CAM 20211

Intravascular Brachytherapy for Preventing and Managing Restenosis after Percutaneous Transluminal Angioplasty (PTA)

Category:Medicine   Last Reviewed:July 2018
Department(s):Medical Affairs   Next Review:July 2999
Original Date:July 1999    

Description:
Intravascular brachytherapy in conjunction with percutaneous transluminal angioplasty (PTA) has been investigated primarily in the coronary arteries but also in the femoropopliteal system. In the coronary arteries, two clinical applications of intravascular brachytherapy have been investigated:

  1. As a technique to reduce the risk of de novo restenosis after intracoronary stent placement (i.e., in-stent restenosis).

    The risk of restenosis in patients who undergo percutaneous transluminal coronary angioplasty (PTCA) for coronary artery disease is estimated at 30-50 percent, based on angiographic studies. Placement of stents as an adjunct to PTCA is one strategy to reduce restenosis. It is estimated that approximately 75 percent of PTCAs performed in the United States include stent placement. However, even with stent placement, the restenosis rate (i.e., in-stent restenosis) is estimated at 20 percent. Intracoronary radiation has been investigated both as an alternative to stent placement to reduce the risk of restenosis and as an adjunctive technique at the time of stent placement to reduce the risk of in-stent restenosis. These applications of intracoronary brachytherapy are off-label indications.
  2. As a treatment of restenosis at the site of a prior intracoronary stent.

    As noted here, there is about a 20 percent risk of in-stent restenosis. Management of in-stent restenosis is notoriously ineffective, with recurrence rates of 30-70 percent. Management has included PTCA alone, restenting, laser angioplasty and rotational atherectomy. These therapies, however, are often ineffective, requiring medical management or surgical revascularization. Intracoronary brachytherapy is an alternative to these therapies for managing in-stent restenosis.

Intravascular brachytherapy has also been investigated as an adjunct to percutaneous transluminal angioplasty of the femoropopliteal systems, as a technique to reduce the risk of a de novo restenosis, either in native or grafted vessels, and with or without stent placement. The greatest amount of clinical experience with intravascular brachytherapy is in the coronary artery system. However, important differences preclude extrapolating results from coronary to peripheral arteries. There is greater anatomic variability in peripheral arteries than in coronary arteries in factors 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 beta radiation, which is more commonly used for the coronary arteries. High-energy radiation sources cannot be administered in most catheterization laboratories or radiology suites, necessitating treatment in the radiation oncology department, which increases logistical complexity for treating peripheral vessels. The use of adjunctive agents, such as stenting and antiplatelet drugs, while extremely common in the coronary arteries, is not as well established for peripheral angioplasty. Stenting has not been definitively shown to be superior to angioplasty alone, although it is used by many experts for certain types of lesions, such as longer segments of the iliac artery or ostial lesions of the aortic branch vessels.

The U.S. Food and Drug Administration (FDA) has approved devices intended for use in intracoronary brachytherapy, the Beta-Cath system (Novoste Corp), which delivers beta radiation, and the CheckMate system (Cordis), which delivers gamma radiation. In 2001, a second beta radiation device, the Galileo Intravascular Radiotherapy System (Guidant), was approved. Both of the beta devices have similar labeling approved by the FDA that limits the approved use of the devices to delivery of radiation to "the site of successful percutaneous coronary intervention" for the treatment of in-stent restenosis in native coronary arteries with discrete lesions. The wording of the gamma device’s approval is slightly different, saying it is "for use in the treatment of native coronary arteries with in-stent restenosis following percutaneous revascularization using current interventional techniques." There are currently no brachytherapy devices approved specifically for use in the peripheral arterial system. As of May 2007, the CheckMate and Galileo systems and devices for intravascular brachytherapy are no longer available, having been discontinued by their respective manufacturers. The Beta-Cath system is now manufactured and distributed by Best Vascular Inc.

Policy:

  • Intravascular coronary brachytherapy using gamma or beta-emitting radiation may be considered MEDICALLY NECESSARY to treat restenosis of a previously placed bare-metal stent in a native coronary artery.
  • Intravascular coronary brachytherapy using gamma radiation or beta-emitting radiation is considered INVESTIGATIONAL to treat or prevent restenosis of drug-eluting stents.
  • Intravascular coronary brachytheraphy using gamma radiation only may be considered MEDICALLY NECESSARY to treat in-stent restenosis of a non-native coronary artery (i.e., saphenous vein graft).
  • Intracoronary coronary brachytherapy to reduce the risk of a de novo restenosis, in conjunction with PTA with or without stent placement is considered INVESTIGATIONAL.
  • Intravascular brachytherapy of the femoropopliteal system is considered INVESTIGATIONAL.

Policy Guidelines
CPT coding for services associated with intracoronary brachytherapy may include a medical physicist, radiation therapist and cardiologist. The following CPT codes may be used to describe the professional services associated with intracoronary brachytherapy:

Radiation Therapy
Medical physicist:
77370: Special medical radiation physics consultation

Radiation therapist
The planning and delivery of intracoronary brachytherapy requires multiple steps that are coded for individually by the radiation therapist. The modifier –26 indicates the professional component. The following CPT codes may be used:

99251-99255: Initial inpatient consultation for a new or established patient
Regarding these codes, it should be noted that in a survey of radiation therapists participating in intracoronary brachytherapy, 75 percent reported they did not see the patient before the procedure. If so, these CPT codes would be inappropriate. (Radiology 2000; 217:723-28)

77263: Therapeutic radiology treatment planning; complex

77290: Therapeutic radiology simulation-aided field setting; complex
Simulation is generated from contrast-enhanced angiographic images

77336: Continuing medical physics consultation
Some claims programs will reject the above code when reported on the same day as 77370 (see above).

77300: Basic radiation dosimetry calculation

77327: Brachytherapy isodose plan; intermediate

77431: Radiation therapy management with complete course of therapy consisting of one or two fractions only

77785-77787: Remote afterloading high dose rate radionuclide brachytherapy
The specific CPT code used will depend on the device. The CPT codes reflect the number of radiation sources in the device.

77470: Special treatment procedure
This CPT code is used when additional physician effort and work are required in cases of special procedures.

77331: Special dosimetry

Cardiologist
At the present time, no specific CPT code describes the cardiologist’s role in performing intravascular brachytherapy. One of the following CPT codes may be used:

93799: Unlisted cardiovascular service or procedure
36247: Selective catheter placement, arterial system; initial third order
36248: Selective catheter placement, arterial system; additional second order, third order and beyond

The above CPT codes represent possible coding options for the intravascular brachytherapy portion of the overall procedure, which typically includes PTCA with or without stent placement. Therefore, the following CPT codes describing PTCA may be used in conjunction with the above CPT codes:

92980: Transcatheter placement of an intracoronary stent(s), percutaneous, with or without other therapeutic intervention, any method; single vessel
92981: As above, with each additional vessel
92982: Percutaneous transluminal coronary balloon angioplasty; single vessel
92984: As above, with each additional vessel
92995: Percutaneous transluminal coronary atherectomy, by mechanical or other method, with or without balloon angioplasty, single vessel
92996: As above, with each additional vessel.

Benefit Application:
BlueCard®/National Account Issues
Claims for intracoronary brachytherapy will require separate reimbursement of the cardiovascular surgeon and radiation therapist. There are no specific CPT codes. The level of the contribution of the radiation therapist is still evolving, and it is possible that radiation planning and dose delivery may require only minimal work on the part of the radiation therapist.

State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved devices may be assessed on the basis of their medical necessity.

Rationale:
This policy regarding intravascular coronary radiation therapy is based on a 2000 TEC Assessment (1) that offered the following observations and conclusions:

  • There are four well-designed randomized clinical trials evaluating the effectiveness of brachytherapy for managing in-stent restenosis in native coronary vessels. The outcomes of these trials indicate that patients with in-stent restenosis treated with brachytherapy do better than patients treated with percutaneous transluminal coronary angioplasty (PTCA) alone or with PTCA and stenting. Angiographic data at six to nine months show significant reduction in the restenosis rate in brachytherapy patients. More importantly, patients receiving brachytherapy have statistically significant reduction in target lesion revascularization rates.
  • There are no randomized controlled trials supporting the use of intracoronary brachytherapy for the prevention of restenosis.

The policy regarding intravascular femoropopliteal radiation therapy is based on a 2002 TEC Assessment (2) that offered the following observations and conclusions:

  • The scientific evidence consisted of two randomized trials comparing percutaneous transluminal angioplasty (PTA) plus brachytherapy with angioplasty alone. (3–5) Both trials had limitations that precluded conclusions on whether brachytherapy is efficacious for the population under consideration. The Vienna-2 trial was unblinded and had no placebo control. It also enrolled heterogeneous subgroups of patients. The second trial was single blinded with a sham brachytherapy placebo control. However, this trial only reported on 22 patients and used an unusual outcome measure as primary outcome.
  • The TEC Assessment concluded that the evidence was insufficient to permit scientific conclusions regarding brachytherapy as an adjunct to peripheral artery angioplasty.

