Systematic review and meta-analysis of randomized controlled trials of paclitaxel-coated balloon angioplasty in the femoropopliteal arteries: Role of paclitaxel dose and bioavailability

Journal of Endovascular Therapy

Volumn 23, Issue 2, 2016, Pages 356-370

  Katsanos, Konstantinos ^a,b   Spiliopoulos, Stavros ^b   Paraskevopoulos, Ioannis ^a   Diamantopoulos, Athanasios ^a   Karnabatidis, Dimitris ^b  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b UNIVERSITY HOSPITAL OF PATRAS   (Greece)

Author keywords

Amputation; Balloon angioplasty; Bioavailability; Dose; Femoropopliteal segment; Meta analysis; Meta regression; Paclitaxel; Restenosis; Stent; Target lesion revascularization

Indexed keywords

PACLITAXEL; BIOCOMPATIBLE COATED MATERIAL; CARDIOVASCULAR AGENT; PACLIEX;

ARTICLE; BALLOON; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG ELUTING BALLOON; FEMORAL ARTERY; FEMOROPOPLITEAL LESION; HUMAN; LIMB AMPUTATION; LIMB ISCHEMIA; LOW DRUG DOSE; META ANALYSIS; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PERIPHERAL OCCLUSIVE ARTERY DISEASE; POPLITEAL ARTERY; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESTENOSIS; REVASCULARIZATION; RISK FACTOR; SYSTEMATIC REVIEW; ADVERSE EFFECTS; AMPUTATION; ANALOGS AND DERIVATIVES; BIOAVAILABILITY; CHI SQUARE DISTRIBUTION; DEVICES; DIAGNOSTIC IMAGING; DRUG EFFECTS; EQUIPMENT DESIGN; LIMB SALVAGE; ODDS RATIO; PATHOPHYSIOLOGY; PERIPHERAL ARTERIAL DISEASE; RECURRENT DISEASE; STENOSIS, OCCLUSION AND OBSTRUCTION; TIME FACTOR; TREATMENT OUTCOME; VASCULAR ACCESS DEVICE; VASCULAR PATENCY;

AMPUTATION; ANGIOPLASTY, BALLOON; BIOLOGICAL AVAILABILITY; CARDIOVASCULAR AGENTS; CHI-SQUARE DISTRIBUTION; COATED MATERIALS, BIOCOMPATIBLE; CONSTRICTION, PATHOLOGIC; EQUIPMENT DESIGN; FEMORAL ARTERY; HUMANS; LIMB SALVAGE; ODDS RATIO; PACLITAXEL; PERIPHERAL ARTERIAL DISEASE; POPLITEAL ARTERY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECURRENCE; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME; VASCULAR ACCESS DEVICES; VASCULAR PATENCY;

EID: 84962722002     PISSN: 15266028     EISSN: 15451550     Source Type: Journal    
DOI: 10.1177/1526602815626557     Document Type: Article

References (45)

