Circulation. 2001;104:1188-1193
doi: 10.1161/hc3601.093987
doi: 10.1161/hc3601.093987
(Circulation. 2001;104:1188.)
© 2001 American Heart Association, Inc.
Basic Science Reports |
Stent-Based Delivery of Sirolimus Reduces Neointimal Formation in a Porcine Coronary Model
From Stanford University Medical Center, Stanford, Calif (T.S., S.H., L.R.B., A.C.Y., P.S.T., A.J.C.); Cordis Co, Warren, NJ (G.K., G.L., G.P., P.N., R.F.); University of Pennsylvania, Philadelphia (R.W., B.D.K.); Cardiovascular Research Foundation, Lenox Hill Hospital, New York, NY (M.B.L.); and University of Texas at San Antonio Health Sciences Center (F.T.).
Correspondence to Andrew J. Carter, DO, FACC, Director, Experimental Coronary Intervention Laboratories, Stanford University Medical Center, Stanford, CA 94305-5218. E-mail a_carter{at}cvmed.stanford.edu
Background—— The purpose of this study was to determine the efficacy of stent-based delivery of sirolimus (SRL) alone or in combination with dexamethasone (DEX) to reduce in-stent neointimal hyperplasia. SRL is a potent immunosuppressive agent that inhibits SMC proliferation by blocking cell cycle progression.
Methods and Results—— Stents were coated with a nonerodable polymer containing 185 µg SRL, 350 µg DEX, or 185 µg SRL and 350 µg DEX. Polymer biocompatibility studies in the porcine and canine models showed acceptable tissue response at 60 days. Forty-seven stents (metal, n=13; SRL, n=13; DEX, n=13; SRL and DEX, n=8) were implanted in the coronary arteries of 16 pigs. The tissue level of SRL was 97±13 ng/artery, with a stent content of 71±10 µg at 3 days. At 7 days, proliferating cell nuclear antigen and retinoblastoma protein expression were reduced 60% and 50%, respectively, by the SRL stents. After 28 days, the mean neointimal area was 2.47±1.04 mm2 for the SRL alone and 2.42±1.04 mm2 for the combination of SRL and DEX compared with the metal (5.06±1.88 mm2, P<0.0001) or DEX-coated stents (4.31±3.21 mm2, P<0.001), resulting in a 50% reduction of percent in-stent stenosis.
Conclusions—— Stent-based delivery of SRL via a nonerodable polymer matrix is feasible and effectively reduces in-stent neointimal hyperplasia by inhibiting cellular proliferation.
Key Words: sirolimus • stents • restenosis
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A. J. Lansky, R. A. Costa, G. S. Mintz, Y. Tsuchiya, M. Midei, D. A. Cox, C. O'Shaughnessy, R. A. Applegate, L. A. Cannon, M. Mooney, 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, April 27, 2004; 109(16): 1948 - 1954. [Abstract] [Full Text] [PDF]
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M. Schillinger, M. Exner, E. Minar, W. Mlekusch, M. Mullner, C. Mannhalter, F. H. Bach, and O. Wagner Heme oxygenase-1 genotype and restenosis after balloon angioplasty: a novel vascular protective factor J. Am. Coll. Cardiol., March 17, 2004; 43(6): 950 - 957. [Abstract] [Full Text] [PDF]
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E. Schampaert, E. A. Cohen, M. Schluter, F. Reeves, M. Traboulsi, L. M. Title, R. E. Kuntz, J. J. Popma, and the C-SIRIUS Investigators The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS) J. Am. Coll. Cardiol., March 17, 2004; 43(6): 1110 - 1115. [Abstract] [Full Text] [PDF]
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 A. Curcio, D. Torella, G. Cuda, C. Coppola, M. C. Faniello, F. Achille, V. G. Russo, M. Chiariello, and C. Indolfi Effect of stent coating alone on in vitro vascular smooth muscle cell proliferation and apoptosis Am J Physiol Heart Circ Physiol, March 1, 2004; 286(3): H902 - H908. [Abstract] [Full Text] [PDF]
