Long-Term Mortality of Matched Patients with Intermittent Claudication Treated by High-Dose Paclitaxel-Coated Balloon Versus Plain Balloon Angioplasty: A Real-World Study
Purpose The aim of this study was to assess the long-term mortality of patients treated by the IN.PACT Admiral (Medtronic, Dublin, Ireland) paclitaxel-coated balloon angioplasty (PCBA) compared with standard plain balloon angioplasty (POBA). Materials and Methods Between January 2013 and January 201...
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| Veröffentlicht in: | Cardiovascular and interventional radiology 2020, Vol.43 (1), p.2-7 |
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| creator | Donas, Konstantinos P. Sohr, Anne Pitoulias, Georgios A. Alfonso, Fernando Torsello, Giovanni |
| description | Purpose
The aim of this study was to assess the long-term mortality of patients treated by the IN.PACT Admiral (Medtronic, Dublin, Ireland) paclitaxel-coated balloon angioplasty (PCBA) compared with standard plain balloon angioplasty (POBA).
Materials and Methods
Between January 2013 and January 2014, 238 patients met the inclusion criteria. A two-step analysis was performed. In step 1, the 5-year mortality of the whole patient population was evaluated regardless of possible differences in the patient demographics. In step 2, a matched paired analysis was performed using propensity scores. In addition, for those patients who were treated with PCBA, a possible correlation between dose of paclitaxel and mortality was evaluated.
Results
Univariate analysis for the whole group of patients (POBA group A,
n
= 84 and PCBA group B,
n
= 121) showed a 5-year mortality rate of 26.2% versus 14.0%,
p
= 0.02, respectively. Univariate analysis of 77 pairs of propensity score-matched patients resulted in mortality of 26.0% versus 20.8%,
p
= 0.4, of group A and B, respectively (median follow-up of 61.7 and 61.8 months,
p
= 0.8, respectively). Comparison of the patients of group B who died versus those who survived showed no correlation between the dose of paclitaxel with increased mortality (
p
= 0.4).
Conclusion
The 5-year findings of the present real-world study showed no increased mortality for the matched patients who underwent PCBA versus POBA. In addition, there was no correlation between mortality and the dose of paclitaxel used. |
| doi_str_mv | 10.1007/s00270-019-02329-z |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2288007333</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2288007333</sourcerecordid><originalsourceid>FETCH-LOGICAL-c375t-5cb28b08057a3048a88b966052a6c172fc7c1e278ca7de792e180ef541197d2e3</originalsourceid><addsrcrecordid>eNp9kU1vEzEQhi0EomngD3BAlrhwMYy98drLLQ0frZSKCsLHbeX1TpKtnHWwvSrbn8SvxG1KkTgwl5Fmnvcdyy8hzzi84gDqdQQQChjwioEoRMWuH5AJnxWCgS6_PyQT4GrGuJT8iBzHeAnApRbyMTkquAQBQk7Ir6XvN2yFYUfPfUjGdWmkfk3PTbJbbOmFSR32KdKrLm3pWZ8y2aWUR3ThzNB2NgO-p6uAJmW-Gelpt9mytz5iFtvsZ36iYwt_uz4xzvmMf8UQh0gvnOn6--G833R-70xM4xs6p5_QOPbNB9fSz2loxyfk0dq4iE_v-pR8ef9utThly48fzhbzJbOFkolJ2wjdgAapTAEzbbRuqrIEKUxpuRJrqyxHobQ1qkVVCeQacC1nnFeqFVhMycuD7z74HwPGVO-6aNE506MfYi2E1vn7i1xT8uIf9NIPoc-vu6GU4FyXkClxoGzwMQZc1_vQ7UwYaw71TZL1Ick6J1nfJllfZ9HzO-uh2WF7L_kTXQaKAxDzqt9g-Hv7P7a_AatEqtU</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2287211860</pqid></control><display><type>article</type><title>Long-Term Mortality of Matched Patients with Intermittent Claudication Treated by High-Dose Paclitaxel-Coated Balloon Versus Plain Balloon Angioplasty: A Real-World Study</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Donas, Konstantinos P. ; Sohr, Anne ; Pitoulias, Georgios A. ; Alfonso, Fernando ; Torsello, Giovanni</creator><creatorcontrib>Donas, Konstantinos P. ; Sohr, Anne ; Pitoulias, Georgios A. ; Alfonso, Fernando ; Torsello, Giovanni</creatorcontrib><description>Purpose
The aim of this study was to assess the long-term mortality of patients treated by the IN.PACT Admiral (Medtronic, Dublin, Ireland) paclitaxel-coated balloon angioplasty (PCBA) compared with standard plain balloon angioplasty (POBA).
