Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial
Whether the rate of drug elution and polymer absorption affects clinical outcomes of biodegradable polymer-based drug-eluting stents (DES) is unknown. The widely used polylactide polymer-based Excel stent (JW Medical, Weihai, China) elutes sirolimus within 180 days, and the polylactide polymer is co...
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| Veröffentlicht in: | Journal of the American College of Cardiology 2016-05, Vol.67 (19), p.2249-2258 |
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| creator | Xu, Bo Gao, Runlin Yang, Yuejin Cao, Xuebin Qin, Lei Li, Yi Li, Zhanquan Li, Xueqi Lin, Hailong Guo, Yong Ma, Yitong Wang, Jian'an Nie, Shaoping Xu, Liang Cao, Eric Guan, Changdong Stone, Gregg W |
| description | Whether the rate of drug elution and polymer absorption affects clinical outcomes of biodegradable polymer-based drug-eluting stents (DES) is unknown. The widely used polylactide polymer-based Excel stent (JW Medical, Weihai, China) elutes sirolimus within 180 days, and the polylactide polymer is completely absorbed within 6 to 9 months. In contrast, the poly-lactide-co-glycolide polymer-based BuMA stent (Sino Medical, Tianjin, China) elutes sirolimus within 30 days, and the poly-lactide-co-glycolide polymer is completely absorbed within 3 months. Thus, both metallic DES elute sirolimus, isolating major differences to the polymer and elution kinetics.
The goal of this study was to compare the safety and effectiveness between the BuMA sirolimus-eluting stent (SES) and Excel SES in an "all-comers" population.
PANDA III was a multicenter trial with few exclusion criteria, powered for sequential noninferiority and superiority testing. The primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization.
Between December 2013 and August 2014, 2,348 patients were randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174). The 1-year primary endpoint of TLF occurred in 6.4% of patients in each group (difference: 0.06%; 95% confidence interval: 1.93% to 2.04%; pnoninferiority = 0.0003; psuperiority = 0.95). There were no significant between-group differences in any of the secondary endpoints other than the incidence of definite/probable stent thrombosis, which occurred less frequently with the BuMA stent (0.5% vs. 1.3%; log-rank p = 0.048).
The BuMA SES was demonstrated to be noninferior to the Excel SES for 1-year TLF, with a lower incidence of stent thrombosis. (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice [PANDA-III]; NCT02017275). |
| doi_str_mv | 10.1016/j.jacc.2016.03.475 |
| format | Article |
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The goal of this study was to compare the safety and effectiveness between the BuMA sirolimus-eluting stent (SES) and Excel SES in an "all-comers" population.
PANDA III was a multicenter trial with few exclusion criteria, powered for sequential noninferiority and superiority testing. The primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization.
Between December 2013 and August 2014, 2,348 patients were randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174). The 1-year primary endpoint of TLF occurred in 6.4% of patients in each group (difference: 0.06%; 95% confidence interval: 1.93% to 2.04%; pnoninferiority = 0.0003; psuperiority = 0.95). There were no significant between-group differences in any of the secondary endpoints other than the incidence of definite/probable stent thrombosis, which occurred less frequently with the BuMA stent (0.5% vs. 1.3%; log-rank p = 0.048).
