Two-year follow-up of a randomized multicenter study comparing a drug-coated balloon with a drug-eluting stent in native small coronary vessels: The RESTORE Small Vessel Disease China trial.

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.

• Authors: Jian Tian, Yi-da 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, Changdong Guan, Runlin Gao, Bo Xu, RESTORE SVD China Investigators
• Journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (Catheter Cardiovasc Interv) Vol. 95 Suppl 1 Pg. 587-597 (02 2020) ISSN: 1522-726X [Electronic] United States
• PMID: 31943693 (Publication Type: Comparative Study, Equivalence Trial, Journal Article, Multicenter Study)
• Copyright: © 2020 Wiley Periodicals, Inc.

Chemical References

• Coated Materials, Biocompatible

Topics

• Aged
• Angioplasty, Balloon, Coronary (adverse effects, instrumentation)
• Cardiac Catheters
• China
• Coated Materials, Biocompatible
• Coronary Artery Disease (diagnostic imaging, therapy)
• Drug-Eluting Stents
• Female
• Humans
• Male
• Middle Aged
• Registries
• Risk Assessment
• Risk Factors
• Time Factors
• Treatment Outcome