Advances on drug-coated balloons

Journal of Cardiovascular Surgery

Volumn 51, Issue 1, 2010, Pages 125-143

  Tepe, G ^a   Schmitmeier, S ^b   Speck, U ^c   Schnorr, B ^c   Kelsch, B ^c   Scheller, B ^d  

^a Rosenheim Hospital   (Germany)

^b Lnnora GmbH   (Germany)

^c CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^d SAARLAND UNIVERSITY   (Germany)

Author keywords

Coronary artery diseases; Drug coated balloon; Peripheral vascular disease; Restenosis

Indexed keywords

IOPROMIDE; PACLITAXEL; PROBUCOL; RAPAMYCIN; VASCULOTROPIN; ZOTAROLIMUS;

ARTERY DISEASE; ARTERY INTIMA PROLIFERATION; BALLOON CATHETER; BARE METAL STENT; CLINICAL TRIAL; CORONARY ARTERY DISEASE; CORONARY ARTERY OBSTRUCTION; DRUG DELIVERY SYSTEM; DRUG ELUTING STENT; HUMAN; IN VITRO STUDY; IN-STENT RESTENOSIS; MATERIAL COATING; NONHUMAN; PERCUTANEOUS CORONARY INTERVENTION; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; REVIEW; TRANSLUMINAL CORONARY ANGIOPLASTY;

ANGIOPLASTY, BALLOON; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; ANIMALS; ARTERIAL OCCLUSIVE DISEASES; COATED MATERIALS, BIOCOMPATIBLE; CONSTRICTION, PATHOLOGIC; CORONARY RESTENOSIS; CORONARY STENOSIS; DRUG CARRIERS; EQUIPMENT DESIGN; HUMANS; RECURRENCE; TREATMENT OUTCOME;

EID: 77950653936     PISSN: 00219509     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (71)

1. Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet 1978;1:263.
2. de Jaegere PP, Eefting FD, PopmaJJ, Serruys PW. Clinical trials on intracoronary stenting. Semin Interv Cardiol 1996;1:233-45.
3. Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med 1987;316:701-6.
4. Edelman ER, Rogers C. Hoop dreams. Stents without restenosis. Circulation 1996;94:1199-202.
5. Schomig A, Neumann FJ, Kasirati A, Schuhlen H, Blasini R, Hadamitzky M et al. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. N Engl J Med 1996;334:1084-9.
6. Colombo A, Hall P, Nakamura S, Almagor Y, Maiello L, Martini G et al. Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance. Circulation 1995;91:1676-88.
7. Dormandy JA, Rutherford RB. Management of peripheral arterial disease (peripheral arterial disease). TASC Working Group. TransAtlantic Inter-Society Consensus (TASC). J Vase Surg 2000;31:S1-S296.
8. Elezi S, Kastrati A, Hadamitzky M, Dirschinger J, Neumann FJ, Schomig A. Clinical and angiographic follow-up after balloon angioplasty with provisional stenting for coronary in-stent restenosis. Catheter Cardiovasc Interv 1999;48:151-6.
9. Camenzind E, Kutryk MJ, Serruys PW. Use of locally delivered conventional drug therapies. Semin Interv Cardiol 1996;1:67-76.
10. Reimers B, Moussa II, Akiyama T, Kobayashi Y, Albiero R, DiFrancesco L et al. Persistent high restenosis after local intrawall delivery of long-acting steroids before coronary stent implantation. J Invasive Cardiol 1998;10:323-31.
11. Kornowski R, Hong MK, Tio FO, Choi SK, Bramwell O, Leon MB. A randomized animal study evaluating the efficacies of locally delivered heparin and urokinase for reducing in-stent restenosis. Coron Artery Dis 1997;8:293-8.
12. Tanabe K, Regar E, Lee CH, Hoye A, van der Giessen WJ, Serruys PW. Local drug delivery using coated stents: new developments and future perspectives. Curr Pharm Des 2004;10:357-67.
13. de Feyter PJ, Vos J, Rensing BJ. Anti-restenosis trials. Curr Interv Cardiol Rep 2000;2:326-31.
14. Marx SO, Jayaraman T, Go LO, Marks AR. Rapamydn-FKBP inhibits cell cycle regulators of proliferation in vascular smooth muscle cells. Circ Res 1995;76:412-7.
15. Axel DI, Kunert W, Goggelmann C, Oberhoff M, Herdeg C, Kuttner A et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation 1997;96:636-45. (Pubitemid 27329445)
16. Gallo R, Padurean A, Jayaraman T, Marx S, Roque M, Adelman S et al. Inhibition of intimal thickening after balloon angioplasty in porcine coronary arteries by targeting regulators of the cell cycle. Circulation 1999;99:2164-70.
17. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773-80.
18. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003; 349:1315-23.
19. Heldman AW, Cheng L, Jenkins GM, Heller PF, Kim DW, Ware M Jr et al. Paclitaxel stent coating inhibits neointimal hyperplasia at 4 weeks in a porcine model of coronary restenosis. Circulation 2001;103:2289-95.
20. Fattori R, Piva T. Drug-eluting stents in vascular intervention. Lancet 2003;361:247-9.
21. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004;350:221-31.
22. Curfman GD, Morrissey S, Jarcho JA, Drazen JM. Drug-eluting coronary stents-promise and uncertainty. N Engl J Med 2007;356:1059-60.
23. Shuchman M. Debating the risks of drug-eluting stents. N Engl J Med 2007;356:325-8.
24. Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 2005; 293:2126-30.
25. Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol 2006;48:2584-91.
26. Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL. Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. Am J Med 2006;119:1056-61.
27. Nordmann AJ, Briel M, Bucher HC. Mortality in randomized controlled trials comparing drug-eluting is. bare metal stents in coronary artery disease: a meta-analysis. Eur Heart J 2006;27:2784-814.
28. van der Giessen Lincoff AM, Schwartz RS, van Beusekom HM, Serruys PW, Holmes DR Jr et al. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation 1996;94:1690-7.
29. Hwang CW, Wu D, Edelman ER. Physiological transport forces govern drug distribution for stent-based delivery. Circulation 2001;104:600-5.
30. Scheller B, Speck U, Schmitt A, Bohm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol 2003;42:1415-20.
31. Schwartz RS, Chronos NA, Virmani R. Preclinical restenosis models and drug-eluting stents: still important, still much to learn. J Am Coll Cardiol 2004;44:1373-85.
32. Scheller B, Speck U, Romeike B, Schmitt A, Sovak M, Bohm M 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.
33. Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation 2004;110:810-4.
34. Albrecht T, Speck U, Baier C, Wolf KJ, Bohm 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.
35. Lansky AJ, Costa RA, Mintz GS, Tsuchiya Y, Midei M, Cox DA et al Non-polymer-based paclitaxel-coated coronary stents for the treatment of patients with de novo coronary lesions: angiographic follow-up of the DELIVER clinical trial. Circulation 2004;109:1948-54.
36. Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M 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.
37. Cremers B, Speck U, Kaufels N, Mahnkopf D, Kuhler M, Bohm M et al. Drug-eluting balloon: very short-term exposure and overlapping. Thromb Haemost 2009;101:201-6.
38. Cremers B, Biedermann M, Mahnkopf D, Bohm M, Scheller B. Comparison of two different paclitaxel-coated balloon catheters in the porcine coronary restenosis model. Clin Res Cardiol 2009;98:325-30.
39. Posa A, Hemetsberger R, Petnehazy O, Petrasi Z, Testor M, Glogar D etal Attainment of local drug delivery with paclitaxel-eluting balloon in porcine coronary arteries. Coron Artery Dis 2008;19: 243-7.
40. Herdeg C, Gohring-Frischholz K, Geisler T, May A, Haase KK, Gawaz M. GENIE catheter for liquid local drug delivery. Euro-Intervention 2007;3:286-8.
41. Dommke C, Haase KK, Suselbeck T, Streitner I, Haghi D, Metz J et al. Local paclitaxel delivery after coronary stenting in an experimental animal model. Thromb Haemost 2007;98:674-80.
