on August 4, 2003
Circulation. 2003
Published online before print August 4, 2003, doi: 10.1161/01.CIR.0000086926.62288.A6
Published online before print August 4, 2003, doi: 10.1161/01.CIR.0000086926.62288.A6
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© American Heart Association, Inc.
Clinical Investigation and Reports |
Randomized Study to Assess the Effectiveness of Slow- and Moderate-Release Polymer-Based Paclitaxel-Eluting Stents for Coronary Artery Lesions
From Ospedale San Raffaele, Milano, Italy (A.C.); PSK No 7 Zaklad Kardiologii, Katowice, Poland (J.D.); John Radcliffe Hospital, Oxford, Great Britain (A.B.); Krankenhaus Siegburg, Siegburg, Germany (E.G.); Krankenhaus der Barmherzigen Brüder, Trier, Germany (K.H.); Internistische Klinik Dr. Müller, Munich, Germany (S.S.); Jagiellonian University, Krakow, Poland (D.D.); Sunnybrook & Women’s College Health Sciences Center, Toronto, Canada (S.F.); Centre Hospitalier Universitaire Jean Minjoz, Besancon ,France (F.S.); Jan Pawel II Hospital, International Cardiology Clinic, Krakow, Poland (K.Z.); Ospedali Riuniti di Bergamo, Bergamo, Italy (G.G.); and Boston Scientific Corporation, Natick, Mass (M.E.R.).
Correspondence to Antonio Colombo, MD, Director, Cardiac Catheterization Laboratory, EMO Centro Cuore Columbus S.r.l., Sede Operativa c/o Casa Cura Columbus, Via M. Buonarroti, 48 20145 Milano, Italy. E-mail colombo{at}emocolumbus.it
Received June 18, 2003; revision received July 8, 2003; accepted July 8, 2003.
Background— Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations.
Methods and Results— We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II compared TAXUS-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls (23.2% and 20.5%; P<0.0001 for both). This corresponded with a reduction in angiographic restenosis from 17.9% to 2.3% in the SR cohort (P<0.0001) and from 20.2% to 4.7% in the MR cohort (P=0.0002). The incidence of major adverse cardiac events at 12 months was significantly lower (P=0.0192) in the TAXUS-SR (10.9%) and TAXUS-MR (9.9%) groups than in controls (22.0% and 21.4%, respectively), predominantly because of a significant reduction in repeat revascularization of the target lesion in TAXUS-treated patients.
Conclusions— Compared with a bare metal stent, paclitaxel-eluting stents reduced in-stent neointimal formation and restenosis and improved 12-month clinical outcome of patients with single de novo coronary lesions.
Key Words: coronary disease • drugs • stents • restenosis
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F. Liistro, M. Fineschi, P. Angioli, G. Sinicropi, G. Falsini, T. Gori, K. Ducci, A. Bravi, and L. Bolognese Effectiveness and Safety of Sirolimus Stent Implantation for Coronary In-Stent Restenosis: The TRUE (Tuscany Registry of Sirolimus for Unselected In-Stent Restenosis) Registry J. Am. Coll. Cardiol., July 18, 2006; 48(2): 270 - 275. [Abstract] [Full Text] [PDF]
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J. Cosgrave, G. Melzi, G. G.L. Biondi-Zoccai, F. Airoldi, A. Chieffo, G. M. Sangiorgi, M. Montorfano, I. Michev, M. Carlino, E. Bonizzoni, et al. Drug-Eluting Stent Restenosis: The Pattern Predicts the Outcome J. Am. Coll. Cardiol., June 20, 2006; 47(12): 2399 - 2404. [Abstract] [Full Text] [PDF]
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P. W. Serruys Fourth Annual American College of Cardiology International Lecture: A Journey in the Interventional Field J. Am. Coll. Cardiol., May 2, 2006; 47(9): 1754 - 1768. [Full Text] [PDF]
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 W. J. Gomes and E. Buffolo Coronary stenting and inflammation: implications for further surgical and medical treatment. Ann. Thorac. Surg., May 1, 2006; 81(5): 1918 - 1925. [Abstract] [Full Text] [PDF]
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 C Roiron, P Sanchez, A Bouzamondo, P Lechat, and G Montalescot Drug eluting stents: an updated meta-analysis of randomised controlled trials Heart, May 1, 2006; 92(5): 641 - 649. [Abstract] [Full Text] [PDF]
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C Stettler, S Allemann, M Egger, S Windecker, B Meier, and P Diem Efficacy of drug eluting stents in patients with and without diabetes mellitus: indirect comparison of controlled trials Heart, May 1, 2006; 92(5): 650 - 657. [Abstract] [Full Text] [PDF]
