A randomized comparison of two paclitaxel‐coated balloons for the treatment of in‐stent restenosis: The LONGTY ISR China randomized trial (LONGTY DCB vs. SeQuent Please DCB)
Objectives This study sought to compare the efficacy and clinical safety of the LONGTY drug‐coated balloon (DCB) with those of SeQuent Please DCB in patients with in‐stent restenosis (ISR). Background Although DCB technologies have evolved, little is known about the clinical efficacy of the new‐gene...
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| Veröffentlicht in: | Catheterization and cardiovascular interventions 2021-05, Vol.97 (S2), p.988-995 |
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| creator | Hu, Po Sun, Yong Li, Chang‐Ling Jin, Rui Xie, Qiang Jiang, Xue‐Jun Wu, Lian‐Pin Jiang, Jian‐Jun Qiu, Xin‐Biao Cao, Yu Ji, Guang Wang, Hua Yao, Zhu‐Hua Li, Bin Xia, Yong Wang, Jian‐An Jiang, Jun |
| description | Objectives
This study sought to compare the efficacy and clinical safety of the LONGTY drug‐coated balloon (DCB) with those of SeQuent Please DCB in patients with in‐stent restenosis (ISR).
Background
Although DCB technologies have evolved, little is known about the clinical efficacy of the new‐generation LONGTY DCB.
Methods
This was a prospective, multicenter, randomized, noninferiority trial comparing LONGTY DCB with SeQuent Please DCB in patients with ISR. The primary endpoint was target lesion late lumen loss at 9 months' follow‐up.
Results
A total of 211 patients with ISR from 13 Chinese sites were included (LONGTY DCB, n = 105; SeQuent Please DCB, n = 106). Device success was achieved in all patients. At the 9 month angiographic follow‐up, target lesion late lumen loss was 0.35 ± 0.42 mm with LONGTY and 0.38 ± 0.45 mm with SeQuent Please (p for noninferiority |
| doi_str_mv | 10.1002/ccd.29589 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2502811683</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2502811683</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3139-8e960c7688065451f203fe6873d4c8e648c4b0ae185546dcf85e2d1c4a4db0ec3</originalsourceid><addsrcrecordid>eNp10U1u1DAUB3ALgWgZWHABZIlNu5ipP2LHYVdSKJVGFOggwSryOC-qKyee2g6lrDgCV-FKnASHGRBCYvVs6-f_s_UQekzJghLCjoxpF6wSqrqD9qlgbF4y-eHubk2rQu6hBzFeEUIqyar7aI_zkheiFPvo-zEOemh9b79Ai43vNzrY6AfsO5xuPN5o42zSn8H9-PrNeJ2yWmvnvB8i7nzA6RJwCqBTD0Oabtkhy5imXYCp-mjjM7zKbnn--nT1EZ9dvMP1pR30361TsNrhgx05qZ_jT3GBL-DtOCW9caAjTMeHD9G9TrsIj3Z1ht6_fLGqX82X56dn9fFybjjl1VxBJYkppVJEikLQjhHegVQlbwujQBbKFGuigSohCtmaTglgLTWFLto1AcNn6GCbuwn-esw_aXobDTinB_BjbJggTFEqFc_06T_0yo9hyK_LihFGJc_dZ-hwq0zwMQbomk2wvQ63DSXNNMcmz7H5Ncdsn-wSx3UP7R_5e3AZHG3BjXVw-_-kpq5PtpE_AbT5qEU</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2520216320</pqid></control><display><type>article</type><title>A randomized comparison of two paclitaxel‐coated balloons for the treatment of in‐stent restenosis: The LONGTY ISR China randomized trial (LONGTY DCB vs. SeQuent Please DCB)</title><source>Wiley Online Library Journals</source><creator>Hu, Po ; Sun, Yong ; Li, Chang‐Ling ; Jin, Rui ; Xie, Qiang ; Jiang, Xue‐Jun ; Wu, Lian‐Pin ; Jiang, Jian‐Jun ; Qiu, Xin‐Biao ; Cao, Yu ; Ji, Guang ; Wang, Hua ; Yao, Zhu‐Hua ; Li, Bin ; Xia, Yong ; Wang, Jian‐An ; Jiang, Jun</creator><creatorcontrib>Hu, Po ; Sun, Yong ; Li, Chang‐Ling ; Jin, Rui ; Xie, Qiang ; Jiang, Xue‐Jun ; Wu, Lian‐Pin ; Jiang, Jian‐Jun ; Qiu, Xin‐Biao ; Cao, Yu ; Ji, Guang ; Wang, Hua ; Yao, Zhu‐Hua ; Li, Bin ; Xia, Yong ; Wang, Jian‐An ; Jiang, Jun</creatorcontrib><description>Objectives
This study sought to compare the efficacy and clinical safety of the LONGTY drug‐coated balloon (DCB) with those of SeQuent Please DCB in patients with in‐stent restenosis (ISR).
