(Circulation. 2001;103:192.)
© 2001 American Heart Association, Inc.
Clinical Investigation and Reports |
Lack of Neointimal Proliferation After Implantation of Sirolimus-Coated Stents in Human Coronary Arteries
A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study
From the Institute Dante Pazzanese of Cardiology, São Paulo, Brazil (J.E.S., M.A.C., A.A., A.S.A., F.F., I.M.F.P., A.C.S., R.S., L.A.M., A.G.M.R.S.); Cordis, a Johnson & Johnson Company, Warren, NJ (R.F., J.J.); Brigham and Women’s Hospital, Boston, Mass (J.J.P.); and Thoraxcenter, Dijkzigt University Hospital, Rotterdam, the Netherlands (P.W.S.).
Correspondence to Prof 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 diretoriaidpc{at}uol.com.br
Background—Restenosis remains an important limitation of interventional cardiology. Therefore, we aimed to determine the safety and efficacy of sirolimus (a cell-cycle inhibitor)-coated BX Velocity stents.
Methods and
Results—Thirty patients with angina pectoris
were electively treated with 2 different formulations of
sirolimus-coated stents (slow release [SR], n=15, and fast release
[FR], n=15). All stents were successfully delivered, and patients
were discharged without clinical complications. Independent core
laboratories analyzed angiographic and 3D volumetric intravascular
ultrasound data (immediately after procedure and at 4-month follow-up).
Eight-month clinical follow-up was obtained for all patients. There was
minimal neointimal hyperplasia in both groups (11.0±3.0% in the SR
group and 10.4±3.0% in the FR group,
P=NS) by ultrasound and
quantitative coronary angiography (in-stent late loss, 0.09±0.3 mm
[SR] and -0.02±0.3 mm [FR]; in-lesion late loss, 0.16±0.3 mm
[SR] and -0.1±0.3 mm [FR]). No in-stent or edge restenosis
(diameter stenosis 
50%) was observed. No major clinical events
(stent thrombosis, repeat revascularization, myocardial infarction, or
death) had occurred by 8 months.
Conclusions—The implantation of sirolimus-coated BX Velocity stents is feasible and safe and elicits minimal neointimal proliferation. Additional placebo-controlled trials are required to confirm these promising results.
Key Words: stents • restenosis • angioplasty
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J. P. Carrozza Jr Sirolimus-eluting stents: does a great stent still need a good interventionalist? J. Am. Coll. Cardiol., March 17, 2004; 43(6): 1116 - 1117. [Full Text] [PDF]
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A. Colombo, J. W. Moses, M. C. Morice, J. Ludwig, D. R. Holmes Jr, V. Spanos, Y. Louvard, B. Desmedt, C. Di Mario, and M. B. Leon Randomized Study to Evaluate Sirolimus-Eluting Stents Implanted at Coronary Bifurcation Lesions Circulation, March 16, 2004; 109(10): 1244 - 1249. [Abstract] [Full Text] [PDF]
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W. W. O'Neill and S. R. Dixon The year in interventional cardiology J. Am. Coll. Cardiol., March 3, 2004; 43(5): 875 - 890. [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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D. R. Holmes Jr, M. B. Leon, J. W. Moses, J. J. Popma, D. Cutlip, P. J. Fitzgerald, C. Brown, T. Fischell, S. C. Wong, M. Midei, et al. Analysis of 1-Year Clinical Outcomes in the SIRIUS Trial: A Randomized Trial of a Sirolimus-Eluting Stent Versus a Standard Stent in Patients at High Risk for Coronary Restenosis Circulation, February 10, 2004; 109(5): 634 - 640. [Abstract] [Full Text] [PDF]
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Y Huang, K Salu, X Liu, S Li, L Wang, E Verbeken, J Bosmans, and I De Scheerder Methotrexate loaded SAE coated coronary stents reduce neointimal hyperplasia in a porcine coronary model Heart, February 1, 2004; 90(2): 195 - 199. [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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D. Mancini, S. Pinney, D. Burkhoff, J. LaManca, S. Itescu, E. Burke, N. Edwards, M. Oz, and A. R. Marks Use of Rapamycin Slows Progression of Cardiac Transplantation Vasculopathy Circulation, July 8, 2003; 108(1): 48 - 53. [Abstract] [Full Text] [PDF]
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P. A. Lemos, P. W. Serruys, and J. E. Sousa Drug-Eluting Stents: Cost Versus Clinical Benefit Circulation, June 24, 2003; 107(24): 3003 - 3007. [Full Text] [PDF]
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W. W. O'Neill and M. B. Leon Drug-Eluting Stents: Costs Versus Clinical Benefit Circulation, June 24, 2003; 107(24): 3008 - 3011. [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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P. B. Berger Can euphoria be bad? J. Am. Coll. Cardiol., April 16, 2003; 41(8): 1289 - 1292. [Full Text] [PDF]
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R Seabra-Gomes In-stent restenosis: intracoronary {beta}-radiation at the crossroads Eur. Heart J., April 1, 2003; 24(7): 583 - 585. [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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E. Barbato, J. Marco, and W. Wijns Direct stenting Eur. Heart J., March 1, 2003; 24(5): 394 - 403. [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.-K. Hong, G. S. Mintz, C. W. Lee, J.-M. Song, K.-H. Han, D.-H. Kang, J.-K. Song, J.-J. Kim, N. J. Weissman, N. E. Fearnot, et al. Paclitaxel Coating Reduces In-Stent Intimal Hyperplasia in Human Coronary Arteries: A Serial Volumetric Intravascular Ultrasound Analysis From the ASian Paclitaxel-Eluting Stent Clinical Trial (ASPECT) Circulation, February 4, 2003; 107(4): 517 - 520. [Abstract] [Full Text] [PDF]
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P.W Radke, A Kaiser, C Frost, and U Sigwart Outcome after treatment of coronary in-stent restenosis: Results from a systematic review using meta-analysis techniques Eur. Heart J., February 1, 2003; 24(3): 266 - 273. [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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