0

The full content of Annals is available to subscribers

Subscribe/Learn More  >
Reviews |

Narrative Review: Drug-Eluting Stents for the Management of Restenosis: A Critical Appraisal of the Evidence

Roderick Tung, MD; Sanjay Kaul, MD; George A. Diamond, MD; and Prediman K. Shah, MD
[+] Article and Author Information

From Cedars-Sinai Medical Center, David Geffen School of Medicine, and University of California, Los Angeles, Los Angeles, California.


Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Sanjay Kaul, MD, Division of Cardiology, Room 5536, South Tower, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048.

Current Author Addresses: Drs. Tung, Kaul, Diamond, and Shah: Division of Cardiology, Room 5536, South Tower, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048.


Ann Intern Med. 2006;144(12):913-919. doi:10.7326/0003-4819-144-12-200606200-00009
Text Size: A A A

Interventional cardiologists have quickly replaced bare metal stents with intravascular drug-eluting stents for treating and preventing restenosis, largely on the basis of empirical evidence that shows profound reduction in angiographic and clinical restenosis. A critical reassessment of the published evidence, however, suggests that the putative superiority of intravascular drug-eluting stents is founded on questionable premises, including 1) overestimation of restenosis benefit, 2) underestimation of the risk for stent thrombosis, 3) overreliance on “soft” rather than “hard” outcomes (need for repeated revascularization vs. death or myocardial infarction), and 4) the attendant overestimation of cost-effectiveness. Because the long-term incremental risks, benefits, and costs of drug-eluting stents have not yet been optimally evaluated in a broad spectrum of patient and lesion cohorts, the rational role of these devices in clinical management warrants reappraisal.

Figures

Grahic Jump Location
Figure 1.
Influence of protocol-mandated angiography on target lesion revascularization.TLRMACETVFntopnbottom(18)

Event-free survival for target lesion revascularization ( ), major adverse cardiac event ( ), and target vessel failure ( ) for patients undergoing protocol-mandated angiography (   = 850) in the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) trial ( ) and TLR rates in patients without protocol-mandated angiography (   = 208) ( ) are shown. Adapted from Holmes et al. . *Bx VELOCITY manufactured by Cordis Corp., Miami Lakes, Florida.

Grahic Jump Location
Grahic Jump Location
Figure 2.
Relationship between angiographic variables and clinical outcomes.topmiddlebottomnnnnP

“Late loss” refers to late lumen loss. Target lesion revascularization ( ), major adverse cardiac outcomes ( ), and target vessel failure ( ) are shown for 4 randomized trials of drug-eluting stents: 1 trial with sirolimus-eluting stent (Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions [SIRIUS] [   = 1058]) and 3 trials with paclitaxel-eluting stent (Treatment of De Novo Coronary Disease Using a Single Paclitaxel Eluting Stent [TAXUS]-IV [   = 1314], TAXUS-V [   = 1156], and Drug-Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Lesions [DELIVER] [   = 1041]). Mean (range) reference vessel diameter and lesion length are as follows: SIRIUS, 2.8 mm (2.5 mm–3.5 mm)  ×  14.4 mm (15.0 mm–30.0 mm); TAXUS-IV, 2.75 mm (2.50 mm–3.75 mm)  ×  13.4 mm (10.0 mm–28.0 mm); TAXUS-V, 2.69 mm (2.25 mm–4.00 mm)  ×  22.9 mm (10.0 mm–46 mm); DELIVER, 2.77 mm (2.50 mm–4.00 mm)  ×  11.1 mm (<25.0 mm). The following bare metal stents were used: Bx VELOCITY (Cordis Corp., Miami Lakes, Florida) in SIRIUS; Express (Boston Scientific, Natick, Massachusetts) in TAXUS-IV; Express II (Boston Scientific) in TAXUS-V; and MULTI-LINK PENTA (Guidant Corp., Santa Clara, California) in DELIVER. *   ≤ 0.05 vs. bare metal stent.

Grahic Jump Location
Grahic Jump Location
Figure 3.
Weighted composite end point analysis for the SIRIUS trial.Prrr(28)P

values are derived from a global z statistic under assumptions of perfect (   = 1.0), partial (   = 0.5), or no (   = 0) correlation among the components of the composite end point . A sensitivity analysis across a target vessel revascularization weight is also shown (the weight of death and myocardial infarction was fixed at 1.0 and 0.5, respectively). Only target vessel revascularization weights ≥ 0.5 achieve statistical significance (   ≤ 0.05) (values below dotted line). SIRIUS = Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions.

Grahic Jump Location

Tables

References

Letters

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Comments

Submit a Comment
Submit a Comment

Summary for Patients

Clinical Slide Sets

Terms of Use

The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.

Toolkit

Buy Now

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Advertisement
Related Articles
Related Point of Care
Topic Collections
PubMed Articles

Buy Now

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Forgot your password?
Enter your username and email address. We'll send you a reminder to the email address on record.
(Required)
(Required)