Paclitaxel-Coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access: 6-Month Interim Results From a Prospective Randomized Controlled Trial
Purpose To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG). Methods The enrollment...
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| Veröffentlicht in: | Journal of endovascular therapy 2012-04, Vol.19 (2), p.263-272 |
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| creator | Katsanos, Konstantinos Karnabatidis, Dimitris Kitrou, Panagiotis Spiliopoulos, Stavros Christeas, Nikolaos Siablis, Dimitris |
| description | Purpose
To report the 6-month results of a prospective randomized trial investigating
angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon
angioplasty (BA) for the treatment of failing native arteriovenous fistulae
(AVF) or prosthetic arteriovenous grafts (AVG).
Methods
The enrollment criteria for this non-inferiority hypothesis trial included
clinical signs of failing dialysis access with angiographic documentation of
a significant venous stenotic lesion in patients with AVF or AVG circuits.
From March to December 2010, 40 patients (29 men; mean age 64.1±14.3
years) were randomized to undergo either PCB dilation (n=20) or
standard BA (n=20) of a stenosed venous outflow lesion. Regular
angiographic follow-up was scheduled bimonthly. Study outcome measures
included device success ( |
| doi_str_mv | 10.1583/11-3690.1 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1010638067</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1583_11-3690.1</sage_id><sourcerecordid>1010638067</sourcerecordid><originalsourceid>FETCH-LOGICAL-c410t-402e94dfdd101b62cfb2566a83025fca77c1140271c73f048b680a9d1c4a33bc3</originalsourceid><addsrcrecordid>eNplkdFu0zAUhiPExMbgghdAlpAQu8jwsR0n5a4Uuk0aoprKdXTiOJ0nxy62M1Hei_fDVceE4Mq_5c_fOfYpildAz6Fq-HuAkstZ3jwpTqASVQlVRZ_uM5OlpKw5Lp7HeEcpAwbwrDhmLFPNTJwUv1aorEn4Q9ty4THpnnxEa713ZO42xm8txrQj9_GcrCwa93j6yVhMJofBB5JuNVkHjWnULhE_kCUaa9wmU2h30UQyV0rH-IHI8ot36ZZcuaSDGcmNjpNNkSyDHwmSVfBxq1Uy95rcoOv9aH7mlhb5TvDW5rgOWfmiOBrQRv3yYT0tvi0_rxeX5fXXi6vF_LpUAmgqBWV6Jvqh74FCJ5kaOlZJiQ2nrBoU1rUCyFANquYDFU0nG4qzHpRAzjvFT4t3B-82-O-TjqkdTVTaWnTaT7HNWip5Q2Wd0Tf_oHd-Ci531wIXTV0zEJCpswOl8kNj0EO7zb-AYZdV7X6WLUC7n2W7Z18_GKdu1P0j-Wd4GXh7ACJu9F_l_jP9BihIpes</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1348772141</pqid></control><display><type>article</type><title>Paclitaxel-Coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access: 6-Month Interim Results From a Prospective Randomized Controlled Trial</title><source>SAGE Complete A-Z List</source><source>MEDLINE</source><source>Alma/SFX Local Collection</source><creator>Katsanos, Konstantinos ; Karnabatidis, Dimitris ; Kitrou, Panagiotis ; Spiliopoulos, Stavros ; Christeas, Nikolaos ; Siablis, Dimitris</creator><creatorcontrib>Katsanos, Konstantinos ; Karnabatidis, Dimitris ; Kitrou, Panagiotis ; Spiliopoulos, Stavros ; Christeas, Nikolaos ; Siablis, Dimitris</creatorcontrib><description><![CDATA[Purpose
To report the 6-month results of a prospective randomized trial investigating
angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon
angioplasty (BA) for the treatment of failing native arteriovenous fistulae
(AVF) or prosthetic arteriovenous grafts (AVG).
Methods
The enrollment criteria for this non-inferiority hypothesis trial included
clinical signs of failing dialysis access with angiographic documentation of
a significant venous stenotic lesion in patients with AVF or AVG circuits.
From March to December 2010, 40 patients (29 men; mean age 64.1±14.3
years) were randomized to undergo either PCB dilation (n=20) or
standard BA (n=20) of a stenosed venous outflow lesion. Regular
angiographic follow-up was scheduled bimonthly. Study outcome measures
included device success (<30% residual stenosis without
postdilation), procedural success (<30% residual stenosis),
and primary patency of the treated lesion (<50% angiographic
restenosis and no need for any interim repeat procedures).
