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Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease

Objective The predominant mode of bare nitinol stent failure is diffuse in-stent restenosis, and failure rates correlate to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene lining to a nitinol stent frame, as found in the VIABAHN endoprosthesis, mitiga...

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Published in:Journal of vascular surgery 2013-08, Vol.58 (2), p.386-395.e4
Main Authors: Geraghty, Patrick J., MD, Mewissen, Mark W., MD, Jaff, Michael R., DO, Ansel, Gary M., MD
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description Objective The predominant mode of bare nitinol stent failure is diffuse in-stent restenosis, and failure rates correlate to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene lining to a nitinol stent frame, as found in the VIABAHN endoprosthesis, mitigates the ingrowth of intimal hyperplasia. We compared the long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endoprosthesis to those obtained with bare nitinol stent implantation. Methods One hundred forty-eight patients with symptomatic complex superficial femoral artery disease (TransAtlantic Inter-Society Consensus I class C and D lesions, accompanied by intermittent claudication or ischemic rest pain) were randomized to endovascular intervention using either bare nitinol stent implantation (76 patients) or nonheparin-bonded VIABAHN endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life were evaluated at 1, 6, 12, 24, and 36 months following intervention. Results The average treated lesion measured 18 ± 8 cm in length, and 58.8% of lesions displayed segmental or complete occlusion. At 3 years, primary patency rates (defined by peak systolic velocity ratio ≤2.0 and no target lesion revascularization) did not significantly differ between patients treated with the VIABAHN stent graft and those who received a bare nitinol stent (24.2% vs 25.9%; P  = .392). Stent fractures were significantly more common in bare nitinol stents (50.0%) than in the VIABAHN endoprostheses (2.6%). Primary-assisted patency rates were higher in those receiving bare nitinol stents than the VIABAHN stent graft (88.8% vs 69.8%; P  = .04), although secondary patency rates did not differ between bare nitinol stent and stent graft recipients (89.3% vs 79.5%; P  = .304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups. Conclusions The long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endograft and bare nitinol stents are similar. Although primary patency rates are low in both study arms, excellent primary-assisted and secondary patency rates were achieved, with sustained augmentation of limb perfusion and quality-of-life measures. Patency rates diminish most rapidly in the first year after device implantation.
doi_str_mv 10.1016/j.jvs.2013.01.050
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Addition of an expanded polytetrafluoroethylene lining to a nitinol stent frame, as found in the VIABAHN endoprosthesis, mitigates the ingrowth of intimal hyperplasia. We compared the long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endoprosthesis to those obtained with bare nitinol stent implantation. Methods One hundred forty-eight patients with symptomatic complex superficial femoral artery disease (TransAtlantic Inter-Society Consensus I class C and D lesions, accompanied by intermittent claudication or ischemic rest pain) were randomized to endovascular intervention using either bare nitinol stent implantation (76 patients) or nonheparin-bonded VIABAHN endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life were evaluated at 1, 6, 12, 24, and 36 months following intervention. Results The average treated lesion measured 18 ± 8 cm in length, and 58.8% of lesions displayed segmental or complete occlusion. At 3 years, primary patency rates (defined by peak systolic velocity ratio ≤2.0 and no target lesion revascularization) did not significantly differ between patients treated with the VIABAHN stent graft and those who received a bare nitinol stent (24.2% vs 25.9%; P  = .392). Stent fractures were significantly more common in bare nitinol stents (50.0%) than in the VIABAHN endoprostheses (2.6%). Primary-assisted patency rates were higher in those