无聚合物西罗莫司洗脱支架与耐用聚合物西罗莫司洗脱支架治疗冠状动脉疾病的9个月血管造影和2年临床随访：Nano随机试验

Nine-month angiographic and two-year clinical follow-up of polymer-free sirolimus-eluting stent versus durable-polymer sirolimus-eluting stent for coronary artery disease: the Nano randomized trial.

作者信息

Zhang Yaojun, Chen Fang, Muramatsu Takashi, Xu Bo, Li Zhanquan, Ge Junbo, He Qing, Yang Zhijian, Li Shumei, Wang Lefeng, Wang Haichang, He Ben, Li Kang, Qi Guoxian, Li Tianchang, Zeng Hesong, Peng Jianjun, Jiang Tieming, Zeng Qiutang, Zhu Jianhua, Fu Guosheng, Bourantas Christos V, Serruys Patrick W, Huo Yong

机构信息

Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.

出版信息

Chin Med J (Engl). 2014;127(11):2153-8.

PMID:24890170

Abstract

BACKGROUND

First generation drug-eluting stents (DES) were associated with a high incidence of late stent thrombosis (ST), mainly due to delayed healing and re-endothelization by the durable polymer coating. This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent (SES) in the treatment of patients with de novo coronary artery lesions.

METHODS

The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES (Lepu Medical Technology, Beijing, China) in the treatment of patients with de novo native coronary lesions. The primary endpoint was in-stent late lumen loss (LLL) at 9-month follow-up. The secondary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction or target lesion revascularization.

RESULTS

A total of 291 patients (Nano group: n = 143, Partner group: n = 148) were enrolled in this trial from 19 Chinese centers. The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months (P < 0.001). The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES (0.34 ± 0.42) mm vs. (0.30 ± 0.48) mm, P = 0.21). The incidence of MACE in the Nano group were 7.6% compared to the Partner group of 5.9% (P = 0.75) at 2 years follow-up. The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES (0.8% vs. 0.7%, 0.8% vs. 1.5%, both P = 1.00).

CONCLUSIONS

In this multicenter randomized Nano trial, the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions. Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES.

摘要

背景

第一代药物洗脱支架（DES）与晚期支架血栓形成（ST）的高发生率相关，主要原因是耐用聚合物涂层导致愈合延迟和再内皮化延迟。本研究旨在评估无纳米聚合物的西罗莫司洗脱支架（SES）治疗初发冠状动脉病变患者的安全性和有效性。

方法

纳米试验是第一项随机试验，旨在比较无纳米聚合物的SES与Partner耐用聚合物SES（中国北京乐普医疗科技）治疗初发天然冠状动脉病变患者的安全性和有效性。主要终点是9个月随访时的支架内晚期管腔丢失（LLL）。次要终点是主要不良心脏事件（MACE），即心脏死亡、心肌梗死或靶病变血运重建的综合指标。

结果

本试验从19个中国中心共纳入291例患者（纳米组：n = 143，Partner组：n = 148）。在9个月的主要终点方面，无纳米聚合物的SES不劣于Partner耐用聚合物DES（P < 0.001）。无聚合物的纳米SES的9个月节段内LLL与Partner SES相当（分别为0.34±0.42）mm和（0.30±0.48）mm，P = 0.21）。在2年随访时，纳米组的MACE发生率为7.6%，而Partner组为5.9%（P = 0.75）。纳米和Partner SES的心脏死亡和支架血栓形成频率均较低（分别为0.8%对0.7%，0.8%对1.5%，P均 = 1.00）。