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 |
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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 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_2372461410</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2372461410</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3534-8efb934af6d98fa7b05796b62d58d00e0664184a851db6b5e1b1aa6db521ab133</originalsourceid><addsrcrecordid>eNp1kc9O3DAQxi1UBBQ48AKVpZ6QumA7iZNwWy20ICH2AhK3yHYm1Mj5g-2AcuMR-jq8Dk_SWXbLrSdbM9_3G818hBxxdsIZE6fG1CeiyJN0i-zxTIhZLuT9l82fl6ncJV9DeGSMlVKUO2Q34aXkLMv3yNuyg_fXPxMoT42znTXKUQ9hdDHQvqHxN9Cb-c0Saw82RD-d0TltsWsNdBH8Dzr4Pgxgon0GqpxDmOlb8OHTQUMc64najg4qWnStWgbss-0eqG0Hp7qIjb5bzVN06N2EfuQ0HoAG63tn2zFgAdwYV6YQkXJAthvlAhxu3n1y9_PidnE5u17-ulrMr2cmyZJ0VkCjyyRVjazLolG5xrVLqaWos6JmDJiUKS9SVWS81lJnwDVXStY6E1xpniT75Puai4s-jRBi9diPvsORlUhykUqecoaq47XK4DmCh6YavG2VnyrOqlVIFYZUfYSE2m8b4qhbqD-V_1JBwela8GIdTP8nVYvF-Rr5F0KBo_U</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2372461410</pqid></control><display><type>article</type><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><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><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</creator><creatorcontrib>Liu, Yi ; Zhang, Yaojun ; Li, Yue ; Qi, Tianjun ; Pan, Defeng ; Wang, Haichang ; Liu, Changhui ; Ma, Dengfeng ; Fang, Zhenfei ; Zhang, Ruining ; Mou, Fangjun ; Tao, Ling ; NANO All-Comers Registry Investigators ; On Behalf of the NANO All‐Comers Registry Investigators</creatorcontrib><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% and long lesions (>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 & Sons, Inc</publisher><subject>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</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 <40% and long lesions (>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 & 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 & 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 & Sons, Inc</general><general>Wiley Subscription Services, Inc</general><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>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope></search><sort><creationdate>20200201</creationdate><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><author>Liu, Yi ; Zhang, Yaojun ; Li, Yue ; Qi, Tianjun ; Pan, Defeng ; Wang, Haichang ; Liu, Changhui ; Ma, Dengfeng ; Fang, Zhenfei ; Zhang, Ruining ; Mou, Fangjun ; Tao, Ling</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3534-8efb934af6d98fa7b05796b62d58d00e0664184a851db6b5e1b1aa6db521ab133</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Aged</topic><topic>all‐comer population</topic><topic>Cardiovascular Agents - administration & 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 & 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 & 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 <40% and long lesions (>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 & 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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