The role of drug-eluting balloons for the in-stent restenosis in femoro-popliteal interventions

Italian Journal of Vascular and Endovascular Surgery

Volumn 21, Issue 4, 2014, Pages 183-189

  Cannavale, A ^a   Krokidis, M ^a  

^a CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

Angioplasty; Balloon; Coronary restenosis; Laser assisted; Peripheral vascular diseases

Indexed keywords

PACLITAXEL;

ARTERY DISEASE; ARTICLE; ATHERECTOMY; DRUG ELUTING BALLOON; ENDOVASCULAR SURGERY; FEMOROPOPLITEAL DISEASE; IMPLANT; IN-STENT RESTENOSIS; PREVENTION; SUSTAINED RELEASE PREPARATION;

EID: 84962040530     PISSN: 18244777     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (50)

1. Marrett E, DiBonaventura Md, Zhang Q. Burden of peripheral arterial disease in Europe and the United States: a patient survey. Health Qual Life Outcomes 2013;11:175.
2. Pietzsch JB, Geisler BP, Garner AM, Zeller T, Jaff MR. Economic analysis of endovascular interventions for femoropopliteal arterial disease: A systematic review and budget impact model for the United States and Germany. Catheter Cardiovasc Interv 2014 [Epub ahead of print].
3. Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clément D, Collet JP et al. ESC Committee for Practice Guidelines. 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.
4. Katsanos K, Tepe G, Tsetis D, Fanelli F. Standards of practice for superficial femoral and popliteal artery angioplasty and stenting. Cardiovasc Intervent Radiol 2014;37:592-603.
5. Katsanos K, Spiliopoulos S, Karunanithy N, Krokidis M, Sabharwal T, Taylor P. Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery. J Vasc Surg 2014;59:1123-1133.e8
6. Yahagi K, Otsuka F, Sakakura K, Sanchez OD, Kutys R, Ladich E et al. Pathophysiology of superficial femoral artery in-stent restenosis. J Cardiovasc Surg (Torino) 2014;55:307-23.
7. 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.
8. Zeller T, Tiefenbacher C, Steinkamp HJ, Langhoff R, Wittenberg G, Schluter M et al. Nitinol stent implantation in TASC A and B superficial femoral artery lesions: the Femoral Artery Conformexx Trial (FACT). J Endovasc Ther 2008;15:390-8.
9. Davaine JM, Azema L, Guyomarch B, Chaillou P, Costargent A, Patra P et al. One-year clinical outcome after primary stenting for Trans-Atlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions (the STELLA «Stenting Long de L'Artere femorale superficielle» cohort). Eur J Vasc Endovasc Surg 2012;44:432-41.
10. Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M et al. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther 2012;19:1-9.
11. Chalmers N, Walker PT, Belli AM, Thorpe AP, Sidhu PS, Robinson G et al. Randomized trial of the SMART stent versus balloon angioplasty in long superficial femoral artery lesions: the SUPER study. Cardiovasc Intervent Radiol 2013;36:353-61.
12. Geraghty PJ, Mewissen MW, Jaff MR, Ansel GM; VIBRANT Investigators. Three-year results of the VIBRANT trial of VIA-BAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease. J Vasc Surg 2013;58:386-95.e4.
13. Lammer J, Zeller T, Hausegger KA, Schaefer PJ, Gschwendtner M, Mueller-Huelsbeck S et al. Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease). J Am Coll Cardiol 2013;62:1320-7.
14. Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB et al. Zilver PTX Investigators. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol 2013;61:2417-27.
15. Dick P, Sabeti S, Mlekusch W, Schlager O, Amighi J, Haumer M 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.
16. Beschorner U, Krankenberg H, Scheinert D, Sievert H, Tübler T, Sixt S et al. Rotational and aspiration atherectomy for infrainguinal in-stent restenosis. Vasa 2013;42:127-33.
17. Shammas NW, Shammas GA, Jerin M. Differences in patient selection and outcomes between SilverHawk atherectomy and laser ablation in the treatment of femoropopliteal in-stent restenosis: a retrospective analysis from a single center. J Endovasc Ther 2013;20:844-52.
18. Yeo KK, Malik U, Laird JR. Outcomes following treatment of femoropopliteal in-stent restenosis: a single center experience. Catheter Cardiovasc Interv 2011;78:604-8.
19. Shammas NW, Shammas GA, Hafez A, Kelly R, Reynolds E, Shammas AN. Safety and one-year revascularization outcome of excimer laser ablation therapy in treating in-stent restenosis of femoropopliteal arteries: a retrospective review from a single center. Cardiovasc Revasc Med 2012;13:341-4.
20. 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.
21. 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.
22. Werner M, Scheinert D, Henn M, Scheinert S, Bräunlich S, Bausback Y et al. Endovascular brachytherapy using liquid Betaemitting rhenium-188 for the treatment of long-segment femoropopliteal in-stent stenosis. J Endovasc Ther 2012;19:467-75.
23. Shin SH, Baril DT, Chaer RA, Makaroun MS, Marone LK. Cryoplasty offers no advantage over standard balloon angioplasty for the treatment of in-stent stenosis. Vascular 2013 Mar 14 [Epub ahead of print].
