Ormiston John A, Mahmud Ehtisham, Turco Mark A, Popma Jeffrey J, Weissman Neil, Cannon Louis A, Mann Tift, Lucca Michael J, Lim Soo-Teik, Hall Jack J, McClean Dougal, Dobies David, Mandinov Lazar, Baim Donald S
Mercy Angiography Unit, Mercy Hospital, Auckland, New Zealand.
JACC Cardiovasc Interv. 2008 Apr;1(2):150-60. doi: 10.1016/j.jcin.2008.01.003.
This study was conducted to determine whether direct stenting with TAXUS Liberté is noninferior to stenting after pre-dilation.
Direct stenting is performed in approximately 30% of patients, but data on clinical and angiographic outcomes with drug-eluting stents are limited.
The TAXUS ATLAS DIRECT STENT is a single-arm, multicenter study that enrolled patients with 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 the quantitative coronary angiography (QCA) subset of the TAXUS ATLAS trial, which used identical inclusion and exclusion criteria but mandated pre-dilation. The primary end point is 9-month analysis-segment percent diameter stenosis (%DS).
Baseline patient characteristics were similar between the groups. On QCA analysis, significantly shorter lesions with larger lumen diameter and less calcification were observed in the direct stent group. Direct stenting was successful in 97.6% of patients and was associated with a shorter procedure time and fewer complications. Follow-up %DS was noninferior for direct stent (26.41%) versus pre-dilation (29.14%) with a 1-sided 95% confidence interval of the difference between the groups (-0.34%) well below the pre-specified noninferiority margin (6.75%). Additionally, significantly lower restenosis (5.9% vs. 11.4%, p = 0.0229) and target lesion revascularization (TLR) 2.9% vs. 7.8%, p = 0.0087) rates were seen for direct stent versus pre-dilation.
Direct stenting of TAXUS Liberté is feasible and highly successful in carefully selected lesions. Direct stenting is noninferior to stenting after pre-dilation on the basis of %DS and can significantly reduce procedural time, procedural complications, and possibly angiographic restenosis and TLR.
本研究旨在确定使用TAXUS Liberté直接支架置入术是否不劣于预扩张后支架置入术。
约30%的患者接受直接支架置入术，但药物洗脱支架的临床和血管造影结果数据有限。
TAXUS ATLAS直接支架置入术是一项单臂、多中心研究，纳入了新发冠状动脉病变患者，这些病变经目测估计长度为10至28毫米，位于直径2.5至4.0毫米的血管中。对照组是TAXUS ATLAS试验的定量冠状动脉造影（QCA）亚组，该试验使用相同的纳入和排除标准，但要求进行预扩张。主要终点是9个月时分析节段直径狭窄百分比（%DS）。
两组患者的基线特征相似。在QCA分析中，直接支架置入组观察到病变明显较短，管腔直径较大且钙化较少。97.6%的患者直接支架置入术成功，且手术时间较短，并发症较少。直接支架置入组的随访%DS不劣于预扩张组（26.41%对29.14%），两组差异的单侧95%置信区间（-0.34%）远低于预先指定的非劣效性界值（6.75%）。此外，直接支架置入组与预扩张组相比，再狭窄率（5.9%对11.4%，p = 0.0229）和靶病变血运重建率（TLR）（2.9%对7.8%，p = 0.0087）显著更低。
TAXUS Liberté直接支架置入术在精心选择的病变中是可行且非常成功的。基于%DS，直接支架置入术不劣于预扩张后支架置入术，并且可以显著减少手术时间、手术并发症，可能还能减少血管造影再狭窄和TLR。