receiving bare nitinol stents than the VIABAHN stent graft (88.8% vs 69.8%; P  = .04), although secondary patency rates did not differ between bare nitinol stent and stent graft recipients (89.3% vs 79.5%; P  = .304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups. Conclusions The long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endograft and bare nitinol stents are similar. Although primary patency rates are low in both study arms, excellent primary-assisted and secondary patency rates were achieved, with sustained augmentation of limb perfusion and quality-of-life measures. Patency rates diminish most rapidly in the first year after device implantation.</description><identifier>ISSN: 0741-5214</identifier><identifier>EISSN: 1097-6809</identifier><identifier>DOI: 10.1016/j.jvs.2013.01.050</identifier><identifier>PMID: 23676191</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Alloys ; Arterial Occlusive Diseases - diagnosis ; Arterial Occlusive Diseases - physiopathology ; Arterial Occlusive Diseases - surgery ; Blood Vessel Prosthesis ; Blood Vessel Prosthesis Implantation - adverse effects ; Blood Vessel Prosthesis Implantation - instrumentation ; Constriction, Pathologic ; Endovascular Procedures - adverse effects ; Endovascular Procedures - instrumentation ; Female ; Femoral Artery - physiopathology ; Femoral Artery - surgery ; Graft Occlusion, Vascular - etiology ; Graft Occlusion, Vascular - physiopathology ; Graft Occlusion, Vascular - therapy ; Hemodynamics ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Polytetrafluoroethylene ; Prosthesis Design ; Prosthesis Failure ; Quality of Life ; Stents ; Surgery ; Time Factors ; Treatment Outcome ; United States ; Vascular Patency</subject><ispartof>Journal of vascular surgery, 2013-08, Vol.58 (2), p.386-395.e4</ispartof><rights>Society for Vascular Surgery</rights><rights>2013 Society for Vascular Surgery</rights><rights>Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c517t-18f7a84ce3d27a552cb008b42f2dc430684276b1fd9b962595eca6cfcf477ade3</citedby><cites>FETCH-LOGICAL-c517t-18f7a84ce3d27a552cb008b42f2dc430684276b1fd9b962595eca6cfcf477ade3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23676191$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Geraghty, Patrick J., MD</creatorcontrib><creatorcontrib>Mewissen, Mark W., MD</creatorcontrib><creatorcontrib>Jaff, Michael R., DO</creatorcontrib><creatorcontrib>Ansel, Gary M., MD</creatorcontrib><creatorcontrib>VIBRANT Investigators</creatorcontrib><title>Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease</title><title>Journal of vascular surgery</title><addtitle>J Vasc Surg</addtitle><description>Objective The predominant mode of bare nitinol stent failure is diffuse in-stent restenosis, and failure rates correlate to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene lining to a nitinol stent frame, as found in the VIABAHN endoprosthesis, mitigates the ingrowth of intimal hyperplasia. We compared the long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endoprosthesis to those obtained with bare nitinol stent implantation. Methods One hundred forty-eight patients with symptomatic complex superficial femoral artery disease (TransAtlantic Inter-Society Consensus I class C and D lesions, accompanied by intermittent claudication or ischemic rest pain) were randomized to endovascular intervention using either bare nitinol stent implantation (76 patients) or nonheparin-bonded VIABAHN endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life were evaluated at 1, 6, 12, 24, and 36 months following intervention. Results The average treated lesion measured 18 ± 8 cm in length, and 58.8% of lesions displayed segmental or complete occlusion. At 3 years, primary patency rates (defined by peak systolic velocity ratio ≤2.0 and no target lesion revascularization) did not significantly differ between patients treated with the VIABAHN stent graft and those who received a bare nitinol stent (24.2% vs 25.9%; P  = .392). Stent fractures were significantly more common in bare nitinol stents (50.0%) than in the VIABAHN endoprostheses (2.6%). Primary-assisted patency rates were higher in those receiving bare nitinol stents than the VIABAHN stent graft (88.8% vs 69.8%; P  = .04), although secondary patency rates did not differ between bare nitinol stent and stent graft recipients (89.3% vs 79.5%; P  = .304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups. Conclusions The long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endograft and bare nitinol stents are similar. Although primary patency rates are low in both study arms, excellent primary-assisted and secondary patency rates were achieved, with sustained augmentation of limb perfusion and quality-of-life measures. Patency rates diminish most rapidly in the first year after device implantation.