Materials and Methods
Between January 2013 and January 2014, 238 patients met the inclusion criteria. A two-step analysis was performed. In step 1, the 5-year mortality of the whole patient population was evaluated regardless of possible differences in the patient demographics. In step 2, a matched paired analysis was performed using propensity scores. In addition, for those patients who were treated with PCBA, a possible correlation between dose of paclitaxel and mortality was evaluated.
Results
Univariate analysis for the whole group of patients (POBA group A,
n
= 84 and PCBA group B,
n
= 121) showed a 5-year mortality rate of 26.2% versus 14.0%,
p
= 0.02, respectively. Univariate analysis of 77 pairs of propensity score-matched patients resulted in mortality of 26.0% versus 20.8%,
p
= 0.4, of group A and B, respectively (median follow-up of 61.7 and 61.8 months,
p
= 0.8, respectively). Comparison of the patients of group B who died versus those who survived showed no correlation between the dose of paclitaxel with increased mortality (
p
= 0.4).
Conclusion
The 5-year findings of the present real-world study showed no increased mortality for the matched patients who underwent PCBA versus POBA. In addition, there was no correlation between mortality and the dose of paclitaxel used.</description><identifier>ISSN: 0174-1551</identifier><identifier>EISSN: 1432-086X</identifier><identifier>DOI: 10.1007/s00270-019-02329-z</identifier><identifier>PMID: 31502025</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Aged ; Angioplasty ; Angioplasty, Balloon - methods ; Angioplasty, Balloon, Coronary - methods ; Arterial Interventions ; Cardiology ; Cardiovascular diseases ; Clinical Investigation ; Correlation ; Demographics ; Demography ; Female ; Humans ; Imaging ; Intermittent Claudication - drug therapy ; Intermittent Claudication - mortality ; Intermittent Claudication - therapy ; Male ; Medicine ; Medicine & Public Health ; Mortality ; Nuclear Medicine ; Paclitaxel ; Paclitaxel - therapeutic use ; Patients ; Prospective Studies ; Radiology ; Retrospective Studies ; Risk Factors ; Stents ; Time Factors ; Treatment Outcome ; Tubulin Modulators - therapeutic use ; Ultrasound</subject><ispartof>Cardiovascular and interventional radiology, 2020, Vol.43 (1), p.2-7</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2019</rights><rights>CardioVascular and Interventional Radiology is a copyright of Springer, (2019). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-5cb28b08057a3048a88b966052a6c172fc7c1e278ca7de792e180ef541197d2e3</citedby><cites>FETCH-LOGICAL-c375t-5cb28b08057a3048a88b966052a6c172fc7c1e278ca7de792e180ef541197d2e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00270-019-02329-z$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00270-019-02329-z$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,778,782,27907,27908,41471,42540,51302</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31502025$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Donas, Konstantinos P.</creatorcontrib><creatorcontrib>Sohr, Anne</creatorcontrib><creatorcontrib>Pitoulias, Georgios A.</creatorcontrib><creatorcontrib>Alfonso, Fernando</creatorcontrib><creatorcontrib>Torsello, Giovanni</creatorcontrib><title>Long-Term Mortality of Matched Patients with Intermittent Claudication Treated by High-Dose Paclitaxel-Coated Balloon Versus Plain Balloon Angioplasty: A Real-World Study</title><title>Cardiovascular and interventional radiology</title><addtitle>Cardiovasc Intervent Radiol</addtitle><addtitle>Cardiovasc Intervent Radiol</addtitle><description>Purpose
The aim of this study was to assess the long-term mortality of patients treated by the IN.PACT Admiral (Medtronic, Dublin, Ireland) paclitaxel-coated balloon angioplasty (PCBA) compared with standard plain balloon angioplasty (POBA).
Materials and Methods
Between January 2013 and January 2014, 238 patients met the inclusion criteria. A two-step analysis was performed. In step 1, the 5-year mortality of the whole patient population was evaluated regardless of possible differences in the patient demographics. In step 2, a matched paired analysis was performed using propensity scores. In addition, for those patients who were treated with PCBA, a possible correlation between dose of paclitaxel and mortality was evaluated.
