One‐year clinical results of the NANO registry: A multicenter, prospective all‐comers registry study in patients receiving implantation of a polymer‐free sirolimus‐eluting stent

Objectives We aimed to evaluate the safety and efficacy of Nano+™ (Lepu Medical, Beijing, China) stent implantation in all‐comer patients at the 1‐year follow‐up. Background The Nano+™ stent is a novel polymer‐free sirolimus‐eluting stent polymer that employs nanoporous stent surface technology to c...

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Veröffentlicht in:Catheterization and cardiovascular interventions 2020-02, Vol.95 (S1), p.658-664
Hauptverfasser: Liu, Yi, Zhang, Yaojun, Li, Yue, Qi, Tianjun, Pan, Defeng, Wang, Haichang, Liu, Changhui, Ma, Dengfeng, Fang, Zhenfei, Zhang, Ruining, Mou, Fangjun, Tao, Ling
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container_issue S1
container_start_page 658
container_title Catheterization and cardiovascular interventions
container_volume 95
creator Liu, Yi
Zhang, Yaojun
Li, Yue
Qi, Tianjun
Pan, Defeng
Wang, Haichang
Liu, Changhui
Ma, Dengfeng
Fang, Zhenfei
Zhang, Ruining
Mou, Fangjun
Tao, Ling
description Objectives We aimed to evaluate the safety and efficacy of Nano+™ (Lepu Medical, Beijing, China) stent implantation in all‐comer patients at the 1‐year follow‐up. Background The Nano+™ stent is a novel polymer‐free sirolimus‐eluting stent polymer that employs nanoporous stent surface technology to control drug‐delivery. The Nano+™ stent is one of the most widely used drug‐eluting stent (DES) in China. Methods A total of 2,481 consecutive patients were included in the multicenter and prospective NANO registry. In this study, the primary endpoint was target lesion failure (TLF) at 1‐year follow‐up, defined as a composite of cardiac death, target vessel nonfatal myocardial infarction (TV‐MI), and clinically driven target lesion revascularization (TLR). The safety endpoint was the occurrence of definite or probable stent thrombosis (ST). Results Up to 40.2% of patients presented with acute myocardial infarction (AMI). A total of 63.9% of the 2,904 lesions were American College of Cardiology/American Heart Association (ACC/AHA) type B2 or C lesions. One‐year follow‐up data were available for 98.4% of patients. The 1‐year rate of TLF was 3.1% with rates of 1.3, 1.8, and 0.4% for clinically driven TLR, cardiac death, and TV‐MI, respectively. ST occurred in 0.4% of patients. Diabetes mellitus, AMI, left ventricular ejection fraction 40 mm) were independent predictors of 1‐year TLF. Conclusions The 1‐year clinical outcomes were excellent for Nano+™ polymer‐free SES implantation in an all‐comer patient population. Follow‐up will be extended up to 5 years, to further elucidate the potential long‐term clinical benefits. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02929030.
doi_str_mv 10.1002/ccd.28734
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Background The Nano+™ stent is a novel polymer‐free sirolimus‐eluting stent polymer that employs nanoporous stent surface technology to control drug‐delivery. The Nano+™ stent is one of the most widely used drug‐eluting stent (DES) in China. Methods A total of 2,481 consecutive patients were included in the multicenter and prospective NANO registry. In this study, the primary endpoint was target lesion failure (TLF) at 1‐year follow‐up, defined as a composite of cardiac death, target vessel nonfatal myocardial infarction (TV‐MI), and clinically driven target lesion revascularization (TLR). The safety endpoint was the occurrence of definite or probable stent thrombosis (ST). Results Up to 40.2% of patients presented with acute myocardial infarction (AMI). A total of 63.9% of the 2,904 lesions were American College of Cardiology/American Heart Association (ACC/AHA) type B2 or C lesions. One‐year follow‐up data were available for 98.4% of patients. The 1‐year rate of TLF was 3.1% with rates of 1.3, 1.8, and 0.4% for clinically driven TLR, cardiac death, and TV‐MI, respectively. ST occurred in 0.4% of patients. Diabetes mellitus, AMI, left ventricular ejection fraction &lt;40% and long lesions (&gt;40 mm) were independent predictors of 1‐year TLF. Conclusions The 1‐year clinical outcomes were excellent for Nano+™ polymer‐free SES implantation in an all‐comer patient population. Follow‐up will be extended up to 5 years, to further elucidate the potential long‐term clinical benefits. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02929030.</description><identifier>ISSN: 1522-1946</identifier><identifier>EISSN: 1522-726X</identifier><identifier>DOI: 10.1002/ccd.28734</identifier><identifier>PMID: 31961057</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley &amp; Sons, Inc</publisher><subject>Aged ; all‐comer population ; Cardiovascular Agents - administration &amp; dosage ; Cardiovascular Agents - adverse effects ; China ; Coronary Artery Disease - diagnostic imaging ; Coronary Artery Disease - mortality ; Coronary Artery Disease - therapy ; Diabetes mellitus ; Drug-Eluting Stents ; Female ; Heart ; Heart attacks ; Humans ; Implants ; Lesions ; Male ; Middle Aged ; Myocardial infarction ; Nanopores ; Patients ; Percutaneous Coronary Intervention - adverse effects ; Percutaneous Coronary Intervention - instrumentation ; Percutaneous Coronary Intervention - mortality ; percutaneous coronary interventions ; Polymers ; polymer‐free drug‐eluting stent ; Prospective Studies ; Prosthesis Design ; Rapamycin ; Registries ; Sirolimus - administration &amp; dosage ; Sirolimus - adverse effects ; Stents ; Surface Properties ; target lesion failure ; Thrombosis ; Time Factors ; Treatment Outcome ; Ventricle</subject><ispartof>Catheterization and cardiovascular interventions, 2020-02, Vol.95 (S1), p.658-664</ispartof><rights>2020 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3534-8efb934af6d98fa7b05796b62d58d00e0664184a851db6b5e1b1aa6db521ab133</citedby><cites>FETCH-LOGICAL-c3534-8efb934af6d98fa7b05796b62d58d00e0664184a851db6b5e1b1aa6db521ab133</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fccd.28734$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fccd.28734$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,777,781,1412,27905,27906,45555,45556</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31961057$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Liu, Yi</creatorcontrib><creatorcontrib>Zhang, Yaojun</creatorcontrib><creatorcontrib>Li, Yue</creatorcontrib><creatorcontrib>Qi, Tianjun</creatorcontrib><creatorcontrib>Pan, Defeng</creatorcontrib><creatorcontrib>Wang, Haichang</creatorcontrib><creatorcontrib>Liu, Changhui</creatorcontrib><creatorcontrib>Ma, Dengfeng</creatorcontrib><creatorcontrib>Fang, Zhenfei</creatorcontrib><creatorcontrib>Zhang, Ruining</creatorcontrib><creatorcontrib>Mou, Fangjun</creatorcontrib><creatorcontrib>Tao, Ling</creatorcontrib><creatorcontrib>NANO All-Comers Registry Investigators</creatorcontrib><creatorcontrib>On Behalf of the NANO All‐Comers Registry Investigators</creatorcontrib><title>One‐year clinical results of the NANO registry: A multicenter, prospective all‐comers registry study in patients receiving implantation of a polymer‐free sirolimus‐eluting stent</title><title>Catheterization and cardiovascular interventions</title><addtitle>Catheter Cardiovasc Interv</addtitle><description>Objectives We aimed to evaluate the safety and efficacy of Nano+™ (Lepu Medical, Beijing, China) stent implantation in all‐comer patients at the 1‐year follow‐up. Background The Nano+™ stent is a novel polymer‐free sirolimus‐eluting stent polymer that employs nanoporous stent surface technology to control drug‐delivery. The Nano+™ stent is one of the most widely used drug‐eluting stent (DES) in China. Methods A total of 2,481 consecutive patients were included in the multicenter and prospective NANO registry. In this study, the primary endpoint was target lesion failure (TLF) at 1‐year follow‐up, defined as a composite of cardiac death, target vessel nonfatal myocardial infarction (TV‐MI), and clinically driven target lesion revascularization (TLR). The safety endpoint was the occurrence of definite or probable stent thrombosis (ST). Results Up to 40.2% of patients presented with acute myocardial infarction (AMI). A total of 63.9% of the 2,904 lesions were American College of Cardiology/American Heart Association (ACC/AHA) type B2 or C lesions. One‐year follow‐up data were available for 98.4% of patients. The 1‐year rate of TLF was 3.1% with rates of 1.3, 1.8, and 0.4% for clinically driven TLR, cardiac death, and TV‐MI, respectively. ST occurred in 0.4% of patients. Diabetes mellitus, AMI, left ventricular ejection fraction &lt;40% and long lesions (&gt;40 mm) were independent predictors of 1‐year TLF. Conclusions The 1‐year clinical outcomes were excellent for Nano+™ polymer‐free SES implantation in an all‐comer patient population. Follow‐up will be extended up to 5 years, to further elucidate the potential long‐term clinical benefits. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02929030.</description><subject>Aged</subject><subject>all‐comer population</subject><subject>Cardiovascular Agents - administration &amp; dosage</subject><subject>Cardiovascular Agents - adverse effects</subject><subject>China</subject><subject>Coronary Artery Disease - diagnostic imaging</subject><subject>Coronary Artery Disease - mortality</subject><subject>Coronary Artery Disease - therapy</subject><subject>Diabetes mellitus</subject><subject>Drug-Eluting Stents</subject><subject>Female</subject><subject>Heart</subject><subject>Heart attacks</subject><subject>Humans</subject><subject>Implants</subject><subject>Lesions</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myocardial infarction</subject><subject>Nanopores</subject><subject>Patients</subject><subject>Percutaneous Coronary Intervention - adverse effects</subject><subject>Percutaneous Coronary Intervention - instrumentation</subject><subject>Percutaneous Coronary Intervention - mortality</subject><subject>percutaneous coronary interventions</subject><subject>Polymers</subject><subject>polymer‐free drug‐eluting stent</subject><subject>Prospective Studies</subject><subject>Prosthesis Design</subject><subject>Rapamycin</subject><subject>Registries</subject><subject>Sirolimus - administration &amp; dosage</subject><subject>Sirolimus - adverse effects</subject><subject>Stents</subject><subject>Surface Properties</subject><subject>target lesion failure</subject><subject>Thrombosis</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Ventricle</subject><issn>1522-1946</issn><issn>1522-726X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc9O3DAQxi1UBBQ48AKVpZ6QumA7iZNwWy20ICH2AhK3yHYm1Mj5g-2AcuMR-jq8Dk_SWXbLrSdbM9_3G818hBxxdsIZE6fG1CeiyJN0i-zxTIhZLuT9l82fl6ncJV9DeGSMlVKUO2Q34aXkLMv3yNuyg_fXPxMoT42znTXKUQ9hdDHQvqHxN9Cb-c0Saw82RD-d0TltsWsNdBH8Dzr4Pgxgon0GqpxDmOlb8OHTQUMc64najg4qWnStWgbss-0eqG0Hp7qIjb5bzVN06N2EfuQ0HoAG63tn2zFgAdwYV6YQkXJAthvlAhxu3n1y9_PidnE5u17-ulrMr2cmyZJ0VkCjyyRVjazLolG5xrVLqaWos6JmDJiUKS9SVWS81lJnwDVXStY6E1xpniT75Puai4s-jRBi9diPvsORlUhykUqecoaq47XK4DmCh6YavG2VnyrOqlVIFYZUfYSE2m8b4qhbqD-V_1JBwela8GIdTP8nVYvF-Rr5F0KBo_U</recordid><startdate>20200201</startdate><enddate>20200201</enddate><creator>Liu, Yi</creator><creator>Zhang, Yaojun</creator><creator>Li, Yue</creator><creator>Qi, Tianjun</creator><creator>Pan, Defeng</creator><creator>Wang, Haichang</creator><creator>Liu, Changhui</creator><creator>Ma, Dengfeng</creator><creator>Fang, Zhenfei</creator><creator>Zhang, Ruining</creator><creator>Mou, Fangjun</creator><creator>Tao, Ling</creator><general>John Wiley &amp; 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dosage</topic><topic>Cardiovascular Agents - adverse effects</topic><topic>China</topic><topic>Coronary Artery Disease - diagnostic imaging</topic><topic>Coronary Artery Disease - mortality</topic><topic>Coronary Artery Disease - therapy</topic><topic>Diabetes mellitus</topic><topic>Drug-Eluting Stents</topic><topic>Female</topic><topic>Heart</topic><topic>Heart attacks</topic><topic>Humans</topic><topic>Implants</topic><topic>Lesions</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Myocardial infarction</topic><topic>Nanopores</topic><topic>Patients</topic><topic>Percutaneous Coronary Intervention - adverse effects</topic><topic>Percutaneous Coronary Intervention - instrumentation</topic><topic>Percutaneous Coronary Intervention - mortality</topic><topic>percutaneous coronary interventions</topic><topic>Polymers</topic><topic>polymer‐free drug‐eluting stent</topic><topic>Prospective Studies</topic><topic>Prosthesis Design</topic><topic>Rapamycin</topic><topic>Registries</topic><topic>Sirolimus - administration &amp; dosage</topic><topic>Sirolimus - adverse effects</topic><topic>Stents</topic><topic>Surface Properties</topic><topic>target lesion failure</topic><topic>Thrombosis</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Ventricle</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Liu, Yi</creatorcontrib><creatorcontrib>Zhang, Yaojun</creatorcontrib><creatorcontrib>Li, Yue</creatorcontrib><creatorcontrib>Qi, Tianjun</creatorcontrib><creatorcontrib>Pan, Defeng</creatorcontrib><creatorcontrib>Wang, Haichang</creatorcontrib><creatorcontrib>Liu, Changhui</creatorcontrib><creatorcontrib>Ma, Dengfeng</creatorcontrib><creatorcontrib>Fang, Zhenfei</creatorcontrib><creatorcontrib>Zhang, Ruining</creatorcontrib><creatorcontrib>Mou, Fangjun</creatorcontrib><creatorcontrib>Tao, Ling</creatorcontrib><creatorcontrib>NANO