doi: 10.1161/01.CIR.0000160371.73867.2E
(Circulation. 2005;111:e176-e177.)
© 2005 American Heart Association, Inc.
Correspondence |
Letter Regarding Article by Hlatky et al, "Medical Costs and Quality of Life 10 to 12 Years After Randomization to Angioplasty or Bypass Surgery for Multivessel Coronary Artery Disease"
Department of Cardiology, Birmingham Heartlands Hospital, Birmingham, United Kingdom
We wish to respond to the article published recently by Hlatky and colleagues in Circulation.1 The study found that early differences between coronary artery bypass grafting (CABG) and angioplasty (PTCA) in costs and quality of life were no longer significant at 10 to 12 years and that CABG was cost-effective as compared with PTCA for multivessel disease. We would like to make a few comments on this study and its findings.
The original BARI (Bypass Angioplasty Revascularization Investigation) trial2 compared PTCA with CABG for multivessel disease; however, coronary stents were not used during the initial revascularization. With the advances in technology in percutaneous coronary intervention (PCI) and widespread use of coronary stents and glycoprotein IIb/IIIa receptor antagonists since the BARI trial began, the outcome in terms of medical costs and quality of life in these patients 10 to 12 years after PTCA may well be entirely different. This is particularly true since the development and use of drug-eluting stents in clinical practice. Stents have been shown to reduce the prevalence of subsequent restenosis as compared with PTCA alone, and the use of drug-eluting stents has reduced the risk of in-stent restenosis even further.3 This would clearly have a significant clinical and economic impact in both the short and long term. The need for repeat revascularization in patients undergoing PTCA with stents (and especially drug-eluting stents) would be considerably reduced.
It must be recognized, however, that stents, especially drug-eluting stents, and glycoprotein IIb/IIIa receptor antagonists would also increase the cost of PCI. CABG has advanced in the past 10 years, and conclusions based on older techniques may not be entirely relevant now.
The original study also found that diabetic patients had a better 5-year survival rate after CABG as compared with PTCA.2 In the 10- to 12-year follow-up, these patients had "higher costs and lower survival rates" with PTCA as compared with CABG.1 Once again, these data reflect the use of PTCA without the use of stents and in particular drug-eluting stents. Current data suggest that diabetic patients do better with drug-eluting stents,4 and this may influence subsequent need for revascularization and hence costs.
The study by Hlatky et al1 provides important information on the long-term follow-up of patients undergoing PTCA versus CABG, but advances in technology in PCI and CABG make it difficult to make temporal assumptions about the older techniques used in the BARI trial.
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References |
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 Top References References |
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- Hlatky MA, Boothroyd DB, Melsop KA, Brooks MM, Mark DB, Pitt B, Reeder GS, Rogers WJ, Ryan TJ, Whitlow PL, Wiens RD. Medical costs and quality of life 10 to 12 years after randomization to angioplasty or bypass surgery for multivessel coronary artery disease. Circulation. 2004; 110: 1960–1966.
[Abstract/Free Full Text]
- Comparison of coronary bypass surgery with angioplasty in patients with multivessel disease. The Bypass Angioplasty Revascularization Investigation (BARI) Investigators. N Engl J Med. 1996; 335: 217–225.
[Abstract/Free Full Text]
- Di Mario C, Griffiths H. Treating multivessel disease in the era of coated stents: conclusion. Heart. 2004; 90: 1003.
[Free Full Text]
- Sarembock IJ. Stent restenosis and the use of drug-eluting stents in patients with diabetes mellitus. Curr Diab Rep. 2004; 4: 13–19.[Medline]
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Response
Stanford University School of Medicine, Stanford, Calif
The University of Pittsburgh, Pittsburgh, Pa
Duke University, Durham, NC
The University of Michigan, Ann Arbor, Mich
The Mayo Clinic, Rochester, Minn
The University of Alabama at Birmingham, Birmingham, Ala
The Boston University School of Medicine, Boston, Mass
The Cleveland Clinic, Cleveland, Ohio
Saint Louis University,, St. Louis, Mo
Randomized trials are necessary for unbiased comparisons of treatments. Most trials report short-term results (
1 year), but this time frame may be insufficient to capture all relevant outcomes. Long-term reports of clinical trials provide a more complete picture of clinical results, but they are feasible only for older technologies. This inherent tension between the need for long-term outcomes from clinical trials and the need to evaluate new treatments is difficult to resolve. Nevertheless, careful analysis of long-term results can provide reliable benchmarks for evaluating newer developments.1
BARI (Bypass Angioplasty Revascularization Investigation) was one of the pivotal clinical trials comparing angioplasty and surgery, but it was completed before the use of coronary stents. We performed a simulation to project the results of BARI if bare metal stents had been used instead of balloon angioplasty.2 This simulation found that routine use of stents would increase total costs as compared with angioplasty, despite reducing restenosis by 29% per lesion.2 By contrast, the cost of bypass surgery has been reduced over time, so that the total cost of routine stenting would actually be 2.5% higher than the cost of bypass surgery.2 We project that patients undergoing bypass surgery would have higher life expectancy and pay a lower cost.3
Drug-eluting stents are now available, and their cost-effectiveness relative to bypass surgery has not been evaluated by head-to-head clinical trials. There are no trial data that show that drug-eluting stents significantly lower costs as compared with bare metal stents. The SIRIUS (Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions) study found the 1-year costs of patients assigned to the drug-eluting stent were 2% higher than they were for the bare metal stent.4 This observation suggests that drug-eluting stents do not reduce aggregate costs, despite their effectiveness in reducing repeat revascularization procedures.
Drug-eluting stents do not reduce the risk of mortality or myocardial infarction,5 and they do not reduce total cost. Consequently, we believe the basic conclusions of the BARI economic analysis are still sound.
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References |
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TopReferencesReferences |
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- Hlatky MA, Boothroyd DB, Melsop KA, Brooks MM, Mark DB, Pitt B, Reeder GS, Rogers WJ, Ryan TJ, Whitlow PL, Wiens RD. Medical costs and quality of life 10 to 12 years after randomization to angioplasty or bypass surgery for multivessel coronary artery disease. Circulation. 2004; 110: 1960–1966.
[Abstract/Free Full Text]
- Yock CA, Boothroyd DB, Owens DK, Winston C, Hlatky MA. Projected long-term costs of coronary stenting in multivessel coronary disease based on the experience of the Bypass Angioplasty Revascularization Investigation (BARI). Am Heart J. 2000; 140: 556–564.[CrossRef][Medline]
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- Yock CA, Boothroyd DB, Owens DK, Garber AM, Hlatky MA. Cost-effectiveness of bypass surgery versus stenting in patients with multivessel coronary artery disease. Am J Med. 2003; 115: 382–389.[CrossRef][Medline]
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- Cohen DJ, Bakhai A, Shi C, Githiora L, Lavelle T, Berezin RH, Leon MB, Moses JW, Carrozza JP Jr, Zidar JP, Kuntz RE; SIRIUS Investigators. Cost-effectiveness of sirolimus-eluting stents for treatment of complex coronary stenoses: results from the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) trial. Circulation. 2004; 110: 508–514.
[Abstract/Free Full Text]
- Babapulle MN, Joseph L, Bélisle P, Brophy JM, Eisenberg MJ. A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet. 2004; 364: 583–591.[CrossRef][Medline]
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Issue Highlights
Circulation 2005 111: 1567.[Full Text]
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