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Alloys</subject><subject>Arterial Occlusive Diseases - diagnosis</subject><subject>Arterial Occlusive Diseases - physiopathology</subject><subject>Arterial Occlusive Diseases - surgery</subject><subject>Blood Vessel Prosthesis</subject><subject>Blood Vessel Prosthesis Implantation - adverse effects</subject><subject>Blood Vessel Prosthesis Implantation - instrumentation</subject><subject>Constriction, Pathologic</subject><subject>Endovascular Procedures - adverse effects</subject><subject>Endovascular Procedures - instrumentation</subject><subject>Female</subject><subject>Femoral Artery - physiopathology</subject><subject>Femoral Artery - surgery</subject><subject>Graft Occlusion, Vascular - etiology</subject><subject>Graft Occlusion, Vascular - physiopathology</subject><subject>Graft Occlusion, Vascular - therapy</subject><subject>Hemodynamics</subject><subject>Humans</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Polytetrafluoroethylene</subject><subject>Prosthesis Design</subject><subject>Prosthesis Failure</subject><subject>Quality of Life</subject><subject>Stents</subject><subject>Surgery</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>United States</subject><subject>Vascular Patency</subject><issn>0741-5214</issn><issn>1097-6809</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><recordid>eNp9kk9rFEEQxQdRzCb6AbxIH73M2NXzH0HYhJgshAi65tr09FSTHmen166exf04flN72OjBg6eC4r0Hr36VJG-AZ8Chej9kw4EywSHPOGS85M-SFfC2TquGt8-TFa8LSEsBxVlyTjRwDlA29cvkTORVXUELq-TX9tEjpkdUnnmkeQzEnGHhEdnD5vLL-n7LgrdqXJYPm_Xl-vae4dS7vXcURWSJHdDTTKxTHtlkg53cyCjgFJjd7Uc1BRWsm5hxnmkXN_iT0bxHb6xegg3unI9T-YD-yJzW40z2gKy3hIrwVfLCqJHw9dO8SL59ut5e3aZ3n282V-u7VJdQhxQaU6um0Jj3olZlKXTHedMVwoheFzmvmkLUVQemb7u2EmVbolaVNtoUda16zC-Sd6fcWO3HjBTkzpLGMTZAN5OEAsqKVwB5lMJJquMVyKORe293yh8lcLmQkYOMZORCRnKQkUz0vH2Kn7sd9n8df1BEwYeTAGPJg0UvSVucNPbWow6yd_a_8R__cevRTlar8TsekQY3-yleT4IkIbn8urzG8hmQcy5y3ua_AW-Ittg</recordid><startdate>20130801</startdate><enddate>20130801</enddate><creator>Geraghty, Patrick J., MD</creator><creator>Mewissen, Mark W., MD</creator><creator>Jaff, Michael R., DO</creator><creator>Ansel, Gary M., MD</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</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>7X8</scope></search><sort><creationdate>20130801</creationdate><title>Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease</title><author>Geraghty, Patrick J., MD ; Mewissen, Mark W., MD ; Jaff, Michael R., DO ; Ansel, Gary M., MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c517t-18f7a84ce3d27a552cb008b42f2dc430684276b1fd9b962595eca6cfcf477ade3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Alloys</topic><topic>Arterial Occlusive Diseases - diagnosis</topic><topic>Arterial Occlusive Diseases - physiopathology</topic><topic>Arterial Occlusive Diseases - surgery</topic><topic>Blood Vessel Prosthesis</topic><topic>Blood Vessel Prosthesis Implantation - adverse effects</topic><topic>Blood Vessel Prosthesis Implantation - instrumentation</topic><topic>Constriction, Pathologic</topic><topic>Endovascular Procedures - adverse effects</topic><topic>Endovascular Procedures - instrumentation</topic><topic>Female</topic><topic>Femoral Artery - physiopathology</topic><topic>Femoral Artery - surgery</topic><topic>Graft Occlusion, Vascular - etiology</topic><topic>Graft Occlusion, Vascular - physiopathology</topic><topic>Graft Occlusion, Vascular - therapy</topic><topic>Hemodynamics</topic><topic>Humans</topic><topic>Kaplan-Meier Estimate</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Polytetrafluoroethylene</topic><topic>Prosthesis Design</topic><topic>Prosthesis Failure</topic><topic>Quality of Life</topic><topic>Stents</topic><topic>Surgery</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>United