All-Comers Registry Investigators</creatorcontrib><creatorcontrib>On Behalf of the NANO All‐Comers Registry Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><jtitle>Catheterization and cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Liu, Yi</au><au>Zhang, Yaojun</au><au>Li, Yue</au><au>Qi, Tianjun</au><au>Pan, Defeng</au><au>Wang, Haichang</au><au>Liu, Changhui</au><au>Ma, Dengfeng</au><au>Fang, Zhenfei</au><au>Zhang, Ruining</au><au>Mou, Fangjun</au><au>Tao, Ling</au><aucorp>NANO All-Comers Registry Investigators</aucorp><aucorp>On Behalf of the NANO All‐Comers Registry Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>One‐year clinical results of the NANO registry: A multicenter, prospective all‐comers registry study in patients receiving implantation of a polymer‐free sirolimus‐eluting stent</atitle><jtitle>Catheterization and cardiovascular interventions</jtitle><addtitle>Catheter Cardiovasc Interv</addtitle><date>2020-02-01</date><risdate>2020</risdate><volume>95</volume><issue>S1</issue><spage>658</spage><epage>664</epage><pages>658-664</pages><issn>1522-1946</issn><eissn>1522-726X</eissn><abstract>Objectives We aimed to evaluate the safety and efficacy of Nano+™ (Lepu Medical, Beijing, China) stent implantation in all‐comer patients at the 1‐year follow‐up. Background The Nano+™ stent is a novel polymer‐free sirolimus‐eluting stent polymer that employs nanoporous stent surface technology to control drug‐delivery. The Nano+™ stent is one of the most widely used drug‐eluting stent (DES) in China. Methods A total of 2,481 consecutive patients were included in the multicenter and prospective NANO registry. In this study, the primary endpoint was target lesion failure (TLF) at 1‐year follow‐up, defined as a composite of cardiac death, target vessel nonfatal myocardial infarction (TV‐MI), and clinically driven target lesion revascularization (TLR). The safety endpoint was the occurrence of definite or probable stent thrombosis (ST). Results Up to 40.2% of patients presented with acute myocardial infarction (AMI). A total of 63.9% of the 2,904 lesions were American College of Cardiology/American Heart Association (ACC/AHA) type B2 or C lesions. One‐year follow‐up data were available for 98.4% of patients. The 1‐year rate of TLF was 3.1% with rates of 1.3, 1.8, and 0.4% for clinically driven TLR, cardiac death, and TV‐MI, respectively. ST occurred in 0.4% of patients. Diabetes mellitus, AMI, left ventricular ejection fraction &lt;40% and long lesions (&gt;40 mm) were independent predictors of 1‐year TLF. Conclusions The 1‐year clinical outcomes were excellent for Nano+™ polymer‐free SES implantation in an all‐comer patient population. Follow‐up will be extended up to 5 years, to further elucidate the potential long‐term clinical benefits. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02929030.</abstract><cop>Hoboken, USA</cop><pub>John Wiley &amp; Sons, Inc</pub><pmid>31961057</pmid><doi>10.1002/ccd.28734</doi><tpages>7</tpages></addata></record>
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subjects Aged
all‐comer population
Cardiovascular Agents - administration & dosage
Cardiovascular Agents - adverse effects
China
Coronary Artery Disease - diagnostic imaging
Coronary Artery Disease - mortality
Coronary Artery Disease - therapy
Diabetes mellitus
Drug-Eluting Stents
Female
Heart
Heart attacks
Humans
Implants
Lesions
Male
Middle Aged
Myocardial infarction
Nanopores
Patients
Percutaneous Coronary Intervention - adverse effects
Percutaneous Coronary Intervention - instrumentation
Percutaneous Coronary Intervention - mortality
percutaneous coronary interventions
Polymers
polymer‐free drug‐eluting stent
Prospective Studies
Prosthesis Design
Rapamycin
Registries
Sirolimus - administration & dosage
Sirolimus - adverse effects
Stents
Surface Properties
target lesion failure
Thrombosis
Time Factors
Treatment Outcome
Ventricle
title One‐year clinical results of the NANO registry: A multicenter, prospective all‐comers registry study in patients receiving implantation of a polymer‐free sirolimus‐eluting stent
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