[TCT2008]抗体涂层支架临床研究1年结果优异

抗体涂层支架临床研究1年结果优异

Antibody-coated Stent Shows Promising Results at One Year

（北京武警总医院  韩玮  翻译）

TCT  2008会议上发布的两个独立的研究结果证实，加速内皮愈合的新型支架具有良好的临床结果，从而增加了征服再狭窄同时避免增加支架血栓风险的希望。这两个研究评价内皮前体细胞捕获支架的安全性和有效性，该支架涂有抗体捕获循环中的内皮前体细胞，加速内皮愈合。

内皮愈合加速通过抑制新生内膜增殖和平滑肌增殖来降低再狭窄，同时通过内皮功能的恢复降低血栓的风险，相反药物洗脱支架抑制支架杆周围的内皮化。

AMI患者中较低的并发症发生率

第一个研究来自新加坡国立大学医院和Tan Tock Seng医院，结果发现STEMI直接PCI中EPC捕获支架有较低的并发症发生率和良好的临床结果，患者接受一个月的二联抗血小板治疗。作者新加坡国立大学医院的Tan Huay-Cheem 在2005年1月－2007年4月间入选了321例STEMI 直接PCI患者，所有患者置入EPC 捕获支架并随访一年。

该研究主要终点是死亡、MI和靶血管再血管化，1年时有三例支架血栓（0.9%），42例MACE(13.1%),死亡24例（7.5%），12例再发心梗（3.7%），16例靶血管再血管化（5%）。通讯作者Lee Yian-Ping 在采访中说，“该结果令人鼓舞，具有生物活性愈合的支架在致血栓疾病比如AMI中具有广阔的应用前景。我们现在看到该支架在STEMI中有良好的安全性和有效性，1年靶血管再血管化结果和DES发表的研究结果相似，同时没有安全性方面的顾虑，比如DES晚期支架血栓的问题，我们最大的该支架在AMI中的全球注册中没有发现晚期血栓。”研究者将要完成100例已经做PCI但无症状的造影随访，该研究主要确定STEMI患者EPC支架支架再狭窄模式和晚期丢失。

复杂病变中EPC捕获支架的应用

在另一个独立研究中的来自阿姆斯特丹的研究者发现EPC捕获支架（OrbusNeich，香港）有良好的1年临床结果，而不需要长期抗血小板治疗（至少一个月）。

研究入选了2005年9月至2007年3月间置入的EPC捕获支架的257例患者，236例完成一年随访。1年随访中死亡率3%（心源性死亡0.8%），MI 2.5%，靶血管再血管化9.7%，明确支架血栓1.2%，1年累积MACE 发生率11.4%。研究者之一Margo Klomp说，“我们单中心一年随访结果优异，对该组具有挑战**例包括分叉病变、多支血管病变和左主干病变中取得如此好的结果感到满意。”

EPC 捕获支架技术能降低长期二联抗血小板治疗的需要，DES置入后需要长期二联抗血小板治疗，而这种药物治疗可能增加出血的危险。Klomp说“这是个小型的研究，但结果令人鼓舞，目前正在进行的eHEALING 全球注册研究将入选大约3000例患者，将在TCT 2008和AHA年会上发布。”

（来源：www.tctmd.com）

Antibody-coated Stent Shows Promising Results at One Year 
 
By TCT Daily Staff

New stent technology that promotes accelerated endothelial healing has shown promising clinical results, raising hopes that restenosis can be avoided without increasing the risk of stent thrombosis, according to the results of two separate studies presented here.

The studies evaluated the safety and efficacy of endothelial progenitor cell-capturing stents, which are coated with an antibody that helps promote rapid endothelialization by capturing circulating endothelial progenitor cells.

Accelerated endothelialization is thought to reduce restenosis by inhibiting neointimal hyperplasia and smooth muscle cell proliferation. It may also reduce the risk of thrombosis by restoring a functional endothelial layer. In contrast, drug-eluting stents inhibit endothelialization of the stent struts.

Low complication rate in patients with acute MI

In the first study, investigators from the National University Hospital and the Tan Tock Seng Hospital in Singapore found that the use of EPC-capturing stents in patients with STEMI who underwent primary percutaneous coronary intervention had a low complication rate and good clinical outcomes. The patients received dual antiplatelet therapy for one month.

Lead investigator Tan Huay-Cheem, MD, of National University Hospital, and colleagues enrolled 321 patients with acute STEMI undergoing primary PCI between January 2005 and April 2007. All patients were implanted with the EPC-capturing stent and followed for one year.

The study endpoints were major adverse coronary events defined as death, MI, and target lesion revascularization. Researchers reported that at one year there were three reported cases of stent thrombosis (0.9%), 42 cases of MACE (13.1%), 24 deaths (7.5%), 12 recurrent MIs (3.7%), and 16 target vessel revascularizations (5%).

"The results were encouraging and set the stage for potential wider use of bioactive prohealing stents in patients with a thrombogenic milieu such as in acute [STEMI]," Lee Yian-Ping, MD, corresponding investigator of the study, said in an interview.

"We now have a stent that is shown to be safe and feasible for implantation in patients with STEMI … at one year with comparable rates of target vessel revascularization compared with published series using drug-eluting stents," Lee said. "Yet there is no safety concern, such as late stent thrombosis [found with] drug-eluting stents, with no reported incidence of late stent thrombosis in our largest world registry to date investigating the use of this stent in patients with STEMI."

The researchers are nearing completion of a follow-up study of a cohort of 100 asymptomatic patients who have undergone PCI. This study is expected to determine the late loss and patterns of in-stent restenosis with the EPC-capture stent in STEMI patients.

EPC-capturing stent in patients with complex lesions

In a separate study, researchers from Amsterdam found that patients implanted with the Genous EPC-capturing stent (OrbusNeich, Hong Kong) showed excellent clinical outcomes at 1 year and did not need long-term dual-antiplatelet therapy (although they did receive such therapy for at least one month).

The investigators treated 257 patients with coronary artery stenosis with the EPC-capturing stent between September 2005 and March 2007. Of these, 236 patients were followed for one year.

At one year, 3% of patients had died (0.8% from coronary causes), 2.5% suffered an MI, and 9.7% had target vessel revascularization; definite stent thrombosis was reported in 1.2% of cases. The cumulative rate of major adverse coronary events was 11.4% at one year.

"Our one-year follow-up single-center registry of patients treated with the EPC-capturing stent showed surprisingly good results," Margo Klomp, MD, one of the researchers from the Academic Medical Center Amsterdam, said in an interview. "We were therefore very content with the excellent findings in this challenging subset of patients with complex lesions, [including] bifurcational lesions, multivessel disease, and lesions located in the left main coronary artery."

The EPC-capturing stent technology could reduce the need for patients to be on long-term dual-antiplatelet therapy, which has been associated with increased risk of bleeding, following implantation with a drug-eluting stent, Klomp said.

"This is a small study, but results are promising. The eHEALING (Healthy EndotheliAl Lining Inhibits Neointimal Growth) worldwide registry is currently being conducted and the one-year preliminary results of approximately 3,000 patients will be presented here at TCT 2008, in part, and at the [American Heart Association meeting in November]," Klomp said.