24. Al Shammeri O, Bitar F, Ghitelman J, Soukas PA. Viabahn for femoropopliteal in-stent restenosis. Ann Saudi Med 2012;32:572-82.
25. Zeller T, Dake MD, Tepe G, Brechtel K, Noory E, Beschorner U et al. Treatment of femoropopliteal in-stent restenosis with paclitaxeleluting stents. JACC Cardiovasc Interv 2013;6:274-81.
26. Leopardi M, Houbballah R, Becquemin JP. Effectiveness of Zilver PTX eluting stent in TASC C/D lesions and restenosis. J Cardiovasc Surg (Torino) 2014;55:229-34.
27. Armstrong EJ, Singh S, Singh GD, Yeo KK, Ludder S, Westin G et al. Angiographic characteristics of femoropoplitea in-stent restenosis: association with long-term outcomes after endovascular intervention. Catheter Cardiovasc Interv 2013;82:1168-74.
28. Krokidis M, Spiliopoulos S, Katsanos K, Sabharwal T. Peripheral applications of drug-coated balloons: past, present and future. Cardiovasc Intervent Radiol 2013;36:281-91.
29. Fanelli F, Cannavale A, Corona M, Lucatelli P, Wlderk A, Salvatori FM. The "DEBELLUM"-lower limb multilevel treatment with drug eluting balloon-randomized trial: 1-year results. J Cardiovasc Surg (Torino) 2014;55:207-16.
30. Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation 2008;118:1358-65.
31. Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 2008;358:689-99.
32. Liistro F, Grotti S, Porto I, Angioli P, Ricci L, Ducci K et al. Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery). JACC Cardiovasc Interv 2013;6:1295-302.
33. Pósa A, Nyolczas N, Hemetsberger R, Pavo N, Petnehazy O, Petrasi Z et al. Optimization of drug-eluting balloon use for safety and efficacy: evaluation of the 2nd generation paclitaxel-eluting DIOR-balloon in porcine coronary arteries. Catheter Cardiovasc Interv 2010;76:395-403.
34. Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv 2014;7:10-9.
35. Buszman PP, Tellez A, Afari ME, Peppas A, Conditt GB, Rousselle SD et al. Tissue uptake, distribution, and healing response after delivery of paclitaxel via second-generation iopromide-based balloon coating: a comparison with the first-generation technology in the iliofemoral porcine model. JACC Cardiovasc Interv 2013;6:883-90.
36. Gray WA. Drug-coated balloons: the coating makes the difference. LINC, Leipzig 2012, 25-28 Jan.
37. Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U et al. Treatment of coronary in-stent restenosis with a paclitaxel coated balloon catheter. N Engl J Med 2006;355:2113-24.
38. Hehrlein C, Dietz U, Kubica J, Jørgensen E, Hoffmann E, Naber C et al. Twelve-month results of a paclitaxel releasing balloon in patients presenting with in-stent restenosis First-in-Man (PEPPER) trial. Cardiovasc Revasc Med 2012;13:260-4.
39. Navarese EP, Austin D, Gurbel PA, Andreotti F, Tantry U, James S et al. Drug-coated balloons in treatment of in-stent restenosis: a meta-analysis of randomised controlled trials. Clin Res Cardiol 2013;102:279-87.
40. Stabile E, Virga V, Salemme L, Cioppa A, Ambrosini V, Sorropago G et al. Drug-eluting balloon for treatment of superficial femoral artery in-stent restenosis. J Am Coll Cardiol 2012;60:1739-42.
41. 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.
42. 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.
43. 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.
44. van den Berg JC, Pedrotti M, Canevascini R, Chimchila Chevili S et al. In-stent restenosis: mid-term results of debulking using excimer laser and drug-eluting balloons: sustained benefit? J Invasive Cardiol 2014;26:333-7.
45. Fanelli F, Cannavale A, Gazzetti M, Lucatelli P, Wlderk A, Cirelli C et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol 2014;37:898-907.
46. Cioppa A, Stabile E, Popusoi G, Salemme L, Cota L, Pucciarelli A et al. Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: One-year single centre clinical results. Cardiovasc Revasc Med 2012;13:219-23.
47. Gandini R, Del Giudice C, Merolla S, Morosetti D, Pampana E, Simonetti G. Treatment of chronic SFA in-stent occlusion with combined laser atherectomy and drug-eluting balloon angioplasty in patients with critical limb ischemia: a single-center, prospective, randomized study. J Endovasc Ther 2013;20:805-14.
48. Directional AthErectomy followed by a PaclItaxel-coated BallooN to InhibiT RestenosIs and maintain vessel PatEncy: A pilot study of anti-restenosis treatment [Internet] ClinicalTrials.gov Web site. http://clinicaltrials.gov/ct2/show/record/NCT01366482.
49. Van Den Berg JC, Pedrotti M, Canevascini R, Chimchila Chevili S, Giovannacci L, Rosso R. Endovascular treatment of in-stent restenosis using excimer laser angioplasty and drug eluting balloons. J Cardiovasc Surg (Torino) 2012;53:215-22.
50. Schillinger M, Mlekusch W, Haumer M, Sabeti S, Ahmadi R, Minar E. Angioplasty and elective stenting of de novo versus recurrent femoropopliteal lesions: 1-year follow-up. J Endovasc Ther 2003;10:288-97.