1. Rooke TW, Hirsch AT, Misra S, et al. Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA guideline recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2013;61:1555-1570.
2. Diamantopoulos A, Katsanos K. Treating femoropopliteal disease: established and emerging technologies. Semin Intervent Radiol. 2014;31:345-352.
3. Kasapis C, Henke PK, Chetcuti SJ, et al. Routine stent implantation vs. Percutaneous transluminal angioplasty in femoropopliteal artery disease: a meta-analysis of randomized controlled trials. Eur Heart J. 2009;30:44-55.
4. Dippel EJ, Makam P, Kovach R, 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;8:92-101.
5. Spiliopoulos S, Katsanos K, Karnabatidis D, et al. Cryoplasty versus conventional balloon angioplasty of the femoropopliteal artery in diabetic patients: long-term results from a prospective randomized single-center controlled trial. Cardiovasc Intervent Radiol. 2010;33:929-938.
6. 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.
7. Diamantopoulos A, Katsanos K. Atherectomy of the femoropopliteal artery: a systematic review and meta-analysis of randomized controlled trials. J Cardiovasc Surg (Torino). 2014;55:655-665.
8. Katsanos K, Spiliopoulos S, Karunanithy N, et al. Bayesian network meta-analysis of nitinol stents, covered stents, drugeluting stents, and drug-coated balloons in the femoropopliteal artery. J Vasc Surg. 2014;59:1123-1133.e8.
9. Dake MD, Ansel GM, Jaff MR, et al. 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;61:2417-2427.
10. Neil N. Stent fracture in the superficial femoral and proximal popliteal arteries: literature summary and economic impacts. Perspect Vasc Surg Endovasc Ther. 2013;25:20-27.
11. Haude M, Erbel R, Erne P, et al. Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12 month results of the prospective, multicentre, first-in-man BIOSOLVE-I trial. Lancet. 2013;381:836-844.
12. Siablis D, Kitrou PM, Spiliopoulos S, et al. Paclitaxel-coated balloon angioplasty versus drug-eluting stenting for the treatment of infrapopliteal long-segment arterial occlusive disease: the ideas randomized controlled trial. JACC Cardiovasc Interv. 2014;7:1048-1056.
13. Higgins JP, Altman DG, Gotzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.
14. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336:924-926.
15. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535.
16. Sacks D, Marinelli DL, Martin LG, et al. Reporting standards for clinical evaluation of new peripheral arterial revascularization devices. J Vasc Interv Radiol. 2003;14(9 pt 2):S395-S404.
17. Tepe G. Cotavance paclitaxel-coated balloon vs. uncoated balloon angioplasty for treatment of in-stent restenosis in SFA and the popliteal arteries: the COPA CABANA trial. Paper presented at: LINC 2015; January 27-30, 2015; Lepzig, Germany. http://www.leipzig-interventional-course. com. Accessed February 2015.
18. Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358:689-699.
19. Werk M, Langner S, Reinkensmeier B, et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon. Femoral paclitaxel randomized pilot trial. Circulation. 2008;118:1358-1365.
20. Fanelli F, Cannavale A, Boatta E, et al. Lower limb multilevel treatment with drug-eluting balloons: 6-month results from the DEBELLUM randomized trial. J Endovasc Ther. 2012;19:571-580.
21. Fanelli F, Cannavale A, Corona M, et al. The "DEBELLUM"-lower limb multilevel treatment with drug eluting balloon-randomized trial: 1-year results. J Cardiovasc Surg (Torino). 2014;55:207-216.
22. Krankenberg H. FAIR: drug-eluting balloon vs. PTA for superficial femoral artery in-stent restenosis 12-month results. Paper presented at: LINC 2014; January 28-31, 2014; Lepzig, Germany. http://www.leipzig-interventional-course. com. Accessed February 2015.
23. Liistro F, Grotti S, Porto I, 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;6:1295-1302.
24. Tepe G, Laird J, Schneider P, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the In.Pact SFA randomized trial. Circulation. 2015;131:495-502.
25. Werk M, Albrecht T, Meyer DR, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012;5:831-840.
26. Scheinert D, Schulte KL, Zeller T, et al. Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial. J Endovasc Ther. 2015;22:14-21.
27. Scheinert D, Duda S, Zeller T, 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;7:10-19.
28. FDA, Review P130024. LutonixR drug coated balloon PTA catheter for treatment of stenotic or obstructive lesions in the femoropopliteal artery. 2014. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p130024. Accessed February 2015.
29. Rosenfield K, Jaff MR, White CJ, et al. Trial of a paclitaxelcoated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373:145-153.
30. Higgins JP, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557-560.
31. Begg CB. Publication bias. In: Cooper H, Hedges LV, eds. The Handbook of Research Synthesis. 1994:399-409.
32. Krokidis M, Spiliopoulos S, Katsanos K, et al. Peripheral applications of drug-coated balloons: past, present and future. Cardiovasc Intervent Radiol. 2013;36:281-291.
33. Zeller T, Baumgartner I, Scheinert D, et al. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the In.Pact deep randomized trial. J Am Coll Cardiol. 2014;64:1568-1576.
34. Cassar K, Bachoo P, Ford I, et al. Markers of coagulation activation, endothelial stimulation and inflammation in patients with peripheral arterial disease. Eur J Vasc Endovasc Surg. 2005;29:171-176.
35. Siablis D, Karnabatidis D, Katsanos K, et al. Infrapopliteal application of paclitaxel-eluting stents for critical limb ischemia: midterm angiographic and clinical results. J Vasc Interv Radiol. 2007;18:1351-1361.
36. Scheller B, Speck U, Abramjuk C, et al. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004;110:810-814.
37. Posa A, Nyolczas N, Hemetsberger R, 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.
38. Ng VG, Mena C, Pietras C, et al. Local delivery of paclitaxel in the treatment of peripheral arterial disease. Eur J Clin Invest. 2015;45:333-345.
39. Cremers B, Biedermann M, Mahnkopf D, et al. Comparison of two different paclitaxel-coated balloon catheters in the porcine coronary restenosis model. Clin Res Cardiol. 2009;98:325-330.
40. Hehrlein C, Richardt G, Wiemer M, et al. Description of Pantera Lux paclitaxel-releasing balloon and preliminary quantitative coronary angiography (QCA) results at six months in patients with coronary in-stent restenosis. EuroIntervention. 2011;7(Suppl K):K119-K124.
41. Granada JF, Stenoien M, Buszman PP, et al. Mechanisms of tissue uptake and retention of paclitaxel-coated balloons: impact on neointimal proliferation and healing. Open Heart. 2014;1:e000117.
42. Axel DI, Kunert W, Goggelmann C, et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation. 1997;96:636-645.
43. Yazdani SK, Pacheco E, Nakano M, et al. Vascular, downstream, and pharmacokinetic responses to treatment with a low dose drug-coated balloon in a swine femoral artery model. Catheter Cardiovasc Interv. 2014;83:132-140.
44. De Labriolle A, Pakala R, Bonello L, et al. Paclitaxel-eluting balloon: from bench to bed. Catheter Cardiovasc Interv. 2009;73:643-652.
45. Karnabatidis D, Spiliopoulos S, Katsanos K, et al. Below-theknee drug-eluting stents and drug-coated balloons. Expert Rev Med Devices. 2012;9:85-94.