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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
Author(s) -
Tian Jian,
Tang Yida,
Qiao Shubin,
Su Xi,
Chen Yundai,
Jin Zening,
Chen Hui,
Xu Biao,
Kong Xiangqing,
Pang Wenyue,
Liu Yong,
Yu Zaixin,
Li Xue,
Li Hui,
Zhao Yanyan,
Wang Yang,
Li Wei,
Guan Changdong,
Gao Runlin,
Xu Bo
Publication year - 2020
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28705
Subject(s) - medicine , target lesion , stent , stenosis , cohort , drug eluting stent , randomized controlled trial , multicenter trial , surgery , prospective cohort study , lesion , myocardial infarction , percutaneous coronary intervention , restenosis , multicenter study
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.