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JACC Cardiovasc Interv. 2018 Dec 10;11(23):2381-2392. doi: 10.1016/j.jcin.2018.09.009.

Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial.

Author information

1
Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, 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.
15
Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. Electronic address: bxu@citmd.com.
16
Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. Electronic address: gaorunlin@citmd.com.

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

PMID:
30522667
DOI:
10.1016/j.jcin.2018.09.009

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