Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the Vienna-3 randomised multicenter study
The aim of the trial was to investigate the effect of Iridium-192 gamma endovascular brachytherapy on reduction of restenosis after femoropopliteal angioplasty. Between Oct, 1998 and Jul, 2001 a total of 134 patients have been randomized after successful angioplasty to brachytherapy or sham irradiat...
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| Veröffentlicht in: | Radiotherapy and oncology 2005, Vol.74 (1), p.3-9 |
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| creator | Pokrajac, Boris Pötter, Richard Wolfram, Roswitha M. Budinsky, Alexandra C. Kirisits, Christian Lileg, Brigitte Mendel, Helmuth Sabeti, Schila Schmid, Rainer Minar, Erich |
| description | The aim of the trial was to investigate the effect of Iridium-192 gamma endovascular brachytherapy on reduction of restenosis after femoropopliteal angioplasty.
Between Oct, 1998 and Jul, 2001 a total of 134 patients have been randomized after successful angioplasty to brachytherapy or sham irradiation in a prospective, randomized, multicenter, double blind controlled trial. Patients with de novo lesion of at least 5
cm or recurrent lesion of any length after prior angioplasty have been enrolled. Brachytherapy was performed with 7
F centering catheter. Mean lesion length was 9.1
cm (1.5–25
cm) and mean intervention length 13.6
cm (4–27.5
cm) in brachytherapy cohort.
In placebo cohort mean lesion length was 10.3
cm (2–25
cm) and mean intervention length 14.1
cm (2–29
cm). A dose of 18
Gy was prescribed 2
mm from the surface of centering balloons. Analyzed (based on angiography) on intention to treat basis the binary restenosis rate at 12 months was 41.7% (28/67) in brachytherapy cohort and 67.1% (45/67) in placebo cohort (
χ
2 test,
P30% residual stenosis after angioplasty) have been 23.4% in the brachytherapy and 53.3% in the placebo group (
P |
| doi_str_mv | 10.1016/j.radonc.2004.08.015 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_67399464</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0167814004003706</els_id><sourcerecordid>67399464</sourcerecordid><originalsourceid>FETCH-LOGICAL-c360t-5ac5ab54b515f31b350034434a7147da0326015c3e8e629b38ebfc725b9ddc0a3</originalsourceid><addsrcrecordid>eNp9kE2L1TAUhoMoznX0H4hk5a71pEnT1oUgw_gBA27UbThNTp1c2qYm7YX-AX-3udwL7lyFA8_7npyHsdcCSgFCvzuWEV2YbVkBqBLaEkT9hB1E23QFtG3zlB0y1hStUHDDXqR0BIAKZPOc3Yhat1JrcWB_7mcXTpjsNmLkfUT7uK-PFHHZ-RLpRPOaeKS00hySTxyHlSIfaAoxLGEZ_Uo4cpx_-TxgWvf3Z3obcyoMPDfxn57mGQvJI-ZVk0_k-JQBb3N37krr5vaX7NmAY6JX1_eW_fh0__3uS_Hw7fPXu48PhZUa1qJGW2Nfq74W9SBFL2sAqZRU2AjVOARZ6azBSmpJV10vW-oH21R13zlnAeUte3vpXWL4veWzTP6QpXHEmcKWjG5k1ymtMqguoI0hpUiDWaKfMO5GgDn7N0dz8W_O_g20Ji_OsTfX_q2fyP0LXYVn4MMFoHzlyVM0yWZBlpyPZFfjgv__hr9UZ5yv</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>67399464</pqid></control><display><type>article</type><title>Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the Vienna-3 randomised multicenter study</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Pokrajac, Boris ; Pötter, Richard ; Wolfram, Roswitha M. ; Budinsky, Alexandra C. ; Kirisits, Christian ; Lileg, Brigitte ; Mendel, Helmuth ; Sabeti, Schila ; Schmid, Rainer ; Minar, Erich</creator><creatorcontrib>Pokrajac, Boris ; Pötter, Richard ; Wolfram, Roswitha M. ; Budinsky, Alexandra C. ; Kirisits, Christian ; Lileg, Brigitte ; Mendel, Helmuth ; Sabeti, Schila ; Schmid, Rainer ; Minar, Erich</creatorcontrib><description>The aim of the trial was to investigate the effect of Iridium-192 gamma endovascular brachytherapy on reduction of restenosis after femoropopliteal angioplasty.