States</topic><topic>Vascular Patency</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Geraghty, Patrick J., MD</creatorcontrib><creatorcontrib>Mewissen, Mark W., MD</creatorcontrib><creatorcontrib>Jaff, Michael R., DO</creatorcontrib><creatorcontrib>Ansel, Gary M., MD</creatorcontrib><creatorcontrib>VIBRANT Investigators</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><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>Journal of vascular surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Geraghty, Patrick J., MD</au><au>Mewissen, Mark W., MD</au><au>Jaff, Michael R., DO</au><au>Ansel, Gary M., MD</au><aucorp>VIBRANT Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease</atitle><jtitle>Journal of vascular surgery</jtitle><addtitle>J Vasc Surg</addtitle><date>2013-08-01</date><risdate>2013</risdate><volume>58</volume><issue>2</issue><spage>386</spage><epage>395.e4</epage><pages>386-395.e4</pages><issn>0741-5214</issn><eissn>1097-6809</eissn><abstract>Objective The predominant mode of bare nitinol stent failure is diffuse in-stent restenosis, and failure rates correlate to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene lining to a nitinol stent frame, as found in the VIABAHN endoprosthesis, mitigates the ingrowth of intimal hyperplasia. We compared the long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endoprosthesis to those obtained with bare nitinol stent implantation. Methods One hundred forty-eight patients with symptomatic complex superficial femoral artery disease (TransAtlantic Inter-Society Consensus I class C and D lesions, accompanied by intermittent claudication or ischemic rest pain) were randomized to endovascular intervention using either bare nitinol stent implantation (76 patients) or nonheparin-bonded VIABAHN endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life were evaluated at 1, 6, 12, 24, and 36 months following intervention. Results The average treated lesion measured 18 ± 8 cm in length, and 58.8% of lesions displayed segmental or complete occlusion. At 3 years, primary patency rates (defined by peak systolic velocity ratio ≤2.0 and no target lesion revascularization) did not significantly differ between patients treated with the VIABAHN stent graft and those who received a bare nitinol stent (24.2% vs 25.9%; P  = .392). Stent fractures were significantly more common in bare nitinol stents (50.0%) than in the VIABAHN endoprostheses (2.6%). Primary-assisted patency rates were higher in those receiving bare nitinol stents than the VIABAHN stent graft (88.8% vs 69.8%; P  = .04), although secondary patency rates did not differ between bare nitinol stent and stent graft recipients (89.3% vs 79.5%; P  = .304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups. Conclusions The long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endograft and bare nitinol stents are similar. Although primary patency rates are low in both study arms, excellent primary-assisted and secondary patency rates were achieved, with sustained augmentation of limb perfusion and quality-of-life measures. Patency rates diminish most rapidly in the first year after device implantation.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>23676191</pmid><doi>10.1016/j.jvs.2013.01.050</doi><oa>free_for_read</oa></addata></record>
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subjects Adult
Aged
Aged, 80 and over
Alloys
Arterial Occlusive Diseases - diagnosis
Arterial Occlusive Diseases - physiopathology
Arterial Occlusive Diseases - surgery
Blood Vessel Prosthesis
Blood Vessel Prosthesis Implantation - adverse effects
Blood Vessel Prosthesis Implantation - instrumentation
Constriction, Pathologic
Endovascular Procedures - adverse effects
Endovascular Procedures - instrumentation
Female
Femoral Artery - physiopathology
Femoral Artery - surgery
Graft Occlusion, Vascular - etiology
Graft Occlusion, Vascular - physiopathology
Graft Occlusion, Vascular - therapy
Hemodynamics
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Polytetrafluoroethylene
Prosthesis Design
Prosthesis Failure
Quality of Life
Stents
Surgery
Time Factors
Treatment Outcome
United States
Vascular Patency
title Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease
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