular events favored CABG, and causes of death were more likely to be cardiac in patients undergoing PCI than in those undergoing CABG.3,4 The benefit of CABG is accentuated in patients with diabetes, as demonstrated in a recent patientlevel pooled analysis of 5,034 subjects with CAD and diabetes. The authors found that CABG + OMT was superior to PCI + OMT or OMT alone for the composite of death, MI, or stroke as well as most of the individual end points, whereas there was no significant difference between PCI + OMT and OMT.5 Thus, there is compelling evidence from clinical trials that stable patients with mild to moderate CAD do not need to undergo urgent ad hoc PCI, whereas patients with extensive, multivessel CAD should often be considered for CABG. Although such evidence has been incorporated into practice guidelines and appropriate use criteria,6,7 all too often these important concepts are neither translated into clinical practice nor effectively communicated to patients. Rather, preangiography discussions tend to set the scene for ad hoc www.ajconline.org
Editorial/Gatekeeper Role in PCI Decision-Making
PCI if anatomic stenoses deemed suitable for intervention are encountered, regardless of symptom severity, extent of ischemia, or an adequate initial trial of OMT. On the surface, such a procedural approach appears intuitive to many patients. Yet the downside may be the lost opportunity to consider all therapeutic options. Many other factors contribute to a pathway favoring ad hoc PCI. Despite the lack of conclusive evidence of any PCI benefit other than modest improvement in short-term angina, a widespread belief persists in the superiority of (and need for) revascularization to treat ischemia. There is often an understandable fear of leaving visually obstructive coronary stenoses untreated, whether out of clinical or medicolegal concern. There is frequently a perceived need to accommodate referring physicians by performing a therapeutic procedure. Similarly, there may be an understandable desire to satisfy patients who wish to be immediately “fixed,” even if such requests are based on an incomplete or inadequate understanding of PCI’s risks and effectiveness. Finally, when a patient with stable CAD is already “on the table” with coronary stenoses amenable to intervention, ad hoc PCI seems both “convenient” and readily achievable. In the aggregate, these considerations argue for an alternative gatekeeper model, specifically one that involves the referring cardiologist or even primary care provider. Such clinicians are ostensibly more impartial regarding choice of therapeutic strategy and often have a more established and nuanced physician-patient relationship. In addition, these clinicians often serve as the initial de facto gatekeeper for the referral to diagnostic angiography itself, and are thus better positioned to facilitate a discussion of all treatment options. However, numerous studies have demonstrated that clinical cardiologists are not necessarily comprehensive or unbiased in the precatheterization informed consent process or discussing all available treatment options.8,9 This preprocedural gatekeeper role is further complicated by the contingency planning required when considering what may be discovered with the diagnostic angiogram. The sum of these factors contributes to a tendency to defer to the “expert.” How then might we develop a better gatekeeper paradigm for the use of PCI in patients with stable CAD? We offer a few potential suggestions. First, before referral for cardiac catheterization, OMT (including lifestyle modification) should be prescribed as the foundational standard of care, with emphasis that this is not an “inferior” treatment. For patients who remain symptomatic or have other highrisk clinical features (e.g., left ventricular dysfunction), the judicious use of noninvasive anatomic imaging may be considered to identify very high-risk anatomic subsets (e.g., left main disease) that could benefit from earlier revascularization. Before invasive coronary angiography, a structured informed consent process, perhaps augmented with visual decision aids, can be employed to set more accurate and realistic patient expectations. After obstructive CAD is diagnosed by angiography (with appropriate use of functional techniques such as fractional flow reserve or instantaneous free wave ratio), it may be worthwhile to employ a multidisciplinary “Heart Team” approach and call a “time out” to ensure that all therapeutic options (OMT, PCI, or CABG) are fully and transparently discussed. Such an approach could even be facilitated through the use of tele-consultation in-
1451
cluding real-time review of diagnostic findings. It is likely that structural changes in reimbursement would be needed to enable this kind of multidisciplinary consultation, although this may be worthwhile given the shift to valuebased care. Such an approach to clinical decision-making could potentially redefine the gatekeeper paradigm in stable patients with CAD into one that is more collaborative, evidence-based, and truly patient centered. Disclosures The authors have no conflicts of interest to disclose. Joshua Schulman-Marcus, MDa,* William S. Weintraub, MDb William E. Boden, MDc a Division of Cardiology Albany Medical Center Albany Medical College Albany, New York b Division of Cardiology Christiana Healthcare System Newark, Delaware c VA New England Healthcare System Massachusetts Veterans Epidemiology, Research, and Informatics Center (MAVERIC) Boston University School of Medicine Boston, Massachusetts *Corresponding author: Tel: 518-262-5076; fax: 518-262-5082. E-mail address: [email protected] (J. Schulman-Marcus). 1. Boden WE, O’Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 2007;356:1503–1516. 2. The BARI 2D Study Group. A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med 2009;360:2503– 2515. 3. Mohr FW, Morice MC, Kappetein AP, Feldman TE, Stahle E, Colombo A, Mack MJ, Holmes DR Jr, Morel MA, Van Dyck N, Houle VM, Dawkins KD, Serruys PW. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet 2013;381:629–638. 4. Milojevic M, Head SJ, Parasca CA, Serruys PW, Mohr FW, Morice MC, Mack MJ, Stahle E, Feldman TE, Dawkins KD, Colombo A, Kappetein AP, Holmes DR Jr. Causes of death following PCI versus CABG in complex CAD: 5-year follow-up of sYNTAX. J Am Coll Cardiol 2016;67:42–55. 5. Mancini GB, Farkouh ME, Brooks MM, Chaitman BR, Boden WE, Vlachos H, Hartigan PM, Siami FS, Sidhu MS, Bittner V, Frye R, Fuster V. Medical treatment and revascularization options in patients with type 2 diabetes and coronary disease. J Am Coll Cardiol 2016;68:985–995. 6. Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith CR Jr, Smith SC Jr, Spertus JA, Williams SV. 2012 ACCF/AHA/ACP/AATS/ PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses As-
1452
The American Journal of Cardiology (www.ajconline.org)
sociation, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2012;60:e44–e164. 7. Patel MR, Calhoon JH, Dehmer GJ, Grantham JA, Maddox TM, Maron DJ, Smith PK. ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 appropriate use criteria for coronary revascularization in patients with stable ischemic heart disease: a report of the American College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascu-
lar Computed Tomography, and Society of Thoracic Surgeons. J Am Coll Cardiol 2017;69:2212–2241. 8. Goff SL, Mazor KM, Ting HH, Kleppel R, Rothberg MB. How cardiologists present the benefits of percutaneous coronary interventions to patients with stable angina: a qualitative analysis. JAMA Intern Med 2014;174:1614–1621. 9. Rothberg MB, Sivalingam SK, Kleppel R, Schweiger M, Hu B, Sepucha KR. Informed decision making for percutaneous coronary intervention for stable coronary disease. JAMA Intern Med 2015;175:1199– 1206.