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用于血栓形成事件高危冠状动脉病变患者的新型涂层支架设计:Camouflage注册研究的早期和长期结果

New coating stent design for patients with high-risk coronary lesions for thrombotic events: early and long-term results of the Camouflage registry.

作者信息

Perez Gilberto, Rodriguez-Granillo Alfredo M, Mieres Juan, Llaurado Claudio, Rubilar Bibiana, Risau Gustavo, Fernandez-Pereira Carlos, Rodriguez Alfredo E

机构信息

Cardiovascular Research Center (CECI), Callao 1441 4B (1024), Capital Federal, Buenos Aires, Argentina.

出版信息

J Invasive Cardiol. 2009 Aug;21(8):378-82.

PMID:19652248
Abstract

BACKGROUND

Semisynthetic coating of the Camouflage bare-metal stent (BMS) (Eucatech AG, Rheinfelden, Germany) mimics luminal endothelial cell glycocalix, potentially preventing the activation of the coagulation system. Purpose. We sought to determine in a clinical registry the acute and long-term clinical and angiographic outcomes of this BMS design in patients with acute coronary syndromes (ACS) or who were unable to be on long-term clopidogrel therapy.

METHODS

From March 2007 to December 2008, 150 patients undergoing coronary stent implantation at three centers in Buenos Aires, Argentina, were included in our registry. Patients with ACS, including non-ST-elevation myocardial infarction (NSTEMI) and STelevation MI (STEMI), or those unable to be on long-term dual antiplatelet therapy were considered for inclusion. The primary endpoint was a major adverse cardiovascular event (MACE) defined as the incidence of cardiac death, MI or target lesion revascularization (TLR). The incidence of acute and late stent thrombosis (ST) was also analyzed. Angiographic late loss and the presence of late stent malapposition (LSM) was recorded at 9-month follow up. Clopidogrel was prescribed for 1 month.

RESULTS

54.7% of patients had acute MI, 36% had STEMI and 20.7% of patients were ineligible for long-term clopidogrel therapy because of previously planned non-vascular or general surgery within 30 days after percutaneous coronary intervention. During 11.5 months of clinical follow up, 2% suffered cardiac death, 4% had a MI, 8.9% underwent TLR and the overall cumulative major adverse cardiac event rate was 15.3%. No patient developed acute or late ST. There were no in-hospital complications for patients who underwent surgery. Intravascular ultrasound studies did not detect the presence of late malapposition.

CONCLUSION

In this high-risk thrombotic patient population, the Camouflage coated stent design demonstrated a very good safety profile, as reflected by the low incidence of hard adverse cardiac events including ST at follow up.

摘要

背景

伪装裸金属支架(BMS)(Eucatech AG,德国莱茵费尔登)的半合成涂层模仿管腔内内皮细胞糖萼,可能预防凝血系统激活。目的:我们试图在一项临床注册研究中确定这种BMS设计在急性冠状动脉综合征(ACS)患者或无法接受长期氯吡格雷治疗的患者中的急性和长期临床及血管造影结果。

方法

2007年3月至2008年12月,在阿根廷布宜诺斯艾利斯的三个中心接受冠状动脉支架植入的150例患者被纳入我们的注册研究。纳入ACS患者,包括非ST段抬高型心肌梗死(NSTEMI)和ST段抬高型心肌梗死(STEMI),或无法接受长期双联抗血小板治疗的患者。主要终点是主要不良心血管事件(MACE),定义为心脏死亡、心肌梗死或靶病变血运重建(TLR)的发生率。还分析了急性和晚期支架血栓形成(ST)的发生率。在9个月随访时记录血管造影晚期丢失和晚期支架贴壁不良(LSM)的情况。氯吡格雷服用1个月。

结果

54.7%的患者发生急性心肌梗死,36%为STEMI,20.7%的患者因在经皮冠状动脉介入治疗后30天内有预先计划的非血管或普通外科手术而不符合长期氯吡格雷治疗条件。在11.5个月的临床随访期间,2%的患者发生心脏死亡,4%发生心肌梗死,8.9%接受了TLR,总体累积主要不良心脏事件发生率为15.3%。没有患者发生急性或晚期ST。接受手术的患者没有院内并发症。血管内超声研究未检测到晚期贴壁不良。

结论

在这个高风险血栓形成患者群体中,伪装涂层支架设计显示出非常好的安全性,随访时包括ST在内的严重不良心脏事件发生率低反映了这一点。

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