(Circulation. 2004;109:1079-1081.)
© 2004 American Heart Association, Inc.
Focused Perspectives |
From the Division of Cardiology, Department of Medicine, Duke University Medical Center and Duke Clinical Research Institute, Durham, NC.
Correspondence to Peter Berger, MD, Division of Cardiology/Department of Medicine, Duke Clinical Research Institute, Duke University Medical Center, 2400 Pratt St, Durham, NC 27705. E-mail berge023{at}mc.duke.edu
Key Words: Focused Perspectives bypass revascularization coronary disease stents
| Introduction |
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See p 1114
| Balloon Angioplasty Versus Stent Placement |
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| The ARTS Trial |
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This most recent analysis of the ARTS study raises 2 important questions. What relevance, if any, do the results of ARTS and the other 10 randomized trials have in the drug-eluting stent era? And what role should economic considerations play when comparing therapies?
| Drug-Eluting Stents |
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| Unresolved Clinical Issues |
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Second, several of the trials suggested an increased mortality rate in patients with diabetes mellitus undergoing PCI rather than CABG3,4,6,10 (although one suggested the opposite,1 and most did not indicate a difference). The reason for the increased mortality among diabetics, if true, is probably related to that fact that an occlusion anywhere in the left anterior descending artery proximal to the anastomosis of a mammary artery graft may result in only a small infarction or be entirely subclinical, whereas a stent can be expected to reduce the frequency of infarction (when reendothelialized) only in that portion of the coronary artery covered by the stent (and may actually increase the risk of infarction until it is reendothelialized). To further evaluate this issue, the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) trial will evaluate treatment with a drug-eluting stent versus bypass surgery in patients with diabetes mellitus and multivessel coronary disease.
Other patient groups characterized by severe atherosclerosis and a prothrombotic state, such as those with chronic kidney disease, may also be better treated with CABG using arterial grafts. Such patients have a markedly increased frequency of death and infarction, not only during a PCI procedure, but also in the years after a successful PCI.18 Despite an exponential increase in chronic kidney disease in the United States and abroad, these patients have been excluded from all of the randomized trials comparing PCI and CABG and most other trials evaluating therapies for coronary disease. The effectiveness of multivessel PCI in patients with diabetes mellitus and chronic kidney disease relative to CABG, particularly when drug-eluting stents are used, remains unclear.
| Economic Impact of Drug-Eluting Stents |
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1.5 drug-eluting stents are placed during a single PCI procedure. The loss of income to hospitals and of the margin coronary revascularization procedures generate could be even greater if the number of CABG cases drops significantly, owing to the large fixed cost of maintaining surgical facilities and personnel. Therefore, it would be overly simplistic to assume that greatly reducing the frequency of repeat revascularization procedures by replacing bare with drug-eluting stents would favorably influence the relative costs of PCI versus CABG. The economic impact of such a change on hospitals and society could be profound, and the impact on the health and well-being of patients is incompletely understood. The dynamics will change again with the imminent availability of a second drug-eluting stent. The choice of revascularization procedure has an easily measurable impact on the incomes of cardiologists, cardiac surgeons, and anesthesiologists.19,20 (An upcoming Bethesda Conference will address the issue of self-referral as a major concern in modern cardiology.) Given that professionalism, by definition, places the patients needs over those of the provider, physicians must strive to ensure that patients receive a balanced picture of the relative advantages of PCI and CABG.
| What Role Should Economic Analyses Play? |
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Many hospitals and health systems depend on margins from cardiovascular services to pay for other services, such as psychiatric and emergency services. Given the large impact of these margins on the ability of hospitals to deliver care to populations whose care is not well reimbursed, choices among revascularization techniques could have very broad implications. Accordingly, it is incumbent on every cardiovascular practitioner to stay current with this rapidly evolving evidence base, including methods of optimizing efficiency. Every effort should be made to include the patient in the choice of procedure. Some patients and physicians may prefer the advantages of PCI over CABG when the anatomy is suitable for either procedure, and others will prefer CABG over PCI. But the relative merits of the procedure for an individual patient, informed without self-interest, ought to govern the decision-making for the physician providing care. Within the context of multiple individual decisions and evolving technology and outcomes, we must strive to deliver the technology in the most efficient and effective manner.
