Long-Term Safety and Efficacy With Paclitaxel-Eluting Stents5-Year Final Results of the TAXUS IV Clinical Trial (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent)
Stephen G. Ellis, MD*,*,
Gregg W. Stone, MD ,
David A. Cox, MD ,
James Hermiller, MD ,
Charles O'Shaughnessy, MD||,
Tift Mann, MD¶,
Mark Turco, MD#,
Ronald Caputo, MD**,
Patrick J. Bergin, MD,
Thomas S. Bowman, MD, MPH,
Donald S. Baim, MD for the TAXUS IV Investigators
* Cleveland Clinic, Cleveland, Ohio
Columbia University Medical Center and The Cardiovascular Research Foundation, New York, New York
Lehigh Valley Hospital, Allentown, Pennsylvania
The Care Group, LLC, Indianapolis, Indiana
|| Elyria Memorial Hospital, Elyria, Ohio
¶ Wake Heart Associates, Raleigh, North Carolina
# Washington Adventist Hospital, Takoma Park, Maryland
** St. Joseph's Hospital Health Center, Syracuse, New York
Innovasa Corporation, Eugene, Oregon
Boston Scientific Corporation, Natick, Massachusetts
* Reprint requests and correspondence: Dr. Stephen G. Ellis, Cleveland Clinic, 9500 Euclid Avenue, Department of Cardiology/F25, Cleveland, Ohio 44195 (Email: elliss{at}ccf.org).
Objectives: The pivotal TAXUS IV (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent) trial evaluated the long-term safety and effectiveness of the paclitaxel-eluting stent (PES) compared with an otherwise identical bare-metal stent (BMS) in a relatively uncomplicated population of patients with a single de novo lesion in a native coronary vessel, treated between March and July 2002.
Background: Long-term follow-up is required to determine whether the early safety and efficacy of drug-eluting stents are maintained.
Methods: The primary end point of this prospective, randomized, double-blind trial was 9-month ischemia-driven target vessel revascularization (TVR) for PES versus the BMS control. Follow-up was complete in 1,230 (95.1%) of 1,294 randomized evaluable patients at 5 years.
Results: Compared with BMS, PES significantly reduced TVR at 9 months (12.1% vs. 4.7%; p < 0.0001); this benefit was maintained through 5 years (27.4% vs. 16.9%; p < 0.0001), given comparable TVR rates for BMS and PES between years 1 and 5 (4.1%/year vs. 3.3%/year; respectively, p = 0.16). Similar patterns were observed for composite major adverse cardiac events (MACE) (32.8% BMS vs. 24.0% PES, p = 0.0001 at 5 years). Stent thrombosis was comparable for PES and BMS at 9 months (0.8% BMS vs. 0.8% PES; p = 0.98) and at 5 years (2.1% BMS vs. 2.2% PES, p = 0.87). The overall revascularization benefits of PES were consistent across multiple subgroups, including sex, diabetes, left anterior descending artery lesion location, reference vessel diameter, lesion length, and multiple stents.
Conclusions: These 5-year results demonstrate the long-term safety and sustained efficacy of PES compared with BMS in patients with noncomplex lesions. (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent; NCT00292474)
Key Words: coronary artery stent • long-term • randomized controlled trial • restenosis • TAXUS • thrombosis
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Abbreviations and Acronyms
| | ARC = Academic Research Consortium | | BMS = bare-metal stent(s) | | MACE = major adverse cardiac events | | non-TL TVR = non-target lesion target vessel revascularization | | PES = paclitaxel-eluting stent(s) | | RVD = reference vessel diameter | | ST = stent thrombosis | | TLR = target lesion revascularization | | TVR = target vessel revascularization | | VLST = very late (Academic Research Consortium definite/probable) stent thrombosis |
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