ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions
Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlanti...
Gespeichert in:
| Veröffentlicht in: | Journal of endovascular therapy 2020-04, Vol.27 (2), p.287-295 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 295 |
|---|---|
| container_issue | 2 |
| container_start_page | 287 |
| container_title | Journal of endovascular therapy |
| container_volume | 27 |
| creator | Bosiers, Marc Setacci, Carlo De Donato, Gianmarco Torsello, Giovanni Silveira, Pierre Galvagni Deloose, Koen Scheinert, Dierk Veroux, Pierfrancesco Hendriks, Jeroen Maene, Lieven Keirse, Koen Navarro, Tulio Callaert, Joren Eckstein, Hans-Henning Teβarek, Jörg Giaquinta, Alessia Wauters, Jeroen |
| description | Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio |
| doi_str_mv | 10.1177/1526602820902014 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2348797978</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1177_1526602820902014</sage_id><sourcerecordid>2348797978</sourcerecordid><originalsourceid>FETCH-LOGICAL-c403t-5e17ff1a7b4df75d4d7576b6fd6844bce3a9329fcb5f07e5a99bcf14cb3005043</originalsourceid><addsrcrecordid>eNp1kMFLwzAUxoMobk7vniRHL9UkTZrG2xybDgYbdop4KWmbjI62qUkr9L-3o9ODIO_wHt_7vQ_eB8A1RncYc36PGQkCREKCBCII0xMwxowyDzOGTg8zCbzDfgQunNsjRDDB-ByMfCwE55iNwfpjuXqbv2ymUQSjps26BzgocLN97xVVNfDLwceuls7BqLU7ZTuYV3ChSmNNbeoib5Qs4Eq53FTuEpxpWTh1dewT8LqYb2fP3mr9tJxNV15Kkd94TGGuNZY8oZnmLKMZZzxIAp0FIaVJqnwpfCJ0mjCNuGJSiCTVmKaJjxBD1J-A28G3tuazVa6Jy9ylqihkpUzrYuLTkIu-wh5FA5pa45xVOq5tXkrbxRjFhxjjvzH2JzdH9zYpVfZ78JNbD3gD4OROxXvT2qr_9n_DbzOyeDc</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2348797978</pqid></control><display><type>article</type><title>ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions</title><source>SAGE Complete A-Z List</source><creator>Bosiers, Marc ; Setacci, Carlo ; De Donato, Gianmarco ; Torsello, Giovanni ; Silveira, Pierre Galvagni ; Deloose, Koen ; Scheinert, Dierk ; Veroux, Pierfrancesco ; Hendriks, Jeroen ; Maene, Lieven ; Keirse, Koen ; Navarro, Tulio ; Callaert, Joren ; Eckstein, Hans-Henning ; Teβarek, Jörg ; Giaquinta, Alessia ; Wauters, Jeroen</creator><creatorcontrib>Bosiers, Marc ; Setacci, Carlo ; De Donato, Gianmarco ; Torsello, Giovanni ; Silveira, Pierre Galvagni ; Deloose, Koen ; Scheinert, Dierk ; Veroux, Pierfrancesco ; Hendriks, Jeroen ; Maene, Lieven ; Keirse, Koen ; Navarro, Tulio ; Callaert, Joren ; Eckstein, Hans-Henning ; Teβarek, Jörg ; Giaquinta, Alessia ; Wauters, Jeroen</creatorcontrib><description>Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.</description><identifier>ISSN: 1526-6028</identifier><identifier>EISSN: 1545-1550</identifier><identifier>DOI: 10.1177/1526602820902014</identifier><identifier>PMID: 31997715</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><ispartof>Journal of endovascular therapy, 2020-04, Vol.27 (2), p.287-295</ispartof><rights>The Author(s) 2020</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c403t-5e17ff1a7b4df75d4d7576b6fd6844bce3a9329fcb5f07e5a99bcf14cb3005043</citedby><cites>FETCH-LOGICAL-c403t-5e17ff1a7b4df75d4d7576b6fd6844bce3a9329fcb5f07e5a99bcf14cb3005043</cites><orcidid>0000-0002-4554-6467 ; 0000-0001-5434-7323 ; 0000-0001-9145-3643 ; 0000-0001-7513-5063</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/1526602820902014$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/1526602820902014$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,780,784,21819,27924,27925,43621,43622</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31997715$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bosiers, Marc</creatorcontrib><creatorcontrib>Setacci, Carlo</creatorcontrib><creatorcontrib>De Donato, Gianmarco</creatorcontrib><creatorcontrib>Torsello, Giovanni</creatorcontrib><creatorcontrib>Silveira, Pierre Galvagni</creatorcontrib><creatorcontrib>Deloose, Koen</creatorcontrib><creatorcontrib>Scheinert, Dierk</creatorcontrib><creatorcontrib>Veroux, Pierfrancesco</creatorcontrib><creatorcontrib>Hendriks, Jeroen</creatorcontrib><creatorcontrib>Maene, Lieven</creatorcontrib><creatorcontrib>Keirse, Koen</creatorcontrib><creatorcontrib>Navarro, Tulio</creatorcontrib><creatorcontrib>Callaert, Joren</creatorcontrib><creatorcontrib>Eckstein, Hans-Henning</creatorcontrib><creatorcontrib>Teβarek, Jörg</creatorcontrib><creatorcontrib>Giaquinta, Alessia</creatorcontrib><creatorcontrib>Wauters, Jeroen</creatorcontrib><title>ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions</title><title>Journal of endovascular therapy</title><addtitle>J Endovasc Ther</addtitle><description>Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.</description><issn>1526-6028</issn><issn>1545-1550</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp1kMFLwzAUxoMobk7vniRHL9UkTZrG2xybDgYbdop4KWmbjI62qUkr9L-3o9ODIO_wHt_7vQ_eB8A1RncYc36PGQkCREKCBCII0xMwxowyDzOGTg8zCbzDfgQunNsjRDDB-ByMfCwE55iNwfpjuXqbv2ymUQSjps26BzgocLN97xVVNfDLwceuls7BqLU7ZTuYV3ChSmNNbeoib5Qs4Eq53FTuEpxpWTh1dewT8LqYb2fP3mr9tJxNV15Kkd94TGGuNZY8oZnmLKMZZzxIAp0FIaVJqnwpfCJ0mjCNuGJSiCTVmKaJjxBD1J-A28G3tuazVa6Jy9ylqihkpUzrYuLTkIu-wh5FA5pa45xVOq5tXkrbxRjFhxjjvzH2JzdH9zYpVfZ78JNbD3gD4OROxXvT2qr_9n_DbzOyeDc</recordid><startdate>20200401</startdate><enddate>20200401</enddate><creator>Bosiers, Marc</creator><creator>Setacci, Carlo</creator><creator>De Donato, Gianmarco</creator><creator>Torsello, Giovanni</creator><creator>Silveira, Pierre Galvagni</creator><creator>Deloose, Koen</creator><creator>Scheinert, Dierk</creator><creator>Veroux, Pierfrancesco</creator><creator>Hendriks, Jeroen</creator><creator>Maene, Lieven</creator><creator>Keirse, Koen</creator><creator>Navarro, Tulio</creator><creator>Callaert, Joren</creator><creator>Eckstein, Hans-Henning</creator><creator>Teβarek, Jörg</creator><creator>Giaquinta, Alessia</creator><creator>Wauters, Jeroen</creator><general>SAGE Publications</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-4554-6467</orcidid><orcidid>https://orcid.org/0000-0001-5434-7323</orcidid><orcidid>https://orcid.org/0000-0001-9145-3643</orcidid><orcidid>https://orcid.org/0000-0001-7513-5063</orcidid></search><sort><creationdate>20200401</creationdate><title>ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions</title><author>Bosiers, Marc ; Setacci, Carlo ; De Donato, Gianmarco ; Torsello, Giovanni ; Silveira, Pierre Galvagni ; Deloose, Koen ; Scheinert, Dierk ; Veroux, Pierfrancesco ; Hendriks, Jeroen ; Maene, Lieven ; Keirse, Koen ; Navarro, Tulio ; Callaert, Joren ; Eckstein, Hans-Henning ; Teβarek, Jörg ; Giaquinta, Alessia ; Wauters, Jeroen</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c403t-5e17ff1a7b4df75d4d7576b6fd6844bce3a9329fcb5f07e5a99bcf14cb3005043</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bosiers, Marc</creatorcontrib><creatorcontrib>Setacci, Carlo</creatorcontrib><creatorcontrib>De Donato, Gianmarco</creatorcontrib><creatorcontrib>Torsello, Giovanni</creatorcontrib><creatorcontrib>Silveira, Pierre Galvagni</creatorcontrib><creatorcontrib>Deloose, Koen</creatorcontrib><creatorcontrib>Scheinert, Dierk</creatorcontrib><creatorcontrib>Veroux, Pierfrancesco</creatorcontrib><creatorcontrib>Hendriks, Jeroen</creatorcontrib><creatorcontrib>Maene, Lieven</creatorcontrib><creatorcontrib>Keirse, Koen</creatorcontrib><creatorcontrib>Navarro, Tulio</creatorcontrib><creatorcontrib>Callaert, Joren</creatorcontrib><creatorcontrib>Eckstein, Hans-Henning</creatorcontrib><creatorcontrib>Teβarek, Jörg</creatorcontrib><creatorcontrib>Giaquinta, Alessia</creatorcontrib><creatorcontrib>Wauters, Jeroen</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of endovascular therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bosiers, Marc</au><au>Setacci, Carlo</au><au>De Donato, Gianmarco</au><au>Torsello, Giovanni</au><au>Silveira, Pierre Galvagni</au><au>Deloose, Koen</au><au>Scheinert, Dierk</au><au>Veroux, Pierfrancesco</au><au>Hendriks, Jeroen</au><au>Maene, Lieven</au><au>Keirse, Koen</au><au>Navarro, Tulio</au><au>Callaert, Joren</au><au>Eckstein, Hans-Henning</au><au>Teβarek, Jörg</au><au>Giaquinta, Alessia</au><au>Wauters, Jeroen</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions</atitle><jtitle>Journal of endovascular therapy</jtitle><addtitle>J Endovasc Ther</addtitle><date>2020-04-01</date><risdate>2020</risdate><volume>27</volume><issue>2</issue><spage>287</spage><epage>295</epage><pages>287-295</pages><issn>1526-6028</issn><eissn>1545-1550</eissn><abstract>Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>31997715</pmid><doi>10.1177/1526602820902014</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-4554-6467</orcidid><orcidid>https://orcid.org/0000-0001-5434-7323</orcidid><orcidid>https://orcid.org/0000-0001-9145-3643</orcidid><orcidid>https://orcid.org/0000-0001-7513-5063</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1526-6028 |
| ispartof | Journal of endovascular therapy, 2020-04, Vol.27 (2), p.287-295 |
| issn | 1526-6028 1545-1550 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2348797978 |
| source | SAGE Complete A-Z List |
| title | ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-05T04%3A42%3A48IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=ZILVERPASS%20Study:%20ZILVER%20PTX%20Stent%20vs%20Bypass%20Surgery%20in%20Femoropopliteal%20Lesions&rft.jtitle=Journal%20of%20endovascular%20therapy&rft.au=Bosiers,%20Marc&rft.date=2020-04-01&rft.volume=27&rft.issue=2&rft.spage=287&rft.epage=295&rft.pages=287-295&rft.issn=1526-6028&rft.eissn=1545-1550&rft_id=info:doi/10.1177/1526602820902014&rft_dat=%3Cproquest_cross%3E2348797978%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2348797978&rft_id=info:pmid/31997715&rft_sage_id=10.1177_1526602820902014&rfr_iscdi=true |