Results
Baseline and procedural variables were comparably distributed between both
groups. Device success was 9/20 (45%) for the PCB device vs. 20/20
(100%) for standard control BA (p<0.001). Procedural success
was 100% in both groups after further high-pressure post-dilation as
necessary. There were no major or minor complications in either group. At 6
months, cumulative target lesion primary patency was significantly higher
after PCB application (70% in PCB group vs. 25% in BA group,
p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006).
Conclusion
PCB angioplasty improves patency after angioplasty of venous stenoses of
failing vascular access used for dialysis.]]></description><identifier>ISSN: 1526-6028</identifier><identifier>EISSN: 1545-1550</identifier><identifier>DOI: 10.1583/11-3690.1</identifier><identifier>PMID: 22545894</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Aged ; Anatomy & physiology ; Angioplasty ; Angioplasty, Balloon - adverse effects ; Angioplasty, Balloon - instrumentation ; Arteriovenous Shunt, Surgical - adverse effects ; Blood Vessel Prosthesis Implantation - adverse effects ; Cardiovascular Agents - administration & dosage ; Catheters ; Cell cycle ; Cell division ; Constriction, Pathologic ; Drug Delivery Systems - instrumentation ; Drug dosages ; Equipment Design ; Family medical history ; Female ; Graft Occlusion, Vascular - diagnostic imaging ; Graft Occlusion, Vascular - etiology ; Graft Occlusion, Vascular - physiopathology ; Graft Occlusion, Vascular - therapy ; Greece ; Hemodialysis ; Humans ; Kaplan-Meier Estimate ; Kidney Failure, Chronic - therapy ; Male ; Middle Aged ; Mortality ; Paclitaxel - administration & dosage ; Patients ; Proportional Hazards Models ; Prospective Studies ; Prostheses ; Radiography ; Renal Dialysis ; Risk Assessment ; Risk Factors ; Stents ; Success ; Time Factors ; Treatment Outcome ; Vascular Patency ; Veins & arteries</subject><ispartof>Journal of endovascular therapy, 2012-04, Vol.19 (2), p.263-272</ispartof><rights>2012 International Society of Endovascular Specialists</rights><rights>Copyright Allen Press Publishing Services Apr 2012</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c410t-402e94dfdd101b62cfb2566a83025fca77c1140271c73f048b680a9d1c4a33bc3</citedby><cites>FETCH-LOGICAL-c410t-402e94dfdd101b62cfb2566a83025fca77c1140271c73f048b680a9d1c4a33bc3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1583/11-3690.1$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1583/11-3690.1$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,776,780,21798,27901,27902,43597,43598</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22545894$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Katsanos, Konstantinos</creatorcontrib><creatorcontrib>Karnabatidis, Dimitris</creatorcontrib><creatorcontrib>Kitrou, Panagiotis</creatorcontrib><creatorcontrib>Spiliopoulos, Stavros</creatorcontrib><creatorcontrib>Christeas, Nikolaos</creatorcontrib><creatorcontrib>Siablis, Dimitris</creatorcontrib><title>Paclitaxel-Coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access: 6-Month Interim Results From a Prospective Randomized Controlled Trial</title><title>Journal of endovascular therapy</title><addtitle>J Endovasc Ther</addtitle><description><![CDATA[Purpose
To report the 6-month results of a prospective randomized trial investigating
angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon
angioplasty (BA) for the treatment of failing native arteriovenous fistulae
(AVF) or prosthetic arteriovenous grafts (AVG).
Methods
The enrollment criteria for this non-inferiority hypothesis trial included
clinical signs of failing dialysis access with angiographic documentation of
a significant venous stenotic lesion in patients with AVF or AVG circuits.
From March to December 2010, 40 patients (29 men; mean age 64.1±14.3
years) were randomized to undergo either PCB dilation (n=20) or
standard BA (n=20) of a stenosed venous outflow lesion. Regular
angiographic follow-up was scheduled bimonthly. Study outcome measures
included device success (<30% residual stenosis without
postdilation), procedural success (<30% residual stenosis),
and primary patency of the treated lesion (<50% angiographic
restenosis and no need for any interim repeat procedures).
Results
Baseline and procedural variables were comparably distributed between both
groups. Device success was 9/20 (45%) for the PCB device vs. 20/20
(100%) for standard control BA (p<0.001). Procedural success
was 100% in both groups after further high-pressure post-dilation as
necessary. There were no major or minor complications in either group. At 6
months, cumulative target lesion primary patency was significantly higher
after PCB application (70% in PCB group vs. 25% in BA group,
p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006).
