Turco Mark A, Ormiston John A, Popma Jeffrey J, Mandinov Lazar, O'Shaughnessy Charles D, Mann Tift, McGarry Thomas F, Wu Chiung-Jen, Chan Charles, Webster Mark W I, Hall Jack J, Mishkel Gregory J, Cannon Louis A, Baim Donald S, Koglin Joerg
Center for Cardiac & Vascular Research, Washington Adventist Hospital, Takoma Park, Maryland 20912, USA.
J Am Coll Cardiol. 2007 Apr 24;49(16):1676-83. doi: 10.1016/j.jacc.2007.01.069. Epub 2007 Apr 6.
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.).
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.
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.
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).
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).
本研究的目的是评估新一代TAXUS Liberté支架（波士顿科学公司，马萨诸塞州纳蒂克）相对于TAXUS Express支架（波士顿科学公司）的非劣效性。
药物洗脱支架（DES）的引入已使临床实践转向更复杂的病变亚组，这促使人们需要更易于输送的DES。TAXUS Liberté旨在将成熟的基于聚合物的紫杉醇洗脱TAXUS技术与更先进的Liberté支架平台相结合。
TAXUS ATLAS研究是一项全球性、前瞻性、单臂试验，评估在直径2.5至4.0毫米的血管中，目测估计长度为10至28毫米的初发冠状动脉病变的治疗结果。对照组是来自TAXUS IV和V试验的符合入选标准的TAXUS Express患者群体。主要终点是TAXUS Liberté相对于TAXUS Express在9个月时靶血管血运重建的非劣效性。
尽管入选标准相似，但经定量冠状动脉造影确定，TAXUS Liberté的基线病变特征比TAXUS Express显著更复杂。主要非劣效性终点达到，单侧95%置信区间比预先指定的非劣效性界值3%低2.98%（p = 0.0487）。
尽管TAXUS Liberté用于治疗更复杂的病变，但仍达到了主要终点，表明TAXUS Liberté不劣于TAXUS Express。已证明将经过验证的TAXUS技术成功转移至更先进的TAXUS Liberté平台。（TAXUS ATLAS：用于治疗初发冠状动脉病变的TAXUS Liberté-SR支架；http://www.clinicaltrials.gov/ct/show/NCT00371709?order=1；NCT00371709）
