Paclitaxel-coated peripheral arterial devices are associated with improved overall survival and limb salvage in patients with chronic limb-threatening ischemia
Paclitaxel (PTX)-coated peripheral arterial devices have been shown to decrease femoropopliteal artery restenosis and the need for reintervention compared with non-PTX-coated devices. The data regarding PTX efficacy and safety come from randomized controlled trials that almost exclusively enrolled p...
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| Veröffentlicht in: | Journal of vascular surgery 2021-11, Vol.74 (5), p.1682-1688.e1 |
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| creator | Kumins, Norman H. King, Alexander H. Ambani, Ravi N. Cho, Jae S. Harth, Karem C. Wong, Virginia L. Colvard, Benjamin Bose, Saideep Thomas, Jones P. Kashyap, Vikram S. |
| description | Paclitaxel (PTX)-coated peripheral arterial devices have been shown to decrease femoropopliteal artery restenosis and the need for reintervention compared with non-PTX-coated devices. The data regarding PTX efficacy and safety come from randomized controlled trials that almost exclusively enrolled patients with claudication. The outcomes of PTX treatment in patients who present with chronic limb-threatening ischemia (CLTI) are unknown. This study compares long-term outcomes in patients with CLTI treated with and without PTX.
We retrospectively reviewed 983 patients with CLTI treated with femoropopliteal artery angioplasty, atherectomy, stent, or combination between 2011 and 2019. Procedures were performed with additional proximal or distal tibial interventions as needed. Kaplan-Meier survival analysis and multivariable Cox-regression analysis compared overall survival (OS), amputation-free survival (AFS), freedom from major amputation (ff-MA), and freedom from target vessel revascularization (ff-TVR) between patients treated with and without PTX.
Demographics, comorbidities, and Rutherford class were similar between 574 PTX (58.5%) and 409 non-PTX (41.6%) patients except that non-PTX patients were more likely to be male (56.2% vs 49.7%), dialysis dependent (19.6% vs 14.3%), and have higher average creatinine (2.3 vs 1.8 mg/dL). Through 4-year follow-up, the PTX group demonstrated a significant increase in OS (56.2% vs 43.9%, P = .013), AFS (52.6% vs 36.1%, P < .0001), ff-MA (87.4% vs 78.7%, P = .0007), and ff-TVR (77.6% vs 70.6%, P = .012). Multivariable Cox-regression analysis demonstrated that PTX treatment was associated with improved OS, AFS, ff-MA, and ff-TVR.
In patients with CLTI, treatment with a PTX-coated device is associated with improved OS, AFS, ff-MA, and ff-TVR through 4-year follow-up. PTX-coated devices may be especially beneficial in patients who present with CLTI. |
| doi_str_mv | 10.1016/j.jvs.2021.05.035 |
| format | Article |
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We retrospectively reviewed 983 patients with CLTI treated with femoropopliteal artery angioplasty, atherectomy, stent, or combination between 2011 and 2019. Procedures were performed with additional proximal or distal tibial interventions as needed. Kaplan-Meier survival analysis and multivariable Cox-regression analysis compared overall survival (OS), amputation-free survival (AFS), freedom from major amputation (ff-MA), and freedom from target vessel revascularization (ff-TVR) between patients treated with and without PTX.
Demographics, comorbidities, and Rutherford class were similar between 574 PTX (58.5%) and 409 non-PTX (41.6%) patients except that non-PTX patients were more likely to be male (56.2% vs 49.7%), dialysis dependent (19.6% vs 14.3%), and have higher average creatinine (2.3 vs 1.8 mg/dL). Through 4-year follow-up, the PTX group demonstrated a significant increase in OS (56.2% vs 43.9%, P = .013), AFS (52.6% vs 36.1%, P < .0001), ff-MA (87.4% vs 78.7%, P = .0007), and ff-TVR (77.6% vs 70.6%, P = .012). Multivariable Cox-regression analysis demonstrated that PTX treatment was associated with improved OS, AFS, ff-MA, and ff-TVR.
