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Drug-Coated Balloon in Superficial Femoral Artery In-Stent Restenosis

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Drug-Coated Balloons

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Abstract

Although the widespread use of new-generation, self-expanding, nitinol stents in superficial femoral artery (SFA) stenosis has reduced the shortcomings associated with a plain old balloon angioplasty (POBA) for SFA, lumen renarrowing at the stented level (in-stent restenosis, ISR) represents a relevant clinical problem.

Several endovascular approach have been attempted to treat ISR (i.e., POBA, debulking, use of covered stents) but, as of today, none of this have been proved to be effective.

In this review we examine the results of different trials exploring the outcome of using drug-coated balloons (DCBs) for the treatment of SFA ISR.

The consistent and positive results of different registries and randomized trials support the concept that the use of DCB is associated with a reduction in recurrent restenosis and target lesion revascularization (TLR) at least at 1 year after plain old balloon angioplasty (POBA). The available data strongly support the use of DCB to reduce SFA ISR recurrence.

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References

  1. Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;382(9901):1329–40. https://doi.org/10.1016/S0140-6736(13)61249-0.

    Article  PubMed  Google Scholar 

  2. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(Suppl S):S5–67. https://doi.org/10.1016/j.jvs.2006.12.037.

    Article  PubMed  Google Scholar 

  3. Rowe VL, Lee W, Weaver FA, Etzioni D. Patterns of treatment for peripheral arterial disease in the United States: 1996–2005. J Vasc Surg. 2009;49:910–7.

    Article  Google Scholar 

  4. Tendera M, Aboyans V, Bartelink ML, et al. ESC guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32:2851–906.

    Article  Google Scholar 

  5. Katsanos K, Tepe G, Tsetis D, et al. Standards of practice for superficial femoral and popliteal artery angioplasty and stenting. Cardiovasc Intervent Radiol. 2014;37:592–603.

    Article  Google Scholar 

  6. Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G, Viva PI. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007;69(6):910–9. https://doi.org/10.1002/ccd.21104.

    Article  PubMed  Google Scholar 

  7. Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354(18):1879–88. https://doi.org/10.1056/NEJMoa051303.

    Article  CAS  PubMed  Google Scholar 

  8. Mehrotra S, Paramasivam G, Mishra S. Paclitaxel-coated balloon for femoropopliteal artery disease. Curr Cardiol Rep. 2017;19:10.

    Article  Google Scholar 

  9. Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012;5:831–40.

    Article  CAS  Google Scholar 

  10. Herten M, Torsello G, Schönefeld E, Imm B, Osada N, Stahlhoff S. Drug-eluting balloons for femoropopliteal lesions show better performance in de novo stenosis or occlusion than in restenosis. J Vasc Surg. 2015;61(2):394–9.

    Article  Google Scholar 

  11. Soga Y, Iida O, Hirano K, Yokoi H, Nanto S, Nobuyoshi M. Mid-term clinical outcome and predictors of vessel patency after femoropopliteal stenting with self-expandable nitinol stent. J Vasc Surg. 2010;52:608–15.

    Article  Google Scholar 

  12. Laird JR, Katzen BT, Scheinert D, et al. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010;3:267–76.

    Article  Google Scholar 

  13. Scheinert D, Scheinert S, Sax J, Piorkowski C, Braunlich S, Ulrich M, Biamino G, Schmidt A. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45:312–5.

    Article  Google Scholar 

  14. Cortese B, Granada J, Scheller B, Scnheider P, Tepe G, Scheinert D, Garcia L, Stabile E, Alfonso F, Ansel G, Zeller T. Drug-coated balloon treatment for lower extremity vascular disease intervention: an international positioning document. Eur Heart J. 2016;37:1096–103. https://doi.org/10.1093/eurheartj/ehv204.

    Article  PubMed  Google Scholar 

  15. Armstrong EJ, Singh S, Singh GD, Yeo KK, Ludder S, Westin G, et al. Angiographic characteristics of femoropopliteal in-stent restenosis: association with long-term outcomes after endovascular intervention. Catheter Cardiovasc Interv. 2013;82:1168–74.

