Circulation. 2001;104:2007-2011
doi: 10.1161/hc4201.098056
doi: 10.1161/hc4201.098056
(Circulation. 2001;104:2007-2011.)
© 2001 American Heart Association, Inc.
Clinical Investigation and Reports |
Sustained Suppression of Neointimal Proliferation by Sirolimus-Eluting Stents
One-Year Angiographic and Intravascular Ultrasound Follow-Up
From the Institute Dante Pazzanese of Cardiology (J.E.S., M.A.C., A.C.A., A.S.A., L.F.T., A.G.M.R.S.), São Paulo, Brazil; Thoraxcenter, Dijkzigt University Hospital (B.J.R., K.K., G.V.L. P.W.S.), Rotterdam, The Netherlands; Cordis, a Johnson and Johnson Company (R.F., J.J.), Warren, NJ; and Brigham and Women’s Hospital (J.J.P.), Boston, Mass.
Correspondence to Professor J. Eduardo Sousa, MD, PhD, Director of the Institute Dante Pazzanese of Cardiology, Av. Dr Dante Pazzanese, 500 - Ibirapuera, 04012180, São Paulo, Brazil. E-mail jesousa{at}uol.com.br
Background— We have previously reported a virtual absence of neointimal hyperplasia 4 months after implantation of sirolimus-eluting stents. The aim of the present investigation was to determine whether these results are sustained over a period of 1 year.
Methods and Results— Forty-five patients with de novo coronary disease were successfully treated with the implantation of a single sirolimus-eluting Bx VELOCITY stent in São Paulo, Brazil (n=30, 15 fast release [group I, GI] and 15 slow release [GII]) and Rotterdam, The Netherlands (15 slow release, GIII). Angiographic and volumetric intravascular ultrasound (IVUS) follow-up was obtained at 4 and 12 months (GI and GII) and 6 months (GIII). In-stent minimal lumen diameter and percent diameter stenosis remained essentially unchanged in all groups (at 12 months, GI and GII; at 6 months, GIII). Follow-up in-lesion minimal lumen diameter was 2.28 mm (GIII), 2.32 mm (GI), and 2.48 mm (GII). No patient approached the 
50% diameter stenosis at 1 year by angiography or IVUS assessment, and no edge restenosis was observed. Neointimal hyperplasia, as detected by IVUS, was virtually absent at 6 months (2±5% obstruction volume, GIII) and at 12 months (GI=2±5% and GII=2±3%).
Conclusions— This study demonstrates a sustained suppression of neointimal proliferation by sirolimus-eluting Bx VELOCITY stents 1 year after implantation.
Key Words: angiography • drugs • stents • restenosis • ultrasonics
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F. Unger, P. W. Serruys, M. H. Yacoub, C. Ilsley, P. K. Paulsen, T. T. Nielsen, L. Eysmann, and F. Kiemeneij Revascularization in multivessel disease: Comparison between two-year outcomes of coronary bypass surgery and stenting J. Thorac. Cardiovasc. Surg., April 1, 2003; 125(4): 809 - 820. [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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M. Haude, T. F.M. Konorza, U. Kalnins, A. Erglis, K. Saunamaki, H. D. Glogar, E. Grube, R. Gil, A. Serra, H. G. Richardt, et al. Heparin-Coated Stent Placement for the Treatment of Stenoses in Small Coronary Arteries of Symptomatic Patients Circulation, March 11, 2003; 107(9): 1265 - 1270. [Abstract] [Full Text] [PDF]
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 S. K. Karnik, B. S. Brooke, A. Bayes-Genis, L. Sorensen, J. D. Wythe, R. S. Schwartz, M. T. Keating, and D. Y. Li A critical role for elastin signaling in vascular morphogenesis and disease Development, March 2, 2003; 130(2): 411 - 423. [Abstract] [Full Text] [PDF]
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M. R Miller, I. S Hanspal, P. W.F Hadoke, D. E Newby, A. G Rossi, D. J Webb, and I. L Megson A novel S-nitrosothiol causes prolonged and selective inhibition of platelet adhesion at sites of vascular injury Cardiovasc Res, March 1, 2003; 57(3): 853 - 860. [Abstract] [Full Text] [PDF]
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K. Tanabe, P. W. Serruys, E. Grube, P. C. Smits, G. Selbach, W. J. van der Giessen, M. Staberock, P. de Feyter, R. Muller, E. Regar, et al. TAXUS III Trial: In-Stent Restenosis Treated With Stent-Based Delivery of Paclitaxel Incorporated in a Slow-Release Polymer Formulation Circulation, February 4, 2003; 107(4): 559 - 564. [Abstract] [Full Text] [PDF]
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A. C. Ferreira, A. A. Peter, T. A. Salerno, H. Bolooki, and E. de Marchena Clinical impact of drug-eluting stents in changing referral practices for coronary surgical revascularization in a tertiary care center Ann. Thorac. Surg., February 1, 2003; 75(2): 485 - 489. [Abstract] [Full Text] [PDF]
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J Gunn, A C Morton, C Wales, C M H Newman, D C Crossman, and D C Cumberland Drug eluting stents: maximising benefit and minimising cost Heart, February 1, 2003; 89(2): 127 - 131. [Abstract] [Full Text] [PDF]
