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Circulation. 2003;108:788-794
Published online before print August 4, 2003, doi: 10.1161/01.CIR.0000086926.62288.A6
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(Circulation. 2003;108:788.)
© 2003 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

Antonio Colombo, MD; Janusz Drzewiecki, MD; Adrian Banning, MD; Eberhard Grube, MD; Karl Hauptmann, MD; Sigmund Silber, MD; Dariusz Dudek, MD; Stephen Fort, MD; Francois Schiele, MD; Krysztof Zmudka, MD; Giulio Guagliumi, MD; Mary E. Russell, MD, for the TAXUS II Study Group

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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S. G. Ellis, A. Colombo, E. Grube, J. Popma, J. Koglin, K. D. Dawkins, and G. W. Stone
Incidence, Timing, and Correlates of Stent Thrombosis With the Polymeric Paclitaxel Drug-Eluting Stent: A TAXUS II, IV, V, and VI Meta-Analysis of 3,445 Patients Followed for Up to 3 Years
J. Am. Coll. Cardiol., March 13, 2007; 49(10): 1043 - 1051.
[Abstract] [Full Text] [PDF]

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 NEJMHome page
G. W. Stone, J. W. Moses, S. G. Ellis, J. Schofer, K. D. Dawkins, M.-C. Morice, A. Colombo, E. Schampaert, E. Grube, A. J. Kirtane, et al.
Safety and Efficacy of Sirolimus- and Paclitaxel-Eluting Coronary Stents
N. Engl. J. Med., March 8, 2007; 356(10): 998 - 1008.
[Abstract] [Full Text] [PDF]

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 NEJMHome page
L. Mauri, W.-h. Hsieh, J. M. Massaro, K. K.L. Ho, R. D'Agostino, and D. E. Cutlip
Stent Thrombosis in Randomized Clinical Trials of Drug-Eluting Stents
N. Engl. J. Med., March 8, 2007; 356(10): 1020 - 1029.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
M. Pfisterer, H. P. Brunner-La Rocca, P. T. Buser, P. Rickenbacher, P. Hunziker, C. Mueller, R. Jeger, F. Bader, S. Osswald, C. Kaiser, et al.
Late Clinical Events After Clopidogrel Discontinuation May Limit the Benefit of Drug-Eluting Stents: An Observational Study of Drug-Eluting Versus Bare-Metal Stents
J. Am. Coll. Cardiol., November 1, 2006; (2006) j.jacc.2006.10.026v1.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
M. J. Eisenberg
Drug-Eluting Stents: The Price Is Not Right
Circulation, October 17, 2006; 114(16): 1745 - 1754.
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 J Am Coll CardiolHome page
F. Saia, G. Piovaccari, A. Manari, A. Santarelli, A. Benassi, E. Aurier, P. Sangiorgio, F. Tarantino, G. Geraci, G. Vecchi, et al.
Clinical Outcomes for Sirolimus-Eluting Stents and Polymer-Coated Paclitaxel-Eluting Stents in Daily Practice: Results From a Large Multicenter Registry
J. Am. Coll. Cardiol., October 3, 2006; 48(7): 1312 - 1318.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
H. Futamatsu, M. Sabate, D. J. Angiolillo, P. Jimenez-Quevedo, C. Corros, K. Morikawa-Futamatsu, F. Alfonso, J. Jiang, P. Cervinka, R. Hernandez-Antolin, et al.
Characterization of Plaque Prolapse After Drug-Eluting Stent Implantation in Diabetic Patients: A Three-Dimensional Volumetric Intravascular Ultrasound Outcome Study
J. Am. Coll. Cardiol., September 19, 2006; 48(6): 1139 - 1145.
[Abstract] [Full Text] [PDF]

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 NEJMHome page
G. J. Laarman, M. J. Suttorp, M. T. Dirksen, L. van Heerebeek, F. Kiemeneij, T. Slagboom, L. R. van der Wieken, J. G.P. Tijssen, B. J. Rensing, and M. Patterson
Paclitaxel-Eluting versus Uncoated Stents in Primary Percutaneous Coronary Intervention
N. Engl. J. Med., September 14, 2006; 355(11): 1105 - 1113.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
G. S. Mintz and N. J. Weissman
Intravascular Ultrasound in the Drug-Eluting Stent Era
J. Am. Coll. Cardiol., August 1, 2006; 48(3): 421 - 429.
[Abstract] [Full Text] [PDF]

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 Circ. Res.Home page
B. E. Stahli, G. G. Camici, J. Steffel, A. Akhmedov, K. Shojaati, M. Graber, T. F. Luscher, and F. C. Tanner
Paclitaxel Enhances Thrombin-Induced Endothelial Tissue Factor Expression via c-Jun Terminal NH2 Kinase Activation
Circ. Res., July 21, 2006; 99(2): 149 - 155.
[Abstract] [Full Text] [PDF]

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S. Elezi, A. Dibra, U. Folkerts, J. Mehilli, S. Heigl, A. Schomig, and A. Kastrati
Cost Analysis From Two Randomized Trials of Sirolimus-Eluting Stents Versus Paclitaxel-Eluting Stents in High-Risk Patients With Coronary Artery Disease
J. Am. Coll. Cardiol., July 18, 2006; 48(2): 262 - 267.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
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 Am Coll CardiolHome page
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.
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 Ann. Thorac. Surg.Home page
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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 HeartHome page
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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 HeartHome page
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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 J Am Coll CardiolHome page
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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 J Am Coll CardiolHome page
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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 Ann. Thorac. Surg.Home page
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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 J Am Coll CardiolHome page
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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