Waksman and colleagues reported on the results of a trial that randomized 120 patients with in-stent restenosis in saphenous vein grafts to receive standard angioplasty and stenting or standard treatment plus intravascular gamma irradiation. (6) At six months, the restenosis rate was lower in those receiving intracoronary irradiation. As noted here, the U.S. Food and Drug Administration (FDA) labeling for intracoronary brachytherapy is limited to its use as a treatment of in-stent restenosis, and its use for primary prevention of in-stent restenosis remains investigational. Serruys and colleagues reported on the results of a randomized trial of intracoronary brachytherapy as primary prevention in 112 patients. (7) The authors reported that the clinical outcomes of the irradiated group were inferior to those of the non-irradiated control group.

Studies are emerging that focus on the long-term outcomes of intracoronary brachytherapy. Of particular concern is the incidence of late stent restenosis. While conventional treatment of in-stent restenosis is associated with early thrombosis, late stent restenosis is uncommon. Grise and colleagues reported on a five-year follow-up of 55 patients enrolled in a clinical trial of gamma irradiation as a treatment of in-stent restenosis. (8) Target lesion revascularization was required in 23.1 percent of the treatment group compared to 48.3 percent in the control group. There were two late revascularizations between three and five years in the treatment group, compared to none in the control group. Long-term anticoagulation therapy has been proposed as a strategy to reduce the incidence of late thrombosis. Meerkin and colleagues focused on the two-year follow-up of 30 patients treated with intracoronary beta irradiation. (9) Late failures occurred in seven of the 30 patients. Studies have also been reported on intracoronary beta irradiation with a novel liquid rhenium-188-filled balloon catheter with favorable outcomes. (10–14)

Comment:
With the success of rapidly evolving drug-eluting stents, trials comparing brachytherapy to drug-eluting stents are needed to determine the appropriate role of brachytherapy in the treatment and prevention of restenosis. For example, Pohl and colleagues compared outcomes of 28 patients treated with intracoronary brachytherapy for in-stent restenosis with 28 patients treated with the implantation of a sirolimus-eluting stent for in-stent restenosis during two time frames. (15) The authors found a lower incidence of recurrence of in-stent restenosis in patients treated with sirolimus-eluting stents. In addition, treatment with sirolimus-eluting stent implantation appeared to be safe and had a lower rate of late luminal loss than treatment with brachytherapy. The use of complex intravascular brachytherapy has been decreasing with the use of drug-eluting stents, and its future role in the treatment of in-stent restenosis is uncertain.

Regarding femoropopliteal irradiation as an adjunct to peripheral angioplasty and stenting, data continue to be inconclusive. Bonvini and colleagues reported on interim results of an ongoing randomized trial, focusing on thrombotic occlusion in those randomized to receive intravascular gamma irradiation. (16) Late occlusion was reported in 27 percent of those in the irradiated group compared to none in the control group. In the Vienna-3 trial, Pokrajac and colleagues reported restenosis rates to be significantly lower at 12-month follow-up in 134 patients randomized after femoropopliteal angioplasty to brachytherapy (41.7 percent) versus sham irradiation (67.1 percent). (17) However, the authors acknowledged some study limitations (small study size, high drop-out rate and angiographic follow-up in only 81 percent of patients). The Vienna-5 trial randomized 88 patients to PTA and femoropopliteal stent implantation with either gamma brachytherapy or sham irradiation and found no difference in recurrence rates at the six- and 12-month follow-up between the two groups (33 percent with brachytherapy vs. 35 percent without at six months; and 59 percent with brachytherapy vs. 43 percent without at 12 months). (18)

2007 Update:
Treating restenosis of bare-metal stents in native coronary arteries: A recent meta-analysis (19) pooled data from 11 separate randomized controlled trials (RCTs) comparing vascular brachytherapy versus PTA, with or without stent placement. In seven of these trials, all patients were treated for in-stent restenosis, while four trials enrolled mixed populations (i.e., some primary lesions). In the seven trials on pure in-stent restenosis, vascular brachytherapy significantly reduced the rate of major adverse cardiovascular events (MACE; RR=0.58; 95 percent CI: 0.50–0.67; p<0.001), restenosis (RR=0.55; 95 percent CI:0.48–0.64; p<0.001) and late lumen loss (standard mean difference = –0.69; 95 percent CI: –0.92, –0.46; p<0.001) at intermediate time points (defined as six-24 months). Only five trials reported long-term outcomes (>three years), of which only three studied pure in-stent restenosis. MACE was the only long-term outcome significantly reduced by vascular brachytherapy.

