European Heart Journal Advance Access originally published online on November 24, 2006
European Heart Journal 2006 27(24):3075-3076; doi:10.1093/eurheartj/ehl408
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Lack of efficacy and cost-effectiveness of drug-eluting stents
Norfolk Suffolk and Cambridgeshire Local Specialised Commissioning Group
Department of Public Health
Victoria House
Capital Park
Fulbourn
Cambridge CB1 5XB
UK
Tel: +44 7803591859
Fax: +44 1223597721
E-mail address: georgios.lyratzopoulos{at}eoe.nhs.uk
The findings of the meta-analysis about the comparative efficacy of drug-eluting stents (DESs) compared with bare-metal stents (BMSs) by Nordmann et al.1 both re-affirm and enhance those observed in previous research. Katritsis et al.2 have also demonstrated the lack of any efficacy superiority of DES over BMS, during the relatively short-term follow-up of between six and 12 months from intervention.
Unsurprisingly for a health intervention with questionable clinical efficacy, the cost-effectiveness ratios of the current practice of nearly routine use of DES represent poor use of available resources. A study using high-quality ‘real-world’ registry data has indicated that at current pricing levels, DESs are likely to be cost-effective for a much smaller minority of patients than originally thought (probably <5%).3 Someone would have expected that DES manufacturers may have changed their pricing policies in response to this health economics evidence, but there is little evidence or information about any such change.
Unlike the opinion expressed by Nordmann et al.,1 their findings do not question DES's safety—the issue is one of lack of efficacy. The hypothesis that DES may, during a short follow-up period of up to 5 years, produce the necessary genomic changes required for the development of cancer is biologically highly implausible. Cancer-related deaths observed in their study are much more likely to represent small numbers chance effects. The lack of any DES efficacy superiority persists, even when non-cardiac deaths are excluded.1 Patients need, and deserve, reassurance that although the evidence questions whether DESs work any better than BMSs, they are actually safe. Moreover, the findings do not question the superiority of angioplasty with stenting (of whatever type) compared with angioplasty alone. Policy-makers should also not lose sight of the fact that primary coronary intervention may, by an overall small degree, be more cost-effective compared with coronary artery bypass grafting.4
Some authorities as well as members of the interventional cardiology community appear to be in a state of denial about the increasing body of evidence questioning both DES's effectiveness and cost-effectiveness. This is disappointing in the era of evidence-based medicine. Moreover, the British Cardiovascular Intervention Society Council recommends Clopidogrel usage, in combination with aspirin, for up to 12 months after DES placement.5 This consensus-based recommendation has a poor evidence basis, and the only current certainty about its impact is that it may produce a small but appreciable excess number of otherwise avoidable haemorrhagic events and an even worse cost-effectiveness ratio for DES usage.
References
- Nordmann AJ, Briel M, Bucher HC. (2006) Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a meta-analysis. Eur Heart J Epub ahead of print.
- Katritsis DG, Karvouni E, Ioannidis JP. (2005) Meta-analysis comparing drug-eluting stents with bare metal stents. Am J Cardiol 95:640–643.[CrossRef][Web of Science][Medline]
- Bagust A, Grayson AD, Palmer ND, Perry RA, Walley T. (2006) Cost effectiveness of drug eluting coronary artery stenting in a UK setting: cost-utility study. Heart 92:68–74.
[Abstract/Free Full Text] - Stroupe KT, Morrison DA, Hlatky MA, Barnett PG, Cao L, Lyttle C, Hynes DM, Henderson WG. (2006) Investigators of Veterans Affairs Cooperative Studies Program 385 (AWESOME: Angina With Extremely Serious Operative Mortality Evaluation) Cost-effectiveness of coronary artery bypass grafts versus percutaneous coronary intervention for revascularization of high-risk patients. Circulation 114:1251–1257 Epub 2006 Sep 11.
- . British Cardiovascular Interventional Society (BCIS) Council statement on stent thrombosis: drug eluting stents. http://www.bcis.org.uk/ (accessed 20 October 2006).
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