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.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical Trials.gov: NCT01539603.
authors: Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Bein-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 463-707, Republic of Korea.
authors: Sang-Don
authors: SD
authors: Park
authors: Chang-Hwan
authors: CH
authors: Yoon
authors: Il-Young
authors: IY
authors: Oh
authors: Jung-Won
authors: JW
authors: Suh
authors: Young-Suk
authors: YS
authors: Cho
authors: Tae-Jin
authors: TJ
authors: Youn
authors: Dong-Ju
authors: DJ
authors: Choi
authors: In-Ho
authors: IH
authors: Chae
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology; D054855:Drug-Eluting Stents; D006801:Humans; D008670:Metals; D009203:Myocardial Infarction / Q000175:diagnosis / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D056910:Republic of Korea; D012107:Research Design; D015607:Stents; D013927:Thrombosis / Q000175:diagnosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D002317:Cardiovascular Agents; D008670:Metals
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