Table 1.
Characteristics of included studies
| PNS vs POBA | Publication year(s) | PNS n | POBA n | Time, months | Outcomes studied | Lesion location | RC | Lesion length | Industry sponsor | Adjunct stenting |
|---|---|---|---|---|---|---|---|---|---|---|
| Brancaccio1 | 2012 | 25 | 25 | 6, 12 | BR | SFA | 3-5 | Unknown | No | 14 POBA |
| Dick2 | 2009 | 34 | 39 | 6, 12 | BR, ABI | SFA | 3-5 | 3-20cm | No | 10 POBA |
| FAST3 | 2007 | 123 | 121 | 12 | BR, TLR, ABI | SFA | 2-5 | 1-10cm | Yes | 13 POBA |
| ETAP4,5 | 2013, 2015 | 119 | 127 | 6, 12, 24 | BR, TLR, ABI | Pop | 2-5 | 5-180mm | Yes | 32 POBA |
| RESILIENT67 | 2009, 2012 | 134 | 72 | 6, 12, | BR, TLR | SFA + Pop | 1-3 | < 15cm | Yes | 29 POBA |
| SM-018 | 2019 | 51 | 52 | 6, 12, 24 | BR, TLR | SFA + Pop | 1-3 | 4-15cm | Yes | 26 POBA |
| SUPER9 | 2012 | 74 | 76 | 12 | BR, TLR | SFA | 1-6 | 5-22cm | Yes | 4 POBA |
| Schillinger10,11 | 2006, 2007 | 51 | 53 | 6, 12, 24 | BR, ABI | SFA + Pop | 3-5 | >3cm | No | 17 POBA |
| DCB vs POBA | Publication year(s) | DCB n | POBA n | Time, months | Outcomes studied | Lesion location | RC | Lesion length | Industry sponsor | Adjunct stenting |
| BIOLUX12 | 2015 | 30 | 30 | 6, 12 | BR, TLR, ABI | SFA + Pop | 2-5 | 3-20cm | Yes | 2 DCB 8 POBA |
| BIOPAC13 | 2018 | 33 | 33 | 6, 12 | BR, TLR | SFA | 2-4 | 4-15cm | Yes | 13 DCB 13 POBA |
| CONSEQUENT14,15 | 2017, 2018 | 78 | 75 | 6, 12 | BR, TLR, ABI | SFA + Pop | 2-4 | 4-27cm | Yes | 11 DCB 14 POBA |
| EffPac16 | 2019 | 85 | 86 | 6, 12 | BR, TLR, ABI | SFA + Pop | 2-4 | <15cm | Yes | 13 DCB 16 POBA† |
| ILLUMENATE.EU17,18 | 2017, 2018 | 222 | 72 | 6, 12, 24 | BR, TLR, ABI | SFA + Pop | 2-4 | 3-20cm | Yes | 38 DCB 9 DCB† |
| ILLUMENATE PK19 | 2017 | 200 | 100 | 6, 12 | BR, TLR, ABI | SFA + Pop | 2-4 | 3-18cm | Yes | 12 DCB 6 POBA† |
| INPACT JP20,21 | 2018, 2018 | 68 | 32 | 6, 12, 24 | BR, TLR, ABI | SFA + Pop | 2-4 | 4-20 cm | Yes | 3 DCB 1 POBA† |
| INPACT SFA22,23 | 2014, 2015 | 220 | 111 | 6, 12, 24 | BR, TLR, ABI | SFA + Pop | 2-4 | 4-18 cm | Yes | 16 DCB 14 POBA† |
| LEVANT I24 | 2014 | 31 | 24 | 6, 12, 24 | BR, TLR, ABI | SFA + Pop | 2-5 | 4-15cm | Yes | 12 DCB 14 POBA |
| LEVANT II25 | 2015 | 316 | 160 | 6, 12 | BR, TLR, ABI | SFA + Pop | 2-4 | <15cm | Yes | 8 DCB 11 POBA† |
| RANGER26,27 | 2017, 2018 | 71 | 34 | 6, 12 | BR, TLR, ABI | SFA + Pop | 2-4 | 2-15cm | Yes | 15 DCB 4 POBA |
PNS = Primary Nitinol Stenting, POBA = Uncoated balloon angioplasty, BR = Binary Restenosis, TLR=Target Lesion Revascularization, ABI = Ankle Brachial Index, RC = Rutherford Classification, SFA = Superficial Femoral Artery, Pop = Popliteal Artery
= These studies were protocoled such that randomization would occur after successful predilation and that patients who dissected during predilation would be screened out of the study.
