Comparison of Particulate Embolization after Femoral Artery Treatment with IN.PACT Admiral versus Lutonix 035 Paclitaxel-Coated Balloons in Healthy Swine

Journal of Vascular and Interventional Radiology

Volumn 27, Issue 11, 2016, Pages 1676-1685.e2

  Kolodgie, Frank D ^a   Pacheco, Erica ^a   Yahagi, Kazuyuki ^a   Mori, Hiroyoshi ^a   Ladich, Elena ^a   Virmani, Renu ^a  

^a CVPATH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PACLITAXEL; PROTEOGLYCAN; BIOCOMPATIBLE COATED MATERIAL; CARDIOVASCULAR AGENT;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; ARTIFICIAL EMBOLIZATION; CONTROLLED STUDY; FEMORAL ARTERY; FOLLOW UP; HISTOLOGY; MORPHOMETRICS; NEOINTIMA; NONHUMAN; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON; PIG; PRIORITY JOURNAL; SKELETAL MUSCLE; ADVERSE EFFECTS; ANIMAL; ARTERIOLE; COMPARATIVE STUDY; CORONARY BLOOD VESSEL; DEVICES; DRUG EFFECTS; EMBOLISM; EQUIPMENT DESIGN; FIBROSIS; NECROSIS; PATHOLOGY; TIME FACTOR; VASCULAR ACCESS DEVICE; VASCULARIZATION;

ANGIOPLASTY, BALLOON; ANIMALS; ARTERIOLES; CARDIOVASCULAR AGENTS; COATED MATERIALS, BIOCOMPATIBLE; CORONARY VESSELS; EMBOLISM; EQUIPMENT DESIGN; FEMORAL ARTERY; FIBROSIS; MODELS, ANIMAL; MUSCLE, SKELETAL; NECROSIS; NEOINTIMA; PACLITAXEL; SUS SCROFA; TIME FACTORS; VASCULAR ACCESS DEVICES;

EID: 84994528994     PISSN: 10510443     EISSN: 15357732     Source Type: Journal    
DOI: 10.1016/j.jvir.2016.06.036     Document Type: Article

References (19)

1. 1 Tepe, G., Zeller, T., Albrecht, T., et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 358 (2008), 689–699.
2. 2 Werk, M., Albrecht, T., Meyer, D.R., et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv 5 (2012), 831–840.
3. 3 Dake, M.D., Ansel, G.M., Jaff, M.R., 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 4 (2011), 495–504.
4. 4 Wood, N.B., Zhao, S.Z., Zambanini, A., et al. Curvature and tortuosity of the superficial femoral artery: a possible risk factor for peripheral arterial disease. J Appl Physiol (1985) 101 (2006), 1412–1418.
5. 5 Fowkes, F.G., Housley, E., Cawood, E.H., Macintyre, C.C., Ruckley, C.V., Prescott, R.J., Edinburgh Artery Study: prevalence of asymptomatic and symptomatic peripheral arterial disease in the general population. Int J Epidemiol 20 (1991), 384–392.
6. 6 Otsuka, F., Nakano, M., Sakakura, K., Ladich, E., Kolodgie, F.D., Virmani, R., Unique demands of the femoral anatomy and pathology and the need for unique interventions. J Cardiovasc Surg (Torino) 54 (2013), 191–210.
7. 7 Tzafriri, A.R., Vukmirovic, N., Kolachalama, V.B., Astafieva, I., Edelman, E.R., Lesion complexity determines arterial drug distribution after local drug delivery. J Control Release 142 (2010), 332–338.
8. 8 Schillinger, M., Minar, E., Percutaneous treatment of peripheral artery disease: novel techniques. Circulation 126 (2012), 2433–2440.
9. 9 Yazdani, S.K., 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 83 (2014), 132–140.
10. 10 Hirsch, A.T., Haskal, Z.J., Hertzer, N.R., et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation, 113, 2006 e463-654.
11. 11 Iida, O., Soga, Y., Hirano, K., et al. Long-term outcomes and risk stratification of patency following nitinol stenting in the femoropopliteal segment: retrospective multicenter analysis. J Endovasc Ther 18 (2011), 753–761.
12. 12 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 7 (2014), 10–19.
13. 13 Gray, W.A., Granada, J.F., Drug-coated balloons for the prevention of vascular restenosis. Circulation 121 (2010), 2672–2680.
14. 14 Iida, O., Soga, Y., Kawasaki, D., et al. Angiographic restenosis and its clinical impact after infrapopliteal angioplasty. Eur J Vasc Endovasc Surg 44 (2012), 425–431.
15. 15 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 128 (2013), 615–621.
16. 16 Thomas, S.D., McDonald, R.R., Varcoe, R.L., Vasculitis resulting from a superficial femoral artery angioplasty with a paclitaxel-eluting balloon. J Vasc Surg 59 (2014), 520–523.
17. 17 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 8 (2015), 1614–1622.
18. 18 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 64 (2014), 1568–1576.
19. 19 Kelsch, B., Scheller, B., Biedermann, M., et al. Dose response to Paclitaxel-coated balloon catheters in the porcine coronary overstretch and stent implantation model. Invest Radiol 46 (2011), 255–263.