Between Oct, 1998 and Jul, 2001 a total of 134 patients have been randomized after successful angioplasty to brachytherapy or sham irradiation in a prospective, randomized, multicenter, double blind controlled trial. Patients with de novo lesion of at least 5
cm or recurrent lesion of any length after prior angioplasty have been enrolled. Brachytherapy was performed with 7
F centering catheter. Mean lesion length was 9.1
cm (1.5–25
cm) and mean intervention length 13.6
cm (4–27.5
cm) in brachytherapy cohort.
In placebo cohort mean lesion length was 10.3
cm (2–25
cm) and mean intervention length 14.1
cm (2–29
cm). A dose of 18
Gy was prescribed 2
mm from the surface of centering balloons. Analyzed (based on angiography) on intention to treat basis the binary restenosis rate at 12 months was 41.7% (28/67) in brachytherapy cohort and 67.1% (45/67) in placebo cohort (
χ
2 test,
P<0.05). Corresponding data for as treated analysis (A total of 38 patients was excluded from analysis due to lack of follow-up, early recurrence within 30 days and >30% residual stenosis after angioplasty) have been 23.4% in the brachytherapy and 53.3% in the placebo group (
P<0.05), respectively. The cumulative patency rates after 24 months on intention to treat analysis were 54% in the brachytherapy and 27% in the placebo group (
P<0.005). Corresponding data for as treated analysis were 77% in the brachytherapy and 39% in the placebo group (
P<0.001). Late thrombosis was not seen.
Significant reduction of restenosis rate was obtained with endovascular gamma brachytherapy after femoropopliteal angioplasty.</description><identifier>ISSN: 0167-8140</identifier><identifier>EISSN: 1879-0887</identifier><identifier>DOI: 10.1016/j.radonc.2004.08.015</identifier><identifier>PMID: 15683661</identifier><language>eng</language><publisher>Ireland: Elsevier Ireland Ltd</publisher><subject>Aged ; Angioplasty ; Angioplasty, Balloon ; Brachytherapy ; Brachytherapy - methods ; Double-Blind Method ; Female ; Femoral Artery - pathology ; Femoral Artery - surgery ; Graft Occlusion, Vascular - prevention & control ; Graft Occlusion, Vascular - radiotherapy ; Humans ; Iridium Radioisotopes - therapeutic use ; Male ; Middle Aged ; Peripheral vascular disease ; Placebos ; Popliteal Artery - pathology ; Popliteal Artery - surgery ; Restenosis ; Treatment Outcome</subject><ispartof>Radiotherapy and oncology, 2005, Vol.74 (1), p.3-9</ispartof><rights>2004 Elsevier Ireland Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c360t-5ac5ab54b515f31b350034434a7147da0326015c3e8e629b38ebfc725b9ddc0a3</citedby><cites>FETCH-LOGICAL-c360t-5ac5ab54b515f31b350034434a7147da0326015c3e8e629b38ebfc725b9ddc0a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0167814004003706$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,4010,27900,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15683661$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pokrajac, Boris</creatorcontrib><creatorcontrib>Pötter, Richard</creatorcontrib><creatorcontrib>Wolfram, Roswitha M.</creatorcontrib><creatorcontrib>Budinsky, Alexandra C.</creatorcontrib><creatorcontrib>Kirisits, Christian</creatorcontrib><creatorcontrib>Lileg, Brigitte</creatorcontrib><creatorcontrib>Mendel, Helmuth</creatorcontrib><creatorcontrib>Sabeti, Schila</creatorcontrib><creatorcontrib>Schmid, Rainer</creatorcontrib><creatorcontrib>Minar, Erich</creatorcontrib><title>Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the Vienna-3 randomised multicenter study</title><title>Radiotherapy and oncology</title><addtitle>Radiother Oncol</addtitle><description>The aim of the trial was to investigate the effect of Iridium-192 gamma endovascular brachytherapy on reduction of restenosis after femoropopliteal angioplasty.
Between Oct, 1998 and Jul, 2001 a total of 134 patients have been randomized after successful angioplasty to brachytherapy or sham irradiation in a prospective, randomized, multicenter, double blind controlled trial. Patients with de novo lesion of at least 5
cm or recurrent lesion of any length after prior angioplasty have been enrolled. Brachytherapy was performed with 7
F centering catheter. Mean lesion length was 9.1
cm (1.5–25
cm) and mean intervention length 13.6
cm (4–27.5
cm) in brachytherapy cohort.