Brancaccio G, Lombardi R, Stefanini T, Torri P, Russo D, Gorji N, Cappelletti D, Celoria GM. Comparison of embolic load in femoropopliteal interventions: percutaneous transluminal angioplasty versus stenting. Vascular and endovascular surgery. 2012 Apr;46(3):229-35.
Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, Koppensteiner R, Minar E, Schillinger M. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheterization and Cardiovascular Interventions. 2009 Dec 1;74(7):1090-5.
Krankenberg H, Schlüter M, Steinkamp HJ. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Journal of Vascular Surgery. 2008 Jan 1;47(1):239.
Rastan A, Krankenberg H, Baumgartner I, Blessing E, Müller-Hülsbeck S, Pilger E, Scheinert D, Lammer J, Gißler M, Noory E, Neumann FJ. Stent placement versus balloon angioplasty for the treatment of obstructive lesions of the popliteal artery: a prospective, multicenter, randomized trial. Circulation. 2013 Jun 25;127(25):2535-41.
Rastan A, Krankenberg H, Baumgartner I, Blessing E, Müller-Hülsbeck S, Pilger E, Scheinert D, Lammer J, Beschorner U, Noory E, Neumann FJ. Stent placement vs. balloon angioplasty for popliteal artery treatment: two-year results of a prospective, multicenter, randomized trial. Journal of endovascular therapy. 2015 Feb;22(1):22-7.
Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ. 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. Circulation: Cardiovascular Interventions. 2010 Jun;3(3):267-76.
Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ. 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. Journal of Endovascular Therapy. 2012 Feb;19(1):1-9.
Iida O, Urasawa K, Komura Y, Soga Y, Inoue N, Hara H, Yajima J, Nakamura S, Ohki T, Ando H, Hirano K. Self-expanding nitinol stent vs percutaneous transluminal angioplasty in the treatment of femoropopliteal lesions: 3-year data from the SM-01 trial. Journal of Endovascular Therapy. 2019 Apr;26(2):158-67.
Chalmers N, Walker PT, Belli AM, Thorpe AP, Sidhu PS, Robinson G, van Ransbeeck M, Fearn SA. Randomized trial of the SMART stent versus balloon angioplasty in long superficial femoral artery lesions: the SUPER study. Cardiovascular and interventional radiology. 2013 Apr 1;36(2):353-61.
Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. New England Journal of Medicine. 2006 May 4;354(18):1879-88.
Schillinger M, Sabeti S, Dick P, et al. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007;115(21):2745-2749.
Scheinert D, Schulte KL, Zeller T, Lammer J, Tepe G. Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX PI randomized trial. Journal of Endovascular Therapy. 2015 Feb;22(1):14-21.
Buszman PP, Nowakowski P, Milewski K, Orlik B, Żurakowski A, Ludyga T, Polczyk F, Dębiński M, Jelonek M, Kachel M, Gąsior M. Clinical Randomized Trial Evaluating Novel, Microcrystalline, and Biocompatible Polymer Paclitaxel-Coated Balloon for the Treatment of Femoropopliteal Occlusive Disease: The BIOPAC Trial. JACC: Cardiovascular Interventions. 2018 Dec 10;11(23):2436-8.
Tepe G, Gögebakan Ö, Redlich U, Tautenhahn J, Ricke J, Halloul Z, Meyer DR, Waliszewski M, Schnorr B, Zeller T, Müller-Hülsbeck S. Angiographic and clinical outcomes after treatment of femoro-popliteal lesions with a novel paclitaxel-matrix-coated balloon catheter. CardioVascular and Interventional Radiology. 2017 Oct 1;40(10):1535-44.
