Randomized Comparison of a Titanium-Nitride-Oxide–Coated Stent With a Stainless Steel Stent for Coronary Revascularization: The TiNOX Trial
Randomized Comparison of a Titanium-Nitride-Oxide–Coated Stent With a Stainless Steel Stent for Coronary Revascularization: The TiNOX Trial
复制标题
DOI：
10.1161/circulationaha.104.486647
复制
发表时间：
2005-05
期刊：
影响因子：
37.8
通讯作者：
S. Windecker;R. Simon;M. Lins;V. Klauss;F. Eberli;M. Roffi;G. Pedrazzini;T. Moccetti;P. Wenaweser;M. Togni;D. Tüller;R. Zbinden;C. Seiler;J. Mehilli;A. Kastrati;B. Meier;O. Hess
中科院分区：
文献类型：
--
作者：
S. Windecker;R. Simon;M. Lins;V. Klauss;F. Eberli;M. Roffi;G. Pedrazzini;T. Moccetti;P. Wenaweser;M. Togni;D. Tüller;R. Zbinden;C. Seiler;J. Mehilli;A. Kastrati;B. Meier;O. Hess
背景——氮化钛氧化物支架涂层已被证明可以减少猪再狭窄模型中的新内膜增生。我们设计了一项前瞻性、随机临床研究来研究氮化钛-氧化物涂层支架与不锈钢支架相比的安全性和有效性。方法和结果——92 名新发病变患者被随机分配接受氮化钛涂层支架 (n = 45) 或其他设计相同的不锈钢支架 (n = 47；对照) 治疗。两组的基线特征相似。 30 天时，两组均未发生支架内血栓或其他不良事件。 6 个月时的定量冠状动脉造影显示，与对照支架相比，使用氮化钛涂层涂层治疗的病变的晚期损失（0.55±0.63 毫米与 0.90±0.76 毫米，P=0.03）和直径狭窄百分比（26±17% 与 36±24%，P=0.04）较低。二元再狭窄从对照组的 33% 降低到氮化钛涂层支架组的 15%（P=0.07）。 6 个月时的血管内超声研究显示，氮化钛-氧化物涂层支架的新内膜体积比对照支架小（18±21 与 48±28 mm3，P<0.0001）。与接受支架治疗的对照患者相比，氮化钛涂层支架在 6 个月时发生的主要不良心脏事件发生率较低（7% 与 27%，P=0.02），这主要是由于目标病变血运重建的需要减少（7% 与 23%，P=0.07）。结论——使用氮化钛-氧化钛涂层支架进行血运重建对于原生冠状动脉病变的患者是安全有效的。与其他相同设计的不锈钢支架相比，氮化钛氧化物涂层支架可减少再狭窄和主要不良心脏事件。
Background—Stent coating with titanium-nitride-oxide has been shown to reduce neointimal hyperplasia in the porcine restenosis model. We designed a prospective, randomized, clinical study to investigate the safety and efficacy of titanium-nitride-oxide–coated stents compared with stainless steel stents. Methods and Results—Ninety-two patients with de novo lesions were randomly assigned to treatment with titanium-nitride-oxide–coated stents (n=45) or stainless steel stents of otherwise identical design (n=47; control). Baseline characteristics were similar in both groups. At 30 days, no stent thromboses or other adverse events had occurred in either group. Quantitative coronary angiography at 6 months revealed lower late loss (0.55±0.63 versus 0.90±0.76 mm, P=0.03) and percent diameter stenosis (26±17% versus 36±24%, P=0.04) in lesions treated with titanium-nitride oxide–coated than in control stents. Binary restenosis was reduced from 33% in the control group to 15% in the titanium-nitride oxide–coated stent group (P=0.07). Intravascular ultrasound studies at 6 months showed smaller neointimal volume in titanium-nitride-oxide–coated stents than in control stents (18±21 versus 48±28 mm3, P<0.0001). Major adverse cardiac events at 6 months were less frequent in titanium-nitride-oxide–coated stents than in control stent–treated patients (7% versus 27%, P=0.02), largely driven by a reduced need for target-lesion revascularization (7% versus 23%, P=0.07). Conclusions—Revascularization with titanium-nitride-oxide–coated stents is safe and effective in patients with de novo native coronary artery lesions. Titanium-nitride-oxide–coated stents reduce restenosis and major adverse cardiac events compared with stainless steel stents of otherwise identical design.