Drug-Eluting Stents for the Prevention and Management of Restenosis
DESCRIPTION
Most angioplasty procedures for coronary artery disease now include placement of conventional bare-metal stents, which have improved both short- and long-term success rates. Stents are small latticed metal tubes that act like scaffolds keeping open narrowed arteries feeding blood to the heart. A stent permanently stays in place to prop open the blood vessel, but the intrusion can cause injury/scarring of the arterial wall leading to in-stent restenosis. In-stent restenosis, which occurs in about 15% - 25% of individuals treated, is the primary limitation currently associated with the use of bare-metal stents and usually occurs during the first 6 months after stent placement. In-stent restenosis occurs in three forms: 1) diffuse neointimal hyperplasia throughout the stent; 2) discrete lesions within the body of the stent, which may result from tissue prolapse or initial inadequate coverage; and 3) margin restenosis, which is usually discrete and may result from a dissection caused by high pressure percutaneous transluminal coronary angioplasty (PTCA) at the time of implantation. The risk of in-stent restenosis is increased in individuals with diabetes, multivessel stenting, small vessels, long coronary lesions, occlusion in vein grafts, occlusion in vessel ostia, and history of prior in-stent restenosis.
Drug-eluting stents (DES) differ from conventional bare-metal stents in that they release a drug (e.g., sirolimus, paclitaxel) over a period of weeks. The eluting drug can block the formation of scar tissue cells during the crucial first few weeks after an angioplasty procedure; thus, significantly reducing the risk of in-stent restenosis.
POLICY
Drug-eluting stents, as an alternative to bare-metal stents, for the treatment of coronary artery disease are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise its use will be considered investigational.
MEDICAL APPROPRIATENESS
Drug-eluting stents are considered medically appropriate for individuals with symptomatic ischemic coronary artery disease that meet ALL of the following criteria:
De novo lesions
Native coronary artery
Lesion length less than or equal to 30 mm
Reference vessel diameter of greater than or equal to 2.5 mm and less than or equal to 3.5 mm
SOURCES
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BlueCross BlueShield of Tennessee network physicians. June 2003.
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Degertekin, M., Regar, E., Tanabe, K., Smits, P. C., van der Giessen, W. J., Carlier, S. G., et al. (2003). Sirolimus-eluting stent for treatment of complex in-stent restenosis: The first clinical experience. Journal of the American College of Cardiology, 41 (2), 184-189. Abstract retrieved May 7, 2003 from PubMed database. (Level 3 Evidence)
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ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2006, December). Drug-eluting stents for the treatment of coronary artery disease. Retrieved December 12, 2008 from ECRI Institute. (35 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Evidence Report. (2006, May). Drug-eluting stents for the treatment of coronary artery disease. Retrieved December 12, 2008 from ECRI Institute. (169 articles and/or guidelines reviewed)
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Morice, M. C., Serruys, P. W., Sousa, E., Fajadet, J., Hayashi, E. B., Perin, M., et al. (2002). A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. The New England Journal of Medicine, 346 (23), 1773-1780. (Level 1 Evidence - Industry sponsored)
Moses, J. W., Leon, M. B., Popma, J. J., Fitzgerald, P. J., Holmes, D. R., O’Shaughnessy, C., et al. (2003). Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. The New England Journal of Medicine, 349(14), 1315-1323. (Level 1 Evidence - Industry sponsored)
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Tanabe, K., Serruys, P. W., Grube, E., Smits, P. C., Selbach, G., van der Giessen, W. J., et al. (2003). TAXUS III Trial: In-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation. Circulation, 107 (4): 559-564.
Togni, M., Eber, S., Widmer, J., Billinger, M., Wenaweser, P., Cook, S., et al. (2007). Impact of vessel size on outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents: A subgroup analysis of the SIRTAX trial. Journal of the American College of Cardiology, 50 (12), 1123-31.
U. S. Food and Drug Administration. (2003, April). Center for Devices and Radiological Health. CYPHER™ sirolimus-eluting coronary stent on RAPTOR® over-the-wire delivery system or RAPTORRAIL® rapid exchange delivery system - P020026. Retrieved December 12, 2008 from http://www.fda.gov/cdrh/pdf2/p020026.html.
ORIGINAL EFFECTIVE DATE: 11/1/2003
MOST RECENT REVIEW DATE: 1/8/2009
ID_BT
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