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Cardiovascular Device Technology and Health Care Cost—Reply

Cardiovascular Device Technology and Health Care Cost—Reply In reply I agree with Dr Dean's statement that the “application of therapy should be based on the evidence.” That is why it is disappointing that he refers to the “life-saving properties” of DESs without offering support for this statement. Indeed, significant mortality benefits have not been seen with DESs.1 The end point used in almost all large, high-quality randomized controlled trials on this subject is a composite outcome, largely driven by decreased need for revascularization. We all recognize that some off-label use of medications may be appropriate because of therapies developed prior to our current standards of medical research or because of rare situations. However, it is inappropriate to broaden the use of invasive, expensive devices with known adverse effects, in the absence of data demonstrating that the benefits are greater than the risks. Although it is true, as Dr Dean notes, that there may be evidence supporting an off-label use of a drug or procedure, given the tremendous profits in the sale of DESs, it is certainly likely that a company with strong data for an off-label indication would be seeking an expansion of labeling from the Food and Drug Administration. Back to top Article Information Correspondence: Dr Redberg, Department of Medicine, University of California, San Francisco, 505 Parnassus, Ste M1180, San Francisco, CA 94143 (redberg@medicine.ucsf.edu). Financial Disclosure: None reported. References 1. Greenhalgh J, Hockenhull J, Rao N, Dundar Y, Dickson RC, Bagust A. Drug-eluting stents versus bare metal stents for angina or acute coronary syndromes. Cochrane Database Syst Rev. 2010;(5):CD00458720464732PubMedGoogle Scholar http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Internal Medicine American Medical Association

Cardiovascular Device Technology and Health Care Cost—Reply

Archives of Internal Medicine , Volume 171 (18) – Oct 10, 2011

Cardiovascular Device Technology and Health Care Cost—Reply

Abstract

In reply I agree with Dr Dean's statement that the “application of therapy should be based on the evidence.” That is why it is disappointing that he refers to the “life-saving properties” of DESs without offering support for this statement. Indeed, significant mortality benefits have not been seen with DESs.1 The end point used in almost all large, high-quality randomized controlled trials on this subject is a composite outcome, largely driven by decreased need...
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Publisher
American Medical Association
Copyright
Copyright © 2011 American Medical Association. All Rights Reserved.
ISSN
0003-9926
eISSN
1538-3679
DOI
10.1001/archinternmed.2011.465
Publisher site
See Article on Publisher Site

Abstract

In reply I agree with Dr Dean's statement that the “application of therapy should be based on the evidence.” That is why it is disappointing that he refers to the “life-saving properties” of DESs without offering support for this statement. Indeed, significant mortality benefits have not been seen with DESs.1 The end point used in almost all large, high-quality randomized controlled trials on this subject is a composite outcome, largely driven by decreased need for revascularization. We all recognize that some off-label use of medications may be appropriate because of therapies developed prior to our current standards of medical research or because of rare situations. However, it is inappropriate to broaden the use of invasive, expensive devices with known adverse effects, in the absence of data demonstrating that the benefits are greater than the risks. Although it is true, as Dr Dean notes, that there may be evidence supporting an off-label use of a drug or procedure, given the tremendous profits in the sale of DESs, it is certainly likely that a company with strong data for an off-label indication would be seeking an expansion of labeling from the Food and Drug Administration. Back to top Article Information Correspondence: Dr Redberg, Department of Medicine, University of California, San Francisco, 505 Parnassus, Ste M1180, San Francisco, CA 94143 (redberg@medicine.ucsf.edu). Financial Disclosure: None reported. References 1. Greenhalgh J, Hockenhull J, Rao N, Dundar Y, Dickson RC, Bagust A. Drug-eluting stents versus bare metal stents for angina or acute coronary syndromes. Cochrane Database Syst Rev. 2010;(5):CD00458720464732PubMedGoogle Scholar

Journal

Archives of Internal MedicineAmerican Medical Association

Published: Oct 10, 2011

Keywords: health care costs,cardiovascular device

References

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