Results
Univariate analysis for the whole group of patients (POBA group A,
n
= 84 and PCBA group B,
n
= 121) showed a 5-year mortality rate of 26.2% versus 14.0%,
p
= 0.02, respectively. Univariate analysis of 77 pairs of propensity score-matched patients resulted in mortality of 26.0% versus 20.8%,
p
= 0.4, of group A and B, respectively (median follow-up of 61.7 and 61.8 months,
p
= 0.8, respectively). Comparison of the patients of group B who died versus those who survived showed no correlation between the dose of paclitaxel with increased mortality (
p
= 0.4).
Conclusion
The 5-year findings of the present real-world study showed no increased mortality for the matched patients who underwent PCBA versus POBA. In addition, there was no correlation between mortality and the dose of paclitaxel used.</description><subject>Aged</subject><subject>Angioplasty</subject><subject>Angioplasty, Balloon - methods</subject><subject>Angioplasty, Balloon, Coronary - methods</subject><subject>Arterial Interventions</subject><subject>Cardiology</subject><subject>Cardiovascular diseases</subject><subject>Clinical Investigation</subject><subject>Correlation</subject><subject>Demographics</subject><subject>Demography</subject><subject>Female</subject><subject>Humans</subject><subject>Imaging</subject><subject>Intermittent Claudication - drug therapy</subject><subject>Intermittent Claudication - mortality</subject><subject>Intermittent Claudication - therapy</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Mortality</subject><subject>Nuclear Medicine</subject><subject>Paclitaxel</subject><subject>Paclitaxel - therapeutic use</subject><subject>Patients</subject><subject>Prospective Studies</subject><subject>Radiology</subject><subject>Retrospective Studies</subject><subject>Risk Factors</subject><subject>Stents</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Tubulin Modulators - therapeutic use</subject><subject>Ultrasound</subject><issn>0174-1551</issn><issn>1432-086X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kU1vEzEQhi0EomngD3BAlrhwMYy98drLLQ0frZSKCsLHbeX1TpKtnHWwvSrbn8SvxG1KkTgwl5Fmnvcdyy8hzzi84gDqdQQQChjwioEoRMWuH5AJnxWCgS6_PyQT4GrGuJT8iBzHeAnApRbyMTkquAQBQk7Ir6XvN2yFYUfPfUjGdWmkfk3PTbJbbOmFSR32KdKrLm3pWZ8y2aWUR3ThzNB2NgO-p6uAJmW-Gelpt9mytz5iFtvsZ36iYwt_uz4xzvmMf8UQh0gvnOn6--G833R-70xM4xs6p5_QOPbNB9fSz2loxyfk0dq4iE_v-pR8ef9utThly48fzhbzJbOFkolJ2wjdgAapTAEzbbRuqrIEKUxpuRJrqyxHobQ1qkVVCeQacC1nnFeqFVhMycuD7z74HwPGVO-6aNE506MfYi2E1vn7i1xT8uIf9NIPoc-vu6GU4FyXkClxoGzwMQZc1_vQ7UwYaw71TZL1Ick6J1nfJllfZ9HzO-uh2WF7L_kTXQaKAxDzqt9g-Hv7P7a_AatEqtU</recordid><startdate>2020</startdate><enddate>2020</enddate><creator>Donas, Konstantinos P.</creator><creator>Sohr, Anne</creator><creator>Pitoulias, Georgios A.</creator><creator>Alfonso, Fernando</creator><creator>Torsello, Giovanni</creator><general>Springer US</general><general>Springer Nature B.V</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>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</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>H94</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>PRINS</scope><scope>7X8</scope></search><sort><creationdate>2020</creationdate><title>Long-Term Mortality of Matched Patients with Intermittent Claudication Treated by High-Dose Paclitaxel-Coated Balloon Versus Plain Balloon Angioplasty: A Real-World Study</title><author>Donas, Konstantinos P. ; Sohr, Anne ; Pitoulias, Georgios A. ; Alfonso, Fernando ; Torsello, Giovanni</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-5cb28b08057a3048a88b966052a6c172fc7c1e278ca7de792e180ef541197d2e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Aged</topic><topic>Angioplasty</topic><topic>Angioplasty, Balloon - methods</topic><topic>Angioplasty, Balloon, Coronary - methods</topic><topic>Arterial Interventions</topic><topic>Cardiology</topic><topic>Cardiovascular diseases</topic><topic>Clinical Investigation</topic><topic>Correlation</topic><topic>Demographics</topic><topic>Demography</topic><topic>Female</topic><topic>Humans</topic><topic>Imaging</topic><topic>Intermittent Claudication - drug therapy</topic><topic>Intermittent Claudication - mortality</topic><topic>Intermittent Claudication - therapy</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Mortality</topic><topic>Nuclear Medicine</topic><topic>Paclitaxel</topic><topic>Paclitaxel - therapeutic use</topic><topic>Patients</topic><topic>Prospective Studies</topic><topic>Radiology</topic><topic>Retrospective Studies</topic><topic>Risk Factors</topic><topic>Stents</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Tubulin Modulators - therapeutic use</topic><topic>Ultrasound</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Donas, Konstantinos P.