I. Coronary artery brachytherapy

A. Is medically necessary when used as an adjunct to percutaneous coronary intervention (PCI) for treatment of in-stent restenosis in a native coronary artery bare-metal stent or saphenous vein graft (SVG).
B. Intravascular brachytherapy (VBT) is considered medically necessary for recurrent drug-eluting stent in-stent restenosis.
C. All other indications are considered investigational.

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[INFORMATIONAL NOTE:
Literature Review

I. In-stent restenosis of native coronary arteries and SVGs

A. Several early multicenter trials of brachytherapy demonstrated the treatment benefits of intracoronary radiation for the treatment of in-stent restenosis:
1. INitial Hyperplasia Inhibition with Beta In-stent Trial [INHIBIT], Waksman et al. (2002)
2. STents And Radiation Therapy [START], Popma et al. (2002)
3. GAMMA-1 trial, Leon, et al. (2001)
4. Coronary Radiation to Inhibit Proliferation Post Stenting [SCRIPPS], Teirstein, et al. (1997)
5. Washington Radiation for In-Stent Restenosis Trial [WRIST], Ajani et al. (2002)
B. Ellis et al., for the TAXUS V ISR Investigators (2008), conducted a randomized study to evaluate two-year outcomes of treatment with a paclitaxel-eluting stent (PES) (n=195) or brachytherapy (n=201) in patients referred for PCI for bare metal stent in-stent restenosis. Between 9 and 24 months, ischemia-driven target lesion revascularization (TLR) tended to be required less in the PES group compared to the brachytherapy group (5.3. vs. 10.3%, p=0.07). At 24 months, ischemia-driven TLR and ischemia-driven target vessel revascularization (TVR) were significantly reduced in the PES group compared to the brachytherapy group (10.1 vs.21.6%, p=0.003, and 18.1 vs. 27.5%, p=0.03, respectively).There were no significant differences between the two groups in death, myocardial infarction, or target vessel thrombosis between 12 and 24 months, or cumulative to 24 months.
C. Holmes et al., for the SISR Investigators (2008) conducted a randomized trial to evaluate the safety and efficacy of sirolimus-eluting stents (SES) (n=259) compared to vascular brachytherapy (VBT) (n=125) for treatment of in-stent restenosis in a bare metal stent. At three years, survival free from TLR or TVR was significantly improved with SES; freedom from TLR was 81.0% for SES vs. 71.6% for brachytherapy, p=0.018; TVR was 78.2% for SES vs. 68.8% for brachytherapy, p=0.022. Target vessel failure and major adverse cardiac events (MACE) were improved with SES but did not reach statistical significance. There was no statistically significant difference in definite or probable stent thrombosis between the two groups. Five-year follow-up of the SISR trial was published by Alli et al. in 2012. There were no differences in safety or efficacy outcomes for treatment of BMS restenosis with SES vs. VBT. There were no significant differences in survival free from TLR, TVR, or major adverse cardiac events between the two groups.
D. Drug-eluting stents were compared to beta-radiation for the treatment of in-stent restenosis in a case series conducted by Zavalloni et al. (2006). The first 68 patients (group I) were treated with brachytherapy using the Novoste Beta-Cath system. The latter 73 patients (group II) were treated with a Cypher™ sirolimus-eluting stent or a Taxus™ paclitaxel-eluting stent. Nine months following treatment, restenosis rates were 37.8% (28/74) for patients in group I and 14.9% (11/74) for patients in group II (p=0.0028). A diffuse pattern of recurrence was more frequently seen after brachytherapy (20/74 vs. 6/74, p=0.005). The “edge effect” following brachytherapy was associated with worse outcomes and accounted for most failures. Recurrence within the original restenotic stent was similar in both groups (12.9% vs. 14.9%, p=.8). Patients treated with drug-eluting stents for diffuse in-stent restenosis experienced more favorable clinical and angiographic outcomes compared to a similar cohort of patients treated with beta-brachytherapy.
E. The three devices described above received FDA approval for in-stent restenosis in native coronary arteries, and most published studies have focused on this indication. Brachytherapy has also been used to successfully treat in-stent restenosis in SVGs. The SVG-WRIST trial (Waksman, et al., 2002), a randomized, double-blind, placebo-controlled trial, evaluated the effect of intravascular gamma radiation in 120 patients with in-stent restenosis in saphenous vein grafts. Patients underwent balloon angioplasty, atherectomy, additional stenting or a combination of these procedures. If the intervention was successful, patients were randomly assigned in a double-blind fashion to intravascular treatment with a ribbon containing iridium-192 (n=60) or nonradioactive seeds (n=60). Revascularization and radiation therapy were successful in all patients. At six months, the restenosis rate was lower in the iridium-192 group (21%) than in the placebo group (44%). At 12 months, revascularization of the target lesion was lower in the iridium-192 group (17%) than in the placebo group (57%). The rate of major cardiac events at 12 months was also lower in the iridium-192 group (32%) than the placebo group (63%).
F. Rha et al. (2005) published a follow-up to the SVG-WRIST trial to determine whether the safety and efficacy of brachytherapy is durable. At 36 months, TLR, repeat percutaneous transluminal coronary angioplasty (PTCA) and TLR-major adverse cardiac events (MACE) remained significantly lower in the irradiated group, although TVR and TVR-MACE did not. The beneficial effect and efficacy of irradiation declined with time and manifested with late recurrences. The authors stated that saphenous vein grafts are known to degenerate over time, and when PCI is required, the clinical outcome of these patients is markedly impaired. The outcomes of patients in the SVG-WRIST trial are driven, therefore, by the restenotic process, with a high likelihood that graft failure was a result of progression of degenerative disease within the graft or within the native coronary arteries distal to the graft. The authors concluded that patients in the SVG-WRIST trial treated with brachytherapy had a marked reduction in the need for repeat TLR at 36 months, with sustained clinical benefit at three years despite late recurrences which were more pronounced in the irradiated group.

