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논문 기본 정보

자료유형
학술저널
저자정보
채인호 (서울대학교) 윤창환 (분당서울대학교병원) 박진주 (분당서울대학교병원 내과) 오일영 (서울의대) 서정원 (분당서울대학교병원) 조영석 (서울대학교) 윤태진 (분당서울대학교병원) 최동주 (서울대학교)
저널정보
대한의학회 Journal of Korean Medical Science Journal of Korean Medical Science Vol.32 No.6
발행연도
2017.1
수록면
933 - 941 (9page)

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The combined use of a drug-eluting balloon (DEB) and a bare metal stent (BMS) for the treatment of de novo non-small vessel coronary artery diseases (CAD) remains to be evaluated. We investigated the efficacy of a sequential treatment using a DEB together with a BMS implantation in comparison to a zotarolimus-eluting stent (ZES). This study was a prospective, randomized, open-label study. We designed it to demonstrate the non-inferiority of a sequential treatment using a DEB first followed by a BMS (DEB + BMS) compared with the use of a ZES. The primary endpoint was in-segment late loss (LL) at 9 months measured by quantitative coronary angiography (QCA). A total of 180 patients were enrolled in the study. The 9-month follow-up angiography was performed in 72 patients with DEB + BMS and 74 patients with ZES. When comparing the DEB + BMS results with the ZES ones, LL was 0.50 ± 0.46 mm in DEB + BMS patients vs. 0.21 ± 0.44 mm in ZES patients (P < 0.001). The mean difference of the LL was 0.31 mm, which was larger than the prespecified non-inferiority margin of 0.19 mm, and the 2-sided 95% confidence interval was 0.15–0.48. The clinical outcomes were not significantly different. In conclusion, the DEB + BMS strategy is inferior to the ZES one in terms of the LL result at 9 months. The DEB strategy for de novo coronary artery lesions needs to be improved for it to become an alternative treatment option. This was a clinical trial study and was registered at www.ClinicalTrials.gov (Identifier: NCT01539603; http://www.clinicaltrials.gov/ct2/show/NCT01539603).

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