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
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首都医科大学附属安贞医院[5]Capital Med Univ, Beijing Friendship Hosp, Dept Cardiol, Beijing, Peoples R China临床科室心血管中心心内科首都医科大学附属北京友谊医院[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江苏省人民医院[8]China Med Univ, Dept Cardiol, Shengjing Hosp, Shenyang, Peoples R China中国医科大学附属盛京医院[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
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.
基金:
Beijing Municipal Science and Technology CommissionBeijing Municipal Science & Technology Commission [Z171100001017214, Z181100006318005]; National Natural Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [81825003]; Cardionovum, Germany
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
通讯作者:
推荐引用方式(GB/T 7714):
Tian Jian,Tang Yi-da,Qiao Shubin,et al.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[J].CATHETERIZATION and CARDIOVASCULAR INTERVENTIONS.2020,95:587-597.doi:10.1002/ccd.28705.
APA:
Tian, Jian,Tang, Yi-da,Qiao, Shubin,Su, Xi,Chen, Yundai...&Xu, Bo.(2020).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.CATHETERIZATION and CARDIOVASCULAR INTERVENTIONS,95,
MLA:
Tian, Jian,et al."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".CATHETERIZATION and CARDIOVASCULAR INTERVENTIONS 95.(2020):587-597