TRIAS HR Pilot Trial: Genous EPC-capturing Stent Feasible

　　
　　Genous支架和Taxus支架治疗再狭窄高危病变的6个月的临床结果相似。

　　最新试验

　　TRIAS HR Pilot研究的6个月临床和造影结果显示Genous内皮祖细胞捕获支架可能是冠状动脉狭窄和再狭窄高危病变的可行的治疗选择。

　　来自荷兰阿姆斯特丹大学的Robbert J. deWinter医生报告TRIALS HR初步研究结果表明：Genous（业聚公司）和Taxus（波士顿公司）支架比较，6个月的临床和造影结果没有统计学差别。根据小样本量初步研究的结果，将进行一项大规模多中心临床试验。

　　根据Robbert J. deWinter 医生所言，Genous支架利用内皮祖细胞捕获技术和加速内皮化过程。能加速支架置入后的愈合过程，抗血栓形成并使再狭窄的可能性最小化，较目前的药物洗脱支架有更好的安全性资料。（图1）

　　初步研究资料

　　6个月的临床结果包括死亡、心肌梗死、再次介入治疗、冠状动脉旁路搭桥和靶血管失败两组间相似。对于再狭窄高危病变也没有明显差别。（图2）

　　支架置入6个月随访，Genous组有44%患者在服用氯吡格雷，而Taxus组为73%。两组的绝大多数患者未发生心绞痛。需要非靶血管再次重建Taxus组和Genous组分别为14%和3.2%。TRIAS HR Pilot研究的总的随访时间为5年。

　　严格评价

　　来自Royal Oak的William Beaumont医院的心导管与介入心脏病学培训计划主任Cindy L. Grines医生对TRIAS HR Pilot研究进行了严格的评价。他认为总的来说，初步研究结果是令人鼓舞的，与药物洗脱支架相比，内皮祖细胞捕获支架具有以下几个潜在的益处：可快速在支架表面覆盖正常内皮组织，需要更短的服用氯吡格雷时间，可降低费用和出血，同样也降低支架血栓的危险。但是Cindy L. Grines医生也提出对该研究存在的担忧：Genous支架几乎无糖尿病患者使用，而用于直径≥2.8mm的多支血管病变，并且该研究不是采用盲法且样本量较小。

 　　(北京安贞医院　乔岩　阜外心血管病医院　高立建　编译)

TRIAS HR Pilot Trial: Genous EPC-capturing Stent Feasible

Six-month clinical outcomes were similar between Genous and Taxus for treatment of high-risk restenosis lesions.

Six-month clinical and angiographic outcomes from the TRIAS HR Pilot Study suggest that the Genous endothelial progenitor cell-capturing stent may be a practical option for treating coronary artery stenosis and lesions at high risk for restenosis.

Robbert J. deWinter, MD, PhD, presented pilot data that compared the Genous stent (OrbusNeich) with the Taxus stent (Boston Scientific). No differences between the two were statistically significant. The underpowered pilot study will be followed by a larger, multicenter trial.

The Genous stent uses EPC-capturing technology and enhances endothelialization, according to
deWinter, of the University of Amsterdam in The Netherlands. The technology produces accelerated healing, protects against thrombus, minimizes restenosis, and has an improved safety profile over current DES, he said (Figure 1).

Pilot data

At 6 months, clinical outcomes including death, MI, repeat PCI, CABG and TVF were similar between groups (Figure 2).

Outcomes for high-risk restenosis lesions were also similar between the two stents, deWinter said.

Forty-four percent of patients who received the Genous stent were taking clopidogrel at 6 months compared with 73% who received the Taxus stent. Most patients in both groups reported no angina.

Fourteen percent of patients treated with Taxus required repeat non-TVR compared with 3.2% of patients treated with the Genous stent.

Total follow-up for the TRIAS HR Pilot Study is 5 years.

Critical appraisal

Cindy L. Grines, MD, director, Cardiac Cath Laboratories and Interventional Cardiology Fellowship Program at William Beaumont Hospital in Royal Oak, Mich., presented a critical appraisal of the TRIAS HR Pilot Study.

Overall, the pilot data are promising, Grines said. Compared with DES, the EPC-capturing stent offers several potential benefits: It quickly establishes normal endothelium, requires a shorter duration of clopidogrel therapy, may reduce cost as well as bleeding, and seems to decrease the risk of stent thrombosis.

Grines voiced several concerns about the trial including the fact that the Genous stent was used in fewer patients with diabetes, was employed in more vessels that were 2.8 mm or greater, and that the study was not blinded and had a small sample size.