Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease

• Published in: JACC. Cardiovascular interventions Vol. 11; no. 23; pp. 2381 - 2392
• Main Authors: 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, Tian, Jian, Guan, Changdong, Xu, Bo, Gao, Runlin, Zeng, Yong, Yang, Qing, Zhang, Jian, Chen, Jue, Wu, Yongjian, Yan, Hongbin, Yang, Yuejin, Wang, Min, Wang, Jiangyou, Xu, Wenjie, Jin, Qinhua, Yang, Duo, Meng, Shuai, Liang, Siwen, Yao, Daokuo, Li, Dongbao, Song, Jie, Dai, Qing, Wang, Kun, Kang, Lina, Wang, Lian, Wang, Hui, Wang, Liansheng, Wan, Jiye, Wei, Liudong, He, Feng, Xing, Xiaochun, Wang, Duanzheng, Jin, Ran, Xue, Yusheng, Wang, Bin, Wang, Manqing, Wang, Jijia
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.12.2018
• Subjects: drug-coated balloon; drug-eluting stent(s); percentage diameter stenosis; small-vessel disease; ATS; LL; SVD; RVD; DCB; MLD; small-vessel disease; ITT; drug-coated balloon; drug-eluting stent(s); DS; TLF; percentage diameter stenosis; DES; MACE; PCI; VSV; TLR; MI; DAPT
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2018.09.009

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). 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. 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. 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). 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) [Display omitted]