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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Polymer-Based, Paclitaxel-Eluting TAXUS Liberté Stent in De Novo Lesions

The Pivotal TAXUS ATLAS Trial

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

^_* Center for Cardiac & Vascular Research, Washington Adventist Hospital, Takoma Park, Maryland
Mercy Angiography Unit, Mercy Hospital, Auckland, New Zealand
Department of Internal Medicine (Cardiovascular Division), Brigham and Women's Hospital, Boston, Massachusetts
Boston Scientific Corporation, Marlborough, Massachusetts
^|| Elyria Memorial Hospital, Elyria, Ohio
^¶ Wake Heart Associates, Wake Medical Center, Raleigh, North Carolina
^# Oklahoma Foundation for Cardiovascular Research, Oklahoma Heart Hospital, Oklahoma City, Oklahoma
^_** Cardiology Section, Chang-Gung Memorial Hospital, Kaohsiung, Taiwan
National Heart Centre, Singapore, Singapore
Cardiac Investigations Unit, Auckland City Hospital, Auckland, New Zealand
The Heart Center, St. Vincent's Hospital, Indianapolis, Indiana
^|||| Prairie Heart Institute, St. John's Hospital, Springfield, Illinois
^¶¶ Cardiac & Vascular Research Center, Northern Michigan Hospital, Petoskey, Michigan

Manuscript received October 16, 2006; revised manuscript received January 4, 2007, accepted January 9, 2007.

^_* 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 goal of this research was to assess non-inferiority of the next-generation TAXUS Liberté stent (Boston Scientific Corp., Natick, Massachusetts) versus the TAXUS Express stent (Boston Scientific Corp.).

Background: The introduction of drug-eluting stents (DES) has shifted clinical practice towards more complex lesion subsets, prompting the need for more deliverable DES. TAXUS Liberté was designed to combine the established polymer-based, paclitaxel-elution TAXUS technology with the more advanced Liberté stent platform.

Methods: The TAXUS ATLAS study is a global, prospective, single-arm trial evaluating outcomes in de novo coronary lesions visually estimated to be 10 to 28 mm in length in vessels 2.5 to 4.0 mm in diameter. The control group is an entry-criteria-matched population of TAXUS Express patients from the TAXUS IV and V trials. The primary end point is non-inferiority of TAXUS Liberté versus TAXUS Express for 9-month target vessel revascularization.

Results: Despite similar inclusion criteria, quantitative coronary angiography-determined baseline lesion characteristics were significantly more complex for TAXUS Liberté than TAXUS Express. The primary non-inferiority end point was met with the 1-sided 95% confidence bound of 2.98% less than the pre-specified non-inferiority margin of 3% (p = 0.0487).

Conclusions: Despite the treatment of more complex lesions with TAXUS Liberté, the primary end point was met, demonstrating that TAXUS Liberté is non-inferior to TAXUS Express. The successful transfer of the proven TAXUS technology to the more advanced TAXUS Liberté platform was demonstrated. (TAXUS ATLAS: TAXUS Liberté-SR Stent for the Treatment of De Novo Coronary Artery Lesions; http://www.clinicaltrials.gov/ct/show/NCT00371709?order=1; NCT00371709 [ClinicalTrials.gov] )

Abbreviations and Acronyms   DES = drug-eluting stent(s)   ITT = intention-to-treat   MACE = major adverse cardiac events   MI = myocardial infarction   MLD = minimum lumen diameter   PP = per protocol   QCA = quantitative coronary angiography   TVR = target vessel revascularization

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