Author + information
- Received June 28, 2004
- Revision received October 18, 2004
- Accepted October 25, 2004
- Published online April 19, 2005.
- Jeffrey W. Moses, MD, FACC⁎,†,
- Roxana Mehran, MD, FACC⁎,†,
- Eugenia Nikolsky, MD⁎,†,
- John M. Lasala, MD, FACC‡,1,
- Woodrow Corey, MD, FACC§,
- Glenn Albin, MD, FACC∥,
- Cary Hirsch, MD, FACC¶,
- Martin B. Leon, MD, FACC⁎,†,
- Mary E. Russell, MD, FACC#,2,
- Stephen G. Ellis, MD, FACC⁎⁎,1 and
- Gregg W. Stone, MD, FACC⁎,†,1,⁎ ()
- ↵⁎Reprint requests and correspondence:
Dr. Gregg W. Stone, The Cardiovascular Research Foundation, 55 East 59th Street, 6th floor, New York, New York 10022.
Objectives We sought to investigate the outcomes of paclitaxel-eluting stent implantation in patients with unstable angina or non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI).
Background Whether the paclitaxel-eluting stent is safe and effective in patients with acute coronary syndromes (ACS) is unknown.
Methods In the TAXUS-IV trial, 1,314 patients with stable or unstable ischemic syndromes undergoing PCI were randomized to treatment with either the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or a bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). The results were stratified by the acuity of the presenting clinical syndrome.
Results Acute coronary syndromes were present in 450 patients (34.2%), 237 of whom were assigned to paclitaxel-eluting stents and 213 to bare-metal stents. The baseline and procedural characteristics were well matched between the groups. Clinical outcomes at 30 days were similar with both stents. At one-year follow-up, patients with ACS assigned to the paclitaxel-eluting stent compared to the control stent had strikingly lower rates of target lesion revascularization (TLR) (3.9% vs. 16.0%, p < 0.0001) and major adverse cardiac events (11.1 vs. 21.7%, p = 0.002). By multivariate analysis, ACS was an independent predictor of in-stent restenosis in the cohort treated with bare-metal stents (hazard ratio [HR] = 2.03 [95% confidence interval (CI) 1.05 to 3.92], p = 0.035), while among patients randomized to the paclitaxel-eluting stents, ACS was an independent predictor of freedom from restenosis (HR = 0.27 [95% CI 0.08 to 0.97], p = 0.04).
Conclusions The use of the paclitaxel-eluting TAXUS stent was safe in patients with unstable ischemic syndromes, and was associated with marked reduction of ischemia-driven TLR and adverse cardiac events at one year.
- Received June 28, 2004.
- Revision received October 18, 2004.
- Accepted October 25, 2004.
- American College of Cardiology Foundation