Preclinical evaluation of a novel drug-eluting balloon in an animal model of in-stent stenosis

Journal of Biomaterials Applications

Volumn 27, Issue 6, 2013, Pages 717-726

  Joner, Michael ^a   Radke, Peter W ^b   Byrne, Robert A ^a   Hartwig, Sonja ^c   Steigerwald, Kristin ^a   Leclerc, Guy ^d   Wittchow, Eric ^c  

^a TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^b UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^c BIOTRONIK SE and Co KG ^*  (Germany)

^d SOLVO BIOTECHNOLOGY   (Hungary)

Author keywords

drug eluting balloon; neointima; Porcine model; restenosis; stent

Indexed keywords

ANIMAL MODEL; CONTROL GROUPS; CORONARY ARTERIES; DOSE-DEPENDENT; FIBRIN DEPOSITION; HUMAN DISEASE; IN-STENT RESTENOSIS; METAL STENTS; NEOINTIMA; PACLITAXEL; PORCINE MODELS; RESTENOSIS; REVASCULARIZATION; STENT; TREATMENT GROUP;

ANGIOGRAPHY; ANIMALS; BALLOONS; DISEASES;

STENTS;

PACLITAXEL;

ANIMAL; ARTICLE; CORONARY BLOOD VESSEL; DISEASE MODEL; DRUG DELIVERY SYSTEM; DRUG EFFECT; EQUIPMENT; EVALUATION; FEMALE; HUMAN; MINIPIG; NEOINTIMA; PATHOLOGY; RESTENOSIS; STENT; SWINE; TRANSLUMINAL CORONARY ANGIOPLASTY; WOUND HEALING;

ANGIOPLASTY, BALLOON, CORONARY; ANIMALS; CORONARY RESTENOSIS; CORONARY VESSELS; DISEASE MODELS, ANIMAL; DRUG DELIVERY SYSTEMS; FEMALE; HUMANS; NEOINTIMA; PACLITAXEL; STENTS; SWINE; SWINE, MINIATURE; WOUND HEALING;

EID: 84872415405     PISSN: 08853282     EISSN: 15308022     Source Type: Journal    
DOI: 10.1177/0885328211423784     Document Type: Article

References (22)

1. ByrneRA, JonerM,Massberg S andKastratiA.Restenosis in bare metal and drug-eluting stents. In: Escaned J, Serruys P (eds) Coronary artery stenosis: Imaging, structure and physiology. Toulouse, France: PCR Publishing Group, 2010; 475-497.
2. Farb A, Sangiorgi G, Carter AJ, Walley VM, Edwards WD, Schwartz RS, et al. Pathology of acute and chronic coronary stenting in humans. Circulation. 1999 ; 99 (1). 44-52
3. Byrne RA, Sarafoff N, Kastrati A, Schomig A. Drug-eluting stents in percutaneous coronary intervention: Abenefit-risk assessment. Drug Saf. 2009 ; 32 (9). 749-770
4. Colombo A, Latib A. Treatment of drug-eluting stent restenosis with another drug-eluting stent: Do not fail the second time!. Rev Esp Cardiol. 2008 ; 61 (11). 1120-1122
5. Alfonso F, Perez-Vizcayno MJ, Cruz A, Garcia J, Jimenez-Quevedo P, Escaned J, et al. Treatment of patients with in-stent restenosis. EuroIntervention. 2009 ; 5: D70 - D78
6. 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 (2). 151-156
7. Alfonso F, Garcia J, Perez-Vizcayno MJ, Hernando L, Hernandez R, Escaned J, et al. New stent implantation for recurrences after stenting for in-stent restenosis: Implications of a third metal layer in human coronary arteries. J Am Coll Cardiol. 2009 ; 54 (11). 1036-1038
8. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, et al. Pathology of drug-eluting stents in humans: Delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 ; 48 (1). 193-202
9. 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 (7). 810-814
10. 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 (20). 2113-2124
11. 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 in-stent restenosis. Circulation. 2009 ; 119 (23). 2986-2994
12. Farb A, Tang AL, Shroff S, Sweet W, Virmani R. Neointimal responses 3 months after (32)P beta-emitting stent placement. Int J Radiat Oncol Biol Phys. 2000 ; 48 (3). 889-898
13. 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 (15). 1462-1467
14. 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 (2). 411-418
15. Joner M, Byrne RA, Lapointe JM, Radke PW, Bayer G, Steigerwald K, et al. Comparative assessment of drug-eluting balloons in an advanced porcine model of coronary restenosis. Thromb Haemost. 2011 ; 105 (5). 864-872
16. 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 (5). 325-330
17. Farb A, Weber DK, Kolodgie FD, Burke AP, Virmani R. Morphological predictors of restenosis after coronary stenting in humans. Circulation. 2002 ; 105 (25). 2974-2980
18. Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, et al. Pathological correlates of late drug-eluting stent thrombosis: Strut coverage as a marker of endothelialization. Circulation. 2007 ; 115 (18). 2435-2441
19. Finn AV, Kolodgie FD, Harnek J, Guerrero LJ, Acampado E, Tefera K, et al. Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclitaxel-eluting stents. Circulation. 2005 ; 112 (2). 270-278
20. 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 (3). 182-186
21. 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 (7). 689-699
22. Alfonso F, Perez-Vizcayno MJ, Fernandez C. Letter by alfonso et al. regarding article "paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis". Circulation. 2010 ; 121 ( 6 ):