A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial
The authors sought to evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with any (bare-metal or drug-eluting stent) in-stent restenosis (ISR). The treatment of ISR remains challenging in contemporary clinical practice. In a multicenter rando...
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| Veröffentlicht in: | JACC. Cardiovascular interventions 2018-02, Vol.11 (3), p.275-283 |
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| creator | Baan, Jr, Jan Claessen, Bimmer E Dijk, Kirsten Boerlage-van Vendrik, Jeroen van der Schaaf, René J Meuwissen, Martijn van Royen, Niels Gosselink, A T Marcel van Wely, Marleen H Dirkali, Atilla Arkenbout, E Karin de Winter, Robbert J Koch, Karel T Sjauw, Krischan D Beijk, Marcel A Vis, M Marije Wykrzykowska, Joanna J Piek, Jan J Tijssen, Jan G P Henriques, José P S |
| description | The authors sought to evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with any (bare-metal or drug-eluting stent) in-stent restenosis (ISR).
The treatment of ISR remains challenging in contemporary clinical practice.
In a multicenter randomized noninferiority trial, patients with any ISR were randomly allocated in a 1:1 fashion to treatment with a DEB (SeQuent Please paclitaxel-eluting balloon, B. Braun Melsungen, Melsungen, Germany), or a DES (XIENCE everolimus-eluting stent, Abbott Vascular, Santa Clara, California). The primary endpoint was noninferiority in terms of in-segment minimal lumen diameter (MLD) at 6-month angiographic follow-up. Secondary endpoints included angiographic parameters at 6 months and clinical follow-up up to 12 months.
A total of 278 patients, of whom 56% had DES-ISR, were randomized at 8 sites to treatment with DEB (n = 141) or DES (n = 137). As compared with DEB, DES was associated with larger MLD and lower % stenosis immediately post-procedure (1.84 ± 0.46 vs. 1.72 ± 0.35; p = 0.018; and 26 ± 10% vs. 30 ± 10%; p = 0.03). Angiographic follow up was completed at 196 ± 53 days in 79% of patients. With respect to the primary endpoint of in-segment MLD at 6 months, DEB was noninferior to DES (DEB 1.71 ± 0.51 mm vs. DES 1.74 ± 0.61 mm; p for noninferiority |
| doi_str_mv | 10.1016/j.jcin.2017.10.024 |
| format | Article |
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The treatment of ISR remains challenging in contemporary clinical practice.
In a multicenter randomized noninferiority trial, patients with any ISR were randomly allocated in a 1:1 fashion to treatment with a DEB (SeQuent Please paclitaxel-eluting balloon, B. Braun Melsungen, Melsungen, Germany), or a DES (XIENCE everolimus-eluting stent, Abbott Vascular, Santa Clara, California). The primary endpoint was noninferiority in terms of in-segment minimal lumen diameter (MLD) at 6-month angiographic follow-up. Secondary endpoints included angiographic parameters at 6 months and clinical follow-up up to 12 months.
A total of 278 patients, of whom 56% had DES-ISR, were randomized at 8 sites to treatment with DEB (n = 141) or DES (n = 137). As compared with DEB, DES was associated with larger MLD and lower % stenosis immediately post-procedure (1.84 ± 0.46 vs. 1.72 ± 0.35; p = 0.018; and 26 ± 10% vs. 30 ± 10%; p = 0.03). Angiographic follow up was completed at 196 ± 53 days in 79% of patients. With respect to the primary endpoint of in-segment MLD at 6 months, DEB was noninferior to DES (DEB 1.71 ± 0.51 mm vs. DES 1.74 ± 0.61 mm; p for noninferiority <0.0001). Target vessel revascularization at 12-month follow-up was similar in both groups (DES 7.1% vs. DEB 8.8%; p = 0.65).