In placebo cohort mean lesion length was 10.3
cm (2–25
cm) and mean intervention length 14.1
cm (2–29
cm). A dose of 18
Gy was prescribed 2
mm from the surface of centering balloons. Analyzed (based on angiography) on intention to treat basis the binary restenosis rate at 12 months was 41.7% (28/67) in brachytherapy cohort and 67.1% (45/67) in placebo cohort (
χ
2 test,
P<0.05). Corresponding data for as treated analysis (A total of 38 patients was excluded from analysis due to lack of follow-up, early recurrence within 30 days and >30% residual stenosis after angioplasty) have been 23.4% in the brachytherapy and 53.3% in the placebo group (
P<0.05), respectively. The cumulative patency rates after 24 months on intention to treat analysis were 54% in the brachytherapy and 27% in the placebo group (
P<0.005). Corresponding data for as treated analysis were 77% in the brachytherapy and 39% in the placebo group (
P<0.001). Late thrombosis was not seen.
Significant reduction of restenosis rate was obtained with endovascular gamma brachytherapy after femoropopliteal angioplasty.</description><subject>Aged</subject><subject>Angioplasty</subject><subject>Angioplasty, Balloon</subject><subject>Brachytherapy</subject><subject>Brachytherapy - methods</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Femoral Artery - pathology</subject><subject>Femoral Artery - surgery</subject><subject>Graft Occlusion, Vascular - prevention & control</subject><subject>Graft Occlusion, Vascular - radiotherapy</subject><subject>Humans</subject><subject>Iridium Radioisotopes - therapeutic use</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Peripheral vascular disease</subject><subject>Placebos</subject><subject>Popliteal Artery - pathology</subject><subject>Popliteal Artery - surgery</subject><subject>Restenosis</subject><subject>Treatment Outcome</subject><issn>0167-8140</issn><issn>1879-0887</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kE2L1TAUhoMoznX0H4hk5a71pEnT1oUgw_gBA27UbThNTp1c2qYm7YX-AX-3udwL7lyFA8_7npyHsdcCSgFCvzuWEV2YbVkBqBLaEkT9hB1E23QFtG3zlB0y1hStUHDDXqR0BIAKZPOc3Yhat1JrcWB_7mcXTpjsNmLkfUT7uK-PFHHZ-RLpRPOaeKS00hySTxyHlSIfaAoxLGEZ_Uo4cpx_-TxgWvf3Z3obcyoMPDfxn57mGQvJI-ZVk0_k-JQBb3N37krr5vaX7NmAY6JX1_eW_fh0__3uS_Hw7fPXu48PhZUa1qJGW2Nfq74W9SBFL2sAqZRU2AjVOARZ6azBSmpJV10vW-oH21R13zlnAeUte3vpXWL4veWzTP6QpXHEmcKWjG5k1ymtMqguoI0hpUiDWaKfMO5GgDn7N0dz8W_O_g20Ji_OsTfX_q2fyP0LXYVn4MMFoHzlyVM0yWZBlpyPZFfjgv__hr9UZ5yv</recordid><startdate>2005</startdate><enddate>2005</enddate><creator>Pokrajac, Boris</creator><creator>Pötter, Richard</creator><creator>Wolfram, Roswitha M.</creator><creator>Budinsky, Alexandra C.</creator><creator>Kirisits, Christian</creator><creator>Lileg, Brigitte</creator><creator>Mendel, Helmuth</creator><creator>Sabeti, Schila</creator><creator>Schmid, Rainer</creator><creator>Minar, Erich</creator><general>Elsevier Ireland Ltd</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>7X8</scope></search><sort><creationdate>2005</creationdate><title>Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the Vienna-3 randomised multicenter study</title><author>Pokrajac, Boris ; Pötter, Richard ; Wolfram, Roswitha M. ; Budinsky, Alexandra C. ; Kirisits, Christian ; Lileg, Brigitte ; Mendel, Helmuth ; Sabeti, Schila ; Schmid, Rainer ; Minar, Erich</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c360t-5ac5ab54b515f31b350034434a7147da0326015c3e8e629b38ebfc725b9ddc0a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Aged</topic><topic>Angioplasty</topic><topic>Angioplasty, Balloon</topic><topic>Brachytherapy</topic><topic>Brachytherapy - methods</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Femoral Artery - pathology</topic><topic>Femoral Artery - surgery</topic><topic>Graft Occlusion, Vascular - prevention & control</topic><topic>Graft Occlusion, Vascular - radiotherapy</topic><topic>Humans</topic><topic>Iridium Radioisotopes - therapeutic use</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Peripheral vascular disease</topic><topic>Placebos</topic><topic>Popliteal Artery - pathology</topic><topic>Popliteal Artery - surgery</topic><topic>Restenosis</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pokrajac, Boris</creatorcontrib><creatorcontrib>Pötter, Richard</creatorcontrib><creatorcontrib>Wolfram, Roswitha M.