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FOCUS ISSUE: DRUG-ELUTING STENTS: TAXUS-IV

Outcomes with the paclitaxel-eluting stent in patients with acute coronary syndromes

Analysis from the TAXUS-IV trial

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,_*

^_* Columbia University Medical Center, New York, New York
The Cardiovascular Research Foundation, New York, New York
Washington University School of Medicine, St. Louis, Missouri
Community Hospitals of Indianapolis, Indianapolis, Indiana
^|| Saint Mary’s Hospital, Duluth, Minnesota
^¶ Valley Hospital, Ridgewood, New Jersey
^# Boston Scientific Corp., Natick, Massachusetts
^_** Cleveland Clinic Foundation, Cleveland, Ohio.

Manuscript received June 28, 2004; revised manuscript received October 18, 2004, accepted October 25, 2004.

^_* Reprint requests and correspondence: Dr. Gregg W. Stone, The Cardiovascular Research Foundation, 55 East 59th Street, 6th floor, New York, New York 10022. (Email: gstone{at}crf.org).

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.

Abbreviations and Acronyms   ACS = acute coronary syndrome   CI = confidence interval   CK = creatine kinase   HR = hazard ratio   MACE = major adverse cardiac events   MI = myocardial infarction   PCI = percutaneous coronary intervention   TLR = target lesion revascularization   TVR = target vessel revascularization

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