In patients with ISR, treatment with DEB was noninferior compared with DES in terms of 6-month MLD. There were no differences in clinical endpoints, including target vessel revascularization up to 12 months. Therefore, use of a DEB is an attractive treatment option for in-stent restenosis, withholding the need for additional stent implantation.</description><identifier>EISSN: 1876-7605</identifier><identifier>DOI: 10.1016/j.jcin.2017.10.024</identifier><identifier>PMID: 29413242</identifier><language>eng</language><publisher>United States</publisher><subject>Aged ; Angioplasty, Balloon, Coronary - adverse effects ; Angioplasty, Balloon, Coronary - instrumentation ; Cardiac Catheters ; Cardiovascular Agents - administration & dosage ; Cardiovascular Agents - adverse effects ; Coated Materials, Biocompatible ; Coronary Angiography ; Coronary Restenosis - diagnostic imaging ; Coronary Restenosis - etiology ; Coronary Restenosis - surgery ; Drug-Eluting Stents ; Everolimus - administration & dosage ; Everolimus - adverse effects ; Female ; Humans ; Male ; Middle Aged ; Netherlands ; Paclitaxel - administration & dosage ; Paclitaxel - adverse effects ; Percutaneous Coronary Intervention - adverse effects ; Percutaneous Coronary Intervention - instrumentation ; Prosthesis Design ; Reoperation ; Time Factors ; Treatment Outcome</subject><ispartof>JACC. Cardiovascular interventions, 2018-02, Vol.11 (3), p.275-283</ispartof><rights>Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29413242$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Baan, Jr, Jan</creatorcontrib><creatorcontrib>Claessen, Bimmer E</creatorcontrib><creatorcontrib>Dijk, Kirsten Boerlage-van</creatorcontrib><creatorcontrib>Vendrik, Jeroen</creatorcontrib><creatorcontrib>van der Schaaf, René J</creatorcontrib><creatorcontrib>Meuwissen, Martijn</creatorcontrib><creatorcontrib>van Royen, Niels</creatorcontrib><creatorcontrib>Gosselink, A T Marcel</creatorcontrib><creatorcontrib>van Wely, Marleen H</creatorcontrib><creatorcontrib>Dirkali, Atilla</creatorcontrib><creatorcontrib>Arkenbout, E Karin</creatorcontrib><creatorcontrib>de Winter, Robbert J</creatorcontrib><creatorcontrib>Koch, Karel T</creatorcontrib><creatorcontrib>Sjauw, Krischan D</creatorcontrib><creatorcontrib>Beijk, Marcel A</creatorcontrib><creatorcontrib>Vis, M Marije</creatorcontrib><creatorcontrib>Wykrzykowska, Joanna J</creatorcontrib><creatorcontrib>Piek, Jan J</creatorcontrib><creatorcontrib>Tijssen, Jan G P</creatorcontrib><creatorcontrib>Henriques, José P S</creatorcontrib><title>A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial</title><title>JACC. Cardiovascular interventions</title><addtitle>JACC Cardiovasc Interv</addtitle><description>The authors sought to evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with any (bare-metal or drug-eluting stent) in-stent restenosis (ISR).
The treatment of ISR remains challenging in contemporary clinical practice.
In a multicenter randomized noninferiority trial, patients with any ISR were randomly allocated in a 1:1 fashion to treatment with a DEB (SeQuent Please paclitaxel-eluting balloon, B. Braun Melsungen, Melsungen, Germany), or a DES (XIENCE everolimus-eluting stent, Abbott Vascular, Santa Clara, California). The primary endpoint was noninferiority in terms of in-segment minimal lumen diameter (MLD) at 6-month angiographic follow-up. Secondary endpoints included angiographic parameters at 6 months and clinical follow-up up to 12 months.
A total of 278 patients, of whom 56% had DES-ISR, were randomized at 8 sites to treatment with DEB (n = 141) or DES (n = 137). As compared with DEB, DES was associated with larger MLD and lower % stenosis immediately post-procedure (1.84 ± 0.46 vs. 1.72 ± 0.35; p = 0.018; and 26 ± 10% vs. 30 ± 10%; p = 0.03). Angiographic follow up was completed at 196 ± 53 days in 79% of patients. With respect to the primary endpoint of in-segment MLD at 6 months, DEB was noninferior to DES (DEB 1.71 ± 0.51 mm vs. DES 1.74 ± 0.61 mm; p for noninferiority <0.0001). Target vessel revascularization at 12-month follow-up was similar in both groups (DES 7.1% vs. DEB 8.8%; p = 0.65).