In patients with CLTI, treatment with a PTX-coated device is associated with improved OS, AFS, ff-MA, and ff-TVR through 4-year follow-up. PTX-coated devices may be especially beneficial in patients who present with CLTI.</description><identifier>ISSN: 0741-5214</identifier><identifier>EISSN: 1097-6809</identifier><identifier>DOI: 10.1016/j.jvs.2021.05.035</identifier><identifier>PMID: 34090989</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; Aged, 80 and over ; Amputation ; Angioplasty ; Angioplasty, Balloon - adverse effects ; Angioplasty, Balloon - instrumentation ; Angioplasty, Balloon - mortality ; Cardiovascular Agents - administration & dosage ; Cardiovascular Agents - adverse effects ; Chronic Disease ; Chronic limb-threatening ischemia ; Coated Materials, Biocompatible ; Equipment Design ; Female ; Femoropopliteal arterial disease ; Humans ; Ischemia - diagnosis ; Ischemia - mortality ; Ischemia - physiopathology ; Ischemia - therapy ; Limb Salvage ; Male ; Middle Aged ; Paclitaxel ; Paclitaxel - administration & dosage ; Paclitaxel - adverse effects ; Paclitaxel-coated balloon ; Peripheral Arterial Disease - diagnosis ; Peripheral Arterial Disease - mortality ; Peripheral Arterial Disease - physiopathology ; Peripheral Arterial Disease - therapy ; Progression-Free Survival ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Time Factors</subject><ispartof>Journal of vascular surgery, 2021-11, Vol.74 (5), p.1682-1688.e1</ispartof><rights>2021 Society for Vascular Surgery</rights><rights>Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c396t-2dadc92e97c75f66dce71b7d24339c3c1627791fcfb5db6f1316992f074351bb3</citedby><cites>FETCH-LOGICAL-c396t-2dadc92e97c75f66dce71b7d24339c3c1627791fcfb5db6f1316992f074351bb3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S074152142100851X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34090989$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kumins, Norman H.</creatorcontrib><creatorcontrib>King, Alexander H.</creatorcontrib><creatorcontrib>Ambani, Ravi N.</creatorcontrib><creatorcontrib>Cho, Jae S.</creatorcontrib><creatorcontrib>Harth, Karem C.</creatorcontrib><creatorcontrib>Wong, Virginia L.</creatorcontrib><creatorcontrib>Colvard, Benjamin</creatorcontrib><creatorcontrib>Bose, Saideep</creatorcontrib><creatorcontrib>Thomas, Jones P.</creatorcontrib><creatorcontrib>Kashyap, Vikram S.</creatorcontrib><title>Paclitaxel-coated peripheral arterial devices are associated with improved overall survival and limb salvage in patients with chronic limb-threatening ischemia</title><title>Journal of vascular surgery</title><addtitle>J Vasc Surg</addtitle><description>Paclitaxel (PTX)-coated peripheral arterial devices have been shown to decrease femoropopliteal artery restenosis and the need for reintervention compared with non-PTX-coated devices. The data regarding PTX efficacy and safety come from randomized controlled trials that almost exclusively enrolled patients with claudication. The outcomes of PTX treatment in patients who present with chronic limb-threatening ischemia (CLTI) are unknown. This study compares long-term outcomes in patients with CLTI treated with and without PTX.
We retrospectively reviewed 983 patients with CLTI treated with femoropopliteal artery angioplasty, atherectomy, stent, or combination between 2011 and 2019. Procedures were performed with additional proximal or distal tibial interventions as needed. Kaplan-Meier survival analysis and multivariable Cox-regression analysis compared overall survival (OS), amputation-free survival (AFS), freedom from major amputation (ff-MA), and freedom from target vessel revascularization (ff-TVR) between patients treated with and without PTX.
Demographics, comorbidities, and Rutherford class were similar between 574 PTX (58.5%) and 409 non-PTX (41.6%) patients except that non-PTX patients were more likely to be male (56.2% vs 49.7%), dialysis dependent (19.6% vs 14.3%), and have higher average creatinine (2.3 vs 1.8 mg/dL). Through 4-year follow-up, the PTX group demonstrated a significant increase in OS (56.2% vs 43.9%, P = .013), AFS (52.6% vs 36.1%, P < .0001), ff-MA (87.4% vs 78.7%, P = .0007), and ff-TVR (77.6% vs 70.6%, P = .012). Multivariable Cox-regression analysis demonstrated that PTX treatment was associated with improved OS, AFS, ff-MA, and ff-TVR.
