Cargando…
Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial
BACKGROUND: The use of a drug-eluting balloon for the treatment of de novo coronary artery lesions remains to be evaluated. A previous trial in patients with stable and unstable angina comparing a bare metal stent mounted on a drug-eluting balloon with a sirolimus-eluting stent failed to meet the pr...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2013
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3598714/ https://www.ncbi.nlm.nih.gov/pubmed/23394404 http://dx.doi.org/10.1186/1745-6215-14-38 |
_version_ | 1782262806700097536 |
---|---|
author | Park, Sang-Don Yoon, Chang-Hwan Oh, Il-Young Suh, Jung-Won Cho, Young-Suk Youn, Tae-Jin Choi, Dong-Ju Chae, In-Ho |
author_facet | Park, Sang-Don Yoon, Chang-Hwan Oh, Il-Young Suh, Jung-Won Cho, Young-Suk Youn, Tae-Jin Choi, Dong-Ju Chae, In-Ho |
author_sort | Park, Sang-Don |
collection | PubMed |
description | BACKGROUND: The use of a drug-eluting balloon for the treatment of de novo coronary artery lesions remains to be evaluated. A previous trial in patients with stable and unstable angina comparing a bare metal stent mounted on a drug-eluting balloon with a sirolimus-eluting stent failed to meet the prespecified non-inferiority criteria versus the sirolimus-eluting stent. The stent struts of a bare metal stent pre-mounted on a drug-eluting balloon may prevent the appropriate delivery of drugs to the vessel wall and may result in reduced efficacy. In the present study we will therefore evaluate the efficacy of a drug-eluting balloon for treating de novo coronary artery lesions using a strategy designed to uniformly deliver drug to the vessel with a bare metal stent. METHODS/DESIGN: The Comparison of Drug-Eluting Balloon first study is a prospective, randomized, open-label trial designed to demonstrate the non-inferiority of first using a drug-eluting balloon (Sequent(®) please; B. Braun, Melsungen, Germany) followed by a bare metal stent (Coroflex(®) Blue; B. Braun) compared with using a drug-eluting stent (Resolute Integrity™; Boston Scientific, Natick, MA, USA) for de novo coronary artery lesions. The primary endpoint of the study is in-segment late loss at 9 months measured by quantitative coronary angiography. Secondary endpoints include angiographic findings such as angiographic success, device success, binary angiographic restenosis, and clinical outcomes such as procedural success, all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. A total of 180 patients will be enrolled in the study. DISCUSSION: The Comparison of Drug-Eluting Balloon first study will evaluate the clinical efficacy, angiographic outcomes and safety of a drug-eluting balloon first followed by a bare metal stent compared with a drug-eluting stent for the treatment of de novo coronary artery lesions. TRIAL REGISTRATION: Clinical Trials.gov: NCT01539603 |
format | Online Article Text |
id | pubmed-3598714 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-35987142013-03-16 Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial Park, Sang-Don Yoon, Chang-Hwan Oh, Il-Young Suh, Jung-Won Cho, Young-Suk Youn, Tae-Jin Choi, Dong-Ju Chae, In-Ho Trials Study Protocol BACKGROUND: The use of a drug-eluting balloon for the treatment of de novo coronary artery lesions remains to be evaluated. A previous trial in patients with stable and unstable angina comparing a bare metal stent mounted on a drug-eluting balloon with a sirolimus-eluting stent failed to meet the prespecified non-inferiority criteria versus the sirolimus-eluting stent. The stent struts of a bare metal stent pre-mounted on a drug-eluting balloon may prevent the appropriate delivery of drugs to the vessel wall and may result in reduced efficacy. In the present study we will therefore evaluate the efficacy of a drug-eluting balloon for treating de novo coronary artery lesions using a strategy designed to uniformly deliver drug to the vessel with a bare metal stent. METHODS/DESIGN: The Comparison of Drug-Eluting Balloon first study is a prospective, randomized, open-label trial designed to demonstrate the non-inferiority of first using a drug-eluting balloon (Sequent(®) please; B. Braun, Melsungen, Germany) followed by a bare metal stent (Coroflex(®) Blue; B. Braun) compared with using a drug-eluting stent (Resolute Integrity™; Boston Scientific, Natick, MA, USA) for de novo coronary artery lesions. The primary endpoint of the study is in-segment late loss at 9 months measured by quantitative coronary angiography. Secondary endpoints include angiographic findings such as angiographic success, device success, binary angiographic restenosis, and clinical outcomes such as procedural success, all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. A total of 180 patients will be enrolled in the study. DISCUSSION: The Comparison of Drug-Eluting Balloon first study will evaluate the clinical efficacy, angiographic outcomes and safety of a drug-eluting balloon first followed by a bare metal stent compared with a drug-eluting stent for the treatment of de novo coronary artery lesions. TRIAL REGISTRATION: Clinical Trials.gov: NCT01539603 BioMed Central 2013-02-08 /pmc/articles/PMC3598714/ /pubmed/23394404 http://dx.doi.org/10.1186/1745-6215-14-38 Text en Copyright ©2013 Park et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study Protocol Park, Sang-Don Yoon, Chang-Hwan Oh, Il-Young Suh, Jung-Won Cho, Young-Suk Youn, Tae-Jin Choi, Dong-Ju Chae, In-Ho Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial |
title | Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial |
title_full | Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial |
title_fullStr | Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial |
title_full_unstemmed | Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial |
title_short | Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial |
title_sort | comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3598714/ https://www.ncbi.nlm.nih.gov/pubmed/23394404 http://dx.doi.org/10.1186/1745-6215-14-38 |
work_keys_str_mv | AT parksangdon comparisonofadrugelutingballoonfirstandthenbaremetalstentwithadrugelutingstentfortreatmentofdenovolesionsstudyprotocolofarandomizedcontrolledtrial AT yoonchanghwan comparisonofadrugelutingballoonfirstandthenbaremetalstentwithadrugelutingstentfortreatmentofdenovolesionsstudyprotocolofarandomizedcontrolledtrial AT ohilyoung comparisonofadrugelutingballoonfirstandthenbaremetalstentwithadrugelutingstentfortreatmentofdenovolesionsstudyprotocolofarandomizedcontrolledtrial AT suhjungwon comparisonofadrugelutingballoonfirstandthenbaremetalstentwithadrugelutingstentfortreatmentofdenovolesionsstudyprotocolofarandomizedcontrolledtrial AT choyoungsuk comparisonofadrugelutingballoonfirstandthenbaremetalstentwithadrugelutingstentfortreatmentofdenovolesionsstudyprotocolofarandomizedcontrolledtrial AT yountaejin comparisonofadrugelutingballoonfirstandthenbaremetalstentwithadrugelutingstentfortreatmentofdenovolesionsstudyprotocolofarandomizedcontrolledtrial AT choidongju comparisonofadrugelutingballoonfirstandthenbaremetalstentwithadrugelutingstentfortreatmentofdenovolesionsstudyprotocolofarandomizedcontrolledtrial AT chaeinho comparisonofadrugelutingballoonfirstandthenbaremetalstentwithadrugelutingstentfortreatmentofdenovolesionsstudyprotocolofarandomizedcontrolledtrial |