Medical Policy



Subject: Intravascular Brachytherapy (Coronary and Non-Coronary)
Document #: THER-RAD.00003 Current Effective Date:    06/28/2017
Status: Reviewed Last Review Date:    05/04/2017

Description/Scope

This document addresses the use of intravascular brachytherapy (IVB), which is a technique that utilizes gamma or beta radiation to treat stenoses occurring at the site of a prior stent (that is, in-stent restenosis). IVB has been investigated primarily in the coronary arteries but also in the femoropopliteal system. This document addresses IVB in the coronary arteries and also in non-coronary vessels such as the femoropopliteal system.

Note: Please see the following related document for additional information:

Position Statement

Medically Necessary:

Intravascular coronary brachytherapy, also called intracoronary brachytherapy (ICB), is considered medically necessary as a treatment of in-stent restenosis.

Investigational and Not Medically Necessary:

Intravascular coronary brachytherapy is considered investigational and not medically necessary for all other uses not specified above as medically necessary, including, but not limited to, the following:

Non-coronary intravascular brachytherapy is considered investigational and not medically necessary for the treatment or prevention of stenosis or restenosis in blood vessels, including, but not limited to, the femoropopliteal vessels.

Rationale

Intravascular Coronary Brachytherapy
There are well-designed, randomized, clinical trials evaluating the effectiveness of brachytherapy using gamma or beta radiation for the management of coronary in-stent restenosis. The outcomes of these trials report that individuals receiving brachytherapy have statistically significant reductions in restenosis and in target lesion revascularization rates (Leon, 2001; Popma, 2002; Waksman, 2002a; Waksman, 2002b; Waksman, 2003), although long-term studies have reported late occurrences of restenosis (Grise, 2002; Maeder, 2008; Meerkin, 2002; Silber, 2005). While there was initial interest in IVB as a first-line treatment of stenoses, clinical trials have suggested that drug-eluting stents are preferred in preventing in-stent restenosis (Ellis, 2008; Oliver, 2008; Park, 2008). Restenosis following bare-metal stent implantation has a high recurrence rate (Holmes, 2008). Clinical trials show that the treatment of restenosis with drug-eluting stents after implantation of bare-metal stents results in better clinical outcomes such as improved event-free survival and reduced angiographic restenosis (Stone, 2006; Holmes, 2006).

Lu (2011) conducted a meta-analysis to compare the outcomes of drug-eluting stents versus ICB for in-stent restenosis. Twelve studies met study criteria and were reviewed; four trials were randomized and eight were nonrandomized. The mid-term follow-up period was 6 to 12 months. Target-vessel revascularization data showed an odds ratio of 0.44% suggesting the occurrence of target-vessel revascularization was significantly reduced by the use of drug-eluting stents. A subgroup analysis showed a difference in the result between the randomized trials and nonrandomized trials with a benefit shown in the drug-eluting stents versus no benefit in the nonrandomized trials. At mid-term follow-up, binary restenosis was found to have occurred in 13.9% of individuals treated with drug-eluting stents and 29.5% of those individuals treated with ICB. At the mid-term follow-up period, late lumen loss showed no significant effect of the use of drug-eluting stents in the randomized trials, but showed a significant reduction in the non-randomized trials. During the mid-term follow-up period, no differences were noted between drug-eluting stents and ICB in cardiac death, myocardial infarction and late stent restenosis. A long-term follow-up period of 24 to 36 months was recorded for target-vessel revascularization, cardiac death and myocardial infarction (insufficient data was provided to perform long-term follow-up analysis for binary stenosis and late lumen loss). A significant difference was found for target-vessel revascularization (odds ratio: 0.61, 95% confidence interval [CI]: 0.43-0.86, P=0.005). There were no significant differences found between drug-eluting stents versus ICB for cardiac death and myocardial infarction. These findings suggest that the use of drug-eluting stents for in-stent restenosis when compared with ICB appears to be associated with reduced occurrences of target-vessel revascularization and binary restenosis, there may be a possible benefit from drug-eluting stents in late lumen loss reduction, but drug-eluting stents were not superior to ICB in reducing death or myocardial infarction.

The American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions in their 2011 Guideline for Percutaneous Coronary Intervention, note that lower rates of restenosis occur with the use of drug-eluting stents when compared to bare-metal stents or vascular brachytherapy and does not recommend brachytherapy for the prevention of restenosis.

Intravascular Non-coronary Brachytherapy
IVB has also been investigated as an adjunct to percutaneous transluminal angioplasty of the femoropopliteal system. While the greatest amount of clinical experience with IVB is in the coronary artery system, there are a number of important differences that preclude extrapolation of results from the coronary to the peripheral arterial system. There is greater anatomic variability in peripheral arteries than coronary arteries, such as length, diameter, thickness, curvature, and orientation. The larger size of peripheral arteries necessitates treatment with a high-energy gamma radiation source, rather than the beta radiation, which is more commonly used for the coronary arteries. Gamma radiation sources for IVB are not currently marketed in the United States, so it is unlikely that this procedure is commonly performed.

Studies have focused on IVB as both an adjunct to primary angioplasty or as a treatment of restenosis. One randomized trial enrolled 113 individuals with either de novo or restenotic lesions of the femoropopliteal system who underwent angioplasty with or without IVB (Wolfram, 2005). At 6 month follow-up, the restenosis rate was lower in the IVB group compared to the angioplasty group. However, by 5 year follow-up, there were no differences in the stenosis rate between the two groups. Diehm and colleagues (2005) reported on the results of a similarly designed trial enrolling 147 individuals. These authors also reported that the short-term improvements in restenoses associated with IVB were not maintained in the longer term.

Mitchell et al (2012) reported on a literature review and meta-analysis of randomized clinical trials for brachytherapy and restenosis following lower limb angioplasty. A total of six trials were identified (687 participants). All six trials reported 12-month data with respect to restenosis; 99/343 brachytherapy participants had restenosis at 12 months versus 147/344 control participants with restenosis at 12 months (pooled odds ratio 0.50; 95% CI, 0.301-0.836; p=0.008). At 24 months, three trials reported data regarding restenosis; 43/154 brachytherapy participants had restenosis versus 82/157 controls (pooled odds ratio 0.32; 95% CI, 0.02-1.621; p=0.17). Rates for re-intervention within 12 months were reported by four trials; 25/166 required re-intervention versus 41/171 controls (pooled odds ratio 0.53; 95% CI, 0.272-1.017; p=0.06). Three trials reported the development of a new stenosis in the irradiated artery within the first year, but it was outside the previously irradiated area (16/109 brachytherapy participants versus 3/115 controls; pooled odds ratio 8.65; 95% CI, 2.176-34.391; p=0.002). With small sample sizes in the trials, it is suggested that there is some early benefit of brachytherapy, but there is an increased risk of new lesions developing and there is a lack of long-term reductions in risk.

The American College of Cardiology Foundation (ACCF)/AHA guideline for the management of patients with peripheral artery disease (Gerhard-Herman 2016) does not include any recommendations for IVB of the femoropopliteal system.

Background/Overview

IVB involves the temporary placement of radioactive substances, usually in the form of a thin catheter filled with radioactive seeds, a radioactive wire, or a balloon coated or filled with radioactive material, into previously cleared vessels at the site of restenosis. When used to treat lesions in the coronary arteries, IVB is referred to as ICB. Radiation reduces the proliferation of the vessel's smooth muscle cells, preventing or delaying long-term occurrence of restenosis.

Definitions

De novo: Something that is newly developed or was not previously present. In the context of this document, de novo refers to new stenotic lesions either in previously untreated vessels or vessels that have received prior ICB but at a new location adjacent to the existing lesion.

Intravascular brachytherapy: A type of medical therapy that involves the placement of a radioactive substance at the site of a previously cleared blood vessel. This therapy is intended to treat recurrences of vessel blockages.

Percutaneous transluminal angioplasty (PTA): A procedure for enlarging a narrowed vascular lumen by inflating and withdrawing through the stenotic region a balloon on the tip of an angiographic catheter. This may include positioning of an intravascular endoluminal stent.

Restenosis: A recurrence of narrowing or constriction.

Stenosis: A constriction or narrowing of a passage.

Stent: A wire mesh tube-like device used to prop open an artery after initial angioplasty.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Intravascular Coronary Brachytherapy
When services may be Medically Necessary when criteria are met: 

CPT  
77770 Remote afterloading high dose rate radionuclide interstitial or intracavitary brachytherapy, includes basic dosimetry, when performed; 1 channel [when specified as coronary intravascular brachytherapy]
77771 Remote afterloading high dose rate radionuclide interstitial or intracavitary brachytherapy, includes basic dosimetry, when performed; 2-12 channels [when specified as coronary intravascular brachytherapy]
77772 Remote afterloading high dose rate radionuclide interstitial or intracavitary brachytherapy, includes basic dosimetry, when performed; over 12 channels [when specified as coronary intravascular brachytherapy]
92974 Transcatheter placement of radiation delivery device for subsequent coronary intravascular brachytherapy
   
