Author + information
- Received August 14, 2018
- Revision received September 5, 2018
- Accepted September 10, 2018
- Published online December 3, 2018.
- Yida Tang, MDa,∗,
- Shubin Qiao, MDa,∗,
- Xi Su, MDb,
- Yundai Chen, MDc,
- Zening Jin, MDd,
- Hui Chen, MDe,
- Biao Xu, MDf,
- Xiangqing Kong, MDg,
- Wenyue Pang, MDh,
- Yong Liu, MDi,
- Zaixin Yu, MDj,
- Xue Li, MDk,
- Hui Li, MDl,
- Yanyan Zhao, BSm,
- Yang Wang, MScm,
- Wei Li, PhDm,
- Jian Tian, MDa,
- Changdong Guan, MScn,
- Bo Xu, MBBSn,∗ (, )
- Runlin Gao, MDa,∗ (, )
- for the RESTORE SVD China Investigators
- aDepartment of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
- bDepartment of Cardiology, Wuhan Asia Heart Hospital, Wuhan, China
- cDepartment of Cardiology, Chinese PLA General Hospital, Beijing, China
- dDepartment of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
- eDepartment of Cardiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China
- fDepartment of Cardiology, Affiliated Nanjing Drum Tower Hospital of Nanjing University School of Medicine, Nanjing, China
- gDepartment of Cardiology, Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China
- hDepartment of Cardiology, Shengjing Hospital of China Medical University, Shenyang, China
- iDepartment of Cardiology, the Fourth Central Hospital of Tianjin, Tianjin, China
- jDepartment of Cardiology, Xiangya Hospital of Central South University, Changsha, China
- kDepartment of Cardiology, Tangdu Hospital of the Fourth Military Medical University, Xi’an, China
- lDepartment of Cardiology, Daqing Oilfield General Hospital, Daqing, China
- mMedical Research and Biometrics Center, National Center for Cardiovascular Diseases of China, Beijing, China
- nCatheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
- ↵∗Address for correspondence:
Dr. Runlin Gao or Dr. Bo Xu, Department of Cardiology or Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, A 167, Beilishi Road, Xicheng District, Beijing 100037, China.
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)
↵∗ Drs. Tang and Qiao contributed equally to this work.
This study was sponsored by Cardionovum through an institutional research grant. The executive committee, together with the sponsor, designed the RESTORE SVD China trial. The sponsor had no role in data collection, data analysis, data interpretation, writing the manuscript, or the decision to submit the manuscript for publication. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 14, 2018.
- Revision received September 5, 2018.
- Accepted September 10, 2018.
- 2018 American College of Cardiology Foundation
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