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FOCUS ISSUE: DRUG-ELUTING STENTS: TAXUS-IV

Polymer-based paclitaxel-eluting stents reduce in-stent neointimal tissue proliferation

A serial volumetric intravascular ultrasound analysis from the TAXUS-IV trial

Neil J. Weissman, MD, FACC^_*,_*, Joerg Koglin, MD, David A. Cox, MD, FACC, James Hermiller, MD, FACC, Charles O’Shaughnessy, MD, FACC^||, James Tift Mann, MD, FACC^¶, Mark Turco, MD, FACC^#, Ronald Caputo, MD, FACC^_**, Patrick Bergin, MD, FACC, Joel Greenberg, MD, FACC, Michael Kutcher, MD, FACC, S. Chiu Wong, MD, FACC^||||, Warren Strickland, MD, FACC^¶¶, Michael Mooney, MD, FACC^##, Mary E. Russell, MD, FACC, Stephen G. Ellis, MD, FACC^_*** and Gregg W. Stone, MD, FACC^,

^_* Washington Hospital Center, Washington, DC
Boston Scientific Corp., Natick, Massachusetts
Mid Carolina Cardiology, Charlotte, North Carolina
St. Vincent’s Hospital, Indianapolis, Indiana
^|| Elyria Memorial Hospital, Elyria, Ohio
^¶ WakeMed, Raleigh, North Carolina
^# Washington Adventist Hospital, Tacoma Park, Maryland
^_** St. Joseph’s Hospital, Syracuse, New York
Sacred Heart Medical Center, Eugene, Oregon
Florida Hospital, Orlando, Florida
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina
^|||| New York Presbyterian Hospital, New York, New York
^¶¶ Huntsville Hospital, Huntsville, Alabama
^## Abbott Northwestern Hospital, Minneapolis, Minnesota
^_*** Cleveland Clinic Foundation, Cleveland Ohio
College of Physicians and Surgeons, Columbia University, New York, New York
Cardiovascular Research Foundation, New York, New York.

Manuscript received August 5, 2004; revised manuscript received September 26, 2004, accepted October 4, 2004.

^_* Reprint requests and correspondence: Dr. Neil J. Weissman, 110 Irving Street, NW, Suite EB-5123, Washington, DC 20010. (Email: Neil.J.Weissman{at}medstar.net).

OBJECTIVES: The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effects of polymer-based, paclitaxel-eluting stents on in-stent neointima formation and late incomplete stent apposition.

BACKGROUND: The TAXUS-IV trial demonstrated that the slow-release, polymer-based, paclitaxel-eluting stent reduces angiographic restenosis and the need for repeat revascularization procedures. Serial IVUS studies reveal details of the pattern of vascular responses provoked by stent implantation that provide insight into device safety and efficacy.

METHODS: In the TAXUS-IV trial, patients were randomized to the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or a bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). As part of a formal substudy, complete volumetric IVUS data were available in 170 patients, including 88 TAXUS patients and 82 controls, at implantation and at nine-month follow-up.

RESULTS: No baseline differences were present in the clinical characteristics or IVUS parameters between the control and TAXUS groups. At nine-month follow-up, IVUS lumen volumes were larger in the TAXUS group (123 ± 43 mm³ vs. 104 ± 44 mm³, p = 0.005), due to a reduction in neointimal volume (18 ± 18 mm³ vs. 41 ± 23 mm³, p < 0.001). Millimeter-by-millimeter analysis within the stent demonstrated uniform suppression of neointimal growth along the entire stent length. Late lumen loss was similar at the proximal edge of the stent between the two groups, and reduced with the TAXUS stent at the distal edge (p = 0.004). Incomplete stent apposition at nine months was observed in only 3.0% of control and 4.0% of TAXUS stents (p = 0.12).

CONCLUSIONS: Polymer-based, paclitaxel-eluting TAXUS stents are effective in inhibiting neointimal tissue proliferation, and do not result in late incomplete stent apposition.

Abbreviations and Acronyms   EEM = external elastic membrane   IVUS = intravascular ultrasound

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