Macromolecular Research, Vol.22, No.6, 639-646, June, 2014
Comparison of Sirolimus Loaded PLGA-PEG Co-Polymer Coronary Stent and Bare Metal Stent in a Porcine Coronary Restenosis Model
E-mail:,
The aim of this study was to compare the effect of the sirolimus loaded PLGA-PEG co-polymer coronary stent with that of the bare metal stent in a porcine coronary restenosis model. Pigs were randomized into two groups (10 pigs, 10 coronary arteries in each group), in which either the sirolimus loaded PLGA-PEG copolymer stent (SPPS, n=10) or the bare metal stent (BMS, n=10) was implanted in the coronary arteries. Histopathologic analysis was performed at 28 days after stenting. There were no significant differences in the injury score, internal elastic lamina (IEL) area, and inflammation score between the two groups. There were significant differences in the lumen area (3.6±0.42 mm2 in the SPPS group vs. 2.5±0.89 mm2 in the BMS group, p<0.001), in the neointimal area (1.2±0.34 mm2 in the SPPS group vs. 2.5±0.99 mm2 in the BMS group, p<0.001), in the percent area stenosis (26.0±6.58% in the SPPS group vs. 48.6±16.95% in the BMS group, p<0.001) and in the fibrin score (1.2±0.41 in the SPPS group vs. 0.5±0.26 in the BMS group, p<0.001). These results demonstrate that SPPS had a superior effect on suppression of
neointimal hyperplasia than BMS at one month after stenting in a porcine coronary restenosis model.
- Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L , Ricci D, Nobuyoshi M, Cleman M, Heuser R, Almond D, Teirstein PS, Fish RD, Colombo A, Brinker J, Moses J, Shaknovich A, Hirshfeld J, Bailey S, Ellis S, Rake R, Goldberg S, N. Engl. J. Med., 331, 496 (1994)
- Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, Belardi J, Sigwart U, Colombo A, Goy JJ, van den Heuvel P, Delcan J, Morel M, N. Engl. J. Med., 331, 489 (1994)
- Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, eds, Lancet, 370, 937 (2007)
- Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock SJ, Mehran R, Leon MB, N. Engl. J. Med., 356, 998 (2007)
- Kuchulakanti PK, Chu WW, Torguson R, Ohlmann P, Rha SW, Clavijo LC, Kim SW, Bui A, Gevorkian N, Xue Z, Smith K, Fournadjieva J, Suddath WO, Satler LF, Pichard AD, Kent KM, Waksman R, Circulation, 113, 1108 (2006)
- Sehgal SN, Transplant. Proc., 35, 7 (2003)
- Kimball PM, Kerman RH, Kahan BD, Transplantation, 51, 486 (1991)
- Eng CP, Sehgal SN, Vezina C, J. Antibiot. (Tokyo), 37, 1231 (1984)
- Calne RY, Collier DS, Lim S, Pollard SG, Samaan A, White DJ, Thiru S, Lancet, 2, 227 (1989)
- Mehilli J, Byrne RA, Wieczorek A, Iijima R, Schulz S, Bruskina O, Pache J, Wessely R, Schomig A, Kastrati A, Eur. Heart J., 29, 1975 (2008)
- Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R, N. Engl. J. Med., 346, 1773 (2002)
- McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW, Lancet, 364, 1519 (2004)
- Ong AT, Hoye A, Aoki J, van Mieghem CA, Granillo GAR, Sonnenschein K, Regar E, McFadden EP, Sianos G, van der Giessen WJ, de Jaegere PP, de Feyter P, van Domburg RT, Serruys PW, J. Am. Coll. Cardiol., 45, 947 (2005)
- Ong AT, McFadden EP, Regar E, de Jaegere PP, van Domburg RT, Serruys PW, J. Am. Coll. Cardiol., 45, 2088 (2005)
- Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A, JAMA, 293, 2126 (2005)
- Raisuke I, Yuji I, Akiyoshi M, Hiroyoshi N, Kazuhiro H, Circ. J., 68, 236 (2004)
- Muramatsu T, Tsukahara R, Ho M, Ito Y, Ishimori H, Hirano K, Nakano M, Matsushita M, Leung WY, J. Invasive Cardiol., 13, 634 (2001)
- Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G, Investigators ES, Lancet, 362, 1093 (2003)
- Babapulle MN, Eisenberg MJ, Circulation, 106, 2734 (2002)
- Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, Russell ME, Circulation, 107, 38 (2003)
- Sousa JE, Costa MA, Abizaid AC, Rensing BJ, Abizaid AS, Tanajura LF, Kozuma K, Van Langenhove G, Sousa AG, Falotico R, Jaeger J, Popma JJ, Serruys PW, Circulation, 104, 2007 (2001)
- Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD, Circulation, 109, 701 (2004)
- Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R, J. Am. Coll. Cardiol., 48, 193 (2006)
- Stefanini GG, Kalesan B, Serruys PW, Heg D, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, van Es GA, Meier B, Windecker S, Juni P, Lancet, 378, 1940 (2011)
- Herrmann J, Bodmeier R, Eur. J. Pharm. Biopharm., 45, 75 (1998)
- Lin SY, Ho LT, Chiou HL, Biomater. Med. Devices Artif. Organs, 13, 187 (1985)
- Herrmann J, Bodmeier R, Int. J. Pharm., 126, 129 (1995)
- Jain RA, Rhodes CT, Railkar AM, Malick AW, Shah NH, Eur. J. Pharm. Biopharm., 50, 257 (2000)
- Kawai F, Yamanaka H, Arch. Microbiol., 146, 125 (1986)
- Stolnik S, Dunn SE, Garnett MC, Davies MC, Coombes AG, Taylor DC, Irving MP, Purkiss SC, Tadros TF, Davis SS, Illum L, Pharm. Res., 11, 1800 (1994)
- Chen J, Chen C, Chen Z, Li Q, Huang N, J. Biomed. Mater. Res. A, 95, 341 (2010)
- Chen JL, Li QL, Chen JY, Chen C, Huang N, Appl. Surf. Sci., 255(15), 6894 (2009)
- Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, Satler LF, Pichard AD, Kent KM, Stone GW, Leon MB, Circulation, 100, 1872 (1999)
- Schwartz RS, Huber KC, Murphy JG, Edwards WD, Camrud AR, Vlietstra RE, Holmes DR, J. Am. Coll. Cardiol., 19, 267 (1992)
- Schwartz RS, Edelman E, Virmani R, Carter A, Granada JF, Kaluza GL, Chronos NA, Robinson KA, Waksman R, Weinberger J, Wilson GJ, Wilensky RL, Circ. Cardiovasc. Interv., 1, 143 (2008)
- Levy Y, Mandler D, Weinberger J, Domb AJ, J. Biomed. Mater. Res. B, 91, 441 (2009)
- Wang X, Venkatraman SS, Boey FY, Loo JS, Tan LP, Biomaterials, 27, 5588 (2006)
- Poma A, Turner AP, Piletsky SA, Trends Biotechnol., 28, 629 (2010)
- Vasapollo G, Del Sole R, Mergola L, Lazzoi MR, Scardino A, Scorrano S, Mele G, Int. J. Mol. Sci., 12(9), 5908 (2011)
- Pan CJ, Tang JJ, Weng YJ, Wang J, Huang N, J. Mater. Sci. Mater. Med., 18, 2193 (2007)
- Schomig A, Neumann FJ, Kastrati A, Schuhlen H, Blasini R, Hadamitzky M, Walter H, Zitzmann-Roth EM, Richardt G, Alt E, Schmitt C, Ulm K, N. Engl. J. Med., 334, 1084 (1996)
- Schomig A, Neumann FJ, Walter H, Schuhlen H, Hadamitzky M, Zitzmann-Roth EM, Dirschinger J, Hausleiter J, Blasini R, Schmitt C, Alt E, Kastrati A, J. Am. Coll. Cardiol., 29, 28 (1997)
- Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R, Circulation, 115, 2435 (2007)
- Finn AV, Nakazawa G, Joner M, Kolodgie FD, Mont EK, Gold HK, Virmani R, Arterioscler. Thromb. Vasc. Biol., 27, 1500 (2007)
- Garg S, Sarno G, Serruys PW, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, Di Mario C, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Juni P, Windecker S, EuroIntervention, 6, 233 (2010)
- Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Juni P, Lancet, 372, 1163 (2008)
- Klauss V, Serruys PW, Pilgrim T, Buszman P, Linke A, Ischinger T, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, van Geuns C, van Es GA, Kalesan B, Wenaweser P, Juni P, Windecker S, JACC Cardiovasc. Interv., 4, 887 (2011)
- Wykrzykowska JJ, Raber L, de Vries T, Bressers M, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Regar E, Juni P, Windecker S, Serruys PW, EuroIntervention, 5, 310 (2009)
- Stefanini GG, Byrne RA, Serruys PW, de Waha A, Meier B, Massberg S, Juni P, Schomig A, Windecker S, Kastrati A, Eur. Heart J., 33, 1214 (2012)