Drug-delivering endovascular treatment versus angioplasty in artery occlusion diseases: a systematic review and meta-analysis

References

• Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2017;69:1465-508
   PubMed Web of Science ®Google Scholar
• Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007;45(SupplS):S5-S67
   Web of Science ®Google Scholar
• European Stroke Organisation, Tendera M, Aboyans V, 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
   PubMed Web of Science ®Google Scholar
• Jaff MR, Rosenfield K, Scheinert D, et al. Drug-coated balloons to improve femoropopliteal artery patency: rationale and design of the LEVANT 2 trial. Am Heart J 2015;169:479-85
   PubMed Web of Science ®Google Scholar
• Pastromas G, Katsanos K, Krokidis M, et al. Emerging stent and balloon technologies in the femoropopliteal arteries. Scientific World J 2014;2014:695402
   Web of Science ®Google Scholar
• Yan BP, Moran D, Hynes BG, et al. Advances in endovascular treatment of critical limb ischemia. Circ J 2011;75:756-65
   PubMed Web of Science ®Google Scholar
• Liistro F, Porto I, Angioli P, et al.Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation 2013;128:615-21
   PubMed Web of Science ®Google Scholar
• Klein AJ, Ross CB. Endovascular treatment of lower extremity peripheral arterial disease. Trends Cardiovasc Med 2016;26:495-512
   PubMed Web of Science ®Google Scholar
• Scheinert D, Katsanos K, Zeller T, et al. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol 2012;60:2290-5
   PubMed Web of Science ®Google Scholar
• Rastan A, Brechtel K, Krankenberg H, et al. Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial. J Am Coll Cardiol 2012;60:587-91
   PubMed Web of Science ®Google Scholar
• Bosiers M, Scheinert D, Peeters P, et al. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg 2012;55:390-8
   PubMed Web of Science ®Google Scholar
• Katsanos K, Spiliopoulos S, Diamantopoulos A, et al. Systematic review of infrapopliteal drug-eluting stents: a meta-analysis of randomized controlled trials. Cardiovasc Inter Ra 2013;36:645-58
   PubMed Web of Science ®Google Scholar
• Katsanos K, Karnabatidis D, Kitrou P, et al. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther 2012;19:263-72
   PubMed Web of Science ®Google Scholar
• Klein AJ, Chen SJ, Messenger JC, et al. Quantitative assessment of the conformational change in the femoropopliteal artery with leg movement. Catheter Cardiovasc Interv 2009;74:787-98
   PubMed Web of Science ®Google Scholar
• Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol 2005;45:312-15
   PubMed Web of Science ®Google Scholar
• Laird JR, Yeo KK. The treatment of femoropopliteal in-stent restenosis: back to the future. J Am Coll Cardiol 2012;59:24-5
   PubMed Web of Science ®Google Scholar
• Waksman R, Pakala R. Drug-eluting balloon: the comeback kid? Circ Cardiovasc Interv 2009;2:352-8
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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;118:1358-65
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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;5:831-40
   PubMed Web of Science ®Google Scholar
• 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;19:571-80
   PubMed Web of Science ®Google Scholar
• Micari A, Cioppa A, Vadala G, et al. 2-year results of paclitaxel-eluting balloons for femoropopliteal artery disease: evidence from a multicenter registry. JACC Cardiovasc Interv 2013;6:282-9
   PubMed Web of Science ®Google Scholar
• Naghi J, Yalvac EA, Pourdjabbar A, et al. New developments in the clinical use of drug-coated balloon catheters in peripheral arterial disease. Med Devices (Auckl) 2016;9:161-74
   PubMedGoogle Scholar
• Katsanos K, Spiliopoulos S, Karunanithy N, et al. Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery. J Vasc Surg 2014;59:1123-33 e1128
   PubMed Web of Science ®Google Scholar
• Jens S, Conijn AP, Koelemay MJ, et al. Randomized trials for endovascular treatment of infrainguinal arterial disease: systematic review and meta-analysis (part 1: above the knee). Eur J Vasc Endovasc Surg 2014;47:524-35
   PubMed Web of Science ®Google Scholar
• Jens S, Conijn AP, Koelemay MJ, et al. Randomized trials for endovascular treatment of infrainguinal arterial disease: systematic review and meta-analysis (part 2: below the knee). Eur J Vasc Endovasc Surg 2014;47:536-44
   PubMed Web of Science ®Google Scholar