A. A meta-analysis by Lu et al. (2012) was conducted to determine whether DES implantation remains favorable in large sample size and long-term follow-up when compared to intracoronary brachytherapy (ICBT) in patients with in-stent restenosis. The analysis included 1942 patients in twelve controlled trials (four randomized controlled and eight nonrandomized controlled trials). DES were significantly more effective in reducing TVR (p=0.009) and binary restenosis (p<0.00001) compared to ICBT at a midterm follow-up of six to twelve months. There were no significant differences in cardiac death, MI, and late stent thrombosis at midterm follow-up. At a follow-up of 24 to 36 months, there continued to be no significant difference in cardiac death (p=0.59) or MI (p=0.65), although a statistically significant difference was found in TVR (p=0.005) in favor of DES.
B. Oliver et al. (2008) conducted a meta-analysis of randomized trials assessing the outcome of brachytherapy or DES for the treatment of in-stent restenosis. The analysis included 14 studies/3103 patients. Neither treatment had any effect on mortality or rate of myocardial infarction. At intermediate follow-up, brachytherapy reduced the rate of revascularization, binary restenosis, and late loss compared to balloon angioplasty and selective bare metal stents alone. MACE rates were lower in patients treated with brachytherapy at both intermediate and long-term follow-up. DES reduced the rate of revascularization, MACE, and binary restenosis compared to brachytherapy, but follow-up was limited to nine months. The authors concluded that vascular brachytherapy improves the long-term outcome of angioplasty compared with bare metal stents alone in the treatment of in-stent restenosis, and DES appear to provide similar results during short-term follow-up.
C. Uchida et al. (2006) conducted a meta-analysis of randomized controlled trials comparing intracoronary gamma- and beta-radiation therapy to placebo for in-stent restenosis. The authors assessed the comparative effectiveness of brachytherapy and the two radiation sources. They also evaluated the performance of the procedure in native coronary arteries and SVG. Five randomized controlled trials that compared brachytherapy to placebo in 1310 patients were reviewed. There was considerable between-study variance, and diabetes was found to be a significant factor in this variance. In multivariate meta-regression analyses adjusted for diabetes and lesion length, neither gamma radiation source nor SVG was a significant factor for the between-study variance (p=0.675 and 0.433, respectively). Neither gamma radiation in SVG nor difference in radiation source (beta or gamma) in native coronary arteries was a significant factor in brachytherapy effectiveness compared to placebo. Intracoronary brachytherapy was effective compared to placebo at mid-term follow-up.
D. Additional proposed indications include:
1. Intracoronary brachytherapy has been proposed as a treatment for new stenosis of native coronary arteries and SVG, as well as restenosis of native coronary arteries and SVG at the unstented site of a previous PCI.
2. Brachytherapy has also been evaluated as a method of primary prevention of restenosis after stent implantation for de novo lesions.
3. VBT may be used for recurrent DES in-stent restenosis. Recent studies have shown that VBT is safe with low recurrence rates at one year post procedure. It is considered to be a safe short-term method of restoring patency although repeat intervention will be eventually medically necessary. In a study of 186 patients with 283 lesions, Negi et al (2016), unstable angina was treated with balloon angioplasty followed by VBT. In 99% of cases treatment was delivered without adverse effects. Similarly, Ohri et al. (2016), reported on 134 patients with 141 treated lesions as well as a control group of 37 patients. This study confirmed the safety and usefulness of the procedure in a high risk population. Additional investigation was recommended.
