Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial

Abstract

The combined use of a drug-eluting balloon (DEB) and a bare metal stent (BMS) for the treatment of de novo non-small vessel coronary artery diseases (CAD) remains to be evaluated. We investigated the efficacy of a sequential treatment using a DEB together with a BMS implantation in comparison to a zotarolimus-eluting stent (ZES). This study was a prospective, randomized, open-label study. We designed it to demonstrate the non-inferiority of a sequential treatment using a DEB first followed by a BMS (DEB + BMS) compared with the use of a ZES. The primary endpoint was in-segment late loss (LL) at 9 months measured by quantitative coronary angiography (QCA). A total of 180 patients were enrolled in the study. The 9-month follow-up angiography was performed in 72 patients with DEB + BMS and 74 patients with ZES. When comparing the DEB + BMS results with the ZES ones, LL was 0.50 ± 0.46 mm in DEB + BMS patients vs. 0.21 ± 0.44 mm in ZES patients (P < 0.001). The mean difference of the LL was 0.31 mm, which was larger than the prespecified non-inferiority margin of 0.19 mm, and the 2-sided 95% confidence interval was 0.15-0.48. The clinical outcomes were not significantly different. In conclusion, the DEB + BMS strategy is inferior to the ZES one in terms of the LL result at 9 months. The DEB strategy for de novo coronary artery lesions needs to be improved for it to become an alternative treatment option.

Trial registration: ClinicalTrials.gov NCT01539603.

Keywords: Bare Metal Stent; Coronary Artery Disease; Drug-eluting Balloon; Drug-eluting Stent; In-segment Late Loss.

Fig. 1

The flowchart of the trial. DEB = drug-eluting balloon, BMS = bare metal stent, ZES = zotarolimus-eluting stent, F/U CAG = follow-up coronary angiography.

Fig. 2

Cumulative frequency plot for minimal LL and late lumen loss. (A) Cumulative frequency plot for minimal lumen diameter before and after index procedure. (B) Cumulative frequency plot for late lumen loss before and after index procedure. LL = late loss, DES = drug-eluting stent, DEB = drug-eluting balloon, BMS = bare metal stent.

Fig. 3

The mean difference of in-stent LL and 95% CI and its subgroup analysis. The broken line denotes the prespecified non-inferiority margin (0.19 mm). LL = late loss, CI = confidence interval.