    Article  Google Scholar 

  16. Ho KJ, Owens C. Diagnosis, classification, and treatment of femoropopliteal artery in-stent restenosis. J Vasc Surg. 2017;65(2):545–57.

    Article  Google Scholar 

  17. Tosaka A, Soga Y, Iida O, Ishihara T, Hirano K, Suzuki K, et al. Classification and clinical impact of restenosis after femoropopliteal stenting. J Am Coll Cardiol. 2012;59:16–23.

    Article  Google Scholar 

  18. Montorsi P, Galli S, Fabbiocchi F, et al. Randomized trial of conventional balloon angioplasty versus cutting balloon for in-stent restenosis. Acute and 24-hour angiographic and intravascular ultrasound changes and long-term follow-up. Ital Heart J. 2004;5:271–9.

    PubMed  Google Scholar 

  19. Dick P, Sabeti S, Mlekusch W, et al. Conventional balloon angioplasty versus peripheral cutting balloon angioplasty for treatment of femoropopliteal artery in-stent restenosis: initial experience. Radiology. 2008;248:297–302.

    Article  Google Scholar 

  20. Stabile S, Virga V, Salemme L, Cioppa A, Ambrosini V, Sorropago G, Tesorio T, Cota L, Popusoi G, Pucciarelli A, Biamino G, Rubino P. Drug-eluting balloon for treatment of superficial femoral artery in-stent restenosis. J Am Coll Cardiol. 2012;60(18):1739–42.

    Article  CAS  Google Scholar 

  21. Virga V, Stabile E, Biamino G, Salemme L, Cioppa A, Giugliano G, et al. Drug-eluting balloons for the treatment of the superficial femoral artery in-stent restenosis: 2-year follow-up. JACC Cardiovasc Interv. 2014;7:411–5.

    Article  Google Scholar 

  22. Bague N, Julia P, et al. Femoropopliteal in-stent restenosis repair: midterm outcomes after paclitaxel eluting balloon use (PLAISIR Trial). Eur J Vasc Endovasc Surg. 2016;53(1):1–8.

    Google Scholar 

  23. Liistro F, Angioli P, Porto I, Ricci L, Ducci K, Grotti S, et al. Paclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR study. J Endovasc Ther. 2014;21:1–8.

    Article  Google Scholar 

  24. Grotti S, Liistro F, Angioli P, Ducci K, Falsini G, Porto I, et al. Paclitaxel-eluting balloon vs standard angioplasty to reduce restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: three-year results of the DEBATE-ISR study. J Endovasc Ther. 2016;23:52–7.

    Article  Google Scholar 

  25. Krankenberg H, Tubler T, Ingwerson M, Schluter M, Scheinert D, Blessing E, Sixt S, Kieback A, Beschorner U, Zeller T. Drug-coated balloon versus standard balloon for superficial femoral artery in-stent restenosis: the randomized femoral artery in-stent restenosis (FAIR) trial. Circulation. 2015;132:2230–6.

    Article  CAS  Google Scholar 

  26. Kinstner CM, Lammer J, Willfort-Ehringer A, Matzek W, Gschwandtner M, Javor D, Funovics M, Schoder M, Koppensteiner R, Loewe C, Ristl R, Wolf F. Paclitaxel-eluting balloon versus standard balloon angioplasty in in-stent restenosis of the superficial femoral and proximal popliteal artery: 1-year results of the PACUBA trial. JACC Cardiovasc Interv. 2016;9(13):1386–92.

    Article  Google Scholar 

  27. Wu R, Zilun L, Wang M, Guangqi C, Chen Y. Paclitaxel-coated versus uncoated balloon angioplasty for femoropopliteal artery in-stent restenosis. Int J Surg. 2017;42:72–82.