Conclusion
PCB angioplasty improves patency after angioplasty of venous stenoses of
failing vascular access used for dialysis.]]></description><subject>Aged</subject><subject>Anatomy & physiology</subject><subject>Angioplasty</subject><subject>Angioplasty, Balloon - adverse effects</subject><subject>Angioplasty, Balloon - instrumentation</subject><subject>Arteriovenous Shunt, Surgical - adverse effects</subject><subject>Blood Vessel Prosthesis Implantation - adverse effects</subject><subject>Cardiovascular Agents - administration & dosage</subject><subject>Catheters</subject><subject>Cell cycle</subject><subject>Cell division</subject><subject>Constriction, Pathologic</subject><subject>Drug Delivery Systems - instrumentation</subject><subject>Drug dosages</subject><subject>Equipment Design</subject><subject>Family medical history</subject><subject>Female</subject><subject>Graft Occlusion, Vascular - diagnostic imaging</subject><subject>Graft Occlusion, Vascular - etiology</subject><subject>Graft Occlusion, Vascular - physiopathology</subject><subject>Graft Occlusion, Vascular - therapy</subject><subject>Greece</subject><subject>Hemodialysis</subject><subject>Humans</subject><subject>Kaplan-Meier Estimate</subject><subject>Kidney Failure, Chronic - therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Paclitaxel - administration & dosage</subject><subject>Patients</subject><subject>Proportional Hazards Models</subject><subject>Prospective Studies</subject><subject>Prostheses</subject><subject>Radiography</subject><subject>Renal Dialysis</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Stents</subject><subject>Success</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Vascular Patency</subject><subject>Veins & arteries</subject><issn>1526-6028</issn><issn>1545-1550</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNplkdFu0zAUhiPExMbgghdAlpAQu8jwsR0n5a4Uuk0aoprKdXTiOJ0nxy62M1Hei_fDVceE4Mq_5c_fOfYpildAz6Fq-HuAkstZ3jwpTqASVQlVRZ_uM5OlpKw5Lp7HeEcpAwbwrDhmLFPNTJwUv1aorEn4Q9ty4THpnnxEa713ZO42xm8txrQj9_GcrCwa93j6yVhMJofBB5JuNVkHjWnULhE_kCUaa9wmU2h30UQyV0rH-IHI8ot36ZZcuaSDGcmNjpNNkSyDHwmSVfBxq1Uy95rcoOv9aH7mlhb5TvDW5rgOWfmiOBrQRv3yYT0tvi0_rxeX5fXXi6vF_LpUAmgqBWV6Jvqh74FCJ5kaOlZJiQ2nrBoU1rUCyFANquYDFU0nG4qzHpRAzjvFT4t3B-82-O-TjqkdTVTaWnTaT7HNWip5Q2Wd0Tf_oHd-Ci531wIXTV0zEJCpswOl8kNj0EO7zb-AYZdV7X6WLUC7n2W7Z18_GKdu1P0j-Wd4GXh7ACJu9F_l_jP9BihIpes</recordid><startdate>20120401</startdate><enddate>20120401</enddate><creator>Katsanos, Konstantinos</creator><creator>Karnabatidis, Dimitris</creator><creator>Kitrou, Panagiotis</creator><creator>Spiliopoulos, Stavros</creator><creator>Christeas, Nikolaos</creator><creator>Siablis, Dimitris</creator><general>SAGE Publications</general><general>Allen Press Inc</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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope></search><sort><creationdate>20120401</creationdate><title>Paclitaxel-Coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access: 6-Month Interim Results From a Prospective Randomized Controlled Trial</title><author>Katsanos, Konstantinos ; Karnabatidis, Dimitris ; Kitrou, Panagiotis ; Spiliopoulos, Stavros ; Christeas, Nikolaos ; Siablis, Dimitris</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c410t-402e94dfdd101b62cfb2566a83025fca77c1140271c73f048b680a9d1c4a33bc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Aged</topic><topic>Anatomy & physiology</topic><topic>Angioplasty</topic><topic>Angioplasty, Balloon - adverse effects</topic><topic>Angioplasty, Balloon - instrumentation</topic><topic>Arteriovenous Shunt, Surgical - adverse effects</topic><topic>Blood Vessel Prosthesis Implantation - adverse effects</topic><topic>Cardiovascular Agents - administration & dosage</topic><topic>Catheters</topic><topic>Cell cycle</topic><topic>Cell division</topic><topic>Constriction, Pathologic</topic><topic>Drug Delivery Systems - instrumentation</topic><topic>Drug dosages</topic><topic>Equipment Design</topic><topic>Family medical history</topic><topic>Female</topic><topic>Graft Occlusion, Vascular - diagnostic imaging</topic><topic>Graft Occlusion, Vascular - etiology</topic><topic>Graft Occlusion, Vascular - physiopathology</topic><topic>Graft Occlusion, Vascular - therapy</topic><topic>Greece</topic><topic>Hemodialysis</topic><topic>Humans</topic><topic>Kaplan-Meier Estimate</topic><topic>Kidney Failure, Chronic - therapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>Paclitaxel - administration & dosage</topic><topic>Patients</topic><topic>Proportional Hazards Models</topic><topic>Prospective Studies</topic><topic>Prostheses</topic><topic>Radiography</topic><topic>Renal