</creatorcontrib><creatorcontrib>Budinsky, Alexandra C.</creatorcontrib><creatorcontrib>Kirisits, Christian</creatorcontrib><creatorcontrib>Lileg, Brigitte</creatorcontrib><creatorcontrib>Mendel, Helmuth</creatorcontrib><creatorcontrib>Sabeti, Schila</creatorcontrib><creatorcontrib>Schmid, Rainer</creatorcontrib><creatorcontrib>Minar, Erich</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Radiotherapy and oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pokrajac, Boris</au><au>Pötter, Richard</au><au>Wolfram, Roswitha M.</au><au>Budinsky, Alexandra C.</au><au>Kirisits, Christian</au><au>Lileg, Brigitte</au><au>Mendel, Helmuth</au><au>Sabeti, Schila</au><au>Schmid, Rainer</au><au>Minar, Erich</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the Vienna-3 randomised multicenter study</atitle><jtitle>Radiotherapy and oncology</jtitle><addtitle>Radiother Oncol</addtitle><date>2005</date><risdate>2005</risdate><volume>74</volume><issue>1</issue><spage>3</spage><epage>9</epage><pages>3-9</pages><issn>0167-8140</issn><eissn>1879-0887</eissn><abstract>The aim of the trial was to investigate the effect of Iridium-192 gamma endovascular brachytherapy on reduction of restenosis after femoropopliteal angioplasty.
Between Oct, 1998 and Jul, 2001 a total of 134 patients have been randomized after successful angioplasty to brachytherapy or sham irradiation in a prospective, randomized, multicenter, double blind controlled trial. Patients with de novo lesion of at least 5
cm or recurrent lesion of any length after prior angioplasty have been enrolled. Brachytherapy was performed with 7
F centering catheter. Mean lesion length was 9.1
cm (1.5–25
cm) and mean intervention length 13.6
cm (4–27.5
cm) in brachytherapy cohort.
In placebo cohort mean lesion length was 10.3
cm (2–25
cm) and mean intervention length 14.1
cm (2–29
cm). A dose of 18
Gy was prescribed 2
mm from the surface of centering balloons. Analyzed (based on angiography) on intention to treat basis the binary restenosis rate at 12 months was 41.7% (28/67) in brachytherapy cohort and 67.1% (45/67) in placebo cohort (
χ
2 test,
P<0.05). Corresponding data for as treated analysis (A total of 38 patients was excluded from analysis due to lack of follow-up, early recurrence within 30 days and >30% residual stenosis after angioplasty) have been 23.4% in the brachytherapy and 53.3% in the placebo group (
P<0.05), respectively. The cumulative patency rates after 24 months on intention to treat analysis were 54% in the brachytherapy and 27% in the placebo group (
P<0.005). Corresponding data for as treated analysis were 77% in the brachytherapy and 39% in the placebo group (
P<0.001). Late thrombosis was not seen.
Significant reduction of restenosis rate was obtained with endovascular gamma brachytherapy after femoropopliteal angioplasty.</abstract><cop>Ireland</cop><pub>Elsevier Ireland Ltd</pub><pmid>15683661</pmid><doi>10.1016/j.radonc.2004.08.015</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Radiotherapy and oncology, 2005, Vol.74 (1), p.3-9 |
| issn | 0167-8140 1879-0887 |
| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Aged Angioplasty Angioplasty, Balloon Brachytherapy Brachytherapy - methods Double-Blind Method Female Femoral Artery - pathology Femoral Artery - surgery Graft Occlusion, Vascular - prevention & control Graft Occlusion, Vascular - radiotherapy Humans Iridium Radioisotopes - therapeutic use Male Middle Aged Peripheral vascular disease Placebos Popliteal Artery - pathology Popliteal Artery - surgery Restenosis Treatment Outcome |
| title | Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the Vienna-3 randomised multicenter study |
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