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R Virmani, F D Kolodgie, A Farb, and A Lafont Drug eluting stents: are human and animal studies comparable? Heart, February 1, 2003; 89(2): 133 - 138. [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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C. Herdeg, M. Oberhoff, A. Baumbach, S. Schroeder, M. Leitritz, A. Blattner, D. I Siegel-Axel, C. Meisner, and K. R Karsch Effects of local all-trans-retinoic acid delivery on experimental atherosclerosis in the rabbit carotid artery Cardiovasc Res, February 1, 2003; 57(2): 544 - 553. [Abstract] [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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M. Degertekin, E. Regar, K. Tanabe, P. C. Smits, W. J. van der Giessen, S. G. Carlier, P. de Feyter, J. Vos, D. P. Foley, J. M. R. Ligthart, et al. Sirolimus-eluting stent for treatment of complex in-stent restenosis: The first clinical experience J. Am. Coll. Cardiol., January 15, 2003; 41(2): 184 - 189. [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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V. Spanos, G. Stankovic, J. Tobis, and A. Colombo The challenge of in-stent restenosis: insights from intravascular ultrasound Eur. Heart J., January 2, 2003; 24(2): 138 - 150. [Full Text] [PDF]
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D. Faxon Restenosis: do we need to understand it to treat it? J. Am. Coll. Cardiol., December 18, 2002; 40(12): 2090 - 2091. [Full Text] [PDF]
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D. J. Drenth, N. J. G. M. Veeger, J. B. Winter, J. G. Grandjean, M. A. Mariani, A. d J. Boven van, and P. W. Boonstra A prospective randomized trial comparing stenting with off-pump coronary surgery for high-grade stenosis in the proximal left anterior descending coronary artery: three-year follow-up J. Am. Coll. Cardiol., December 4, 2002; 40(11): 1955 - 1960. [Abstract] [Full Text] [PDF]
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 R. Rajani, J. Smyth, C. G. Koffman, I. Abbs, and D. J. A. Goldsmith Differential Effect of sirolimus vs prednisolone in the treatment of sclerosing encapsulating peritonitis Nephrol. Dial. Transplant., December 1, 2002; 17(12): 2278 - 2280. [Full Text] [PDF]
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M. N. Babapulle and M. J. Eisenberg Coated Stents for the Prevention of Restenosis: Part II Circulation, November 26, 2002; 106(22): 2859 - 2866. [Full Text] [PDF]
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G. M. Lanza, X. Yu, P. M. Winter, D. R. Abendschein, K. K. Karukstis, M. J. Scott, L. K. Chinen, R. W. Fuhrhop, D. E. Scherrer, and S. A. Wickline Targeted Antiproliferative Drug Delivery to Vascular Smooth Muscle Cells With a Magnetic Resonance Imaging Nanoparticle Contrast Agent: Implications for Rational Therapy of Restenosis Circulation, November 26, 2002; 106(22): 2842 - 2847. [Abstract] [Full Text] [PDF]
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R. Virmani, F. Liistro, G. Stankovic, C. Di Mario, M. Montorfano, A. Farb, F. D. Kolodgie, and A. Colombo Mechanism of Late In-Stent Restenosis After Implantation of a Paclitaxel Derivate-Eluting Polymer Stent System in Humans Circulation, November 19, 2002; 106(21): 2649 - 2651. [Abstract] [Full Text] [PDF]
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C. A. Herzog, J. Z. Ma, and A. J. Collins Comparative Survival of Dialysis Patients in the United States After Coronary Angioplasty, Coronary Artery Stenting, and Coronary Artery Bypass Surgery and Impact of Diabetes Circulation, October 22, 2002; 106(17): 2207 - 2211. [Abstract] [Full Text] [PDF]
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E. Regar, P.W. Serruys, C. Bode, C. Holubarsch, J.L. Guermonprez, W. Wijns, A. Bartorelli, C. Constantini, M. Degertekin, K. Tanabe, et al. Angiographic Findings of the Multicenter Randomized Study With the Sirolimus-Eluting Bx Velocity Balloon-Expandable Stent (RAVEL): Sirolimus-Eluting Stents Inhibit Restenosis Irrespective of the Vessel Size Circulation, October 8, 2002; 106(15): 1949 - 1956. [Abstract] [Full Text] [PDF]
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J.-F. Deux, A. Meddahi-Pelle, A. F. Le Blanche, L. J. Feldman, S. Colliec-Jouault, F. Bree, F. Boudghene, J.-B. Michel, and D. Letourneur Low Molecular Weight Fucoidan Prevents Neointimal Hyperplasia in Rabbit Iliac Artery In-Stent Restenosis Model Arterioscler Thromb Vasc Biol, October 1, 2002; 22(10): 1604 - 1609. [Abstract] [Full Text] [PDF]
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J. J. Popma, R. E. Kuntz, and D. S. Baim A Decade of Improvement in the Clinical Outcomes of Percutaneous Coronary Intervention for Multivessel Coronary Artery Disease Circulation, September 24, 2002; 106(13): 1592 - 1594. [Full Text] [PDF]
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M. Degertekin, P. W. Serruys, D. P. Foley, K. Tanabe, E. Regar, J. Vos, P. C. Smits, W. J. van der Giessen, M. van den Brand, P. de Feyter, et al. Persistent Inhibition of Neointimal Hyperplasia After Sirolimus-Eluting Stent Implantation: Long-Term (Up to 2 Years) Clinical, Angiographic, and Intravascular Ultrasound Follow-Up Circulation, September 24, 2002; 106(13): 1610 - 1613. [Abstract] [Full Text] [PDF]
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V.S. Srinivas, M. M. Brooks, K. M. Detre, S. B. King III, A. K. Jacobs, J. Johnston, and D. O. Williams Contemporary Percutaneous Coronary Intervention Versus Balloon Angioplasty for Multivessel Coronary Artery Disease: A Comparison of the National Heart, Lung and Blood Institute Dynamic Registry and the Bypass Angioplasty Revascularization Investigation (BARI) Study Circulation, September 24, 2002; 106(13): 1627 - 1633. [Abstract] [Full Text] [PDF]
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