on April 12, 2004
Circulation. 2004
Published online before print April 12, 2004, doi: 10.1161/01.CIR.0000127110.49192.72
Published online before print April 12, 2004, doi: 10.1161/01.CIR.0000127110.49192.72
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© American Heart Association, Inc.
Clinical Investigation and Reports |
One-Year Clinical Results With the Slow-Release, Polymer-Based, Paclitaxel-Eluting TAXUS Stent
The TAXUS-IV Trial
From The Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, New York, NY (G.W.S.); Cleveland Clinic Foundation (S.G.E.); Mid Carolina Cardiology, Charlotte, NC (D.A.C.); St. Vincent’s Hospital, Indianapolis, Ind (J.H.); Elyria Memorial Hospital, Elyria, Ohio (C.O.); WakeMed, Raleigh, NC (J.T.M.); Washington Adventist Hospital, Tacoma Park, MD (M.T.); St. Joseph’s Hospital, Syracuse, NY (R.C.); Sacred Heart Medical Center, Eugene, Ore (P.B.); Florida Hospital, Orlando, Fla (J.G.); Brigham and Women’s Hospital, Boston, Mass (J.J.P.); Boston Scientific Corp, Natick, Mass (M.E.R.).
Correspondence to Gregg W. Stone, MD, The Cardiovascular Research Foundation, 55 E 59th St, 6th Floor, New York, NY 10022. E-mail gstone{at}crf.org
Received February 9, 2004; accepted February 9, 2004.
Background— The safety and efficacy of the slow-release, polymer-based, paclitaxel-eluting stent after implantation in a broad cross section of de novo coronary lesions at 1 year are unknown.
Methods and Results— In the TAXUS-IV trial, 1314 patients with single de novo coronary lesions 10 to 28 mm in length, with reference-vessel diameter 2.5 to 3.75 mm, coverable by a single study stent, were prospectively randomized to the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or an identical-appearing bare-metal EXPRESS stent. By actuarial analysis, the TAXUS stent compared with the bare-metal stent reduced the 12-month rates of target-lesion revascularization by 73% (4.4% versus 15.1%, P<0.0001), target-vessel revascularization by 62% (7.1% versus 17.1%, P<0.0001), target-vessel failure by 52% (10.0% versus 19.4%, P<0.0001), and composite major adverse cardiac events by 49% (10.8% versus 20.0%, P<0.0001). The 1-year rates of cardiac death (1.4% versus 1.3%), myocardial infarction (3.5% versus 4.7%), and subacute thrombosis (0.6% versus 0.8%) were similar between the paclitaxel-eluting and control stents, respectively. Between 9 and 12 months, there were significantly fewer myocardial infarctions (0% versus 1.1%, P=0.007), target-vessel revascularizations (2.4% versus 5.8%, P=0.002), and major adverse cardiac events (2.4% versus 6.3%, P=0.0009) in the paclitaxel-eluting stent than in the control stent group, respectively.
Conclusions— The relative efficacy reported at 9 months for the polymer-based, paclitaxel-eluting TAXUS stent compared with the EXPRESS stent is preserved and continues to increase at 1 year, with no safety concerns apparent.
Key Words: stents • paclitaxel • hyperplasia • restenosis
Related Article:
Circulation 2004 109: 1906-1910.
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P. Urban, A. H. Gershlick, G. Guagliumi, P. Guyon, C. Lotan, J. Schofer, A. Seth, J. E. Sousa, W. Wijns, C. Berge, et al. Safety of Coronary Sirolimus-Eluting Stents in Daily Clinical Practice: One-Year Follow-Up of the e-Cypher Registry Circulation, March 21, 2006; 113(11): 1434 - 1441. [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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R. Beyar, L. Gruberg, D. Deleanu, A. Roguin, Y. Almagor, S. Cohen, G. Kumar, and T. Wenderow Remote-Control Percutaneous Coronary Interventions: Concept, Validation, and First-in-Humans Pilot Clinical Trial J. Am. Coll. Cardiol., January 17, 2006; 47(2): 296 - 300. [Abstract] [Full Text] [PDF]
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J. R. Nebeker, R. Virmani, C. L. Bennett, J. M. Hoffman, M. H. Samore, J. Alvarez, C. J. Davidson, J. M. McKoy, D. W. Raisch, B. K. Whisenant, et al. Hypersensitivity Cases Associated With Drug-Eluting Coronary Stents: A Review of Available Cases From the Research on Adverse Drug Events and Reports (RADAR) Project J. Am. Coll. Cardiol., January 3, 2006; 47(1): 175 - 181. [Abstract] [Full Text] [PDF]
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S. C. Smith Jr, T. E. Feldman, J. W. Hirshfeld Jr, A. K. Jacobs, M. J. Kern, S. B. King III, D. A. Morrison, W. W. O'Neill, H. V. Schaff, P. L. Whitlow, et al. ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention--Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) Circulation, January 3, 2006; 113(1): 156 - 175. [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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J. A. Alarcon, J. M. Arribas, V. Ruiz, L. Czupryniak, M. Pawlowski, J. Loba, R. F. Bonvini, V. Verin, R. Waksman, R. M. Wolfram, et al. Drug-eluting coronary stents. N. Engl. J. Med., December 1, 2005; 353(22): 2404 - 2408. [Full Text] [PDF]
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K. D. Dawkins, E. Grube, G. Guagliumi, A. P. Banning, K. Zmudka, A. Colombo, L. Thuesen, K. Hauptman, J. Marco, W. Wijns, et al. Clinical Efficacy of Polymer-Based Paclitaxel-Eluting Stents in the Treatment of Complex, Long Coronary Artery Lesions From a Multicenter, Randomized Trial: Support for the Use of Drug-Eluting Stents in Contemporary Clinical Practice Circulation, November 22, 2005; 112(21): 3306 - 3313. [Abstract] [Full Text] [PDF]
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D. J. Moliterno Healing Achilles -- Sirolimus versus Paclitaxel N. Engl. J. Med., August 18, 2005; 353(7): 724 - 727. [Full Text] [PDF]
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J. A. Brinker, C. J. Davidson, and W. Laskey Preventing in-hospital cardiac and renal complications in high-risk PCI patients Eur. Heart J. Suppl., August 1, 2005; 7(suppl_G): G13 - G24. [Abstract] [Full Text] [PDF]
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