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

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...

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Veröffentlicht in:Chinese medical journal 2014, Vol.127 (11), p.2153-2158
Hauptverfasser: 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
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container_end_page 2158
container_issue 11
container_start_page 2153
container_title Chinese medical journal
container_volume 127
creator 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
description 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.
doi_str_mv 10.3760/cma.j.issn.0366-6999.20133148
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Ltd. All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c437t-b59271816a3160d9da2c0cfe0fd73bebc411ddd6fba685d44556a0b9f7d3d7893</citedby><cites>FETCH-LOGICAL-c437t-b59271816a3160d9da2c0cfe0fd73bebc411ddd6fba685d44556a0b9f7d3d7893</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Uhttp://image.cqvip.com/vip1000/qk/85656X/85656X.jpg</thumbnail><link.rule.ids>314,776,780,860,4010,27900,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24890170$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zhang, Yaojun</creatorcontrib><creatorcontrib>Chen, Fang</creatorcontrib><creatorcontrib>Muramatsu, Takashi</creatorcontrib><creatorcontrib>Xu, Bo</creatorcontrib><creatorcontrib>Li, Zhanquan</creatorcontrib><creatorcontrib>Ge, Junbo</creatorcontrib><creatorcontrib>He, Qing</creatorcontrib><creatorcontrib>Yang, Zhijian</creatorcontrib><creatorcontrib>Li, Shumei</creatorcontrib><creatorcontrib>Wang, Lefeng</creatorcontrib><creatorcontrib>Wang, Haichang</creatorcontrib><creatorcontrib>He, Ben</creatorcontrib><creatorcontrib>Li, Kang</creatorcontrib><creatorcontrib>Qi, Guoxian</creatorcontrib><creatorcontrib>Li, Tianchang</creatorcontrib><creatorcontrib>Zeng, Hesong</creatorcontrib><creatorcontrib>Peng, Jianjun</creatorcontrib><creatorcontrib>Jiang, Tieming</creatorcontrib><creatorcontrib>Zeng, Qiutang</creatorcontrib><creatorcontrib>Zhu, Jianhua</creatorcontrib><creatorcontrib>Fu, Guosheng</creatorcontrib><creatorcontrib>Bourantas, Christos V</creatorcontrib><creatorcontrib>Serruys, Patrick W</creatorcontrib><creatorcontrib>Huo, Yong</creatorcontrib><title>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</title><title>Chinese medical journal</title><addtitle>Chinese Medical Journal</addtitle><description>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.</description><subject>Aged</subject><subject>Coronary Artery Disease - drug therapy</subject><subject>Coronary Artery Disease - surgery</subject><subject>Drug-Eluting Stents</subject><subject>Female</subject><subject>Humans</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Sirolimus - therapeutic use</subject><subject>临床表现</subject><subject>冠状动脉疾病</subject><subject>支架</subject><subject>洗脱</subject><subject>纳米聚合物</subject><subject>聚合物涂层</subject><subject>随机试验</subject><subject>雷帕霉素</subject><issn>0366-6999</issn><issn>2542-5641</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1ks9uEzEQh1cIRNPCKyBzAPXixV7veuMDB1TxT6rKBc6W1x4njrx2au8SpY_Cs3DncXgFHCXNjdPI0jfzG83nqnpDSc16Tt7pUdWb2uUcasI4x1wIUTeEMkbb5ZNq0XRtgzve0qfV4gxcVJc5bwhpuq7nz6uLpl0KQnuyqP7cuQB4jGFaIxVWLq6S2q6dLg-Dpl3Ee1AJae-C08ojG72POzxvUbRoG_1-hIRtAkDZpejdOGcMfp5cWKE8QZjQT0h5zsjMSQ0e8Knnv7iNJS2mGFTaI5UmKMW4DCrD39-_0LQGdKdCRKnsF0f3AGXL5JR_UT2zymd4eapX1Y9PH7_ffMG33z5_vflwi3XL-gkPnWh6uqRcMcqJEUY1mmgLxJqeDTDollJjDLeD4svOtG3XcUUGYXvDTL8U7Kp6e5y7U8GWg8lNnFMoifJhrcdNEVEmEEYKeH0Etynez5AnObqswXsVIM5Z0o4VC0VCU9D3R1SnmHMCK7fJjeUAkhJ5kC6LdLmRB-ny4FQenMpH6aX_1SlqHkYw5-5HywV4fQpYx7C6L9c-M60QXJRvwf4BaBq-yA</recordid><startdate>2014</startdate><enddate>2014</enddate><creator>Zhang, Yaojun</creator><creator>Chen, Fang</creator><creator>Muramatsu, Takashi</creator><creator>Xu, Bo</creator><creator>Li, Zhanquan</creator><creator>Ge, Junbo</creator><creator>He, Qing</creator><creator>Yang, Zhijian</creator><creator>Li, Shumei</creator><creator>Wang, Lefeng</creator><creator>Wang, Haichang</creator><creator>He, Ben</creator><creator>Li, Kang</creator><creator>Qi, Guoxian</creator><creator>Li, Tianchang</creator><creator>Zeng, Hesong</creator><creator>Peng, Jianjun</creator><creator>Jiang, Tieming</creator><creator>Zeng, Qiutang</creator><creator>Zhu, Jianhua</creator><creator>Fu, Guosheng</creator><creator>Bourantas, Christos V</creator><creator>Serruys, Patrick W</creator><creator>Huo, Yong</creator><general>Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China</general><general>Thoraxcenter, Erasmus Medical Center, Rotterdam, 3015CE, The Netherlands%Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China%Thoraxcenter, Erasmus Medical Center, Rotterdam, 3015CE, The Netherlands%Department of Cardiology, Beijing Fuwai Hospital, Beijing 100037, China%Department of Cardiology, Liaoning Provincial People's Hospital, Shenyang, Liaoning 110016, China%Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China%Department of Cardiology, Beijing Hospital, Beijing 100730, China</general><scope>2RA</scope><scope>92L</scope><scope>CQIGP</scope><scope>W91</scope><scope>~WA</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>2B.