Three RCTs have directly compared vascular brachytherapy versus drug-eluting stents (DES) as treatments for in-stent restenosis. (20-22) Two of these were large, multicenter trials that randomized nearly 400 patients each (20, 21), while the third was a single-center trial that closed early (n=37) because the vascular brachytherapy devices were no longer available. (22) In each of the two completed trials, DES significantly decreased the rate of target lesion revascularization and angiographic restenosis at six-nine months by about half, when compared with vascular brachytherapy. However, longer-term follow-up data were not reported. Editorials published at the same time as these reports cited the marked decline in use of bare-metal stents for primary percutaneous interventions. (23, 24) The editorialists also had reservations about generalizing results from RCTs of vascular brachytherapy for restenosis in bare-metal stents to draw conclusions about effectiveness of vascular brachytherapy to treat restenosis in DES.

Treating restenosis in drug-eluting stents: Two clinical series reported on use of vascular brachytherapy to treat restenosis in a DES. One series (n=61) compared outcomes with a prior consecutive series (n=50) treated with repeat DES. (25) At eight months after treatment, rates of target lesion and target vessel revascularization were similar in the two series, although the MACE rate was smaller in the vascular brachytherapy group than in the repeat DES group (9.8 percent vs. 2.4 percent; p=0.044). The second series only included five patients, all with recurrent stenosis after sequential treatment with sirolimus- and paclitaxel-eluting stents. (26) Further study is needed to determine if vascular brachytherapy is useful to treat restenosis in DES.

In-stent restenosis in saphenous vein graft (SVG): The 2007 literature search did not identify any new studies that might alter the recommendation of this policy that vascular brachytherapy may be considered medically necessary to treat in-stent restenosis of SVGs.

Preventing restenosis after primary PTCA with or without stent placement: Five studies reported on use of vascular brachytherapy to prevent restenosis after primary percutaneous interventions, including three with long-term (3.8 to five years) follow-up (27-29) and two with intermediate-term (nine-16 months) follow-up. (30, 31) The studies with long-term follow-up reported that early benefit from vascular brachytherapy was not sustained because of delayed and progressive restenosis and thrombotic complications. In one of the studies, the delayed restenosis and thrombosis occurred despite the use of combined antiplatelet therapy. (29)

Treating or preventing restenosis after angioplasty in femoropopliteal arteries: Two studies reported long-term follow-up after endovascular brachytherapy to prevent restenosis in femoropopliteal arteries treated with balloon angioplasty. (32, 33) Both reported that brachytherapy delayed restenosis when measured after short-term follow-up, but these benefits were not sustained, and the rates of restenosis were similar in treated and control groups with longer follow-up.

2008 Update:
The policy was updated with a MEDLINE search for the period May 2007 to June 2008. No studies were identified that would change the policy statement. For the treatment of bare metal stent restenosis, the previous update states that long-term follow-up comparing drug-eluting stents to vascular brachytherapy is needed, given that the available studies were limited to nine months of follow-up. Three studies were identified that address this issue: two randomized controlled trials reporting one-year (n=129) and two-year (n=396) clinical outcomes and a retrospective cohort study with three-year (n=360) outcomes. Most failure was symptom-related in these studies, as protocol angiography was limited to the initial six- or nine-month follow-up. Park reported one-year MACE (major adverse cardiovascular events) rates of 7.7 percent versus 18.8 percent (p=0.07) in a study of 129 patients from Asia in the drug-eluting stent (sirolimus) and vascular brachytherapy groups, respectively. (34) This was driven primarily by statistically improved target lesion revascularization rates of 4.6 percent versus 18.8 percent (p=0.01). Ellis et al. reported two-year target lesion revascularization rates of 10.1 percent and 21.6 percent (p=0.03, n=396) in the drug-eluting stent (paclitaxel) and brachytherapy groups, respectively. (35) However, there were no significant differences between the two groups with regard to death, myocardial infarction or target vessel thrombosis at 24 months. A five-year follow-up for this study is planned. Last, three-year MACE-free survival was 92.5 percent in the drug-eluting stent (sirolimus) treated cohort and 82.4 percent (p=0.03) in the brachytherapy cohort in a retrospective registry review of 360 patients from Asia reported by Lee. (36) These medium-term results are important. However, more information is needed regarding the long-term safety and efficacy of drug-eluting stents.