In patients with CLTI, treatment with a PTX-coated device is associated with improved OS, AFS, ff-MA, and ff-TVR through 4-year follow-up. PTX-coated devices may be especially beneficial in patients who present with CLTI.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Amputation</subject><subject>Angioplasty</subject><subject>Angioplasty, Balloon - adverse effects</subject><subject>Angioplasty, Balloon - instrumentation</subject><subject>Angioplasty, Balloon - mortality</subject><subject>Cardiovascular Agents - administration & dosage</subject><subject>Cardiovascular Agents - adverse effects</subject><subject>Chronic Disease</subject><subject>Chronic limb-threatening ischemia</subject><subject>Coated Materials, Biocompatible</subject><subject>Equipment Design</subject><subject>Female</subject><subject>Femoropopliteal arterial disease</subject><subject>Humans</subject><subject>Ischemia - diagnosis</subject><subject>Ischemia - mortality</subject><subject>Ischemia - physiopathology</subject><subject>Ischemia - therapy</subject><subject>Limb Salvage</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Paclitaxel</subject><subject>Paclitaxel - administration & dosage</subject><subject>Paclitaxel - adverse effects</subject><subject>Paclitaxel-coated balloon</subject><subject>Peripheral Arterial Disease - diagnosis</subject><subject>Peripheral Arterial Disease - mortality</subject><subject>Peripheral Arterial Disease - physiopathology</subject><subject>Peripheral Arterial Disease - therapy</subject><subject>Progression-Free Survival</subject><subject>Retrospective Studies</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Time Factors</subject><issn>0741-5214</issn><issn>1097-6809</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kctuFDEQRS0EIpPAB7BBXrLpxo92eyxWKAoPKRIsYG257ep0jfqF7enA1_CreDKBJRvbZZ17VVWXkFec1Zzx9u2hPmypFkzwmqmaSfWE7Dgzumr3zDwlO6YbXinBmwtymdKBMc7VXj8nF7Jhhpm92ZHfX50fMbufMFZ-cRkCXSHiOkB0I3Uxl6I8AmzoIZUPoC6lxeMDeo95oDitcdlKVY4iGmk6xg23k3wOdMSpo8mNm7sDijNdXUaYczpr_RCXGf0DVeUhQrGdcb6jmPwAE7oX5FnvxgQvH-8r8v3DzbfrT9Xtl4-fr9_fVl6aNlciuOCNAKO9Vn3bBg-adzqIRkrjpeet0Nrw3vedCl3bc8lbY0RfNiQV7zp5Rd6cfcssP46Qsp1KCzCOboblmKxQcs8Ua7gqKD-jPi4pRejtGnFy8ZflzJ5ysQdbcrGnXCxTtuRSNK8f7Y_dBOGf4m8QBXh3BqAMuSFEm3zZk4eAEXy2YcH_2P8BQhGikA</recordid><startdate>202111</startdate><enddate>202111</enddate><creator>Kumins, Norman H.</creator><creator>King, Alexander H.</creator><creator>Ambani, Ravi N.</creator><creator>Cho, Jae S.</creator><creator>Harth, Karem C.</creator><creator>Wong, Virginia L.</creator><creator>Colvard, Benjamin</creator><creator>Bose, Saideep</creator><creator>Thomas, Jones P.</creator><creator>Kashyap, Vikram S.</creator><general>Elsevier 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>7X8</scope></search><sort><creationdate>202111</creationdate><title>Paclitaxel-coated peripheral arterial devices are associated with improved overall survival and limb salvage in patients with chronic limb-threatening ischemia</title><author>Kumins, Norman H. ; King, Alexander H. ; Ambani, Ravi N. ; Cho, Jae S. ; Harth, Karem C. ; Wong, Virginia L. ; Colvard, Benjamin ; Bose, Saideep ; Thomas, Jones P. ; Kashyap, Vikram S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c396t-2dadc92e97c75f66dce71b7d24339c3c1627791fcfb5db6f1316992f074351bb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Amputation</topic><topic>Angioplasty</topic><topic>Angioplasty, Balloon - adverse effects</topic><topic>Angioplasty, Balloon - instrumentation</topic><topic>Angioplasty, Balloon - mortality</topic><topic>Cardiovascular Agents - administration & dosage</topic><topic>Cardiovascular Agents - adverse effects</topic><topic>Chronic Disease</topic><topic>Chronic limb-threatening ischemia</topic><topic>Coated Materials, Biocompatible</topic><topic>Equipment Design</topic><topic>Female</topic><topic>Femoropopliteal arterial disease</topic><topic>Humans</topic><topic>Ischemia - diagnosis</topic><topic>Ischemia - mortality</topic><topic>Ischemia - physiopathology</topic><topic>Ischemia - therapy</topic><topic>Limb Salvage</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Paclitaxel</topic><topic>Paclitaxel - administration & dosage</topic><topic>Paclitaxel - adverse effects</topic><topic>Paclitaxel-coated balloon</topic><topic>Peripheral Arterial Disease - diagnosis</topic><topic>Peripheral Arterial Disease - mortality</topic><topic>Peripheral Arterial Disease - physiopathology</topic><topic>Peripheral Arterial Disease - therapy</topic><topic>Progression-Free Survival</topic><topic>Retrospective Studies</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kumins, Norman H.