Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial
Yida Tang, Shubin Qiao, Xi Su, Yundai Chen, Zening Jin, Hui Chen, Biao Xu, Xiangqing Kong, Wenyue Pang, Yong Liu, Zaixin Yu, Xue Li, Hui Li, Yanyan Zhao, Yang Wang, Wei Li, Jian Tian, Changdong Guan, Bo Xu, Runlin Gao, RESTORE SVD China Investigators, Runlin Gao, Shubin Qiao, Runlin Gao, Bo Xu, Yida Tang, Shubin Qiao, Xi Su, Yong Zeng, Qing Yang, Jian Zhang, Runlin Gao, Shubin Qiao, Bo Xu, Yida Tang, Changdong Guan, Jian Tian, Jue Chen, Yongjian Wu, Hongbin Yan, Yuejin Yang, Xi Su, Min Wang, Jiangyou Wang, Wenjie Xu, Yundai Chen, Qinhua Jin, Zening Jin, Duo Yang, Shuai Meng, Hui Chen, Siwen Liang, Daokuo Yao, Dongbao Li, Biao Xu, Jie Song, Qing Dai, Kun Wang, Lina Kang, Lian Wang, Xiangqing Kong, Hui Wang, Liansheng Wang, Wenyue Pang, Jiye Wan, Yong Liu, Liudong Wei, Feng He, Xiaochun Xing, Zaixin Yu, Duanzheng Wang, Ran Jin, Xue Li, Yusheng Xue, Bin Wang, Hui Li, Manqing Wang, Jijia Wang, Yida Tang, Shubin Qiao, Xi Su, Yundai Chen, Zening Jin, Hui Chen, Biao Xu, Xiangqing Kong, Wenyue Pang, Yong Liu, Zaixin Yu, Xue Li, Hui Li, Yanyan Zhao, Yang Wang, Wei Li, Jian Tian, Changdong Guan, Bo Xu, Runlin Gao, RESTORE SVD China Investigators, Runlin Gao, Shubin Qiao, Runlin Gao, Bo Xu, Yida Tang, Shubin Qiao, Xi Su, Yong Zeng, Qing Yang, Jian Zhang, Runlin Gao, Shubin Qiao, Bo Xu, Yida Tang, Changdong Guan, Jian Tian, Jue Chen, Yongjian Wu, Hongbin Yan, Yuejin Yang, Xi Su, Min Wang, Jiangyou Wang, Wenjie Xu, Yundai Chen, Qinhua Jin, Zening Jin, Duo Yang, Shuai Meng, Hui Chen, Siwen Liang, Daokuo Yao, Dongbao Li, Biao Xu, Jie Song, Qing Dai, Kun Wang, Lina Kang, Lian Wang, Xiangqing Kong, Hui Wang, Liansheng Wang, Wenyue Pang, Jiye Wan, Yong Liu, Liudong Wei, Feng He, Xiaochun Xing, Zaixin Yu, Duanzheng Wang, Ran Jin, Xue Li, Yusheng Xue, Bin Wang, Hui Li, Manqing Wang, Jijia Wang
Abstract
Objectives: The aim of this study was to evaluate the angiographic efficacy and clinical outcomes of the Restore paclitaxel-coated balloon in a randomized trial designed to enable its approval with an indication for small-vessel disease (SVD).
Background: Higher rates of restenosis and stent thrombosis limit the effectiveness of drug-eluting stent (DES) treatment of SVD. Whether a drug-coated balloon (DCB)-only strategy is effective in de novo SVD is not yet established.
Methods: In the noninferiority RESTORE SVD China trial, eligible patients with reference vessel diameter ≥2.25 and ≤2.75 mm were randomized to the Restore DCB or the RESOLUTE Integrity DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Patients with RVD ≥2.00 and <2.25 mm were enrolled in a nested very small vessel registry. Angiographic and clinical follow-up were planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment percentage diameter stenosis.
Results: Between August 2016 and June 2017, a total of 230 subjects at 12 sites were randomized to the DCB group (n = 116) or DES group (n = 114); 32 patients were treated with the DCB in the very small vessel cohort. Nine-month in-segment percentage diameter stenosis was 29.6 ± 2.0% with the DCB versus 24.1 ± 2.0% with the DES; the 1-sided 97.5% upper confidence limit of the difference was 10.9%, achieving noninferiority of the DCB compared with the DES (p for noninferiority < 0.001). The DCB and DES had comparable 1-year rates of target lesion failure (4.4% vs. 2.6%, p = 0.72).
Conclusions: In this multicenter randomized trial, the Restore DCB was noninferior to the RESOLUTE DES for 9-month in-segment percentage diameter stenosis. (Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease; NCT02946307).
Keywords: drug-coated balloon; drug-eluting stent(s); percentage diameter stenosis; small-vessel disease.
Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed