A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities
Objectives * Varithena 017 Investigator Group: Michael Vasquez, MD, Venous Institute of Buffalo, Amherst, NY; Antonios Gasparis, MD, Stony Brook University Medical Center, Stony Brook, NY; Kathleen Gibson, MD, Lake Washington Vascular, Bellevue, WA; James Theodore King, MD, Vein Clinics of America,...
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| Veröffentlicht in: | Phlebology 2017-05, Vol.32 (4), p.272-281 |
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| creator | Vasquez, Michael Gasparis, Antonios P |
| description | Objectives
*
Varithena 017 Investigator Group: Michael Vasquez, MD, Venous Institute of Buffalo, Amherst, NY; Antonios Gasparis, MD, Stony Brook University Medical Center, Stony Brook, NY; Kathleen Gibson, MD, Lake Washington Vascular, Bellevue, WA; James Theodore King, MD, Vein Clinics of America, Oakbrook Terrace, IL; Nick Morrison, MD, Morrison Vein Institute, Scottsdale, AZ; Girish Munavalli, MD, Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC; Eulogio J. Sanchez, MD, Batey Cardiovascular Center, Bradenton, FL. Varithena® is a trademark of Provensis Ltd, a BTG International group company.
To determine the efficacy and safety of polidocanol endovenous microfoam (PEM 0.5%, 1.0%) and placebo each administered with endovenous thermal ablation.
Methods
A multicenter, randomized, placebo-controlled, blinded study was conducted in patients with great saphenous vein incompetence and symptomatic and visible superficial venous disease. Co-primary endpoints were physician-assessed and patient-assessed appearance change from Baseline to Week 8.
Results
A total of 117 patients received treatment (38 placebo, 39 PEM 0.5%, 40 PEM 1%). Physician-rated vein appearance at Week 8 was significantly better with PEM (p = 0.001 vs. placebo); patient-assessed appearance trended similarly. Polidocanol endovenous microfoam provided improvements in clinically meaningful change in patient-assessed and physician-assessed appearance (p |
| doi_str_mv | 10.1177/0268355516637300 |
| format | Article |
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*
Varithena 017 Investigator Group: Michael Vasquez, MD, Venous Institute of Buffalo, Amherst, NY; Antonios Gasparis, MD, Stony Brook University Medical Center, Stony Brook, NY; Kathleen Gibson, MD, Lake Washington Vascular, Bellevue, WA; James Theodore King, MD, Vein Clinics of America, Oakbrook Terrace, IL; Nick Morrison, MD, Morrison Vein Institute, Scottsdale, AZ; Girish Munavalli, MD, Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC; Eulogio J. Sanchez, MD, Batey Cardiovascular Center, Bradenton, FL. Varithena® is a trademark of Provensis Ltd, a BTG International group company.
To determine the efficacy and safety of polidocanol endovenous microfoam (PEM 0.5%, 1.0%) and placebo each administered with endovenous thermal ablation.
Methods
A multicenter, randomized, placebo-controlled, blinded study was conducted in patients with great saphenous vein incompetence and symptomatic and visible superficial venous disease. Co-primary endpoints were physician-assessed and patient-assessed appearance change from Baseline to Week 8.
Results
A total of 117 patients received treatment (38 placebo, 39 PEM 0.5%, 40 PEM 1%). Physician-rated vein appearance at Week 8 was significantly better with PEM (p = 0.001 vs. placebo); patient-assessed appearance trended similarly. Polidocanol endovenous microfoam provided improvements in clinically meaningful change in patient-assessed and physician-assessed appearance (p < 0.05), need for additional treatment (p < 0.05), saphenofemoral junction reflux elimination, symptoms, and QOL. In PEM recipients, the most frequent adverse event was superficial thrombophlebitis (35.4%)
Conclusions
Endovenous thermal ablation + PEM significantly improved physician-assessed appearance at Week 8, increased the proportion of patients with a clinically meaningful change in appearance, and reduced need for additional treatment. www.clinicaltrials.gov (NCT01197833)</description><identifier>ISSN: 0268-3555</identifier><identifier>EISSN: 1758-1125</identifier><identifier>DOI: 10.1177/0268355516637300</identifier><identifier>PMID: 26957489</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Adult ; Aged ; Endovascular Procedures ; Female ; Humans ; Male ; Middle Aged ; Original ; Polyethylene Glycols - administration & dosage ; Saphenous Vein ; Thrombophlebitis - therapy ; Varicose Veins - therapy ; Venous Insufficiency - therapy</subject><ispartof>Phlebology, 2017-05, Vol.32 (4), p.272-281</ispartof><rights>The Author(s) 2016</rights><rights>The Author(s) 2016 2016 SAGE Publications</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c434t-39595c262b72f8bd2ca8f5bfd3a824e170c36d7123a284e7241a28f1c0c553893</citedby><cites>FETCH-LOGICAL-c434t-39595c262b72f8bd2ca8f5bfd3a824e170c36d7123a284e7241a28f1c0c553893</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/0268355516637300$$EPDF$$P50$$Gsage$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/0268355516637300$$EHTML$$P50$$Gsage$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,21818,27923,27924,43620,43621</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26957489$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vasquez, Michael</creatorcontrib><creatorcontrib>Gasparis, Antonios P</creatorcontrib><creatorcontrib>Varithena® 017 Investigator Group</creatorcontrib><creatorcontrib>on behalf of the Varithena® 017 Investigator Group</creatorcontrib><title>A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities</title><title>Phlebology</title><addtitle>Phlebology</addtitle><description>Objectives
*
Varithena 017 Investigator Group: Michael Vasquez, MD, Venous Institute of Buffalo, Amherst, NY; Antonios Gasparis, MD, Stony Brook University Medical Center, Stony Brook, NY; Kathleen Gibson, MD, Lake Washington Vascular, Bellevue, WA; James Theodore King, MD, Vein Clinics of America, Oakbrook Terrace, IL; Nick Morrison, MD, Morrison Vein Institute, Scottsdale, AZ; Girish Munavalli, MD, Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC; Eulogio J. Sanchez, MD, Batey Cardiovascular Center, Bradenton, FL. Varithena® is a trademark of Provensis Ltd, a BTG International group company.
To determine the efficacy and safety of polidocanol endovenous microfoam (PEM 0.5%, 1.0%) and placebo each administered with endovenous thermal ablation.
Methods
A multicenter, randomized, placebo-controlled, blinded study was conducted in patients with great saphenous vein incompetence and symptomatic and visible superficial venous disease. Co-primary endpoints were physician-assessed and patient-assessed appearance change from Baseline to Week 8.
Results
A total of 117 patients received treatment (38 placebo, 39 PEM 0.5%, 40 PEM 1%). Physician-rated vein appearance at Week 8 was significantly better with PEM (p = 0.001 vs. placebo); patient-assessed appearance trended similarly. Polidocanol endovenous microfoam provided improvements in clinically meaningful change in patient-assessed and physician-assessed appearance (p < 0.05), need for additional treatment (p < 0.05), saphenofemoral junction reflux elimination, symptoms, and QOL. In PEM recipients, the most frequent adverse event was superficial thrombophlebitis (35.4%)
Conclusions
Endovenous thermal ablation + PEM significantly improved physician-assessed appearance at Week 8, increased the proportion of patients with a clinically meaningful change in appearance, and reduced need for additional treatment. www.clinicaltrials.gov (NCT01197833)</description><subject>Adult</subject><subject>Aged</subject><subject>Endovascular Procedures</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Original</subject><subject>Polyethylene Glycols - administration & dosage</subject><subject>Saphenous Vein</subject><subject>Thrombophlebitis - therapy</subject><subject>Varicose Veins - therapy</subject><subject>Venous Insufficiency - therapy</subject><issn>0268-3555</issn><issn>1758-1125</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>AFRWT</sourceid><sourceid>EIF</sourceid><recordid>eNp1kc1u1TAQhS0EopfCnhXyAzTgnzhONkhVBS1SJTawjhxncq8r_0S2E0TflLfBIVAVJFYz8jnn82gGodeUvKVUyneENS0XQtCm4ZIT8gQdqBRtRSkTT9Fhk6tNP0MvUrojhDAp5XN0xppOyLrtDujHJXaLzUaDzxAvcFR-DM7cw3iBZ6s0DKHSwecYrIUR52iUxWHCUGwr-LAknE8QXXlVg1XZBI-_mXzCIf6qYcl4DtaMQSsf7OOcMzqGKShXqKCyKxNg4_FcIKVNO-a4STip-bSHVigW43VwM2TwGnAZGK8mmcECXlU0OiRTCOklejYpm-DV73qOvn788OXqprr9fP3p6vK20jWvc8U70QnNGjZINrXDyLRqJzFMI1ctq4FKonkzSsq4Ym0NktW0NBPVRAvB246fo_c7d14GB-O2yKhsP0fjVPzeB2X6vxVvTv0xrL2oiWhrUgBkB5R1pBRheshS0m9n7v89c4m8efznQ-DPXYuh2g1JHaG_C0v0ZQf_B_4EmSS4uw</recordid><startdate>20170501</startdate><enddate>20170501</enddate><creator>Vasquez, Michael</creator><creator>Gasparis, Antonios P</creator><general>SAGE Publications</general><scope>AFRWT</scope><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>5PM</scope></search><sort><creationdate>20170501</creationdate><title>A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities</title><author>Vasquez, Michael ; Gasparis, Antonios P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c434t-39595c262b72f8bd2ca8f5bfd3a824e170c36d7123a284e7241a28f1c0c553893</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Endovascular Procedures</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Original</topic><topic>Polyethylene Glycols - administration & dosage</topic><topic>Saphenous Vein</topic><topic>Thrombophlebitis - therapy</topic><topic>Varicose Veins - therapy</topic><topic>Venous Insufficiency - therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vasquez, Michael</creatorcontrib><creatorcontrib>Gasparis, Antonios P</creatorcontrib><creatorcontrib>Varithena® 017 Investigator Group</creatorcontrib><creatorcontrib>on behalf of the Varithena® 017 Investigator Group</creatorcontrib><collection>Sage Journals GOLD Open Access 2024</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Phlebology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vasquez, Michael</au><au>Gasparis, Antonios P</au><aucorp>Varithena® 017 Investigator Group</aucorp><aucorp>on behalf of the Varithena® 017 Investigator Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities</atitle><jtitle>Phlebology</jtitle><addtitle>Phlebology</addtitle><date>2017-05-01</date><risdate>2017</risdate><volume>32</volume><issue>4</issue><spage>272</spage><epage>281</epage><pages>272-281</pages><issn>0268-3555</issn><eissn>1758-1125</eissn><abstract>Objectives
*
Varithena 017 Investigator Group: Michael Vasquez, MD, Venous Institute of Buffalo, Amherst, NY; Antonios Gasparis, MD, Stony Brook University Medical Center, Stony Brook, NY; Kathleen Gibson, MD, Lake Washington Vascular, Bellevue, WA; James Theodore King, MD, Vein Clinics of America, Oakbrook Terrace, IL; Nick Morrison, MD, Morrison Vein Institute, Scottsdale, AZ; Girish Munavalli, MD, Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC; Eulogio J. Sanchez, MD, Batey Cardiovascular Center, Bradenton, FL. Varithena® is a trademark of Provensis Ltd, a BTG International group company.
To determine the efficacy and safety of polidocanol endovenous microfoam (PEM 0.5%, 1.0%) and placebo each administered with endovenous thermal ablation.
Methods
A multicenter, randomized, placebo-controlled, blinded study was conducted in patients with great saphenous vein incompetence and symptomatic and visible superficial venous disease. Co-primary endpoints were physician-assessed and patient-assessed appearance change from Baseline to Week 8.
Results
A total of 117 patients received treatment (38 placebo, 39 PEM 0.5%, 40 PEM 1%). Physician-rated vein appearance at Week 8 was significantly better with PEM (p = 0.001 vs. placebo); patient-assessed appearance trended similarly. Polidocanol endovenous microfoam provided improvements in clinically meaningful change in patient-assessed and physician-assessed appearance (p < 0.05), need for additional treatment (p < 0.05), saphenofemoral junction reflux elimination, symptoms, and QOL. In PEM recipients, the most frequent adverse event was superficial thrombophlebitis (35.4%)
Conclusions
Endovenous thermal ablation + PEM significantly improved physician-assessed appearance at Week 8, increased the proportion of patients with a clinically meaningful change in appearance, and reduced need for additional treatment. www.clinicaltrials.gov (NCT01197833)</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>26957489</pmid><doi>10.1177/0268355516637300</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0268-3555 |
| ispartof | Phlebology, 2017-05, Vol.32 (4), p.272-281 |
| issn | 0268-3555 1758-1125 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5405840 |
| source | MEDLINE; SAGE Complete A-Z List |
| subjects | Adult Aged Endovascular Procedures Female Humans Male Middle Aged Original Polyethylene Glycols - administration & dosage Saphenous Vein Thrombophlebitis - therapy Varicose Veins - therapy Venous Insufficiency - therapy |
| title | A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities |
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