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P. B. Berger, S. H. Wilson, P. Fasseas, and J. L. Orford Reply J. Am. Coll. Cardiol., February 18, 2004; 43(4): 714 - 715. [Full Text] [PDF]
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R. Virmani, G. Guagliumi, A. Farb, G. Musumeci, N. Grieco, T. Motta, L. Mihalcsik, M. Tespili, O. Valsecchi, and F. D. Kolodgie Localized Hypersensitivity and Late Coronary Thrombosis Secondary to a Sirolimus-Eluting Stent: Should We Be Cautious? Circulation, February 17, 2004; 109(6): 701 - 705. [Abstract] [Full Text] [PDF]
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A C Morton and J Gunn Methotrexate eluting stents: to modify or cure? Heart, February 1, 2004; 90(2): 121 - 122. [Full Text] [PDF]
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M. Schillinger, W. Mlekusch, R. M. Wolfram, A. C. Budinsky, M. Exner, H. Rumpold, O. Wagner, B. Pokrajac, R. Potter, and E. Minar Endovascular Brachytherapy: Effect on Acute Inflammatory Response after Percutaneous Femoropopliteal Arterial Interventions Radiology, February 1, 2004; 230(2): 556 - 560. [Abstract] [Full Text] [PDF]
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A. Abizaid, M. A. Costa, D. Blanchard, M. Albertal, H. Eltchaninoff, G. Guagliumi, L. Geert-Jan, A. S. Abizaid, A. G.M.R. Sousa, E. Wuelfert, et al. Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients: Insights from the RAVEL Trial Eur. Heart J., January 2, 2004; 25(2): 107 - 112. [Abstract] [Full Text] [PDF]
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Y. Matsumoto, T. Uwatoku, K. Oi, K. Abe, T. Hattori, K. Morishige, Y. Eto, Y. Fukumoto, K.-i. Nakamura, Y. Shibata, et al. Long-Term Inhibition of Rho-Kinase Suppresses Neointimal Formation After Stent Implantation in Porcine Coronary Arteries: Involvement of Multiple Mechanisms Arterioscler Thromb Vasc Biol, January 1, 2004; 24(1): 181 - 186. [Abstract] [Full Text] [PDF]
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K. Schurmann, J. Lahann, P. Niggemann, B. Klosterhalfen, J. Meyer, A. Kulisch, D. Klee, R. W. Gunther, and D. Vorwerk Biologic Response to Polymer-coated Stents: In Vitro Analysis and Results in an Iliac Artery Sheep Model Radiology, January 1, 2004; 230(1): 151 - 162. [Abstract] [Full Text] [PDF]
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M. Degertekin, P. W. Serruys, K. Tanabe, C. H. Lee, J. E. Sousa, A. Colombo, M.-C. Morice, J. M.R. Ligthart, and P. J. de Feyter Long-Term Follow-Up of Incomplete Stent Apposition in Patients Who Received Sirolimus-Eluting Stent for De Novo Coronary Lesions: An Intravascular Ultrasound Analysis Circulation, December 2, 2003; 108(22): 2747 - 2750. [Abstract] [Full Text] [PDF]
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 E. Bell, X. Cao, J. A. Moibi, S. R. Greene, R. Young, M. Trucco, Z. Gao, F. M. Matschinsky, S. Deng, J. F. Markman, et al. Rapamycin Has a Deleterious Effect on MIN-6 Cells and Rat and Human Islets Diabetes, November 1, 2003; 52(11): 2731 - 2739. [Abstract] [Full Text] [PDF]
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B. Scheller, U. Speck, A. Schmitt, M. Bohm, and G. Nickenig Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation J. Am. Coll. Cardiol., October 15, 2003; 42(8): 1415 - 1420. [Abstract] [Full Text] [PDF]
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 J. W. Moses, M. B. Leon, J. J. Popma, P. J. Fitzgerald, D. R. Holmes, C. O'Shaughnessy, R. P. Caputo, D. J. Kereiakes, D. O. Williams, P. S. Teirstein, et al. Sirolimus-Eluting Stents versus Standard Stents in Patients with Stenosis in a Native Coronary Artery N. Engl. J. Med., October 2, 2003; 349(14): 1315 - 1323. [Abstract] [Full Text] [PDF]