| Summary |
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| Footnotes |
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| References |
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2. Rodriguez A, Boullon F, Perez-Balino N, et al, on behalf of the ERACI Group. Argentine randomized trial of percutaneous transluminal coronary angioplasty versus coronary artery bypass surgery in multivessel disease (ERACI): in-hospital results and 1-year follow-up. J Am Coll Cardiol. 1993; 22: 10601067.[Abstract]
3. CABRI Trial Participants. First-year results of CABRI (Coronary Angioplasty vs. Bypass Revascularization Investigation). Lancet. 1995; 346: 11791184.[CrossRef][Medline] [Order article via Infotrieve]
4. King SB III, Lembo NJ, Weintraub WS. A randomized trial comparing the coronary angioplasty with coronary bypass surgery. N Engl J Med. 1994; 331: 10441050.
5. Hamm CW, Reimers J, Ischinger T, et al. A randomized study of coronary angioplasty compared with bypass surgery in patients with symptomatic multivessel coronary disease. N Engl J Med. 1994; 331: 10371043.
6. The Bypass Angioplasty Revascularization Investigation (BARI) Investigators. Comparison of coronary bypass surgery with angioplasty in patients with multivessel disease. N Engl J Med. 1996; 335: 217225.
7. Zhang Z, Mahoney EM, Stables RH, et al. Disease-specific health status after stent-assisted percutaneous coronary intervention and coronary artery bypass surgery: one-year results from the Stent Or Surgery trial. Circulation. 2003; 108: 16941700.
8. Favarato D, Hueb W, Gersh BJ, et al. Relative cost comparison of treatments for coronary artery disease: the first year follow-up of MASS II study. Circulation. 2003; 108 (suppl II): II-21II-23.[Medline] [Order article via Infotrieve]
9. Rodriguez A, Bernardi V, Navia J, et al. Argentine randomized study: coronary angioplasty with stenting versus coronary bypass surgery in patients with multiple-vessel disease (ERACI II): 30 day and one-year follow-up results. J Am Coll Cardiol. 2001; 37: 5158.
10. Serruys PW, Unger F, Sousa JE, et al. Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. N Engl J Med. 2001; 344: 11171124.
11. Morrison DA, Sethi G, Sacks J, et al, for the Investigators of the Department of Veterans Affairs Cooperative Study #385, the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME). Percutaneous coronary intervention versus coronary artery bypass graft surgery for patients with medically refractory myocardial ischemia and risk factors for adverse outcomes with bypass: a multicenter, randomized trial. J Am Coll Cardiol. 2001; 38: 143149.
12. Serruys PW, Van Hout B, Bonnier H, et al. Randomized comparison of implantation of heparin coated stents with balloon angioplasty in selected patients with coronary artery disease. Lancet. 1998; 352: 673681.[CrossRef][Medline] [Order article via Infotrieve]
13. Legrand VMG, Serruys PW, Unger F, et al. Three-year outcome after coronary stenting versus bypass surgery for the treatment of multivessel disease. Circulation. 2004; 109: 11141120.
14. Moses JW, Leon MB, Popma JJ, et al, for the SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003; 349: 13151323.
15. Extended clinical trial results and registry data show durable safety and efficacy for drug eluting stents, even in the "real" world. Heartwire. Available at: http://www.theheart.org. Accessed February 20, 2004.
16. Berger PB, Alderman EL, Nadel A, et al. Frequency of early occlusion and stenosis in the left internal mammary artery among patients undergoing CABG through a median sternotomy on conventional bypass: benchmark for the MIDCAB. Circulation. 1999; 100: 23532358.
17. de Canniere D, Jansens JL, Goldschmidt-Clermont P, et al. Combination of minimally invasive coronary bypass and percutaneous transluminal coronary angioplasty in the treatment of double-vessel coronary disease: two-year follow-up of a new hybrid procedure compared with "on-pump" double bypass grafting. Am Heart J. 2001; 142: 563570.[CrossRef][Medline] [Order article via Infotrieve]
18. Best PJM, Lennon R, Ting HH, et al. The impact of renal insufficiency on clinical outcomes in patients after percutaneous coronary interventions. J Am Coll Cardiol. 2002; 39: 11131119.
19. Transformation of heart care is putting specialists at odds. Wall Street Journal. September 10, 2003.
20. Zientek DM. Physician entrepreneurs, self-referral, and conflicts of interest: an overview. HEC Forum. 2003; 15: 111133.[CrossRef][Medline] [Order article via Infotrieve]
21. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy of Sciences Press; 2001.
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