Author + information
- Received August 4, 2009
- Revision received October 6, 2009
- Accepted October 8, 2009
- Published online December 1, 2009.
- 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‡‡,
- TAXUS IV Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Stephen G. Ellis, Cleveland Clinic, 9500 Euclid Avenue, Department of Cardiology/F25, Cleveland, Ohio 44195
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)
This work was supported by Boston Scientific Corporation. Dr. Ellis is a consultant/advisory board member for Boston Scientific, Abbott, and Cordis, and has received research support from Boston Scientific and Cordis. Dr. Stone is an advisory board member for Boston Scientific and Abbott Vascular. Drs. Cox and Hermiller are consultants/advisory board members for Boston Scientific. Dr. O'Shaughnessey is a consultant/advisory board member, a Speakers' Bureau member, and has received research support from Boston Scientific. Dr. Turco is a Speakers' Bureau member/advisory board member/consultant for Boston Scientific, Medtronic, and Cordis. Drs. Bowman and Baim are full-time employees of Boston Scientific Corporation, Inc. Dr. Donald Baim passed away unexpectedly on November 6, 2009.
- Received August 4, 2009.
- Revision received October 6, 2009.
- Accepted October 8, 2009.
- American College of Cardiology Foundation