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

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.

Author information

  • 1Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.
  • 2Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.
  • 3Thoraxcenter, Erasmus Medical Center, Rotterdam, 3015CE, The Netherlands.
  • 4Department of Cardiology, Beijing Fuwai Hospital, Beijing 100037, China.
  • 5Department of Cardiology, Liaoning Provincial People's Hospital, Shenyang, Liaoning 110016, China.
  • 6Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
  • 7Department of Cardiology, Beijing Hospital, Beijing 100730, China.
  • 8Department of Cardiology, Jiangsu Provincial People's Hospital, Nanjing, Jiangsu 210029, China.
  • 9Department of Cardiology, Second Affiliated Hospital of Jilin University Changchun, Jilin, Jilin 130041, China.
  • 10Department of Cardiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
  • 11Department of Cardiology, Xijing Hospital, The Fourth Military Medical University, Xi'an, Shanxi 710032, China.
  • 12Department of Cardiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China.
  • 13Department of Cardiology, Beijing Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
  • 14Department of Cardiology, First Affiliated Hospital of China Medical University, Shenyang, Liaoning 110001, China.
  • 15Department of Cardiology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.
  • 16Department of Cardiology, Affiliated Tongji Hospital, Huazhong University of Science and Technology, Tongji School of Medicine, Wuhan, Hubei 430032, China.
  • 17Department of Cardiology, Beijing Millennium Monument Hospital, Capital Medical University, Beijing 100038, China.
  • 18Department of Cardiology, Tianjin Armed Policemen Hospital, Tianjin 300162, China.
  • 19Department of Cardiology, Affiliated Union Medical Hospital of Huazhong University of Science and Technology, Tongji School of Medicine, Wuhan, Hubei 430022, China.
  • 20Department of Cardiology, First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang 310003, China.
  • 21Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310016, China.
  • 22Department of Cardiology, Peking University First Hospital, Beijing 100034, China. Email: huoyong@263.net.cn.

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.

PMID:
24890170
[PubMed - indexed for MEDLINE]
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