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FOCUS ISSUE: DRUG-ELUTING STENTS: TAXUS-IV

Gender-based outcomes after paclitaxel-eluting stent implantation in patients with coronary artery disease

Alexandra J. Lansky, MD, FACC^_*, Ricardo A. Costa, MD^_*, Michael Mooney, MD, FACC, Mark G. Midei, MD, FACC, Henry K. Lui, MD, FACC, Warren Strickland, MD, FACC^||, Roxana Mehran, MD, FACC^_*, Martin B. Leon, MD, FACC^_*, Mary E. Russell, MD, FACC^¶, Stephen G. Ellis, MD, FACC^#, Gregg W. Stone, MD, FACC^_*,_* TAXUS-IV Investigators

^_* Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York
Abbott Northwestern Hospital, Minneapolis, Minnesota
St. Joseph’s Medical Center Towson, Towson, Maryland
Research Associates of Jackson, Jackson, Tennessee
^|| Huntsville Hospital, Huntsville, Alabama
^¶ Boston Scientific Corp., Natick, Massachusetts
^# The 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, Cardiovascular Research Foundation, 55 East 59th Street, 6th Floor, New York, New York 10022. (Email: gstone{at}crf.org).

OBJECTIVES: We sought to determine whether gender influences the results of paclitaxel-eluting stent implantation.

BACKGROUND: The TAXUS-IV trial demonstrated the safety and effectiveness of the slow-release, polymer-based, paclitaxel-eluting TAXUS stent compared to bare-metal stents in patients undergoing elective coronary intervention. Whether these results are generalizable to women is not known.

METHODS: A total of 1,314 patients with coronary lesions 10- to 28-mm long in 2.5- to 3.75-mm vessels were randomized to TAXUS stent versus bare-metal EXPRESS stents (Boston Scientific Corp., Natick, Massachusetts). Outcomes examined were stratified by gender.

RESULTS: A total of 662 patients (including 187 women) were assigned to the TAXUS stent, and 652 (180 women) received the control stent. Women were older than men, and had more hypertension, diabetes, renal insufficiency, unstable angina, and heart failure, but less smoking. Among patients receiving the TAXUS stent, women compared with men had higher unadjusted one-year rates of target lesion revascularization (TLR) (7.6% vs. 3.2%, p = 0.03), though female gender was not an independent predictor of TLR (odds ratio [OR] = 1.72 [95% confidence interval (CI) 0.68 to 4.37], p = 0.25). Moreover, restenosis rates were similar in men and women treated with the TAXUS stent (8.6% vs. 7.6%, respectively, p = 0.80), as was late loss (0.22 vs. 0.23 mm, p = 0.90). Compared to control stents, treatment with the TAXUS stent in women resulted in a significant reduction in nine-month restenosis (8.6% vs. 29.2%, p = 0.0001) and one-year TLR (7.6% vs. 14.9%, p = 0.02). The only independent predictor of freedom from restenosis in women was randomization to the TAXUS stent (OR = 0.28 [95% CI 0.11 to 0.74], p = 0.01).

CONCLUSIONS: The benefits of the paclitaxel-eluting stent in reducing clinical and angiographic restenosis are generalizable to women.

Abbreviations and Acronyms   CI = confidence interval   MACE = major adverse cardiac events   OR = odds ratio   TLR = target lesion revascularization   TVR = target vessel revascularization

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