    Article  Google Scholar 

  28. Gray BH, Buchan JA, et al. JACC Cardiovasc Interv. 2016;9(13):1393–6.

    Article  Google Scholar 

  29. Zeller T, Rastan A, Macharzina R, Beschorner U, Noory E. Drug-coated balloons: how should we incorporate into our practice in treating superficial femoral artery lesions? Curr Treat Options Cardiovasc Med. 2015;17(5):380.

    Article  Google Scholar 

  30. Ott I, Cassese S, et al. ISAR-PEBIS (Paclitaxel-eluting balloon versus conventional balloon angioplasty for in-stent restenosis of superficial femoral artery): a randomized trial. J Am Heart Assoc. 2017;6:e006321.

    Article  Google Scholar 

  31. Brodmann M, Keirse K, Scheinert D, Spak L, Jaff MR, Schmahl R, Li P, Zeller T. Drug-coated balloon treatment for femoropopliteal artery disease. The IN.PACT global study de novo in-stent restenosis imaging cohort. J Am Coll Cardiol Intv. 2017;10(20):2113–23.

    Article  Google Scholar 

  32. Niazi K, Tukaye D. Challenges of stent restenosis in superficial femoral and popliteal artery disease. J Am Coll Cardiol Interv. 2017;10(20):2124–5.

    Article  Google Scholar 

  33. Schmidt A, Zeller T, Sievert H, Krankenberg H, Torsello G, Stark MA, et al. Photoablation using the turbo-booster and excimer laser for in-stent restenosis treatment: twelve month results from the PATENT study. J Endovasc Ther. 2014;21:52–60.

    Article  Google Scholar 

  34. Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, et al. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer laser randomized controlled study for treatment of FemoropopliTEal in-stent restenosis). JACC Cardiovasc Interv. 2015;8(Pt A):92–101.

    Article  Google Scholar 

  35. Laird JR Jr, Yeo KK, Rocha-Singh K, Das T, Joye J, Dippel E, et al. Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis: twelve-month results from the SALVAGE study. Catheter Cardiovasc Interv. 2012;80:852–9.

    Article  Google Scholar 

  36. Van den Berg JC, Pedrotti M, Canevascini R, Chimchila Chevili S, Giovannacci L, Rosso R. In-stent restenosis: mid-term results of debulking using excimer laser and drug-eluting balloons: sustained benefit? J Invasive Cardiol. 2014;26(7):333–7.

    PubMed  Google Scholar 

  37. Photoablative atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis in instent femoro-popliteal obstructions (PHOTOPAC). Available at: https://clinicaltrials.gov/ct2/show/NCT01298947.

  38. Beschorner U, Krankenberg H, Scheinert D, Sievert H, Tubler T, Sixt S, et al. Rotational and aspiration atherectomy for infrainguinal in-stent restenosis. Vasa. 2013;42:127–33.

    Article  Google Scholar 

  39. Sixt S, Carpio Cancino OG, Treszl A, Beschorner U, Macharzina R, Rastan A, et al. Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries. J Vasc Surg. 2013;58:682–6.

    Article  Google Scholar 

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Authors and Affiliations

  1. Division of Cardiology, Department of Advanced Biomedical Sciences, “Federico II” University, Napoli, Italy

    Donato Gerardi, Arturo Alfani, Giovanni Esposito & Eugenio Stabile

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  1. Donato Gerardi
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  2. Arturo Alfani
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  3. Giovanni Esposito
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  4. Eugenio Stabile
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Editors and Affiliations

  1. Cardiac Department, San Carlo Clinic, Milano, Italy

    Bernardo Cortese

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Gerardi, D., Alfani, A., Esposito, G., Stabile, E. (2019). Drug-Coated Balloon in Superficial Femoral Artery In-Stent Restenosis. In: Cortese, B. (eds) Drug-Coated Balloons . Springer, Cham. https://doi.org/10.1007/978-3-319-92600-1_15

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  • DOI: https://doi.org/10.1007/978-3-319-92600-1_15

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-92599-8

  • Online ISBN: 978-3-319-92600-1

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