Background
Although DCB technologies have evolved, little is known about the clinical efficacy of the new‐generation LONGTY DCB.
Methods
This was a prospective, multicenter, randomized, noninferiority trial comparing LONGTY DCB with SeQuent Please DCB in patients with ISR. The primary endpoint was target lesion late lumen loss at 9 months' follow‐up.
Results
A total of 211 patients with ISR from 13 Chinese sites were included (LONGTY DCB, n = 105; SeQuent Please DCB, n = 106). Device success was achieved in all patients. At the 9 month angiographic follow‐up, target lesion late lumen loss was 0.35 ± 0.42 mm with LONGTY and 0.38 ± 0.45 mm with SeQuent Please (p for noninferiority <.001). The target lesion revascularization rates at 1 year were similar in both DCB groups (15.24 vs. 13.21%; p = .673). Over an extended follow‐up of 2 years, the clinical endpoints, including cardiac death, myocardial infarction, and thrombus rate, were extremely low and similar in both groups.
Conclusions
In this multicenter, head‐to‐head, randomized trial, the new‐generation LONGTY DCB was noninferior to the SeQuent Please DCB for the primary endpoint of target lesion late lumen loss at 9 months.</description><identifier>ISSN: 1522-1946</identifier><identifier>EISSN: 1522-726X</identifier><identifier>DOI: 10.1002/ccd.29589</identifier><identifier>PMID: 33734575</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley & Sons, Inc</publisher><subject>Balloon treatment ; clinical outcomes ; coronary artery disease ; drug‐coated balloon ; Implants ; Lesions ; Myocardial infarction ; Paclitaxel ; Patients ; Restenosis ; stent restenosis ; Stents ; Thrombosis</subject><ispartof>Catheterization and cardiovascular interventions, 2021-05, Vol.97 (S2), p.988-995</ispartof><rights>2021 Wiley Periodicals LLC.</rights><rights>2021 Wiley Periodicals LLC</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3139-8e960c7688065451f203fe6873d4c8e648c4b0ae185546dcf85e2d1c4a4db0ec3</cites><orcidid>0000-0003-1647-2072 ; 0000-0003-0409-8941</orcidid></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.29589$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fccd.29589$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33734575$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hu, Po</creatorcontrib><creatorcontrib>Sun, Yong</creatorcontrib><creatorcontrib>Li, Chang‐Ling</creatorcontrib><creatorcontrib>Jin, Rui</creatorcontrib><creatorcontrib>Xie, Qiang</creatorcontrib><creatorcontrib>Jiang, Xue‐Jun</creatorcontrib><creatorcontrib>Wu, Lian‐Pin</creatorcontrib><creatorcontrib>Jiang, Jian‐Jun</creatorcontrib><creatorcontrib>Qiu, Xin‐Biao</creatorcontrib><creatorcontrib>Cao, Yu</creatorcontrib><creatorcontrib>Ji, Guang</creatorcontrib><creatorcontrib>Wang, Hua</creatorcontrib><creatorcontrib>Yao, Zhu‐Hua</creatorcontrib><creatorcontrib>Li, Bin</creatorcontrib><creatorcontrib>Xia, Yong</creatorcontrib><creatorcontrib>Wang, Jian‐An</creatorcontrib><creatorcontrib>Jiang, Jun</creatorcontrib><title>A randomized comparison of two paclitaxel‐coated balloons for the treatment of in‐stent restenosis: The LONGTY ISR China randomized trial (LONGTY DCB vs. SeQuent Please DCB)</title><title>Catheterization and cardiovascular interventions</title><addtitle>Catheter Cardiovasc Interv</addtitle><description>Objectives
This study sought to compare the efficacy and clinical safety of the LONGTY drug‐coated balloon (DCB) with those of SeQuent Please DCB in patients with in‐stent restenosis (ISR).
Background
Although DCB technologies have evolved, little is known about the clinical efficacy of the new‐generation LONGTY DCB.
Methods
This was a prospective, multicenter, randomized, noninferiority trial comparing LONGTY DCB with SeQuent Please DCB in patients with ISR. The primary endpoint was target lesion late lumen loss at 9 months' follow‐up.