No studies were identified for other indications (drug-eluting stent restenosis, saphenous vein-graft stenosis, preventing stenosis in primary PTCA or preventing restenosis in femoropopliteal arteries).

2009 Update:
Treating restenosis of bare-metal stents in native coronary arteries: Holmes et al. reported on a three-year follow-up of one of the major clinical trials comparing brachytherapy to drug-eluting stents (DES). (37) In the principal publication of this trial reporting nine-month outcomes, DES decreased target lesion revascularization and angiographic restenosis. (21) The three-year results are that DES versus brachytherapy has greater survival free from target lesion revascularization (81 percent versus 71.6 percent, respectively), and greater survival free from target vessel revascularization (78.2 percent versus 68.8 percent, respectively). Deaths and MI were slightly higher in the DES group, but not statistically significantly different. However, the studies were not powered for these endpoints.

Treating restenosis in drug-eluting stents: Only case series of patients had been reported before. Bonello et al. reported another case series of 99 patients with restenosis in DES treated with brachytherapy. (38) In this series, at 12 months the target lesion revascularization rate was 11 percent and the MACE rate was 26 percent. Such case series data cannot determine whether brachytherapy is as or more effective than other methods of treating these restenoses.

In-stent restenosis in SVGs: Mishra et al. reported a retrospective comparison of patients with stenosis in SVG stents treated with DES or brachytherapy. (39) Outcomes were reported at six months. DES-treated patients had lower rates of non-Q-wave myocardial infarction than brachytherapy patients (0 percent versus 20 percent, respectively). Target lesion revascularization or major adverse cardiac events were lower, but not statistically significantly different, in the DES group than the brachytherapy group (21 percent versus three percent, p=0.13). The pattern of results for other outcomes suggests that DES is at least equivalent to brachytherapy and rates of outcomes are better (although not statistically significant in most cases).

Treating restenosis after treatment of peripheral vascular lesions: No studies were found relevant to this indication.

In summary, the additional studies seem to be indicating at least equivalence, if not superiority, of drug-eluting stents (DES) in treating restenosis of stents, whether they are bare metal stents, DES or saphenous vein stents. At this time, no changes are being made to the existing vascular brachytherapy policy statements.

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 six to 12 months. Target-vessel revascularization data showed an odds ratio of 0.44 percent, 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 percent of individuals treated with drug-eluting stents and 29.5 percent 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 percent confidence interval: 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 Femoropopliteal Radiation
IVB has also been investigated as an adjunct to percutaneous transluminal angioplasty (PTA) 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 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 six-month follow-up, the restenosis rate was lower in the IVB group compared to the angioplasty group. However, by five-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 percent confidence interval 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 percent confidence interval 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 percent confidence interval 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; confidence interval 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 focused update guideline for the management of patients with peripheral artery disease (Rooke, 2011) does not include any recommendations for IVB of the femoropopliteal system.

Definitions
De novo: Something that is newly developed or was not previously present. In the context of this policy, 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.