42. v van Zuylen L, Karlsson MO, Verweij J, Brouwer E, de Bruijn P, Nooter K et al Pharmacokinetic modeling of paclitaxel encapsulation in Cremophor EL micelles. Cancer Chemother Pharmacol 2001;47:309-18. (Pubitemid 32640770)
43. Cremers B, Toner JL, Schwartz LB, von Oepen R, Speck U, Kaufels N et al. Inhibition of coronary neointimal hyperplasia in swine using a novel zotarolimus-eluting balloon catheter. Eur Heart J 2009;30(Abstract Supplement):P3206.
44. Mauri L, Orav EJ, Candia SC, Cudip DE, Kuntz RE. Robustness of late lumen loss in discriminating drug-eluting stents across variable observational and randomized trials. Circulation 2005;112:2833-9. (Pubitemid 41641678)
45. Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med 2006;355:2113-24. (Pubitemid 44749319)
46. Camenzind E. Treatment of in-stent restenosis-back to the future? N Engl J Med 2006;355:2149-51.
47. Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U et al. Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol 2008;97:773-81.
48. Unverdorben M, Kleber FX, Heuer H, Betge S, Vallbracht C, Leschke M et al. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol 2009 [In press].
49. Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary instent restenosis. Circulation 2009;119:2986-94.
50. Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J et al. Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA 2005;293:165-71. (Pubitemid 40095867)
51. Herdeg C, Goehring-Frischholz K, Haase KK, Geisler T, Zuern C, Hartmann U et al Catheter-based delivery of fluid paclitaxel for prevention of restenosis in native coronary artery lesions after stent implantation. Circ Cardiovasc Intervent 2009;2:294-301.
52. Herdeg C, Gohring-Frischholz K, Helber U, Geisler T, May A, Haase KK, Gawaz M. Successful local antiproliferative paclitaxel delivery in a repeatedly restenosed lesion of the right coronary artery after drug eluting-stent implantation. Clin Res Cardiol 2008;97:49-52.
53. Herdeg C, Goehring-Frischholz K, Zuern C, Geisler T, Hartmann U, Hoevelborn T et al. Local catheter-based delivery of antithrombotic or antiproliferative drugs: a new concept for prevention of restenosis. Thromb Res 2008;123:236-43.
54. FanggidayJC, Stella PR, Guyomi SH, Doevendans PA. Safety and efficacy of drug-eluting balloons in percutaneous treatment of bifurcation lesions: the DEBIUT (drug-eluting balloon in bifurcation Utrecht) registry. Catheter Cardiovasc Interv 2008;71:629-35.
55. Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 2008;358:689-99. (Pubitemid 351240748)
56. Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U et al. Inhibition of restenosis in femoropopliteal arteries: pacli-taxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation 2008;118:1358-65.
57. Diehm C, Schuster A, Allenberg JR, Darius H, Haberl R, Lange S et al. High prevalence of peripheral arterial disease and co-morbid-ity in 6880 primary care patients: cross-sectional study. Atherosclerosis 2004;172:95-105. (Pubitemid 38058606)
58. Mukherjee D, Lingam P, Chetcuti S, Grossman PM, Moscucci M, Luciano AE et al. Missed opportunities to treat atherosclerosis in patients undergoing peripheral vascular interventions: insights from the University of Michigan Peripheral Vascular Disease Quality Improvement Initiative (PVD-QI2). Circulation 2002; 106: 1909-12. (Pubitemid 35176293)
59. Johnston KW. Femoral and popliteal arteries: reanalysis of results of balloon angioplasty. Radiology 1992;183:767-71.
60. Muradin GS, Bosch JL, Stijnen T, Hunink MG. Balloon dilation and stent implantation for treatment of femoropopliteal arterial disease: meta-analysis. Radiology 2001;221:137-45. (Pubitemid 32880382)
61. Cejna M, Thurnher S, Illiasch H, Horvath W, Waldenberger P, Hornik K et al. PTA versus Palmaz stent placement in femoropopliteal artery obstructions: a multicenter prospective randomized study. J Vase Interv Radiol 2001;12:23-31. (Pubitemid 32097991)
62. Grimm J, Muller-Hulsbeck S, Jahnke T, Hilbert C, Brossmann J, Heller M. Randomized study to compare PTA alone versus PTA with Palmaz stent placement for femoropopliteal lesions. J Vase Interv Radiol 2001;12:935-42.
63. Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med 2006;354:1879-88. (Pubitemid 43872689)
64. Krankenberg H, Schluter M, Steinicamp HJ, Biirgelin K, Scheinert D, Schulte KL et al. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation 2007;116:285-92. (Pubitemid 47196564)
65. Lugmayr HF, Holzer H, Kastner M, Riedelsberger H, Auterith A. Treatment of complex arteriosclerotic lesions with nitinol stents in the superficial femoral and popliteal arteries: a midterm follow-up. Radiology 2002;222:37-43. (Pubitemid 34031461)
66. Jahnke T, Voshage G, Müller-Hülsbeck S, Grimm J, Heller M, BrossmannJ. Endovascular placement of self-expanding nitinol coil stents for the treatment of femoropopliteal obstructive disease. J Vase Interv Radiol 2002;13:257-66. (Pubitemid 34226415)
67. Sabeti S, Schillinger M, AmighiJ, Sherif C, Mlekusch W, Ahmadi R et al. Primary patency of femoropopliteal arteries treated with nitinol versus stainless steel self-expanding stents: propensity score-adjusted analysis. Radiology 2004;232:516-21. (Pubitemid 38971294)
68. Duda SH, Pusich B, Richter G, Landwehr P, Oliva VL, Tielbeek A et al. Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results. Circulation 2002;106:1505-9.
69. Scheinert D, Scheinert S, Sax J, Piorkowski C, Braunlich S, Ulrich M et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol 2005;45:312-5. (Pubitemid 40094743)
70. Schlager O, Dick P, Sabeti S, AmighiJ, Mlekusch W, Minar E et al. Long-segment SFA stenting-the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J Endovasc Ther 2005;12:676-84. (Pubitemid 43100925)
71. Scheller B, Speck U. Potential solutions to the current problem: coated balloon. Eurolntervention 2008;4:C63-6.