Polymer-based, paclitaxel-eluting TAXUS Liberté stent in de novo lesions: the pivotal TAXUS ATLAS trial.
OBJECTIVE
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).
Turco
Mark A
MA
Center for Cardiac & Vascular Research, Washington Adventist Hospital, Takoma Park, Maryland 20912, USA. MTurco@ahm.com
Ormiston
John A
JA
Popma
Jeffrey J
JJ
Mandinov
Lazar
L
O'Shaughnessy
Charles D
CD
Mann
Tift
T
McGarry
Thomas F
TF
Wu
Chiung-Jen
CJ
Chan
Charles
C
Webster
Mark W I
MW
Hall
Jack J
JJ
Mishkel
Gregory J
GJ
Cannon
Louis A
LA
Baim
Donald S
DS
Koglin
Joerg
J
D000368:Aged; D023921:Coronary Stenosis / Q000188:drug therapy*; D023381:Endpoint Determination; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018919:Neovascularization, Physiologic / Q000187:drug effects*; D017239:Paclitaxel / Q000008:administration & dosage*; D011108:Polymers; D011446:Prospective Studies; D015607:Stents; D050257:Tubulin Modulators / Q000008:administration & dosage*
D011108:Polymers; D050257:Tubulin Modulators; D017239:Paclitaxel