Jian Tian1, Yi-da Tang1, Shubin Qiao1, Xi Su2, Yundai Chen3, Zening Jin4, Hui Chen5, Biao Xu6, Xiangqing Kong7, Wenyue Pang8, Yong Liu9, Zaixin Yu10, Xue Li11, Hui Li12, Yanyan Zhao13, Yang Wang13, Wei Li13, Changdong Guan14, Runlin Gao1, Bo Xu14. 1. Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 2. Department of Cardiology, Wuhan Asia Heart Hospital, Wuhan, China. 3. Department of Cardiology, Chinese PLA General Hospital, Beijing, China. 4. Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. 5. Department of Cardiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China. 6. Department of Cardiology, Affiliated Nanjing Drum Tower Hospital of Nanjing University School of Medicine, Nanjing, China. 7. Department of Cardiology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. 8. Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, China. 9. Department of Cardiology, The Fourth Central Hospital of Tianjin, Tianjin, China. 10. Department of Cardiology, Xiangya Hospital of Central South University, Changsha, China. 11. Department of Cardiology, Tangdu Hospital of the Fourth Military Medical University, Xi'an, China. 12. Department of Cardiology, Daqing Oilfield General Hospital, Daqing, China. 13. Medical Research and Biometrics Center, National Center for Cardiovascular Diseases of China, Beijing, China. 14. Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.
Abstract
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.
RCT Entities:
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.
Authors: Maciej T Wybraniec; Paweł Bańka; Tomasz Bochenek; Tomasz Roleder; Katarzyna Mizia-Stec Journal: Cardiol J Date: 2020-09-28 Impact factor: 2.737