Drug-eluting Stents

Medical Policy: 02.02.12 
Original Effective Date: October 2007 
Reviewed: August 2011 
Revised: July 2008 

Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

Description: 

Percutaneous coronary intervention (PCI) is the most frequently used method of myocardial revascularization. Atherectomy, brachytherapy, and implantation of coronary stents are interventions falling into the broader category of PCI. Restenosis following PCI with stents has been determined to occur in up to 20% of stented arteries, requiring repeat revascularization procedures. Drug-eluting stents were developed to address the problem of restenosis. They differ from bare-metal stents in that they release an antiproliferative drug believed to inhibit neointimal hyperplasia.

Several drug-eluting stents have received U.S. Food and Drug Administration (FDA) approval including:

• CYPHER™ Sirolimus-Eluting Coronary Stent, indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length ≤ 30mm in native coronary arteries with reference vessel diameter of ≥ 2.5mm to ≤ 3.5mm.
• ENDEAVOR™ Zotarolimus-Eluting Coronary Stent, indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length ≤ 27mm in native coronary arteries with reference vessel diameters of ≥ 2.5mm to ≤ 3.5mm.
• TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent, indicated for improving luminal diamter for the treatment of de novo lesions in native coronary arteries ≥ 2.25mm to ≤ 4.0mm in diameter in lesions ≤ 28mm in length, and within bare metal stent restenotic lesions ≥ 2.5mm to ≤3.75mm in diameter and ≤ 28mm in length.
• TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent, indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries ≥ 2.5mm to ≤ 4.0mm in diameter in lesions ≤ 28mm in length.
• XIENCE™V Everolimus-Eluting Stent, indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 28mm) with reference diameters of 2.5mm to 4.25mm.

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Prior Approval: 

Not applicable

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Policy: 

Drug-eluting stents may be considered medically necessary for the following indications:

• Treatment of symptomatic and/or ischemic heart disease due to de novo lesions in native coronary arteries
• Restenosis within a previously placed stent

Other uses of drug-eluting stents, including vein graft stenosis are considered investigational.

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Procedure Codes and Billing Guidelines: 

• To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
• G0290 Transcatheter placement of a drug eluting intracoronary stent(s), percutaneous, with or without other therapeutic intervention, any method; single vessel
• G0291 Transcatheter placement of a drug eluting intracoronary stent(s), percutaneous, with or without other therapeutic intervention, any method; each additional vessel
• 92980 Transcatheter placement of an intracoronary stent(s), percutaneous, with or without other therapeutic intervention, any method; single vessel
• 92981 Transcatheter placement of an intracoronary stent(s), percutaneous, with or without other therapeutic intervention, any method; each additional vessel (List separately in addition to code for primary procedure)

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Selected References: 

