Drug-eluting Stents for the Treatment of Coronary Artery Disease: Review of Systematic Reviews

July 24, 2009 | Evidence Reports

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Drug-eluting stents (DESs) were developed to address the problem of in-stent restenosis, which occurs within 6 months of treatment in up to 20% of cases treated by bare-metal stent (BMS) implantation. DESs are coated with an active drug that can block the intimal cell division and/or inhibit inflammation that leads to restenosis. Once implanted, the drug elutes from the stent over the course of a few days to a few weeks and reaches a therapeutic concentration only in the local implantation area. Localized elution of the drug avoids potential risks associated with systemic exposure to the drug. At the time of this report, five DESs were commercially available on the U.S. market: the Cypher, TAXUS Express2 (including TAXUS Express2 Atom stent), TAXUS Liberte, Endeavor, and Xience V stents. These DESs are coated with sirolimus, paclitaxel, zotarolimus, or everolimus.

Percutaneous coronary intervention (PCI, balloon angioplasty with or without stent implantation) can be performed as either an inpatient or outpatient procedure, although inpatient procedures are considered the standard of care for stent implantation.

The following indications are approved product labeling by the U.S. Food and Drug Administration (FDA) for available DESs:

FDA’s premarket approval (PMA) documents...

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