</creatorcontrib><creatorcontrib>Sohr, Anne</creatorcontrib><creatorcontrib>Pitoulias, Georgios A.</creatorcontrib><creatorcontrib>Alfonso, Fernando</creatorcontrib><creatorcontrib>Torsello, Giovanni</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>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</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>AIDS and Cancer Research Abstracts</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>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Cardiovascular and interventional radiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Donas, Konstantinos P.</au><au>Sohr, Anne</au><au>Pitoulias, Georgios A.</au><au>Alfonso, Fernando</au><au>Torsello, Giovanni</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-Term Mortality of Matched Patients with Intermittent Claudication Treated by High-Dose Paclitaxel-Coated Balloon Versus Plain Balloon Angioplasty: A Real-World Study</atitle><jtitle>Cardiovascular and interventional radiology</jtitle><stitle>Cardiovasc Intervent Radiol</stitle><addtitle>Cardiovasc Intervent Radiol</addtitle><date>2020</date><risdate>2020</risdate><volume>43</volume><issue>1</issue><spage>2</spage><epage>7</epage><pages>2-7</pages><issn>0174-1551</issn><eissn>1432-086X</eissn><abstract>Purpose
The aim of this study was to assess the long-term mortality of patients treated by the IN.PACT Admiral (Medtronic, Dublin, Ireland) paclitaxel-coated balloon angioplasty (PCBA) compared with standard plain balloon angioplasty (POBA).
Materials and Methods
Between January 2013 and January 2014, 238 patients met the inclusion criteria. A two-step analysis was performed. In step 1, the 5-year mortality of the whole patient population was evaluated regardless of possible differences in the patient demographics. In step 2, a matched paired analysis was performed using propensity scores. In addition, for those patients who were treated with PCBA, a possible correlation between dose of paclitaxel and mortality was evaluated.
Results
Univariate analysis for the whole group of patients (POBA group A,
n
= 84 and PCBA group B,
n
= 121) showed a 5-year mortality rate of 26.2% versus 14.0%,
p
= 0.02, respectively. Univariate analysis of 77 pairs of propensity score-matched patients resulted in mortality of 26.0% versus 20.8%,
p
= 0.4, of group A and B, respectively (median follow-up of 61.7 and 61.8 months,
p
= 0.8, respectively). Comparison of the patients of group B who died versus those who survived showed no correlation between the dose of paclitaxel with increased mortality (
p
= 0.4).
Conclusion
The 5-year findings of the present real-world study showed no increased mortality for the matched patients who underwent PCBA versus POBA. In addition, there was no correlation between mortality and the dose of paclitaxel used.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>31502025</pmid><doi>10.1007/s00270-019-02329-z</doi><tpages>6</tpages></addata></record> |
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| issn | 0174-1551 1432-086X |
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| subjects | Aged Angioplasty Angioplasty, Balloon - methods Angioplasty, Balloon, Coronary - methods Arterial Interventions Cardiology Cardiovascular diseases Clinical Investigation Correlation Demographics Demography Female Humans Imaging Intermittent Claudication - drug therapy Intermittent Claudication - mortality Intermittent Claudication - therapy Male Medicine Medicine & Public Health Mortality Nuclear Medicine Paclitaxel Paclitaxel - therapeutic use Patients Prospective Studies Radiology Retrospective Studies Risk Factors Stents Time Factors Treatment Outcome Tubulin Modulators - therapeutic use Ultrasound |
| title | Long-Term Mortality of Matched Patients with Intermittent Claudication Treated by High-Dose Paclitaxel-Coated Balloon Versus Plain Balloon Angioplasty: A Real-World Study |
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