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Two-year follow-up of a randomized multicenter study comparing a drug-coated balloon with a drug-eluting stent in native small coronary vessels: The RESTORE Small Vessel Disease China trial

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单位: [1]Chinese Acad Med Sci & Peking Union Med Coll, Fu Wai Hosp, Natl Ctr Cardiovasc Dis, Dept Cardiol, 167 North Lishi Rd, Beijing 100037, Peoples R China [2]Wuhan Asia Heart Hosp, Dept Cardiol, Wuhan, Peoples R China [3]Chinese Peoples Liberat Army Gen Hosp, Dept Cardiol, Beijing, Peoples R China [4]Capital Med Univ, Beijing Anzhen Hosp, Dept Cardiol, Beijing, Peoples R China [5]Capital Med Univ, Beijing Friendship Hosp, Dept Cardiol, Beijing, Peoples R China [6]Nanjing Univ, Sch Med, Affiliated Nanjing Drum Tower Hosp, Dept Cardiol, Nanjing, Peoples R China [7]Nanjing Med Univ, Affiliated Hosp 1, Jiangsu Prov Hosp, Dept Cardiol, Nanjing, Peoples R China [8]China Med Univ, Dept Cardiol, Shengjing Hosp, Shenyang, Peoples R China [9]Fourth Cent Hosp Tianjin, Dept Cardiol, Tianjin, Peoples R China [10]Cent South Univ, Dept Cardiol, Xiangya Hosp, Changsha, Peoples R China [11]Fourth Mil Med Univ, Dept Cardiol, Tangdu Hosp, Xian, Peoples R China [12]Daqing Oilfield Gen Hosp, Dept Cardiol, Daqing, Peoples R China [13]Natl Ctr Cardiovasc Dis China, Med Res & Biometr Ctr, Beijing, Peoples R China [14]Chinese Acad Med Sci, Fu Wai Hosp, Natl Ctr Cardiovasc Dis, Catheterizat Labs, Beijing, Peoples R China
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关键词: coronary artery disease percutaneous coronary intervention angioplasty balloon coronary stents follow-up studies

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Objectives To report the clinical outcomes of the RESTORE drug-coated balloon (DCB; Cardionovum, Bonn, Germany) for treatment of de novo small vessel disease (SVD) beyond 1 year. Background Previous reports have demonstrated the noninferiority of the RESTORE DCB to the RESOLUTE Integrity drug-eluting stent (DES; Medtronic, Minneapolis, Minnesota) in terms of 9-month in-segment percent diameter stenosis. Methods In the prospective, multicenter, noninferiority RESTORE SVD China trial, 230 patients with visually-estimated reference vessel diameter (RVD) >= 2.25 and <= 2.75 mm were randomized to DCB or DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Furthermore, 32 patients with RVD >= 2.00 and <2.25 mm were enrolled in a nested very small vessel (VSV) registry. Clinical follow-up were performed at 2 years to evaluate target lesion failure (TLF) in both groups and the VSV cohort. Results Overall, 256 (97.7%) patients (115 and 109 in the DCB and DES groups, respectively, and 32 in the VSV cohort) completed 2 years of follow-up. There was no significant difference in TLF between the DCB and DES groups (5.2 vs. 3.7%, p = .75). Target lesion revascularization was acceptable at 1 month, 1 year, and 2 years, and did not differ significantly with DCB from that in the DES group (0.9 vs. 0%, p = 1.0, 4.4 vs. 2.6%, p = .72, 5.2 vs. 2.8%, p = .50, respectively). Conclusions Compared to the second-generation DES, the RESTORE DCB did not increase the risk of clinical outcomes. Late catch-up phenomen requiring revascularization was not significant in this study.

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出版当年[2019]版:
大类 | 3 区 医学
小类 | 4 区 心脏和心血管系统
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 心脏和心血管系统
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出版当年[2018]版:
Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
最新[2023]版:
Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

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第一作者单位: [1]Chinese Acad Med Sci & Peking Union Med Coll, Fu Wai Hosp, Natl Ctr Cardiovasc Dis, Dept Cardiol, 167 North Lishi Rd, Beijing 100037, Peoples R China
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