Titanium Nitride Oxide Coated Stents and Paclitaxel Eluting Stents for Acute Myocardial Infarction(TITAX AMI)(幻灯)

描述：

这项试验的目的是评价在应用氧化氮钛合金支架(TITANOX)和紫杉醇洗脱支架（PES）治疗ST段抬高MI和非ST段抬高MI时的临床疗效。

药物/操作的选择：

在对犯罪病变或完全闭塞的梗死相关血管进行造影后，将患者随机分为应用TITANOX组（n=214）或PES组（n=211）.

主要发现：

在所有入选患者中，ST段抬高性心肌梗死患者占42%，58%患者为非ST段抬高性心肌梗死，19%为糖尿病患者，45%的患者发生左冠脉前降支梗死，67%患者发生B1/B2型病变，12%的患者进行多支血管的PCI。

1年主要临床终点TITANOX组和PES组没有差别（10.3% vs. 12.8%,P=0.5）.联合事件MI发生率在TITANOX组更低（4.2% vs. 8.1%,P=0.1），TLR（9.3% vs. 7.1%,P=0.5）或心源性死亡（0.5% vs. 1.9%，P=0.2）两者亦无明显差别。次级临床终点：心源性死亡或心肌梗死在TITANOX支架更低（4.2% vs. 8.5%,P=0.08），支架血栓明显更低（0.9% vs. 4.3%,P=0.03）

解释：

在行PCI治疗ST段抬高和非ST段抬高性心肌梗死患者中，1年MACE发生率两者没有差别。

选择氧化氮钛合金作为支架涂层基于这样的理论：氮氧化物能抑制血小板聚集，最大限度减少纤维蛋白的增多，减少炎症，促进愈合。而临床终点两组也没有明显差别，但在MI和TLR具有不同结果：TITANOX支架MI、1年支架血栓发生率明显低于PES组，但是TLR率高。

入选条件：

冠心病
冠心病/急性心肌梗死

治疗：
支架
支架/药物洗脱

研究设计：
随机入选425例患者，平均年龄64岁，其中女性患者所占比例为25%，随访时间为：1年。

主要临床终点：
12个月主要心脏不良事件（MACE），定义为靶病变血运重建、反复心肌梗死或心源性死亡。

次级临床终点：
全因死亡，心源性死亡或再梗死和支架血栓的联合事件。

患者入选条件：
非ST段抬高性心肌梗死或ST段抬高性心肌梗死

排除标准：
无保护左主干疾病；开口病变/再狭窄病变；有阿司匹林、氯吡格雷或肝素的禁忌症；预期存活寿命<12个月；所需支架长度>28mm.

Title: Titanium Nitride Oxide Coated Stents and Paclitaxel Eluting Stents for Acute Myocardial Infarction (TITAX AMI - Presented at TCT 2007)
Year Presented: 2007
Topic(s): Interventional Cardiology
Summary Posted: 10/24/2007
Writer: Ms. Sabina A. Murphy  (view disclosure)
Reviewer: C. Michael Gibson, M.D., F.A.C.C.  (view disclosure)

Description

The goal of the trial was to evaluate use of a titanium-nitride-oxide coated stent compared with a paclitaxel-eluting stent among patients undergoing percutaneous coronary intervention (PCI) for ST elevation or non-ST elevation myocardial infarction.

Drugs/Procedures Used

Following visualization of the culprit lesion or a totally occluded infarct-related vessel during coronary angiography, patients were randomized to use of the titanium nitride oxide coated stent (n = 214) or paclitaxel-eluting stent (n = 211).

Principal Findings

The index event was ST elevation MI in 42% of patients and non-ST elevation MI in 58%. Diabetes was present in 19% of patients. The infarct artery was the left anterior descending in 45% of patients and 67% had type B1 or B2 lesions. Multivessel PCI was performed in 12% of cases.

There was no difference in the primary endpoint of MACE at 1 year for the TITANOX stent compared with the paclitaxel-eluting stent (10.3% vs. 12.8%, p = 0.5). Among the components of the composite, MI trended lower with the TITANOX stent (4.2% vs. 8.1%, p = 0.1) and there was no difference in TLR (9.3% vs. 7.1%, p = 0.5) or cardiac death (0.5% vs. 1.9%, p = 0.2). The secondary endpoint of cardiac death or MI also trended lower with the TITANOX stent (4.2% vs. 8.5%, p = 0.08). Stent thrombosis was significantly lower with the TITANOX stent (0.9% vs. 4.3%, p = 0.03).

Interpretation

Among patients undergoing PCI for ST elevation or non-ST elevation MI, there was no difference in MACE at 1 year with the TITANOX stent compared with the paclitaxel-eluting stent.

Titanium-nitride-oxide was selected for coating the stent based on the theory that nitride oxide can inhibit platelet aggregation, minimize fibrin growth, reduce inflammation and promote healing. While neither endpoint was significant different between groups, divergent results were observed for MI and TLR: MI was directionally lower with the TITANOX stent but TLR was directionally higher with the TITANOX stent. The rate of stent thrombosis at 1 year was significantly lower with the TITANOX stent than the paclitaxel-eluting stent.

Conditions
• Coronary heart disease
• Coronary heart disease / Acute MI

Therapies
 • Stent
 • Stent/drug-eluting

Study Design
Randomized.
Patients Enrolled: 425
Mean Follow-Up: One year
Mean Patient Age: Mean age 64 years
% Female: 25

Primary Endpoints
Major adverse cardiac event (MACE) at 12 months, defined as the composite of target lesion revascularization (TLR), recurrent MI, or death from cardiac causes

Secondary Endpoints
All-cause mortality, composite of cardiac death or reinfarction and stent thrombosis

Patient Population
Non ST elevation MI or ST elevation MI.

Exclusions:
Unprotected left main disease; ostial or restenotic lesions; contraindication to aspirin, clopidogrel or heparins; life expectancy <12 months; and stent length needed longer than 28 mm.

References: Presented by Dr. Pasi Karjalainen, at TCT 2007, Washington, DC.