</creatorcontrib><creatorcontrib>King, Alexander H.</creatorcontrib><creatorcontrib>Ambani, Ravi N.</creatorcontrib><creatorcontrib>Cho, Jae S.</creatorcontrib><creatorcontrib>Harth, Karem C.</creatorcontrib><creatorcontrib>Wong, Virginia L.</creatorcontrib><creatorcontrib>Colvard, Benjamin</creatorcontrib><creatorcontrib>Bose, Saideep</creatorcontrib><creatorcontrib>Thomas, Jones P.</creatorcontrib><creatorcontrib>Kashyap, Vikram S.</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>Journal of vascular surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kumins, Norman H.</au><au>King, Alexander H.</au><au>Ambani, Ravi N.</au><au>Cho, Jae S.</au><au>Harth, Karem C.</au><au>Wong, Virginia L.</au><au>Colvard, Benjamin</au><au>Bose, Saideep</au><au>Thomas, Jones P.</au><au>Kashyap, Vikram S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Paclitaxel-coated peripheral arterial devices are associated with improved overall survival and limb salvage in patients with chronic limb-threatening ischemia</atitle><jtitle>Journal of vascular surgery</jtitle><addtitle>J Vasc Surg</addtitle><date>2021-11</date><risdate>2021</risdate><volume>74</volume><issue>5</issue><spage>1682</spage><epage>1688.e1</epage><pages>1682-1688.e1</pages><issn>0741-5214</issn><eissn>1097-6809</eissn><abstract>Paclitaxel (PTX)-coated peripheral arterial devices have been shown to decrease femoropopliteal artery restenosis and the need for reintervention compared with non-PTX-coated devices. The data regarding PTX efficacy and safety come from randomized controlled trials that almost exclusively enrolled patients with claudication. The outcomes of PTX treatment in patients who present with chronic limb-threatening ischemia (CLTI) are unknown. This study compares long-term outcomes in patients with CLTI treated with and without PTX.
We retrospectively reviewed 983 patients with CLTI treated with femoropopliteal artery angioplasty, atherectomy, stent, or combination between 2011 and 2019. Procedures were performed with additional proximal or distal tibial interventions as needed. Kaplan-Meier survival analysis and multivariable Cox-regression analysis compared overall survival (OS), amputation-free survival (AFS), freedom from major amputation (ff-MA), and freedom from target vessel revascularization (ff-TVR) between patients treated with and without PTX.
Demographics, comorbidities, and Rutherford class were similar between 574 PTX (58.5%) and 409 non-PTX (41.6%) patients except that non-PTX patients were more likely to be male (56.2% vs 49.7%), dialysis dependent (19.6% vs 14.3%), and have higher average creatinine (2.3 vs 1.8 mg/dL). Through 4-year follow-up, the PTX group demonstrated a significant increase in OS (56.2% vs 43.9%, P = .013), AFS (52.6% vs 36.1%, P < .0001), ff-MA (87.4% vs 78.7%, P = .0007), and ff-TVR (77.6% vs 70.6%, P = .012). Multivariable Cox-regression analysis demonstrated that PTX treatment was associated with improved OS, AFS, ff-MA, and ff-TVR.
In patients with CLTI, treatment with a PTX-coated device is associated with improved OS, AFS, ff-MA, and ff-TVR through 4-year follow-up. PTX-coated devices may be especially beneficial in patients who present with CLTI.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>34090989</pmid><doi>10.1016/j.jvs.2021.05.035</doi><oa>free_for_read</oa></addata></record> |
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| issn | 0741-5214 1097-6809 |
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| source | MEDLINE; Elsevier ScienceDirect Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Aged Aged, 80 and over Amputation Angioplasty Angioplasty, Balloon - adverse effects Angioplasty, Balloon - instrumentation Angioplasty, Balloon - mortality Cardiovascular Agents - administration & dosage Cardiovascular Agents - adverse effects Chronic Disease Chronic limb-threatening ischemia Coated Materials, Biocompatible Equipment Design Female Femoropopliteal arterial disease Humans Ischemia - diagnosis Ischemia - mortality Ischemia - physiopathology Ischemia - therapy Limb Salvage Male Middle Aged Paclitaxel Paclitaxel - administration & dosage Paclitaxel - adverse effects Paclitaxel-coated balloon Peripheral Arterial Disease - diagnosis Peripheral Arterial Disease - mortality Peripheral Arterial Disease - physiopathology Peripheral Arterial Disease - therapy Progression-Free Survival Retrospective Studies Risk Assessment Risk Factors Time Factors |
| title | Paclitaxel-coated peripheral arterial devices are associated with improved overall survival and limb salvage in patients with chronic limb-threatening ischemia |
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