Results
A total of 211 patients with ISR from 13 Chinese sites were included (LONGTY DCB, n = 105; SeQuent Please DCB, n = 106). Device success was achieved in all patients. At the 9 month angiographic follow‐up, target lesion late lumen loss was 0.35 ± 0.42 mm with LONGTY and 0.38 ± 0.45 mm with SeQuent Please (p for noninferiority <.001). The target lesion revascularization rates at 1 year were similar in both DCB groups (15.24 vs. 13.21%; p = .673). Over an extended follow‐up of 2 years, the clinical endpoints, including cardiac death, myocardial infarction, and thrombus rate, were extremely low and similar in both groups.
Conclusions
In this multicenter, head‐to‐head, randomized trial, the new‐generation LONGTY DCB was noninferior to the SeQuent Please DCB for the primary endpoint of target lesion late lumen loss at 9 months.</description><subject>Balloon treatment</subject><subject>clinical outcomes</subject><subject>coronary artery disease</subject><subject>drug‐coated balloon</subject><subject>Implants</subject><subject>Lesions</subject><subject>Myocardial infarction</subject><subject>Paclitaxel</subject><subject>Patients</subject><subject>Restenosis</subject><subject>stent restenosis</subject><subject>Stents</subject><subject>Thrombosis</subject><issn>1522-1946</issn><issn>1522-726X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp10U1u1DAUB3ALgWgZWHABZIlNu5ipP2LHYVdSKJVGFOggwSryOC-qKyee2g6lrDgCV-FKnASHGRBCYvVs6-f_s_UQekzJghLCjoxpF6wSqrqD9qlgbF4y-eHubk2rQu6hBzFeEUIqyar7aI_zkheiFPvo-zEOemh9b79Ai43vNzrY6AfsO5xuPN5o42zSn8H9-PrNeJ2yWmvnvB8i7nzA6RJwCqBTD0Oabtkhy5imXYCp-mjjM7zKbnn--nT1EZ9dvMP1pR30361TsNrhgx05qZ_jT3GBL-DtOCW9caAjTMeHD9G9TrsIj3Z1ht6_fLGqX82X56dn9fFybjjl1VxBJYkppVJEikLQjhHegVQlbwujQBbKFGuigSohCtmaTglgLTWFLto1AcNn6GCbuwn-esw_aXobDTinB_BjbJggTFEqFc_06T_0yo9hyK_LihFGJc_dZ-hwq0zwMQbomk2wvQ63DSXNNMcmz7H5Ncdsn-wSx3UP7R_5e3AZHG3BjXVw-_-kpq5PtpE_AbT5qEU</recordid><startdate>20210501</startdate><enddate>20210501</enddate><creator>Hu, Po</creator><creator>Sun, Yong</creator><creator>Li, Chang‐Ling</creator><creator>Jin, Rui</creator><creator>Xie, Qiang</creator><creator>Jiang, Xue‐Jun</creator><creator>Wu, Lian‐Pin</creator><creator>Jiang, Jian‐Jun</creator><creator>Qiu, Xin‐Biao</creator><creator>Cao, Yu</creator><creator>Ji, Guang</creator><creator>Wang, Hua</creator><creator>Yao, Zhu‐Hua</creator><creator>Li, Bin</creator><creator>Xia, Yong</creator><creator>Wang, Jian‐An</creator><creator>Jiang, Jun</creator><general>John Wiley & Sons, Inc</general><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-1647-2072</orcidid><orcidid>https://orcid.org/0000-0003-0409-8941</orcidid></search><sort><creationdate>20210501</creationdate><title>A randomized comparison of two paclitaxel‐coated balloons for the treatment of in‐stent restenosis: The LONGTY ISR China randomized trial (LONGTY DCB vs. SeQuent Please DCB)</title><author>Hu, Po ; Sun, Yong ; Li, Chang‐Ling ; Jin, Rui ; Xie, Qiang ; Jiang, Xue‐Jun ; Wu, Lian‐Pin ; Jiang, Jian‐Jun ; Qiu, Xin‐Biao ; Cao, Yu ; Ji, Guang ; Wang, Hua ; Yao, Zhu‐Hua ; Li, Bin ; Xia, Yong ; Wang, Jian‐An ; Jiang, Jun</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3139-8e960c7688065451f203fe6873d4c8e648c4b0ae185546dcf85e2d1c4a4db0ec3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Balloon treatment</topic><topic>clinical outcomes</topic><topic>coronary artery disease</topic><topic>drug‐coated balloon</topic><topic>Implants</topic><topic>Lesions</topic><topic>Myocardial infarction</topic><topic>Paclitaxel</topic><topic>Patients</topic><topic>Restenosis</topic><topic>stent