E. In the BetAce randomized trial, Ribichini et al. (2006) evaluated brachytherapy for prevention of in-stent restenosis after angioplasty of de novo lesions in patients with high plasma angiotensin converting enzyme (ACE). Elevated plasma ACE levels have been proposed to increase the risk of in-stent restenosis. Thirty-one patients (33 stenoses) were randomized to stent implantation (control group), and 30 patients (31 stenoses) were randomized to brachytherapy and stented angioplasty. Following angioplasty, in-stent minimal lumen diameter (MLD) was similar in both groups. At six months, MLD had decreased in the control group to 1.74 ± 0.8 mm, compared to 2.25 ± 1.05 mm in the brachytherapy group. The mean in-stent diameter was 2.3 ± 0.8 mm in the control group vs. 2.9 ± 1.05 mm in the brachytherapy group, and the restenosis rate was 37.5% in the control group vs. 17.9% in the brachytherapy group. At six months, a higher need for TVR was seen in the control group (35.5%) than in the brachytherapy group (13.3%). The authors concluded that this study confirms that patients with high plasma ACE levels are exposed to an increased risk for in-stent restenosis and that the preventive use of brachytherapy in these patients reduced neointimal formation and increased MLD.
F. Ferrero et al. (2007) reported five-year follow-up of the BetAce trial, analyzing the incidence of death, MI, and ischemia-driven TVR. The incidence of stent thrombosis was slightly higher in the brachytherapy group (10%) than in the control group (6.5%). This difference was not statistically significant. Although there was a significantly higher need for TVR in the control group at six months, the difference lost its significance at 12 months and five years because of a late catch-up phenomenon in the brachytherapy group, with a higher incidence of edge stenosis and stent occlusion. Five-year event-free survival rank for death, MI and TVR was 43% in the brachytherapy group compared to 45% in the control group (p=0.95). The occurrence of additional ischemic events in both groups equalized the long-term clinical outcomes. The authors stated that intracoronary beta radiation at the time of stent implantation only transiently prevents excessive neointimal proliferation that leads to stenosis recurrence in the first year after treatment. The late catch-up phenomenon, along with the natural progression of the atherosclerotic disease in other segments, is responsible for the loss of the clinical benefit of brachytherapy in the long term.
G. Syeda et al. (2006) conducted a double-blind, randomized trial of beta brachytherapy for prevention of restenosis after stent implantation in native coronary de novo lesions. Eighty-nine diabetic patients (106 lesions) were randomly assigned to treatment with beta radiation or placebo treatment. Angiographic analysis at nine months demonstrated a late lumen loss of 0.7 ± 0.9 mm in the brachytherapy group vs. 1.2 ± 0.8 mm in the control group at the injured segment, 0.9 ± 1.0 vs. 1.3 ± 0.7 mm at the radiated segment, and 0.9 ± 1.0 vs. 1.3 ± 0.7 mm at the target segment. Binary restenosis rates were significantly lower in the brachytherapy group in all subsegments. TVR for restenosis was necessary in nine lesions (17.6%) in the brachytherapy group vs. 18 (34%) in the placebo group. Late thrombosis occurred in four brachytherapy patients after premature discontinuation of antiplatelet therapy, resulting in a MACE rate of 37.2%, compared to 38.6% in the placebo group. The authors concluded that, in diabetic patients with de novo coronary lesions, intracoronary radiation after stent implantation significantly reduced restenosis. This clinical benefit was reduced, however, by the frequent occurrence of new thrombosis.