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A. E. Rodriguez, J. F. Granada, M. Rodriguez-Alemparte, C. F. Vigo, J. Delgado, C. Fernandez-Pereira, A. Pocovi, A. M. Rodriguez-Granillo, D. Schulz, A. E. Raizner, et al. Oral Rapamycin After Coronary Bare-Metal Stent Implantation to Prevent Restenosis: The Prospective, Randomized Oral Rapamycin in Argentina (ORAR II) Study J. Am. Coll. Cardiol., April 18, 2006; 47(8): 1522 - 1529. [Abstract] [Full Text] [PDF]
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G. Weisz, M. B. Leon, D. R. Holmes Jr, D. J. Kereiakes, M. R. Clark, B. M. Cohen, S. G. Ellis, P. Coleman, C. Hill, C. Shi, et al. Two-Year Outcomes After Sirolimus-Eluting Stent Implantation: Results From the Sirolimus-Eluting Stent in de Novo Native Coronary Lesions (SIRIUS) Trial J. Am. Coll. Cardiol., April 4, 2006; 47(7): 1350 - 1355. [Abstract] [Full Text] [PDF]
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G. W. Stone, S. G. Ellis, C. D. O'Shaughnessy, S. L. Martin, L. Satler, T. McGarry, M. A. Turco, D. J. Kereiakes, L. Kelley, J. J. Popma, et al. Paclitaxel-Eluting Stents vs Vascular Brachytherapy for In-Stent Restenosis Within Bare-Metal Stents: The TAXUS V ISR Randomized Trial JAMA, March 15, 2006; 295(11): 1253 - 1263. [Abstract] [Full Text] [PDF]
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S. G. Raja Drug-Eluting Stents and the Future of Coronary Artery Bypass Surgery: Facts and Fiction. Ann. Thorac. Surg., March 1, 2006; 81(3): 1162 - 1171. [Abstract] [Full Text] [PDF]
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M.-C. Morice, A. Colombo, B. Meier, P. Serruys, C. Tamburino, G. Guagliumi, E. Sousa, H.-P. Stoll, and for the REALITY Trial Investigators Sirolimus- vs Paclitaxel-Eluting Stents in De Novo Coronary Artery Lesions: The REALITY Trial: A Randomized Controlled Trial JAMA, February 22, 2006; 295(8): 895 - 904. [Abstract] [Full Text] [PDF]
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S. J. Brener Wish List and REALITY: Choice of Stents and End Points for Treatment of De Novo Coronary Artery Lesions JAMA, February 22, 2006; 295(8): 937 - 938. [Full Text] [PDF]
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R. Wessely, A. Schomig, and A. Kastrati Sirolimus and Paclitaxel on Polymer-Based Drug-Eluting Stents: Similar But Different J. Am. Coll. Cardiol., February 21, 2006; 47(4): 708 - 714. [Abstract] [Full Text] [PDF]
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P. W. Serruys, M. J.B. Kutryk, and A. T.L. Ong Coronary-Artery Stents N. Engl. J. Med., February 2, 2006; 354(5): 483 - 495. [Full Text] [PDF]
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C.-H. Lee, H.-C. Tan, and Y.-T. Lim Update on Drug-Eluting Stents for Prevention of Restenosis Asian Cardiovasc Thorac Ann, February 1, 2006; 14(1): 75 - 82. [Abstract] [Full Text] [PDF]
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H. Kelbaek, L. Thuesen, S. Helqvist, L. Klovgaard, E. Jorgensen, S. Aljabbari, K. Saunamaki, L. R. Krusell, G. V.H. Jensen, H. E. Botker, et al. The Stenting Coronary Arteries in Non-stress/benestent Disease (SCANDSTENT) Trial J. Am. Coll. Cardiol., January 17, 2006; 47(2): 449 - 455. [Abstract] [Full Text] [PDF]
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A. E. Rodriguez, J. Mieres, C. Fernandez-Pereira, C. F. Vigo, M. Rodriguez-Alemparte, D. Berrocal, L. Grinfeld, and I. Palacios Coronary Stent Thrombosis in the Current Drug-Eluting Stent Era: Insights From the ERACI III Trial J. Am. Coll. Cardiol., January 3, 2006; 47(1): 205 - 207. [Full Text] [PDF]
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 A. G. Touchard and R. S. Schwartz Preclinical Restenosis Models: Challenges and Successes Toxicol Pathol, January 1, 2006; 34(1): 11 - 18. [Abstract] [Full Text] [PDF]
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A Bagust, A D Grayson, N D Palmer, R A Perry, and T Walley Cost effectiveness of drug eluting coronary artery stenting in a UK setting: cost-utility study Heart, January 1, 2006; 92(1): 68 - 74. [Abstract] [Full Text] [PDF]
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 P. Ramrakha and J. Hill Chapter 15 Major trials in cardiology Oxford Handbook of Cardiology, January 1, 2006; 1(1): med-9780198525974-chapter - med-9780198525974-chapter. [Full Text]
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