Department of Cardiology, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
JACC Cardiovasc Interv. 2011 Aug;4(8):896-904. doi: 10.1016/j.jcin.2011.05.011.
This study sought to demonstrate the noninferiority of endothelial progenitor cell capturing stents (ECS) relative to drug-eluting stents (DES) regarding target lesion failure (TLF) and the composite of cardiac death, myocardial infarction, and target lesion repeat revascularization within 1 year.
A "pro-healing" approach for prevention of in-stent restenosis is theoretically favorable over the use of cytotoxic/cytostatic drugs released from DES to treat coronary artery disease. Promoting accelerated endothelialization of the stent, ECS have shown promising results in studies with patients carrying noncomplex lesions.
We undertook an international, clinical trial in 26 centers planning to randomize 1,300 patients with stable coronary artery disease and with a high risk of restenosis between treatment, with either ECS or DES. After a routine review with 50% of the patients enrolled, early cessation of the trial was recommended by the data and safety monitoring board when TLF in the ECS population was higher and treatment of new patients with an ECS would be unreasonable.
At 1 year evaluating 304 patients receiving ECS and 318 receiving DES, TLF occurred in 17.4% of the ECS-treated patients and in 7.0% of the DES-treated patients (p = 0.98 for noninferiority).
Within 1 year, inhibition of intimal hyperplasia by the ECS is not sufficiently strong to compete with DES in terms of restenosis prevention in patients/lesions with a high risk of restenosis. Furthermore, long-term follow-up is pivotal to fully appreciate the clinical value of ECS, including the effect on late intimal hyperplasia regression.
本研究旨在证明内皮祖细胞捕获支架（ECS）在 1 年内的靶病变失败（TLF）和心脏死亡、心肌梗死和靶病变再次血运重建的复合终点方面不劣于药物洗脱支架（DES）。
与从 DES 释放的细胞毒性/细胞抑制药物治疗冠状动脉疾病相比，预防支架内再狭窄的“促愈合”方法在理论上更有利。促进支架内皮化的加速，ECS 在携带非复杂病变的患者的研究中显示出有希望的结果。
我们在 26 个中心进行了一项国际临床试验，计划对 1300 例稳定型冠状动脉疾病且有再狭窄高风险的患者进行随机分组，分别接受 ECS 或 DES 治疗。在入组的 50%患者进行常规评估后，数据和安全监测委员会建议提前停止试验，因为 ECS 组的 TLF 更高，对新患者进行 ECS 治疗将是不合理的。
在 1 年时，对 304 例接受 ECS 治疗的患者和 318 例接受 DES 治疗的患者进行评估，ECS 治疗组的 TLF 发生率为 17.4%，DES 治疗组为 7.0%（p=0.98，非劣效性）。
在 1 年内，ECS 抑制内膜增生的作用不足以与 DES 在有再狭窄高风险的患者/病变中预防再狭窄方面竞争。此外，长期随访对于充分了解 ECS 的临床价值至关重要，包括对晚期内膜增生消退的影响。