The BuMA SES was demonstrated to be noninferior to the Excel SES for 1-year TLF, with a lower incidence of stent thrombosis. (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice [PANDA-III]; NCT02017275).</description><identifier>ISSN: 0735-1097</identifier><identifier>EISSN: 1558-3597</identifier><identifier>DOI: 10.1016/j.jacc.2016.03.475</identifier><identifier>PMID: 27173037</identifier><language>eng</language><publisher>United States: Elsevier Limited</publisher><subject>Absorbable Implants ; Absorption ; Biodegradability ; Biodegradation ; Cardiology ; Cardiovascular disease ; Composite materials ; Confidence intervals ; Coronary Artery Disease - therapy ; Drug delivery ; Drug dosages ; Drug-Eluting Stents ; Elution ; Female ; Heart attacks ; Heart diseases ; Humans ; Implants ; Incidence ; Ischemia ; Kinetics ; Male ; Middle Aged ; Myocardial infarction ; Myocardial Infarction - epidemiology ; Myocardial Revascularization - statistics & numerical data ; Patients ; Percutaneous Coronary Intervention ; Polyesters - chemistry ; Polylactic acid ; Polymers ; Polymers - chemistry ; Prospective Studies ; Prosthesis Design ; Rapamycin ; Sirolimus ; Stents ; Surgical implants ; Thromboembolism ; Thrombosis ; Thrombosis - etiology</subject><ispartof>Journal of the American College of Cardiology, 2016-05, Vol.67 (19), p.2249-2258</ispartof><rights>Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited May 17, 2016</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,781,785,27928,27929</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27173037$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Xu, Bo</creatorcontrib><creatorcontrib>Gao, Runlin</creatorcontrib><creatorcontrib>Yang, Yuejin</creatorcontrib><creatorcontrib>Cao, Xuebin</creatorcontrib><creatorcontrib>Qin, Lei</creatorcontrib><creatorcontrib>Li, Yi</creatorcontrib><creatorcontrib>Li, Zhanquan</creatorcontrib><creatorcontrib>Li, Xueqi</creatorcontrib><creatorcontrib>Lin, Hailong</creatorcontrib><creatorcontrib>Guo, Yong</creatorcontrib><creatorcontrib>Ma, Yitong</creatorcontrib><creatorcontrib>Wang, Jian'an</creatorcontrib><creatorcontrib>Nie, Shaoping</creatorcontrib><creatorcontrib>Xu, Liang</creatorcontrib><creatorcontrib>Cao, Eric</creatorcontrib><creatorcontrib>Guan, Changdong</creatorcontrib><creatorcontrib>Stone, Gregg W</creatorcontrib><creatorcontrib>PANDA III Investigators</creatorcontrib><title>Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial</title><title>Journal of the American College of Cardiology</title><addtitle>J Am Coll Cardiol</addtitle><description>Whether the rate of drug elution and polymer absorption affects clinical outcomes of biodegradable polymer-based drug-eluting stents (DES) is unknown. The widely used polylactide polymer-based Excel stent (JW Medical, Weihai, China) elutes sirolimus within 180 days, and the polylactide polymer is completely absorbed within 6 to 9 months. In contrast, the poly-lactide-co-glycolide polymer-based BuMA stent (Sino Medical, Tianjin, China) elutes sirolimus within 30 days, and the poly-lactide-co-glycolide polymer is completely absorbed within 3 months. Thus, both metallic DES elute sirolimus, isolating major differences to the polymer and elution kinetics.
The goal of this study was to compare the safety and effectiveness between the BuMA sirolimus-eluting stent (SES) and Excel SES in an "all-comers" population.
PANDA III was a multicenter trial with few exclusion criteria, powered for sequential noninferiority and superiority testing. The primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization.
Between December 2013 and August 2014, 2,348 patients were randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174). The 1-year primary endpoint of TLF occurred in 6.4% of patients in each group (difference: 0.06%; 95% confidence interval: 1.93% to 2.04%; pnoninferiority = 0.0003; psuperiority = 0.95). There were no significant between-group differences in any of the secondary endpoints other than the incidence of definite/probable stent thrombosis, which occurred less frequently with the BuMA stent (0.5% vs. 1.3%; log-rank p = 0.048).