Albrecht T, Waliszewski M, Roca C, Redlich U, Tautenhahn J, Pech M, Halloul Z, Gögebakan Ö, Meyer DR, Gemeinhardt I, Zeller T. Two-year clinical outcomes of the CONSEQUENT trial: can femoropopliteal lesions be treated with sustainable clinical results that are economically sound?. Cardiovascular and interventional radiology. 2018 Jul 1;41(7):1008-14.
Teichgräber U, Lehmann T, Aschenbach R, Scheinert D, Zeller T, Brechtel K, Blessing E, Lichtenberg M, Sixt S, Brucks S, Beschorner U. Efficacy and safety of a novel paclitaxel-nano-coated balloon for femoropopliteal angioplasty: one-year results of the EffPac trial. Eurointervention: Journal of Europcr in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2020 Apr 3;15(18):e1633-40.
Schroeder H, Werner M, Meyer DR, Reimer P, Krüger K, Jaff MR, Brodmann M. Low-Dose Paclitaxel–Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon). Circulation. 2017 Jun 6;135(23):2227-36.
Brodmann M, Werner M, Meyer DR, Reimer P, Krüger K, Granada JF, Jaff MR, Schroeder H, ILLUMENATE EU RCT Investigators. Sustainable antirestenosis effect with a low-dose drug-coated balloon: the ILLUMENATE European randomized clinical trial 2-year results. JACC: Cardiovascular Interventions. 2018 Dec 10;11(23):2357-64.
Krishnan P, Faries P, Niazi K, Jain A, Sachar R, Bachinsky WB, Cardenas J, Werner M, Brodmann M, Mustapha JA, Mena-Hurtado C. Stellarex drug-coated balloon for treatment of femoropopliteal disease: twelve-month outcomes from the randomized ILLUMENATE pivotal and pharmacokinetic studies. Circulation. 2017 Sep 19;136(12):1102-13.
Iida O, Soga Y, Urasawa K, Saito S, Jaff MR, Wang H, Ookubo H, Yokoi H. Drug-coated balloon vs standard percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal arteries: one-year results of the MDT-2113 SFA Japan randomized trial. Journal of Endovascular Therapy. 2018 Feb;25(1):109-17.
Iida O, Soga Y, Urasawa K, Saito S, Jaff MR, Wang H, Ookubo H, Yokoi H, MDT-2113 SFA Japan Investigators. Drug-coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2-year results of the MDT-2113 SFA Japan randomized trial. Catheterization and Cardiovascular Interventions. 2019 Mar 1;93(4):664-72.
Tepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, Metzger C, Scheinert D, Zeller T, Cohen DJ, Snead DB. 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 Feb 3;131(5):495-502.
Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, Krishnan P, Scheinert D, Micari A, Cohen DJ, Wang H. Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN. PACT SFA. Journal of the American College of Cardiology. 2015 Dec 1;66(21):2329-38.
Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G, Naisbitt S, Rosenfield K. 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: Cardiovascular Interventions. 2014 Jan 1;7(1):10-9.
Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, Brodmann M, Pilger E, Zeller T, Krishnan P, Gammon R. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. New England Journal of Medicine. 2015 Jul 9;373(2):145-53.
Bausback Y, Willfort-Ehringer A, Sievert H, Geist V, Lichtenberg M, Del Giudice C, Sauguet A, Diaz-Cartelle J, Marx C, Stroebel A, Schult I. Six-month results from the initial randomized study of the Ranger paclitaxel-coated balloon in the femoropopliteal segment. Journal of Endovascular Therapy. 2017 Aug;24(4):459-67.
Steiner S, Willfort-Ehringer A, Sievert H, Geist V, Lichtenberg M, Del Giudice C, Sauguet A, Diaz-Cartelle J, Marx C, Ströbel A, Schult I. 12-month results from the first-in-human randomized study of the ranger paclitaxel-coated balloon for femoropopliteal treatment. JACC: Cardiovascular Interventions. 2018 May 21;11(10):934-41.