In patients with ISR, treatment with DEB was noninferior compared with DES in terms of 6-month MLD. There were no differences in clinical endpoints, including target vessel revascularization up to 12 months. Therefore, use of a DEB is an attractive treatment option for in-stent restenosis, withholding the need for additional stent implantation.</description><subject>Aged</subject><subject>Angioplasty, Balloon, Coronary - adverse effects</subject><subject>Angioplasty, Balloon, Coronary - instrumentation</subject><subject>Cardiac Catheters</subject><subject>Cardiovascular Agents - administration & dosage</subject><subject>Cardiovascular Agents - adverse effects</subject><subject>Coated Materials, Biocompatible</subject><subject>Coronary Angiography</subject><subject>Coronary Restenosis - diagnostic imaging</subject><subject>Coronary Restenosis - etiology</subject><subject>Coronary Restenosis - surgery</subject><subject>Drug-Eluting Stents</subject><subject>Everolimus - administration & dosage</subject><subject>Everolimus - adverse effects</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Netherlands</subject><subject>Paclitaxel - administration & dosage</subject><subject>Paclitaxel - adverse effects</subject><subject>Percutaneous Coronary Intervention - adverse effects</subject><subject>Percutaneous Coronary Intervention - instrumentation</subject><subject>Prosthesis Design</subject><subject>Reoperation</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>1876-7605</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kE1OwzAUhC0kREvhAiyQl2wS_JPEMbtQAlSqBCqFbeQmDrhy7GIniHINLsBZOBmWCqxGmvk0em8AOMEoxghn5-t4XSsTE4RZMGJEkj0wxjnLIpahdAQOvV8jlCHOyAEYEZ5gShIyBp8FXAjT2E59yAZObbcRTnlroG3hvai16sW71FGph16ZZ3gptLYhfZLODx6Wb9JZrbrB_xMPvTQ9bK2D_YuESydF3wXn-ysUFmYLZybaIQvpg1qv_AVcBvSqWJSBV0Ifgf1WaC-Pf3UCHq_L5fQ2mt_dzKbFPNoQjPuIrDhOMCctpSxHBDctxXnKKeNp07R5kiGMaCIyhEJQs_AwbzImicxrzJOU0gk42_VunH0dwjlVp3wttRZG2sFXmHOeMU4RDujpLzqsOtlUG6c64bbV35D0BwAydKs</recordid><startdate>20180212</startdate><enddate>20180212</enddate><creator>Baan, Jr, Jan</creator><creator>Claessen, Bimmer E</creator><creator>Dijk, Kirsten Boerlage-van</creator><creator>Vendrik, Jeroen</creator><creator>van der Schaaf, René J</creator><creator>Meuwissen, Martijn</creator><creator>van Royen, Niels</creator><creator>Gosselink, A T Marcel</creator><creator>van Wely, Marleen H</creator><creator>Dirkali, Atilla</creator><creator>Arkenbout, E Karin</creator><creator>de Winter, Robbert J</creator><creator>Koch, Karel T</creator><creator>Sjauw, Krischan D</creator><creator>Beijk, Marcel A</creator><creator>Vis, M Marije</creator><creator>Wykrzykowska, Joanna J</creator><creator>Piek, Jan J</creator><creator>Tijssen, Jan G P</creator><creator>Henriques, José P S</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20180212</creationdate><title>A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial</title><author>Baan, Jr, Jan ; Claessen, Bimmer E ; Dijk, Kirsten Boerlage-van ; Vendrik, Jeroen ; van der Schaaf, René J ; Meuwissen, Martijn ; van Royen, Niels ; Gosselink, A T Marcel ; van Wely, Marleen H ; Dirkali, Atilla ; Arkenbout, E Karin ; de Winter, Robbert J ; Koch, Karel T ; Sjauw, Krischan D ; Beijk, Marcel A ; Vis, M Marije ; Wykrzykowska, Joanna J ; Piek, Jan J ; Tijssen, Jan G P ; Henriques, José P S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p211t-2b914192f3378021df318593795ddf84601034a600f31c71329d67e2e8c194533</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Aged</topic><topic>Angioplasty, Balloon, Coronary - adverse effects</topic><topic>Angioplasty, Balloon, Coronary - instrumentation</topic><topic>Cardiac Catheters</topic><topic>Cardiovascular Agents - administration & dosage</topic><topic>Cardiovascular Agents - adverse effects</topic><topic>Coated Materials, Biocompatible</topic><topic>Coronary Angiography</topic><topic>Coronary Restenosis - diagnostic imaging</topic><topic>Coronary Restenosis - etiology</topic><topic>Coronary Restenosis - surgery</topic><topic>Drug-Eluting Stents</topic><topic>Everolimus - administration & dosage</topic><topic>Everolimus - adverse effects</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Netherlands</topic><topic>Paclitaxel - administration & dosage</topic><topic>Paclitaxel - adverse effects</topic><topic>Percutaneous Coronary Intervention - adverse effects</topic><topic>Percutaneous Coronary Intervention - instrumentation</topic><topic>Prosthesis Design</topic><topic>Reoperation</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Baan, Jr, Jan</creatorcontrib><creatorcontrib>Claessen, Bimmer E</creatorcontrib><creatorcontrib>Dijk, Kirsten Boerlage-van</creatorcontrib><creatorcontrib>Vendrik, Jeroen</creatorcontrib><creatorcontrib>van