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.

Small vessel coronary artery disease: How small can we go with myocardial revascularization?

“…Also, the RESTORE SVD randomized trial compared DCB with zotarolimus-eluting stent in 256 patients with de novo lesions within vessels between 2.0 and 2.75 mm in size [66]. Target lesion failure did not differ significantly between DCB and DES group at two years (5.2% vs. 3.7%, p = 0.75) [66].…”

Adverse Events in Primary Percutaneous Coronary Angioplasty With Drug-Eluting Stents Compared With Drug-Coated Balloons: A Retrospective Outlook

“…This was shown in a study that demonstrated an increased incidence of stent thrombosis among AMI patients treated with DES as compared with balloon angioplasty alone, thus paving a potential role of a DCB in PPCI [5]. The presence of a drug on the semi-compliant DCB provides a potential advantage in reducing the potential risk of in-stent restenosis or stent thrombosis [12].…”

Drug-coated Balloons for Small Coronary Disease—A Literature Review

“…At 9 months, similar in-segment percent diameter stenosis was found (29.6 ± 2% versus 24.1 ± 2%, p < 0.001 for non-inferiority) and there was no difference in TLR, cardiac death, MI and any revascularization. No difference was also found in TLF (4.4% versus 2.6%, p = 0.72) after 1 year and up to 2 years (5.2 versus 3.7%, p = 0.75) [ 36 ].…”