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Reduced Risk of Restenosis in Small Vessels and Reduced Risk of Myocardial Infarction in Long Lesions With the New Thin-Strut TAXUS Liberté Stent

1-Year Results From the TAXUS ATLAS Program

Mark A. Turco, MD^_*,_*, John A. Ormiston, MBChB, Jeffrey J. Popma, MD, Jack J. Hall, MD, Tift Mann, MD^||, Louis A. Cannon, MD^¶, Mark W.I. Webster, MBChB^#, Gregory J. Mishkel, MD^_**, Charles D. O'Shaughnessy, MD, Thomas F. McGarry, MD, Lazar Mandinov, MD, Keith D. Dawkins, MD, Donald S. Baim, MD

^_* Center for Cardiac & Vascular Research, Washington Adventist Hospital, Takoma Park, Maryland
Mercy Angiography Unit, Mercy Hospital, Auckland, New Zealand
Angiographic Core Laboratory, Brigham and Women's Hospital, Boston, Massachusetts
The Heart Center, St. Vincent's Hospital, Indianapolis, Indiana
^|| Wake Heart Associates, Wake Medical Center, Raleigh, North Carolina
^¶ Cardiac & Vascular Research Center, Northern Michigan Hospital, Petoskey, Michigan
^# Cardiac Investigations Unit, Auckland City Hospital, Auckland, New Zealand
^_** Prairie Heart Institute, St. John's Hospital, Springfield, Illinois
Elyria Memorial Hospital, Elyria, Ohio
Oklahoma Foundation for Cardiovascular Research, Oklahoma Heart Hospital, Oklahoma City, Oklahoma
Boston Scientific Corporation, Natick, Massachusetts

^_* Reprint requests and correspondence: Dr. Mark A. Turco, Center for Cardiac & Vascular Research, Washington Adventist Hospital, 7600 Carroll Avenue, Takoma Park, Maryland 20912 (Email: MTurco{at}ahm.com).

Objectives: The TAXUS ATLAS Small Vessel (SV) and Long Lesion (LL) multicenter studies compared the performance of the thin-strut (0.0038 inch) TAXUS Liberté 2.25-mm stent (Boston Scientific; Natick, Massachusetts) and the TAXUS Liberté 38-mm long stent (Boston Scientific; Natick, Massachusetts) with the earlier paclitaxel-eluting TAXUS Express (Boston Scientific) stent that has identical polymer, drug dosage, and release kinetics but different stent geometry and thicker struts (0.0052 inch).

Background: The TAXUS Liberté stent was designed with thinner and more even strut spacing to provide more uniform drug distribution, as well as increased flexibility and conformability. Clinical benefits of the new stent design have not been evaluated.

Methods: The TAXUS ATLAS SV and LL studies are nonrandomized studies comparing outcomes of the TAXUS Liberté 2.25 mm (N = 261) and TAXUS Liberté 38 mm (N = 150) stents to TAXUS Express historical control groups derived from the TAXUS IV and V trials. Inclusion/exclusion criteria for TAXUS Express and Liberté groups were similar in both studies.

Results: Each study met its primary end point of noninferiority of 9-month in-segment diameter stenosis. Furthermore, TAXUS Liberté 2.25 mm, when compared with TAXUS Express, significantly reduced the rate of both 9-month angiographic restenosis (18.5% vs. 32.7%, p = 0.0219) and 12-month target lesion revascularization (6.1% vs. 16.9%, p = 0.0039). In addition, TAXUS Liberté 38 mm significantly reduced the risk of 12-month myocardial infarction compared with TAXUS Express (1.4% vs. 6.5%, p = 0.0246).

Conclusions: The thinner-strut TAXUS Liberté stent improved outcomes compared with the earlier TAXUS Express stent in both SVs and LLs (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748; A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475).

Key Words: stent • restenosis • revascularization • paclitaxel

Abbreviations and Acronyms   CI = confidence interval   DS = percent diameter stenosis   LL = long lesion(s)   MACE = major adverse cardiac events   MI = myocardial infarction   MLD = minimum lumen diameter   RVD = reference vessel diameter   SV = small vessel(s)   TLR = target lesion revascularization

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