The BuMA SES was demonstrated to be noninferior to the Excel SES for 1-year TLF, with a lower incidence of stent thrombosis. (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice [PANDA-III]; NCT02017275).</description><subject>Absorbable Implants</subject><subject>Absorption</subject><subject>Biodegradability</subject><subject>Biodegradation</subject><subject>Cardiology</subject><subject>Cardiovascular disease</subject><subject>Composite materials</subject><subject>Confidence intervals</subject><subject>Coronary Artery Disease - therapy</subject><subject>Drug delivery</subject><subject>Drug dosages</subject><subject>Drug-Eluting Stents</subject><subject>Elution</subject><subject>Female</subject><subject>Heart attacks</subject><subject>Heart diseases</subject><subject>Humans</subject><subject>Implants</subject><subject>Incidence</subject><subject>Ischemia</subject><subject>Kinetics</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myocardial infarction</subject><subject>Myocardial Infarction - epidemiology</subject><subject>Myocardial Revascularization - statistics & numerical data</subject><subject>Patients</subject><subject>Percutaneous Coronary Intervention</subject><subject>Polyesters - chemistry</subject><subject>Polylactic acid</subject><subject>Polymers</subject><subject>Polymers - chemistry</subject><subject>Prospective Studies</subject><subject>Prosthesis Design</subject><subject>Rapamycin</subject><subject>Sirolimus</subject><subject>Stents</subject><subject>Surgical implants</subject><subject>Thromboembolism</subject><subject>Thrombosis</subject><subject>Thrombosis - etiology</subject><issn>0735-1097</issn><issn>1558-3597</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqF0DlOAzEUAFALgSAsF6BAlmhoZrDHO10WlogIkBJEGTljGxzNEuyZIrfhLJyMIYSGhupvT1_6H4BTjFKMML9cpkud52nW5SkiKRVsB_QwYzIhTIld0EOCsAQjJQ7AYYxLhBCXWO2Dg0xgQRARPbAe-NrY16CNXhQWPtXFurQhGehoDZz6UBe-bGNyXbSNr17htLFVE-GLb97gyDtnw3d3M60rqCvz-dFfxDqsNvW9r2zj83gFZ2_d7v7DqA_H4zGcBa-LY7DndBHtyTYegeeb69nwLpk83o6H_UmyykTWJAJTyrFjLJOOUiu1so4rQqQSxpkFUYbT3DKkCWU5JQI5ww2WwuXGMkkJOQIXP3tXoX5vbWzmpY-5LQpd2bqN885mknBJ8P9USIUIZ5R39PwPXdZtqLpDOqUQxjgTqlNnW9UuSmvmq-BLHdbz3_-TL2Y4h8E</recordid><startdate>20160517</startdate><enddate>20160517</enddate><creator>Xu, Bo</creator><creator>Gao, Runlin</creator><creator>Yang, Yuejin</creator><creator>Cao, Xuebin</creator><creator>Qin, Lei</creator><creator>Li, Yi</creator><creator>Li, Zhanquan</creator><creator>Li, Xueqi</creator><creator>Lin, Hailong</creator><creator>Guo, Yong</creator><creator>Ma, Yitong</creator><creator>Wang, Jian'an</creator><creator>Nie, Shaoping</creator><creator>Xu, Liang</creator><creator>Cao, Eric</creator><creator>Guan, Changdong</creator><creator>Stone, Gregg W</creator><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20160517</creationdate><title>Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial</title><author>Xu, Bo ; Gao, Runlin ; Yang, Yuejin ; Cao, Xuebin ; Qin, Lei ; Li, Yi ; Li, Zhanquan ; Li, Xueqi ; Lin, Hailong ; Guo, Yong ; Ma, Yitong ; Wang, Jian'an ; Nie, Shaoping ; Xu, Liang ; Cao, Eric ; Guan, Changdong ; Stone, Gregg W</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p272t-714461f5528f44e8a9ef6933897dfdb39d64ce50a345c4370fd6d187fcde58433</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Absorbable Implants</topic><topic>Absorption</topic><topic>Biodegradability</topic><topic>Biodegradation</topic><topic>Cardiology</topic><topic>Cardiovascular disease</topic><topic>Composite materials</topic><topic>Confidence intervals</topic><topic>Coronary Artery Disease - therapy</topic><topic>Drug delivery</topic><topic>Drug dosages</topic><topic>Drug-Eluting Stents</topic><topic>Elution</topic><topic>Female</topic><topic>Heart attacks</topic><topic>Heart diseases</topic><topic>Humans</topic><topic>Implants</topic><topic>Incidence</topic><topic>Ischemia</topic><topic>Kinetics</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Myocardial infarction</topic><topic>Myocardial Infarction - epidemiology</topic><topic>Myocardial Revascularization - statistics & numerical data</topic><topic>Patients</topic><topic>Percutaneous Coronary Intervention</topic><topic>Polyesters - chemistry</topic><topic>Polylactic acid</topic><topic>Polymers</topic><topic>Polymers - chemistry</topic><topic>Prospective Studies</topic><topic>Prosthesis Design</topic><topic>Rapamycin</topic><topic>Sirolimus</topic><topic>Stents</topic><topic>Surgical implants</topic><topic>Thromboembolism</topic><topic>Thrombosis</topic><topic>Thrombosis - etiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Xu, Bo</creatorcontrib><creatorcontrib>Gao, Runlin</creatorcontrib><creatorcontrib>Yang, Yuejin</creatorcontrib><creatorcontrib>Cao, Xuebin</creatorcontrib><creatorcontrib>Qin, Lei</creatorcontrib><creatorcontrib>Li, Yi</creatorcontrib><creatorcontrib>Li, Zhanquan</creatorcontrib><creatorcontrib>Li, Xueqi</creatorcontrib><creatorcontrib>Lin, Hailong</creatorcontrib><creatorcontrib>Guo, Yong</creatorcontrib><creatorcontrib>Ma, Yitong</creatorcontrib><creatorcontrib>Wang, Jian'an</creatorcontrib><creatorcontrib>Nie, Shaoping</creatorcontrib><creatorcontrib>Xu, Liang</creatorcontrib><creatorcontrib>Cao, Eric</creatorcontrib><creatorcontrib>Guan, Changdong</creatorcontrib><creatorcontrib>Stone, Gregg W</creatorcontrib><creatorcontrib>PANDA III Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of the American College of Cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Xu, Bo</au><au>Gao, Runlin</au><au>Yang, Yuejin</au><au>Cao, Xuebin</au><au>Qin, Lei</au><au>Li, Yi</au><au>Li, Zhanquan</au><au>Li, Xueqi</au><au>Lin, Hailong</au><au>Guo, Yong</au><au>Ma, Yitong</au><au>Wang, Jian'an</au><au>Nie, Shaoping</au><au>Xu, Liang</au><au>Cao, Eric</au><au>Guan, Changdong</au><au>Stone, Gregg W</au><aucorp>PANDA III Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial</atitle><jtitle>Journal of the American College of Cardiology</jtitle><addtitle>J Am Coll Cardiol</addtitle><date>2016-05-17</date><risdate>2016</risdate><volume>67</volume><issue>19</issue><spage>2249</spage><epage>2258</epage><pages>2249-2258</pages><issn>0735-1097</issn><eissn>1558-3597</eissn><abstract>Whether the rate of drug elution and polymer absorption affects clinical outcomes of biodegradable polymer-based drug-eluting stents (DES) is unknown. The widely used polylactide polymer-based Excel stent (JW Medical, Weihai, China) elutes sirolimus within 180 days, and the polylactide polymer is completely absorbed within 6 to 9 months. In contrast, the poly-lactide-co-glycolide polymer-based BuMA stent (Sino Medical, Tianjin, China) elutes sirolimus within 30 days, and the poly-lactide-co-glycolide polymer is completely absorbed within 3 months. Thus, both metallic DES elute sirolimus, isolating major differences to the polymer and elution kinetics.
The goal of this study was to compare the safety and effectiveness between the BuMA sirolimus-eluting stent (SES) and Excel SES in an "all-comers" population.
PANDA III was a multicenter trial with few exclusion criteria, powered for sequential noninferiority and superiority testing. The primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization.
Between December 2013 and August 2014, 2,348 patients were randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174). The 1-year primary endpoint of TLF occurred in 6.4% of patients in each group (difference: 0.06%; 95% confidence interval: 1.93% to 2.04%; pnoninferiority = 0.0003; psuperiority = 0.95). There were no significant between-group differences in any of the secondary endpoints other than the incidence of definite/probable stent thrombosis, which occurred less frequently with the BuMA stent (0.5% vs. 1.3%; log-rank p = 0.048).
The BuMA SES was demonstrated to be noninferior to the Excel SES for 1-year TLF, with a lower incidence of stent thrombosis. (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice [PANDA-III]; NCT02017275).</abstract><cop>United States</cop><pub>Elsevier Limited</pub><pmid>27173037</pmid><doi>10.1016/j.jacc.2016.03.475</doi><tpages>10</tpages></addata></record> |
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| subjects | Absorbable Implants Absorption Biodegradability Biodegradation Cardiology Cardiovascular disease Composite materials Confidence intervals Coronary Artery Disease - therapy Drug delivery Drug dosages Drug-Eluting Stents Elution Female Heart attacks Heart diseases Humans Implants Incidence Ischemia Kinetics Male Middle Aged Myocardial infarction Myocardial Infarction - epidemiology Myocardial Revascularization - statistics & numerical data Patients Percutaneous Coronary Intervention Polyesters - chemistry Polylactic acid Polymers Polymers - chemistry Prospective Studies Prosthesis Design Rapamycin Sirolimus Stents Surgical implants Thromboembolism Thrombosis Thrombosis - etiology |
| title | Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial |
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