</scope><scope>4A8</scope><scope>92I</scope><scope>93N</scope><scope>PSX</scope><scope>TCJ</scope></search><sort><creationdate>2014</creationdate><title>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</title><author>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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c437t-b59271816a3160d9da2c0cfe0fd73bebc411ddd6fba685d44556a0b9f7d3d7893</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Aged</topic><topic>Coronary Artery Disease - drug therapy</topic><topic>Coronary Artery Disease - surgery</topic><topic>Drug-Eluting Stents</topic><topic>Female</topic><topic>Humans</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Sirolimus - therapeutic use</topic><topic>临床表现</topic><topic>冠状动脉疾病</topic><topic>支架</topic><topic>洗脱</topic><topic>纳米聚合物</topic><topic>聚合物涂层</topic><topic>随机试验</topic><topic>雷帕霉素</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhang, Yaojun</creatorcontrib><creatorcontrib>Chen, Fang</creatorcontrib><creatorcontrib>Muramatsu, Takashi</creatorcontrib><creatorcontrib>Xu, Bo</creatorcontrib><creatorcontrib>Li, Zhanquan</creatorcontrib><creatorcontrib>Ge, Junbo</creatorcontrib><creatorcontrib>He, Qing</creatorcontrib><creatorcontrib>Yang, Zhijian</creatorcontrib><creatorcontrib>Li, Shumei</creatorcontrib><creatorcontrib>Wang, Lefeng</creatorcontrib><creatorcontrib>Wang, Haichang</creatorcontrib><creatorcontrib>He, Ben</creatorcontrib><creatorcontrib>Li, Kang</creatorcontrib><creatorcontrib>Qi, Guoxian</creatorcontrib><creatorcontrib>Li, Tianchang</creatorcontrib><creatorcontrib>Zeng, Hesong</creatorcontrib><creatorcontrib>Peng, Jianjun</creatorcontrib><creatorcontrib>Jiang, Tieming</creatorcontrib><creatorcontrib>Zeng, Qiutang</creatorcontrib><creatorcontrib>Zhu, Jianhua</creatorcontrib><creatorcontrib>Fu, Guosheng</creatorcontrib><creatorcontrib>Bourantas, Christos V</creatorcontrib><creatorcontrib>Serruys, Patrick W</creatorcontrib><creatorcontrib>Huo, Yong</creatorcontrib><collection>中文科技期刊数据库</collection><collection>中文科技期刊数据库-CALIS站点</collection><collection>中文科技期刊数据库-7.0平台</collection><collection>中文科技期刊数据库-医药卫生</collection><collection>中文科技期刊数据库- 镜像站点</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Wanfang Data Journals - Hong Kong</collection><collection>WANFANG Data Centre</collection><collection>Wanfang Data Journals</collection><collection>万方数据期刊 - 香港版</collection><collection>China Online Journals (COJ)</collection><collection>China Online Journals (COJ)</collection><jtitle>Chinese medical journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhang, Yaojun</au><au>Chen, Fang</au><au>Muramatsu, Takashi</au><au>Xu, Bo</au><au>Li, Zhanquan</au><au>Ge, Junbo</au><au>He, Qing</au><au>Yang, Zhijian</au><au>Li, Shumei</au><au>Wang, Lefeng</au><au>Wang, Haichang</au><au>He, Ben</au><au>Li, Kang</au><au>Qi, Guoxian</au><au>Li, Tianchang</au><au>Zeng, Hesong</au><au>Peng, Jianjun</au><au>Jiang, Tieming</au><au>Zeng, Qiutang</au><au>Zhu, Jianhua</au><au>Fu, Guosheng</au><au>Bourantas, Christos V</au><au>Serruys, Patrick W</au><au>Huo, Yong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Chinese medical journal</jtitle><addtitle>Chinese Medical Journal</addtitle><date>2014</date><risdate>2014</risdate><volume>127</volume><issue>11</issue><spage>2153</spage><epage>2158</epage><pages>2153-2158</pages><issn>0366-6999</issn><eissn>2542-5641</eissn><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.</abstract><cop>China</cop><pub>Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China</pub><pmid>24890170</pmid><doi>10.3760/cma.j.issn.0366-6999.20133148</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record>
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subjects Aged
Coronary Artery Disease - drug therapy
Coronary Artery Disease - surgery
Drug-Eluting Stents
Female
Humans
Immunosuppressive Agents - therapeutic use
Male
Middle Aged
Prospective Studies
Sirolimus - therapeutic use
临床表现
冠状动脉疾病
支架
洗脱
纳米聚合物
聚合物涂层
随机试验
雷帕霉素
title 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
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