In:
Catheterization and Cardiovascular Interventions, Wiley, Vol. 95, No. S1 ( 2020-02), p. 587-597
Abstract:
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.
Type of Medium:
Online Resource
ISSN:
1522-1946
,
1522-726X
Language:
English
Publisher:
Wiley
Publication Date:
2020
detail.hit.zdb_id:
2001555-0
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