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J. E. Sousa, P. W. Serruys, and M. A. Costa New Frontiers in Cardiology: Drug-Eluting Stents: Part I Circulation, May 6, 2003; 107(17): 2274 - 2279. [Full Text] [PDF]
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M. Schillinger, M. Exner, W. Mlekusch, M. Haumer, H. Rumpold, R. Ahmadi, S. Sabeti, O. Wagner, and E. Minar Endovascular Revascularization Below the Knee: 6-month Results and Predictive Value of C-reactive Protein Level Radiology, May 1, 2003; 227(2): 419 - 425. [Abstract] [Full Text] [PDF]
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K. D. Smith, L. E. Wrenshall, R. F. Nicosia, R. Pichler, C. L. Marsh, C. E. Alpers, N. Polissar, and C. L. Davis Delayed Graft Function and Cast Nephropathy Associated with Tacrolimus Plus Rapamycin Use J. Am. Soc. Nephrol., April 1, 2003; 14(4): 1037 - 1045. [Abstract] [Full Text] [PDF]
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H. Takeuchi, K. Ohmori, I. Kondo, A. Oshita, K. Shinomiya, Y. Yu, Y. Takagi, K. Mizushige, K. Kangawa, and M. Kohno Potentiation of C-type natriuretic peptide with ultrasound and microbubbles to prevent neointimal formation after vascular injury in rats Cardiovasc Res, April 1, 2003; 58(1): 231 - 238. [Abstract] [Full Text] [PDF]
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 A. Diez-Juan and V. Andres Coordinate Control of Proliferation and Migration by the p27Kip1/Cyclin-Dependent Kinase/Retinoblastoma Pathway in Vascular Smooth Muscle Cells and Fibroblasts Circ. Res., March 7, 2003; 92(4): 402 - 410. [Abstract] [Full Text] [PDF]
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 K. Egashira Molecular Mechanisms Mediating Inflammation in Vascular Disease: Special Reference to Monocyte Chemoattractant Protein-1 Hypertension, March 1, 2003; 41(3): 834 - 841. [Abstract] [Full Text] [PDF]
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G. A. Visner, F. Lu, H. Zhou, J. Liu, K. Kazemfar, and A. Agarwal Rapamycin Induces Heme Oxygenase-1 in Human Pulmonary Vascular Cells: Implications in the Antiproliferative Response to Rapamycin Circulation, February 18, 2003; 107(6): 911 - 916. [Abstract] [Full Text] [PDF]
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M. R Bennett IN-STENT STENOSIS: PATHOLOGY AND IMPLICATIONS FOR THE DEVELOPMENT OF DRUG ELUTING STENTS Heart, February 1, 2003; 89(2): 218 - 224. [Full Text] [PDF]
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J. E. Sousa, M. A. Costa, A. G.M.R. Sousa, A. C. Abizaid, A. C. Seixas, A. S. Abizaid, F. Feres, L. A. Mattos, R. Falotico, J. Jaeger, et al. Two-Year Angiographic and Intravascular Ultrasound Follow-Up After Implantation of Sirolimus-Eluting Stents in Human Coronary Arteries Circulation, January 28, 2003; 107(3): 381 - 383. [Abstract] [Full Text] [PDF]
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J. E. Sousa, M. A. Costa, A. Abizaid, A. G.M.R. Sousa, F. Feres, L. A. Mattos, M. Centemero, G. Maldonado, A. S. Abizaid, I. Pinto, et al. Sirolimus-Eluting Stent for the Treatment of In-Stent Restenosis: A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study Circulation, January 7, 2003; 107(1): 24 - 27. [Abstract] [Full Text] [PDF]
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 M. A. Albert and E. M. Antman Preoperative Evaluation for Cardiac Surgery Card. Surg. Adult, January 1, 2003; 2(2003): 235 - 248. [Full Text]
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