A. A guideline update for PCI published by the American College of Cardiology (ACC), American Heart Association (AHA) and the Society for Cardiovascular Angiography and Interventions (SCAI) (Smith et al., 2005) states that vascular brachytherapy has been successful in treating restenosis occurring within stents, while other adjunctive therapies, such as the cutting balloon, rotary ablation, excimer laser and restenting have shown mixed results. The ACC/AHA/SCAI guideline states that brachytherapy can be useful as a safe and effective treatment for in stent restenosis. (Class IIa recommendation). A Class IIa recommendation indicates that there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment but that the weight of evidence is in favor of usefulness/efficacy. No changes to this recommendation were made in focused updates to the PCI guideline published in 2007 and 2009.
B. A 2011 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) PCI guideline (Wijns et al.) does not include recommendations for brachytherapy. The background of the guideline references studies demonstrating superiority of DES over brachytherapy.
C. Guidelines for PCI issued by the European Society of Cardiology (ESC) state that brachytherapy proved to be the only evidence-based nonsurgical treatment for in-stent restenosis. The guideline also states that a prolonged intake of clopidogrel for one year after radiation is necessary. The ESC guideline recommends brachytherapy for the treatment of in-stent restenosis in native coronary arteries as a Class 1A recommendation. Brachytherapy for treatment of in-stent restenosis of a saphenous vein bypass graft is considered as a Class 1B recommendation. Class I indicates evidence and/or general agreement that a given diagnostic procedure/treatment is beneficial, useful and effective. Level of evidence A indicates that data is derived from multiple randomized clinical trials or meta-analyses, while level of evidence B indicates data is derived from a single randomized clinical trial or large non-randomized studies (Silber et al., 2005).
D. Guidelines on Myocardial Revascularization developed by The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) state that currently, intracoronary brachytherapy is of very limited use: restenosis rates have declined and in-stent restenoses after BMS are treated by DES or Coronary Artery Bypass Graft (CABG).