der Schaaf, René J</creatorcontrib><creatorcontrib>Meuwissen, Martijn</creatorcontrib><creatorcontrib>van Royen, Niels</creatorcontrib><creatorcontrib>Gosselink, A T Marcel</creatorcontrib><creatorcontrib>van Wely, Marleen H</creatorcontrib><creatorcontrib>Dirkali, Atilla</creatorcontrib><creatorcontrib>Arkenbout, E Karin</creatorcontrib><creatorcontrib>de Winter, Robbert J</creatorcontrib><creatorcontrib>Koch, Karel T</creatorcontrib><creatorcontrib>Sjauw, Krischan D</creatorcontrib><creatorcontrib>Beijk, Marcel A</creatorcontrib><creatorcontrib>Vis, M Marije</creatorcontrib><creatorcontrib>Wykrzykowska, Joanna J</creatorcontrib><creatorcontrib>Piek, Jan J</creatorcontrib><creatorcontrib>Tijssen, Jan G P</creatorcontrib><creatorcontrib>Henriques, José P S</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>JACC. Cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Baan, Jr, Jan</au><au>Claessen, Bimmer E</au><au>Dijk, Kirsten Boerlage-van</au><au>Vendrik, Jeroen</au><au>van der Schaaf, René J</au><au>Meuwissen, Martijn</au><au>van Royen, Niels</au><au>Gosselink, A T Marcel</au><au>van Wely, Marleen H</au><au>Dirkali, Atilla</au><au>Arkenbout, E Karin</au><au>de Winter, Robbert J</au><au>Koch, Karel T</au><au>Sjauw, Krischan D</au><au>Beijk, Marcel A</au><au>Vis, M Marije</au><au>Wykrzykowska, Joanna J</au><au>Piek, Jan J</au><au>Tijssen, Jan G P</au><au>Henriques, José P S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial</atitle><jtitle>JACC. Cardiovascular interventions</jtitle><addtitle>JACC Cardiovasc Interv</addtitle><date>2018-02-12</date><risdate>2018</risdate><volume>11</volume><issue>3</issue><spage>275</spage><epage>283</epage><pages>275-283</pages><eissn>1876-7605</eissn><abstract>The authors sought to evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with any (bare-metal or drug-eluting stent) in-stent restenosis (ISR).
The treatment of ISR remains challenging in contemporary clinical practice.
In a multicenter randomized noninferiority trial, patients with any ISR were randomly allocated in a 1:1 fashion to treatment with a DEB (SeQuent Please paclitaxel-eluting balloon, B. Braun Melsungen, Melsungen, Germany), or a DES (XIENCE everolimus-eluting stent, Abbott Vascular, Santa Clara, California). The primary endpoint was noninferiority in terms of in-segment minimal lumen diameter (MLD) at 6-month angiographic follow-up. Secondary endpoints included angiographic parameters at 6 months and clinical follow-up up to 12 months.
A total of 278 patients, of whom 56% had DES-ISR, were randomized at 8 sites to treatment with DEB (n = 141) or DES (n = 137). As compared with DEB, DES was associated with larger MLD and lower % stenosis immediately post-procedure (1.84 ± 0.46 vs. 1.72 ± 0.35; p = 0.018; and 26 ± 10% vs. 30 ± 10%; p = 0.03). Angiographic follow up was completed at 196 ± 53 days in 79% of patients. With respect to the primary endpoint of in-segment MLD at 6 months, DEB was noninferior to DES (DEB 1.71 ± 0.51 mm vs. DES 1.74 ± 0.61 mm; p for noninferiority <0.0001). Target vessel revascularization at 12-month follow-up was similar in both groups (DES 7.1% vs. DEB 8.8%; p = 0.65).
In patients with ISR, treatment with DEB was noninferior compared with DES in terms of 6-month MLD. There were no differences in clinical endpoints, including target vessel revascularization up to 12 months. Therefore, use of a DEB is an attractive treatment option for in-stent restenosis, withholding the need for additional stent implantation.</abstract><cop>United States</cop><pmid>29413242</pmid><doi>10.1016/j.jcin.2017.10.024</doi><tpages>9</tpages></addata></record> |
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| identifier | EISSN: 1876-7605 |
| ispartof | JACC. Cardiovascular interventions, 2018-02, Vol.11 (3), p.275-283 |
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| subjects | Aged Angioplasty, Balloon, Coronary - adverse effects Angioplasty, Balloon, Coronary - instrumentation Cardiac Catheters Cardiovascular Agents - administration & dosage Cardiovascular Agents - adverse effects Coated Materials, Biocompatible Coronary Angiography Coronary Restenosis - diagnostic imaging Coronary Restenosis - etiology Coronary Restenosis - surgery Drug-Eluting Stents Everolimus - administration & dosage Everolimus - adverse effects Female Humans Male Middle Aged Netherlands Paclitaxel - administration & dosage Paclitaxel - adverse effects Percutaneous Coronary Intervention - adverse effects Percutaneous Coronary Intervention - instrumentation Prosthesis Design Reoperation Time Factors Treatment Outcome |
| title | A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial |
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