• Katsanos K, Spiliopoulos S, Paraskevopoulos I, et al. Systematic review and meta-analysis of randomized controlled trials of paclitaxel-coated balloon angioplasty in the femoropopliteal arteries: role of paclitaxel dose and bioavailability. J Endovasc Ther 2016;23:356-70
   PubMed Web of Science ®Google Scholar
• Giacoppo D, Cassese S, Harada Y, et al. Drug-coated balloon versus plain balloon angioplasty for the treatment of femoropopliteal artery disease: an updated systematic review and meta-analysis of randomized clinical trials. JACC Cardiovasc Interv 2016;9:1731-42
   PubMed Web of Science ®Google Scholar
• Higgins JPT. Cochrane Collaboration Handbook for Systematic Reviews of Interventions Version 5.1.0. Updated March 2011. The Cochrane Collaboration, 2011. Available at: www.cochrane-handbook.org [Last accessed May 21, 2015]
   Google Scholar
• Hardy RJ, Thompson SG. Detecting and describing heterogeneity in meta-analysis. Stat Med 1998;17:841-56
   PubMed Web of Science ®Google Scholar
• Takkouche B, Cadarso-Suarez C, Spiegelman D. Evaluation of old and new tests of heterogeneity in epidemiologic meta-analysis. Am J Epidemiol 1999;150:206-15
   PubMed Web of Science ®Google Scholar
• National Research Council. Combining Information: Statistical Issues and Opportunities for Research. Washington (DC): National Academy Press, 1992
   Google Scholar
• Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629-34
   PubMed Web of Science ®Google Scholar
• Duval S, Tweedie R. Trim and fill: a simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis. Biometrics 2000;56:455-63
   PubMed Web of Science ®Google Scholar
• Liistro F, Angioli P, Porto I, 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
   PubMed Web of Science ®Google Scholar
• Dake MD, Ansel GM, Jaff MR, et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation 2016;133:1472-83, discussion 1483
   PubMed Web of Science ®Google Scholar
• Scheinert D, Schmidt A, Zeller T, et al. German center subanalysis of the LEVANT 2 global randomized study of the lutonix drug-coated balloon in the treatment of femoropopliteal occlusive disease. J Endovasc Ther 2016;23:409-16
   PubMed Web of Science ®Google Scholar
• Grotti S, Liistro F, Angioli P, 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
   PubMed Web of Science ®Google Scholar
• Rosenfield K, Jaff MR, White CJ, et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med 2015;373:145-53
   PubMed Web of Science ®Google Scholar
• 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;55:207-16
   PubMed Web of Science ®Google Scholar
• Laird JR, Schneider PA, Tepe G, et al. Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN.PACT SFA. J Am Coll Cardiol 2015;66:2329-38
   PubMed Web of Science ®Google Scholar
• 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;64:1568-76
   PubMed Web of Science ®Google Scholar
• Ohki T, Yokoi H, Kichikawa K, et al. Two-year analysis of the Japanese cohort from the Zilver PTX randomized controlled trial supports the validity of multinational clinical trials. J Endovasc Ther 2014;21:644-53
   PubMed Web of Science ®Google Scholar
• Dake MD, Ansel GM, Jaff MR, et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv 2011;4:495-504
   PubMed Web of Science ®Google Scholar
• 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;358:689-99
   PubMed Web of Science ®Google Scholar
• Zeller T, Beschorner U, Pilger E, et al. Paclitaxel-coated balloon in infrapopliteal arteries: 12-month results from the BIOLUX P-II randomized trial (Biotronik’s–first in man study of the Passeo-18 LUX drug releasing PTA balloon catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries). JACC Cardiovasc Interv 2015;8:1614-22
   PubMed Web of Science ®Google Scholar
• Cassese S, Ndrepepa G, Liistro F, et al. Drug-coated balloons for revascularization of infrapopliteal arteries: a meta-analysis of randomized trials. JACC Cardiovasc Interv 2016;9:1072-80
   PubMed Web of Science ®Google Scholar
• Zeller T, Baumgartner I, Scheinert D, et al. PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial. Trials 2014;15:63
   PubMed Web of Science ®Google Scholar
• Laird JR, Armstrong EJ. Drug-coated balloons for infrapopliteal disease: digging deep to understand the impact of a negative trial. J Am Coll Cardiol 2014;64:1577-9
   PubMed Web of Science ®Google Scholar
• Liou K, Jepson N, Cao C, et al. Drug-eluting balloon versus second generation drug eluting stents in the treatment of in-stent restenosis: a systematic review and meta-analysis. Heart Lung Circ 2016;25:1184-94
   PubMed Web of Science ®Google Scholar