Prior to the widespread use of drug-eluting stents, in-stent restenosis following PCI was a significant clinical problem, frequently resulting in the need for repeat revascularization procedures. Intracoronary brachytherapy was shown to be an effective treatment for in-stent restenosis of native coronary arteries or saphenous vein grafts. Brachytherapy procedures have decreased in frequency, however, and drug-eluting stents have emerged as the treatment of choice in the majority of cases. Brachytherapy may still play a role in the treatment of in-stent restenosis in selected patients, however.

There is insufficient evidence in the published medical literature to demonstrate the safety and efficacy of brachytherapy for expanded indications, including treatment for new stenosis of native coronary arteries and SVGs; restenosis of native coronary arteries and SVGs at the unstented site of a previous PCI; or as primary prevention of restenosis after stent implantation for de novo lesions.]

2. Alli OO, Teirstein PS, Satler L et al. Five-year follow-up of the sirolimus-eluting stents vs vascular brachytherapy for bare metal in-stent restenosis (SISR) trial. Am Heart J. 2012 Mar; 163(3):438-445.

3. Bonow RO, Mann DL, Zipes DP, et al ed. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine, 9th Edition. Saunders, an imprint of Elsevier; 2011.

4. Brenner DJ, Miller RC. Long-term efficacy of intracoronary irradiation in inhibiting in-stent restenosis. Circulation. 2001 Mar 6; 103(9):1330-1332.

5. Castagna MT, Mintz GS, Waksman R, et al. Comparative efficacy of γ-irradiation for treatment of in-stent restenosis in saphenous vein graft versus native coronary artery in-stent restenosis: an intravascular ultrasound study. Circulation. 2001 Dec 17; 104(25):3020-3022.

6. Castagna MT, Mintz GS, Weissman NJ, et al. Intravascular ultrasound analysis of the impact of gamma radiation therapy on the treatment of saphenous vein graft in-stent restenosis. Am J Cardiol. 2002 Dec 15; 90(12):1378-1381.

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 Jul; 29(13):1625-1634.

8. Ferrero V, Ribichini F, Heyndrickx GR, et al. Angiographic and three-dimensional intravascular ultrasound analysis of combined intracoronary beta radiation and self-expanding stent implantation in human coronary arteries. Am J Cardiol. 2004 Nov 15; 94(10):1237-1242.

9. Ferrero V, Ribichini F, Piessens M, et al. Intracoronary β-irradiation for the treatment of de novo lesions: 5-year clinical follow-up of the BetAce randomized trial. Am Heart J. 2007 Mar; 153(3):398-402.

10. Geiger MH, Ludwig J, Burckhard R, et al. High-dose intracoronary irradiation after de novo stent implantation. Strahlenther Onkol. 2006 Jan; 182(1):9-15.

11. Grise MA, Massullo V, Jani S, et al. Five-year clinical follow-up after intracoronary radiation: results of a randomized clinical trial. Circulation. 2002 Jun 11; 105(23):2737-2740.

12. 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 Aug; 1(4):439-448.

13. Kolh P, Wijns W, Danchin N, et al. Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) and the European Association for Percutaneous Cardiovascular Interventions (EAPCI), Guidelines on myocardial revascularization. Eur J Cardiothorac Surg. 2010 Sep; 38 Suppl:S1-S52.

14. 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 Jan 25; 344(4):250-256.

15. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: executive summary: 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. Catheter Cardiovasc Interv. 2012 Feb 15; 79(3):453-495.

16. Lu YG, Chen YM, Li L, et al. Drug-eluting stents vs. intracoronary brachytherapy for in-stent restenosis: a meta-analysis. Clin Cardiol. 2011 Jun; 34(6):344-351.

17. Negi SI, Torguson R, Gai J, et al. Intracoronary brachytherapy for recurrent drug-eluting stent failure. JACC Cardiovasc Interv. 2016 Jun; 9(12):1259-1265.

18. Ohri N, Sharma S, Kini A, et al. Intracoronary brachytherapy for in-stent restenosis of drug-eluting stents. Advances in Radiat Oncol. 2016 Jan-Mar; 1(1): 4-9.

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20. Popma JJ, Suntharalingam M, Lansky AJ, et al. Randomized trial of 90Sr/90Y β-radiation versus placebo control for treatment of in-stent restenosis. Circulation. 2002 Aug 27; 106(9):1090-1096.

21. Rha SW, Kuchulakanti P, Ajani AE, et al. Three-year follow-up after intravascular γ-radiation for in-stent restenosis in saphenous vein grafts. Catheter Cardiovasc Interv. 2005 Jun; 65(2):257-262.

22. Ribichini F, Ferrero V, Piessens M, et al. Intracoronary β-irradiation prevents excessive in-stent neointimal proliferation in de novo lesions of patients with high plasma ACE levels. The BetAce randomized trial. Cardiovasc Revasc Med. 2005 Jan-Mar; 6(1):7-13.

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27. Syeda B, Schukro C, Kirisits C, et al. Randomized blinded clinical trial of intracoronary brachytherapy with 90Sr/Y beta-radiation for the prevention of restenosis after stent implantation in native coronary arteries in diabetic patients. Radiother Oncol. 2006 Jan; 78(1):60-66.

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