ICD-10 Procedure  
02700T6-02734TZ Dilation of coronary artery, with radioactive intraluminal device [by number of arteries and approach; includes codes 02700T6, 02700TZ, 02703T6, 02703TZ, 02704T6, 02704TZ, 02710T6, 02710TZ, 02713T6, 02713TZ, 02714T6, 02714TZ, 02720T6, 02720TZ, 02723T6, 02723TZ, 02724T6, 02724TZ, 02730T6, 02730TZ, 02733T6, 02733TZ, 02734T6, 02734TZ]
   
ICD-10 Diagnosis  
  All coronary vascular diagnoses including, but not limited to, the following:
T82.855A-T82.855S Stenosis of coronary artery stent

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Non-coronary Intravascular Brachytherapy
When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT  
77770 Remote afterloading high dose rate radionuclide interstitial or intracavitary brachytherapy, includes basic dosimetry, when performed; 1 channel [when specified as non-coronary intravascular brachytherapy]
77771 Remote afterloading high dose rate radionuclide interstitial or intracavitary brachytherapy, includes basic dosimetry, when performed; 2-12 channels [when specified as non-coronary intravascular brachytherapy]
77772 Remote afterloading high dose rate radionuclide interstitial or intracavitary brachytherapy, includes basic dosimetry, when performed; over 12 channels [when specified as non-coronary intravascular brachytherapy]
93799 Unlisted cardiovascular service or procedure [when specified as transcatheter placement of radiation delivery device for non-coronary intravascular brachytherapy]
   
ICD-10 Diagnosis  
  Noncoronary vascular disease diagnoses, including but not limited to, the following:
I70.0-I70.92 Atherosclerosis
I73.9 Peripheral vascular disease, unspecified
I74.0-I74.9 Arterial embolism and thrombosis
I75.011-I75.89 Atheroembolism
I77.1 Stricture of artery
T82.818D Embolism due to vascular prosthetic devices, implants and grafts, subsequent encounter
T82.818S Embolism due to vascular prosthetic devices, implants and grafts, sequela
T82.856A-T82.856S Stenosis of peripheral vascular stent
T82.858D Stenosis of other vascular prosthetic devices, implants and grafts, subsequent encounter
T82.858S Stenosis of other vascular prosthetic devices, implants and grafts, sequela
T82.868D Thrombosis due to vascular prosthetic devices, implants and grafts, subsequent encounter
T82.868S Thrombosis due to vascular prosthetic devices, implants and grafts, sequela
   
References

Peer Reviewed Publications:

  1. Diehm N, Silvestro A, Do DD et al. Endovascular brachytherapy after femoropopliteal balloon angioplasty fails to show robust clinical benefit over time. J Endovasc Ther. 2005; 12(6):723-730.
  2. Ellis SG, O'Shaughnessy, Martin SL et al. Two year clinical outcomes after paclitaxel-eluting stent or brachytherapy treatment for bare metal stent restonsis: the TAXUS V ISR trial. Eur Heart J 2008; 29(13):1595-1596.
  3. Feres F, Munoz JS, Abizaid A, et al. Comparison between sirolimus-eluting stents and intracoronary catheter-based beta radiation for the treatment of in-stent restenosis. Am J Cardiol. 2005; 96(12):1656-1662.
  4. Grise MA, Massullo V, Jani S et al. Five-year clinical follow-up after intracoronary radiation: results of a randomized clinical trial. Circulation. 2002; 105(23):2737-2740.
  5. Holmes DR Jr, 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):1264-1273.
  6. Holmes DR Jr, Teirstein PS, Satler L, et al. 3-year follow-up of the SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial. JACC Cardiovasc Interv. 2008; 1(4):439-448.
  7. Leon MB, Teirstein PS, Moses JW, et al. Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting. N Engl J Med. 2001; 344(4):250-256.
  8. Lu YG, Chen YM, Li L, et al. Drug-eluting stents vs. intracoronary brachytherapy for in-stent restenosis: a meta-analysis. Clin Cardiol. 2011; 34(6):344-351.
  9. Maeder MT, Pfisterer ME, Buser PT et al. Long-term outcomes after intracoronary Beta-irradiation for in-stent restenosis in bare-metal stents. J Invasive Cardiol. 2008; 20(4):179-184.
  10. Meerkin D, Joyal M, Tardif JC et al. Two-year angiographic follow-up of intracoronary Sr90 therapy for restenosis prevention after balloon angioplasty. Circulation. 2002; 106(5):539-543.
  11. Mitchell D, O'Callaghan AP, Boyle EM, et al. Endovascular brachytherapy and restenosis following lower limb angioplasty: Systematic review and meta-analysis of randomized clinical trials. Int J Surg. 2012; 10(3):124-128.
  12. Oliver LN, Buttner PG, Hobson H, Golledge J. A meta-analysis of randomised controlled trials assessing drug-eluting stents and vascular brachytherapy in the treatment of coronary artery in-stent restenosis. Int J Cardiol. 2008; 126(2):216-223.
  13. Park SW, Lee SW, Koo BK et al. Treatment of diffuse in-stent restenosis with drug eluting stents vs. intracoronary beta-radiation therapy. Int J. Cardiol 2008; 131(1):70-77.
  14. Pohl T, Kupatt C, Steinbeck G, Boekstegers P. Angiographic and clinical outcome for the treatment of in-stent restenosis with sirolimus-eluting stent compared to vascular brachytherapy. Z Kardiol. 2005; 94(6):405-410.
  15. Popma JJ, Suntharalingam M, Lansky AJ, et al. Randomized trial of 90Sr/90Y beta-radiation versus placebo control for treatment of in-stent restenosis. Circulation. 2002; 106(9):1090-1096.
  16. Serruys PW, Wijns W, Sianos G et al. Direct stenting versus direct stenting followed by centered beta-radiation with intravascular ultrasound-guided dosimetry and long term anti-platelet treatment: Results of a randomized trial: Beta-Radiation Investigation with Direct Stenting and Galileo in Europe (BRIDGE). J Am Coll Cardiol. 2004; 44(3):528-537.
  17. Silber S, Popma JJ, Suntharalingam M, et al. START Investigators. Two-year clinical follow-up of 90Sr/90 Y beta-radiation versus placebo control for the treatment of in-stent restenosis. Am Heart J. 2005; 149(4):689-694.
  18. Stone GW, Ellis SG, O'Shaughnessy CD, et al. Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA. 2006; 295(11):1253-1263.
  19. Waksman R, Ajani AE, White RL, et al. Five-year follow-up after intracoronary gamma radiation therapy for in-stent restenosis. Circulation. 2004; 109(3):340-344.
  20. Waksman R, Ajani AE, White RL et al. Intravascular gamma radiation for in-stent restenosis in saphenous-vein bypass grafts. N Engl J Med. 2002a; 346(16):1194-1199.
  21. Waksman R, Raizner AE, Yeung AC, et al. Use of localized intracoronary beta radiation in treatment of in-stent restenosis: the INHIBIT randomized controlled trial. Lancet. 2002b; 359(9306):551-557.
  22. Wolfram RM, Budinsky AC, Pokrajac B, et al. Vascular brachytherapy with 192lr after femoropopliteal stent implantation in high risk patients: twelve month follow-up results from the Vienna-5 trial. Radiology. 2005; 236(1):343-351.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, et al. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2016: S0735-1097(16)36902-9.
  2. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention. a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011; 58(24):e44-122.
Websites for Additional Information
  1. The American Heart Association. Available at: http://www.americanheart.org/. Accessed on March 10, 2017.
Index

Brachytherapy, Intravascular Coronary
Brachytherapy, Intravascular Non-Coronary
Novoste Beta-Cath System

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed 05/04/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale and References sections.
  10/01/2016 Updated Coding section with 10/01/2016 ICD-10-CM diagnosis code changes and ICD-10-PCS procedure code descriptor changes.
Reviewed 05/05/2016 MPTAC review. Updated Rationale and References sections.
  01/01/2016 Changed the document number from RAD.00016 to THER-RAD.00003. Updated Coding section with 01/01/2016 CPT changes, removed codes 77785, 77786, 77787 deleted 12/31/2015; also removed ICD-9 codes.
Reviewed 05/07/2015 MPTAC review. Updated Description/Scope.
Reviewed 05/15/2014 MPTAC review.
Reviewed 05/09/2013 MPTAC review. Updated Rationale and References.
Reviewed 05/10/2012 MPTAC review. Updated Rationale and References.
Reviewed 05/19/2011 MPTAC review. Updated Rationale and References.
Reviewed 05/13/2010 MPTAC review. No change to Position Statement.
Reviewed 05/21/2009 MPTAC review. Updated References and Web Sites.
  01/01/2009 Updated Coding section with 01/01/2009 CPT changes; removed 77781, 77782, 77783, 77784 deleted 12/31/2008.
Reviewed 05/15/2008 MPTAC review. References and Web Sites updated.
  02/21/2008 The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.
Reviewed 05/17/2007 MPTAC review. No change to criteria. References and Coding Sections were updated.
Reviewed 06/08/2006 MPTAC review. No change to criteria. References were updated to include recently published articles regarding trials data outcomes and the 2005 ACC/AHA/SCAI Guideline Update for Percutaneous Coronary Intervention. 
Revised 07/14/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.  
Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

04/27/2004

RAD.00016 Intravascular Brachytherapy (Coronary and Non-Coronary)
WellPoint Health Networks, Inc.

12/02/2004

4.04.08 Intracoronary Brachytherapy