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References:
  1. 2000 TEC Assessments; Tab 19.
  2. 2002 TEC Assessments; Tab 22.
  3. Bonello L, Kaneshige K, De Labriolle A et al. Vascular brachytherapy for patients with drug-eluting stent restenosis. J Interv Cardiol 2008; 21(6):528-34.
  4. Bonvini R, Baumgartner I, Do DD et al. Late acute thrombotic occlusion after endovascular brachytherapy and stenting of femoropopliteal arteries. J Am Coll Cardiol 2003; 41(3):409-12.
  5. 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): 723-30.
  6. 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.
  7. Ellis SG, O'Shaughnessy CD, Martin SL et al. Two-year clinical outcomes after paclitaxel-eluting stent or brachytherapy treatment for bare metal stent restenosis: the TAXUS V ISR trial. Eur Heart J 2008; 29(13):1625-34.
  8. 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.
  9. Ferrero V, Ribichini F, Piessens M et al. Intracoronary beta-irradiation for the treatment of de novo lessons: 5-year clinical follow-up of the BetAce randomized trial. Am Heart J 2007; 153(3):398-402.
  10. Geiger MH, Ludwig J, Burckhard R et al. High-dose intracoronary irradiation after de novo stent implantation. Results of the EVEREST (Evaluation of Endoluminal Radiation in Elective Stenting) trial. Strahlenther Onkol 2006; 182(1):9-15.
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  12. Gruberg L, Caiati R, Aronson D et al. Five year clinical follow up after intracoronary radiation for the prevention of in-stent restenosis. J Invasive Cardiol 2006; 18(10):494-8.
  13. Hoher M, Wohrle J, Wohlfrom M et al. Intracoronary beta-irradiation with a rhenium-188-filled balloon catheter: a randomized trial in patients with de novo and restenotic lesions. Circulation 2003; 107(24):3022-7.
  14. Holmes DR, 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):439-48.
  15. Holmes DR Jr, Teirstein P, Satler L et al. Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare metal stents. JAMA 2006; 295(11):1264-73.
  16. Koo BK, Lee MM, Oh S et al. Effects of beta-radiation with a 188rhenium-filled balloon catheter system on non-stented adjacent coronary artery segments. Int J Cardiol 2004; 96(1):73-7.
  17. Krueger K, Landwehr P, Bendel M et al. Endovascular gamma irradiation of femoropopliteal de novo stenoses immediately after PTA: interim results of prospective randomized controlled trial. Radiology 2002; 224(2):519-28.
  18. Lee SW, Park SW, Hong MK et al. Comparison of angiographic and clinical outcomes between rotational atherectomy versus balloon angioplasty followed by radiation therapy with a rhenium-188-mercaptoacetyltriglycine-filled balloon in the treatment of diffuse in-stent restenosis. Int J Cardiol 2005; 102(2):179-85.
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Coding Section

Codes  Number  Description  
CPT   See Policy Guidelines 
ICD-9 Diagnosis  411-414  Coronary atherosclerosis; code range
  440.2  Atherosclerosis of native arteries of the extremities
  440.3  Atherosclerosis of bypass graft of extremities 
ICD-9 Procedure  92.27  Implantation or insertion of radioactive elements 
  36.0-36.09  Code range, PTCA 
ICD-10-CM (effective 10/01/15)   I25.10

Arteriosclerotic cardiovascular disease 

   I70.209 Unspecified atherosclerosis of native arteries of extremities, unspecified extremity 
   I70.399 Other atherosclerosis of unspecified type of bypass graft(s) of the extremities, unspecified extremity 
ICD-10-PCS (effective 10/01/15)  0JHN01Z Insertion of Radioactive Element into Upper Extremity Subcutaneous Tissue and Fascia, Open Approach
  0JHV31Z Insertion of Radioactive Element into Upper Extremity Subcutaneous Tissue and Fascia, Percutaneous Approach
  0JHW01Z  Insertion of Radioactive Element into Lower Extremity Subcutaneous Tissue and Fascia, Open Approach 
  0JHW31Z  Insertion of Radioactive Element into Lower Extremity Subcutaneous Tissue and Fascia, Percutaneous Approach 
  02C03ZZ Extirpation of Matter from Coronary Artery, One Site, Percutaneous Approach 
  02C04ZZ  Extirpation of Matter from Coronary Artery, One Site, Percutaneous Endoscopic Approach
  02C13ZZ  Extirpation of Matter from Coronary Artery, Two Sites, Percutaneous Approach 
  02C14ZZ  Extirpation of Matter from Coronary Artery, Two Sites, Percutaneous Endoscopic Approach 
  02C23ZZ  Extirpation of Matter from Coronary Artery, Three Sites, Percutaneous Approach 
  02C24ZZ Extirpation of Matter from Coronary Artery, Three Sites, Percutaneous Endoscopic Approach 
  02C33ZZ Extirpation of Matter from Coronary Artery, Four or More Sites, Percutaneous Approach
  02C34ZZ Extirpation of Matter from Coronary Artery, Four or More Sites, Percutaneous Endoscopic Approach

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

07/30/2018 

Annual review, no change to policy intent 

07/31/2017 

Annual review, no change to policy intent. 

07/13/2016 

Annual review, no change to policy intent. 

07/20/2015 

Annual review, no change to policy intent. Added guidelines and coding.

07/22/2014

Annual review. Updated rationale and references. Added definitions section. No change to policy intent.


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