Dialysis</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Stents</topic><topic>Success</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Vascular Patency</topic><topic>Veins & arteries</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Katsanos, Konstantinos</creatorcontrib><creatorcontrib>Karnabatidis, Dimitris</creatorcontrib><creatorcontrib>Kitrou, Panagiotis</creatorcontrib><creatorcontrib>Spiliopoulos, Stavros</creatorcontrib><creatorcontrib>Christeas, Nikolaos</creatorcontrib><creatorcontrib>Siablis, Dimitris</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of endovascular therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Katsanos, Konstantinos</au><au>Karnabatidis, Dimitris</au><au>Kitrou, Panagiotis</au><au>Spiliopoulos, Stavros</au><au>Christeas, Nikolaos</au><au>Siablis, Dimitris</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Paclitaxel-Coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access: 6-Month Interim Results From a Prospective Randomized Controlled Trial</atitle><jtitle>Journal of endovascular therapy</jtitle><addtitle>J Endovasc Ther</addtitle><date>2012-04-01</date><risdate>2012</risdate><volume>19</volume><issue>2</issue><spage>263</spage><epage>272</epage><pages>263-272</pages><issn>1526-6028</issn><eissn>1545-1550</eissn><abstract><![CDATA[Purpose
To report the 6-month results of a prospective randomized trial investigating
angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon
angioplasty (BA) for the treatment of failing native arteriovenous fistulae
(AVF) or prosthetic arteriovenous grafts (AVG).
Methods
The enrollment criteria for this non-inferiority hypothesis trial included
clinical signs of failing dialysis access with angiographic documentation of
a significant venous stenotic lesion in patients with AVF or AVG circuits.
From March to December 2010, 40 patients (29 men; mean age 64.1±14.3
years) were randomized to undergo either PCB dilation (n=20) or
standard BA (n=20) of a stenosed venous outflow lesion. Regular
angiographic follow-up was scheduled bimonthly. Study outcome measures
included device success (<30% residual stenosis without
postdilation), procedural success (<30% residual stenosis),
and primary patency of the treated lesion (<50% angiographic
restenosis and no need for any interim repeat procedures).
Results
Baseline and procedural variables were comparably distributed between both
groups. Device success was 9/20 (45%) for the PCB device vs. 20/20
(100%) for standard control BA (p<0.001). Procedural success
was 100% in both groups after further high-pressure post-dilation as
necessary. There were no major or minor complications in either group. At 6
months, cumulative target lesion primary patency was significantly higher
after PCB application (70% in PCB group vs. 25% in BA group,
p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006).
Conclusion
PCB angioplasty improves patency after angioplasty of venous stenoses of
failing vascular access used for dialysis.]]></abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>22545894</pmid><doi>10.1583/11-3690.1</doi><tpages>10</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1526-6028 |
| ispartof | Journal of endovascular therapy, 2012-04, Vol.19 (2), p.263-272 |
| issn | 1526-6028 1545-1550 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1010638067 |
| source | SAGE Complete A-Z List; MEDLINE; Alma/SFX Local Collection |
| subjects | Aged Anatomy & physiology Angioplasty Angioplasty, Balloon - adverse effects Angioplasty, Balloon - instrumentation Arteriovenous Shunt, Surgical - adverse effects Blood Vessel Prosthesis Implantation - adverse effects Cardiovascular Agents - administration & dosage Catheters Cell cycle Cell division Constriction, Pathologic Drug Delivery Systems - instrumentation Drug dosages Equipment Design Family medical history Female Graft Occlusion, Vascular - diagnostic imaging Graft Occlusion, Vascular - etiology Graft Occlusion, Vascular - physiopathology Graft Occlusion, Vascular - therapy Greece Hemodialysis Humans Kaplan-Meier Estimate Kidney Failure, Chronic - therapy Male Middle Aged Mortality Paclitaxel - administration & dosage Patients Proportional Hazards Models Prospective Studies Prostheses Radiography Renal Dialysis Risk Assessment Risk Factors Stents Success Time Factors Treatment Outcome Vascular Patency Veins & arteries |
| title | Paclitaxel-Coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access: 6-Month Interim Results From a Prospective Randomized Controlled Trial |
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