• Holmes DR, Teirstein P, Satler L et al. Sirolimus-Eluting Stents vs Vascular Brachytherapy for In-Stent Restenosis Within Bare-Metal Stents. The SISR Randomized Trial. JAMA 2006; 295(11):1264-72.
• Stone GW, Ellis SG, O’Shaughnessy CD et al. Paclitaxel-Eluting Stents vs Vascular Brachytherapy for In-Stent Restenosis Within Bare-Metal Stents. JAMA 2006; 295(11):1253-63.
• Eisenstein EL, Anstrom KJ, Kong DF et al. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation. JAMA 2007; 297(2): 209-11.
• Spaulding C, Daemen J, Boersma E et al A Pooled Analysis of Data Comparing sirolimus-eluting Stents with Bare Metal Stents. N Engl J Med. 2007 Mar 8;356(10):989-97.
• Stone GW, Moses JW, Ellis SG et al. Safety and Efficacy of Sirolimus- and Paclitaxel-eluting coronary stents. N Engl J Med. 2007 Mar 8; 356(10):998-1008.
• Kastrati A, Mehilli J, Pache J et al. Analysis of 14 Trials Comparing Sirolimus-eluting stents with Bare-Metal Stents. N Engl J Med. 2007 Mar 8;356(10):1030-9.
• Hodgson JM, Stone GW, Lincoff MA et al. Late stent thrombosis: Considerations and Practical Advice for the Use of Drug-eluting Stents: A Report from the Society for Cardiovascular Angiography and Interventions Drug-eluting Stent Task Force. Catheter Cardiovasc Interv. 2007 Mar; 69(3):327-33.
• Meier P, Zbinden R, Togni M et al. Coronary Collateral Function Long After Drug-eluting Stent Implantation. J Am Coll Cardiol. 2007 Jan 2;49(1):21-2.
• Camenzind E, Steg PG, Wijns W. Stent Thrombosis Late After Implantation of First-Generation Drug-eluting Stents. Circulation. 2007;115:1440-55.
• Daemen J, Wenaweser P, Tsuchida K et al. early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet 2007; 369:667-78.
• King SB III, Smith SC Jr., Hirshfeld JW Jr. et al.  2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention. JACC 2008; 51:172-209.
• Ruygrok P. SPIRIT II study: a clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions. J Am Coll Cardiol. 2007;49(suppl B):28B.
• Pocock SJ, Lansky AJ, Mehran R, et al. Angiographic surrogate endpoints in drug-eluting stent trials. J Am Coll Cardiol. 2008;51(1):23-32.
• Stone GW, Midei M, Newman W et al. Comparison of an everolimus-eluting stent with a paclitaxel-eluting stent in patients with coronary artery disease. A randomized trial. JAMA. 2008;299(16):1903-13.
• Miyazawa A, Ako J, Hongo Y et al. Comparison of vascular response to zotarolimus-eluting stent versus sirolimus-eluting stent: intravascular ultrasound results from ENDEAVOR III. Am Heart J 2008 Jan; 155(1):108-13.
• Toutouzas K, Patsa C, vaina S et al. Drug-eluting stents versus coronary artery bypass surgery in patients in isolated proximal lesion in left anterior artery descending artery suffering from chronic stable angina. Catheter Cardiovasc Interv. 2007 Nove 15; 70(6): 832-7.
• Jain AK, Meredith IT, Lotan C et al. Real-world safety and efficacy of the zotarolimus-eluting stent: early data from the E-Five Registry.
• Mehta RH, Leon MB, Sketch MH Jr. et al. The relation between clinical features, angiographic findings, and the target lesion revascularization rate in patients receiving the endeavor zotarolimus-eluting stent for treatment of native coronary artery disease: an analysis of ENDEAVOR I, ENDEAVOR II, ENDEAVOR II Continued Access Registry, and ENDEAVOR III. Am J Cardiol 2007 Oct 22; 100(8B);62M-72M.
• Meredith IT, Ormiston J, Whitbourn R et al. Four-year clinical follow-up after implantation of the endeavor zotarolimus-eluting stent: ENDEAVOR I, the first-in-human study. Am J Cardiol 2007 Oct 22; 100(8B);56M-61M.
• Kirtane AJ, Gupta A, Iyengar S et al. Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation. 2009 Jun30;119(25):3198-206. Epub 2009 Jun 15.
• Brar SS, Leon MB, Stone GW et al. Use of drug-eluting stents in acute myocardial infarction: a systematic review and meta-analysis. J Am Coll Cardiol. 2009 May 5;53(18):1677-89.
• Trikalinos TA, Alsheikh-Ali AA, Tatsioni A et al. Percutaneous coronary interventions for non-acute coronary artery disease: a quantitative 20 year synopsis and a network meta-analysis. Lancet. 2009 Mar 14;373(9667):911-8.
• Pfisterer M, Brunner-La Rocca HP, Rickenbacher P et al. Long-term benefit-risk balance of drug-eluting vs. bare-metal stents in daily practice: does stent diameter matter? Three-year follow-up of BASKET. Eur Heart J. 2009 Jan;30(1):16-24. Epub 2008 Nov 25.
• Jakabcin J, Spacek R, Bystron M et al. Long-term health outcome and mortality evaluation after invasive coronary treatment using drug eluting stents with or without the IVUS guidance. Randomized control trial. HOME DES IVUS. Catheter Cardiovasc Interv. 2010 Mar 1;75(4):578-83.
• Joyal D, Filion KB, Eisenberg MJ. Effectiveness and safety of drug-eluting stents in vein grafts: a meta-analysis. Am Heart J. 2010 Feb;159-69.e4.
• Colmenarez HJ, Escand J, Fernandez C et al. Efficacy and safety of drug-eluting stents in chronic total coronary occlusion recanalization: a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Apr 27;55(17):1854-66.
• Health technology forecast [database online]. Plymouth Meeting (PA): ECRI Institute; 2010 Apr 6.Drug-eluting coronary stents. Available: http://www.ecri.org
• Health technology forecast [database online]. Plymouth Meeting (PA): ECRI Institute; 2010 Apr 6.Drug-eluting and non-drug-eluting bioabsorbable stents for the coronary and peripheral arteries. Available: http://www.ecri.org
• Spinler SA. Percutaneous Coronary Intervention: Assessing Coronary Vascular Risk Associated with Bare-Metal and Drug-Eluting Stents. Am J Manag Care. 2009; 15:S42-47.

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Policy History: 

Date                                       Reason                               Action

August 2011                          Annual review                     Policy renewed

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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.