Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg

New England Journal of Medicine

Volumn 358, Issue 7, 2008, Pages 689-699

  Tepe, Gunnar ^a,f   Zeller, Thomas ^b   Albrecht, Thomas ^c   Heller, Stephan ^a   Schwarzwälder, Uwe ^b   Beregi, Jean Paul ^e   Claussen, Claus D ^a   Oldenburg, Anja ^c   Scheller, Bruno ^d   Speck, Ulrich ^c  

^a UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^b UNIVERSITY HEART CENTER FREIBURG BAD KROZINGEN   (Germany)

^c CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^d SAARLAND UNIVERSITY   (Germany)

^e C2RM   (France)

^f UNIVERSITY OF TÜBINGEN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; HEPARIN; IOPROMIDE; NONIONIC CONTRAST MEDIUM; PACLITAXEL;

ADULT; AGED; ANGIOCARDIOGRAPHY; ARTERY OCCLUSION; ARTICLE; ATHEROSCLEROSIS; BALLOON CATHETER; BLEEDING; CIGARETTE SMOKING; CLINICAL FEATURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES MELLITUS; DRUG DELIVERY SYSTEM; DRUG HYPERSENSITIVITY; EMBOLISM; FEMALE; FEMOROPOPLITEAL ARTERY STENOSIS; FOLLOW UP; HUMAN; LEG; MAJOR CLINICAL STUDY; MALE; MATERIAL COATING; MULTICENTER STUDY; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; RESTENOSIS; REVASCULARIZATION; THROMBOSIS; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

EID: 39049086820     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa0706356     Document Type: Article

References (22)

1. Dormandy JA, Rutherford RB. Management of peripheral arterial disease (PAD): TransAtlantic Inter-Society Consensus (TASC). J Vasc Surg 2000;31:S1-S296.
2. Minar E, Pokrajac B, Maca T, et al. Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty: results of a prospective randomized study. Circulation 2000;102:2694-9.
3. Johnston KW. Femoral and popliteal arteries: reanalysis of results of balloon angioplasty. Radiology 1992;183:767-71.
4. Idem. Factors that influence the outcome of aortoiliac and femoropopliteal percutaneous transluminal angioplasty. Surg Clin North Am 1992;72:843-50.
5. Duda SH, Poerner TC, Wiesinger B, et al. Drug-eluting stents: potential applications for peripheral arterial occlusive disease. J Vasc Interv Radiol 2003;14:291-301.
6. Cejna M, Thurnher S, Illiasch H, et al. PTA versus Palmaz stent placement in femoropopliteal artery obstructions: a multicenter prospective randomized study. J Vasc Interv Radiol 2001;12:23-31.
7. Grimm J, Müller-Hülsbeck S, Jahnke T, Hilbert C, Brossman J, Heller M. Randomized study to compare PTA alone versus PTA with Palmaz stent placement for femoropopliteal lesions. J Vasc Interv Radiol 2001;12:935-42.
8. Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med 2006;354:1879-88.
9. Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol 2005;45:312-5.
10. Duda SH, Pusich B, Richter G, et al. Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results. Circulation 2002;106:1505-9.
11. Duda SH, Bosiers M, Lammer J, et al. Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial. J Vasc Interv Radiol 2005;16:331-8.
12. Duda SH, Bosiers M, Lammer J, et al. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther 2006;13:701-10.
13. Scheller B, Speck U, Schmitt A, Böhm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol 2003;42:1415-20.
14. Speck U, Scheller B, Abramjuk C, et al. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology 2006;240:411-8.
15. Scheller B, Speck U, Abramjuk C, Bernhardt U, Böhm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation 2004;110:810-4.
16. Scheller B, Speck U, Romeike B, et al. Contrast media as carriers for local drug delivery: successful inhibition of neointimal proliferation in the porcine coronary stent model. Eur Heart J 2003;24:1462-7.
17. Scheller B, Speck U, Schmitt A, et al. Acute cardiac tolerance of current contrast media and the new taxane protaxel using iopromide as carrier during porcine coronary angiography and stenting. Invest Radiol 2002;37:29-34.
18. Albrecht T, Speck U, Beier Cl, Wolf KJ, Böhm M, Scheller B. Reduction of stenosis due to intimal hyperplasia after stent supported angioplasty of peripheral arteries by local administration of paclitaxel in swine. Invest Radiol 2007;42:579-85.
19. Scheller B, Hehrlein C, Bocksch W, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med 2006;355:2113-24.
20. Rutherford RB, Baker JD, Ernst C, et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg 1997;26:517-38. [Erratum, J Vasc Surg 2001;33:805.]
21. Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of paclitaxel from angiographic contrast media. Invest Radiol 2004;39:182-6.
22. Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA Guidelines for the Management of Patients with Peripheral Arterial Disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Associations 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) - summary of recommendations. J Vasc Interv Radiol 2006;17:1383-97.