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

Sang-Don Park, Chang-Hwan Yoon, Il-Young Oh, Jung-Won Suh, Young-Suk Cho, Tae-Jin Youn, Dong-Ju Choi, In-Ho Chae, Sang-Don Park, Chang-Hwan Yoon, Il-Young Oh, Jung-Won Suh, Young-Suk Cho, Tae-Jin Youn, Dong-Ju Choi, In-Ho Chae

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/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.

Figures

Figure 1
Figure 1
Drug-eluting balloon first study algorithm. BMS, bare metal stent; DEB, drug-eluting balloon; DES, drug-eluting stent; PCI, percutaneous coronary intervention.

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