restenosis</topic><topic>Stents</topic><topic>Thrombosis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hu, Po</creatorcontrib><creatorcontrib>Sun, Yong</creatorcontrib><creatorcontrib>Li, Chang‐Ling</creatorcontrib><creatorcontrib>Jin, Rui</creatorcontrib><creatorcontrib>Xie, Qiang</creatorcontrib><creatorcontrib>Jiang, Xue‐Jun</creatorcontrib><creatorcontrib>Wu, Lian‐Pin</creatorcontrib><creatorcontrib>Jiang, Jian‐Jun</creatorcontrib><creatorcontrib>Qiu, Xin‐Biao</creatorcontrib><creatorcontrib>Cao, Yu</creatorcontrib><creatorcontrib>Ji, Guang</creatorcontrib><creatorcontrib>Wang, Hua</creatorcontrib><creatorcontrib>Yao, Zhu‐Hua</creatorcontrib><creatorcontrib>Li, Bin</creatorcontrib><creatorcontrib>Xia, Yong</creatorcontrib><creatorcontrib>Wang, Jian‐An</creatorcontrib><creatorcontrib>Jiang, Jun</creatorcontrib><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><collection>MEDLINE - Academic</collection><jtitle>Catheterization and cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hu, Po</au><au>Sun, Yong</au><au>Li, Chang‐Ling</au><au>Jin, Rui</au><au>Xie, Qiang</au><au>Jiang, Xue‐Jun</au><au>Wu, Lian‐Pin</au><au>Jiang, Jian‐Jun</au><au>Qiu, Xin‐Biao</au><au>Cao, Yu</au><au>Ji, Guang</au><au>Wang, Hua</au><au>Yao, Zhu‐Hua</au><au>Li, Bin</au><au>Xia, Yong</au><au>Wang, Jian‐An</au><au>Jiang, Jun</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized comparison of two paclitaxel‐coated balloons for the treatment of in‐stent restenosis: The LONGTY ISR China randomized trial (LONGTY DCB vs. SeQuent Please DCB)</atitle><jtitle>Catheterization and cardiovascular interventions</jtitle><addtitle>Catheter Cardiovasc Interv</addtitle><date>2021-05-01</date><risdate>2021</risdate><volume>97</volume><issue>S2</issue><spage>988</spage><epage>995</epage><pages>988-995</pages><issn>1522-1946</issn><eissn>1522-726X</eissn><abstract>Objectives
This study sought to compare the efficacy and clinical safety of the LONGTY drug‐coated balloon (DCB) with those of SeQuent Please DCB in patients with in‐stent restenosis (ISR).
Background
Although DCB technologies have evolved, little is known about the clinical efficacy of the new‐generation LONGTY DCB.
Methods
This was a prospective, multicenter, randomized, noninferiority trial comparing LONGTY DCB with SeQuent Please DCB in patients with ISR. The primary endpoint was target lesion late lumen loss at 9 months' follow‐up.
Results
A total of 211 patients with ISR from 13 Chinese sites were included (LONGTY DCB, n = 105; SeQuent Please DCB, n = 106). Device success was achieved in all patients. At the 9 month angiographic follow‐up, target lesion late lumen loss was 0.35 ± 0.42 mm with LONGTY and 0.38 ± 0.45 mm with SeQuent Please (p for noninferiority <.001). The target lesion revascularization rates at 1 year were similar in both DCB groups (15.24 vs. 13.21%; p = .673). Over an extended follow‐up of 2 years, the clinical endpoints, including cardiac death, myocardial infarction, and thrombus rate, were extremely low and similar in both groups.
Conclusions
In this multicenter, head‐to‐head, randomized trial, the new‐generation LONGTY DCB was noninferior to the SeQuent Please DCB for the primary endpoint of target lesion late lumen loss at 9 months.</abstract><cop>Hoboken, USA</cop><pub>John Wiley & Sons, Inc</pub><pmid>33734575</pmid><doi>10.1002/ccd.29589</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-1647-2072</orcidid><orcidid>https://orcid.org/0000-0003-0409-8941</orcidid></addata></record> |
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| ispartof | Catheterization and cardiovascular interventions, 2021-05, Vol.97 (S2), p.988-995 |
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| language | eng |
| recordid | cdi_proquest_miscellaneous_2502811683 |
| source | Wiley Online Library Journals |
| subjects | Balloon treatment clinical outcomes coronary artery disease drug‐coated balloon Implants Lesions Myocardial infarction Paclitaxel Patients Restenosis stent restenosis Stents Thrombosis |
| title | A randomized comparison of two paclitaxel‐coated balloons for the treatment of in‐stent restenosis: The LONGTY ISR China randomized trial (LONGTY DCB vs. SeQuent Please DCB) |
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