A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (BEYOND) clinical trial in China

Abstract

Background: Treatment of coronary bifurcation lesions remains challenging; a simple strategy has been preferred as of late, but the disadvantage is ostium stenosis or even occlusion of the side branch (SB). Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported. This prospective, multicenter, randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon (PEB) compared with regular balloon angioplasty (BA) in the treatment of non-left main coronary artery bifurcation lesions.

Methods: Between December 2014 and November 2015, a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers. Patients were randomly allocated at a 1:1 ratio to a PEB group (n = 113) and a BA group (n = 109). The primary efficacy endpoint was angiographic target lesion stenosis at 9 months. Secondary efficacy and safety endpoints included target lesion revascularization, target vessel revascularization, target lesion failure, major adverse cardiac and cerebral events (MACCEs), all-cause death, cardiac death, non-fatal myocardial infarction, and thrombosis in target lesions. The main analyses performed in this clinical trial included case shedding analysis, base-value equilibrium analysis, effectiveness analysis, and safety analysis. SAS version 9.4 was used for the statistical analyses.

Results: At the 9-month angiographic follow-up, the difference in the primary efficacy endpoint of target lesion stenosis between the PEB (28.7% ± 18.7%) and BA groups (40.0% ± 19.0%) was -11.3% (95% confidence interval: -16.3% to -6.3%, Psuperiority <0.0001) in the intention-to-treat analysis, and similar results were recorded in the per-protocol analysis, demonstrating the superiority of PEB to BA. Late lumen loss was significantly lower in the PEB group than in the BA group (-0.06 ± 0.32 vs. 0.18 ± 0.34 mm, P < 0.0001). For intention-to-treat, there were no significant differences between PEB and BA in the 9-month percentages of MACCEs (0.9% vs. 3.7%, P = 0.16) or non-fatal myocardial infarctions (0 vs. 0.9%, P = 0.49). There were no clinical events of target lesion revascularization, target vessel revascularization, target lesion failure, all-cause death, cardiac death or target lesion thrombosis in either group.

Conclusions: In de novo non-left main coronary artery bifurcations treated with provisional T stenting, SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis.

Trial registration: ClinicalTrials.gov, NCT02325817; https://clinicaltrials.gov.

Figures

Figure 1

Study flow chart. Follow-up window: 30 days: ±7 days, 6 months: ±30 days; 9 months: ±30 days.

Figure 2

Primary endpoint of target lesion stenosis at 9 months. ∗Covariance analysis model included the factors of group, center, and pre-procedure diameter of the stenosis of target lesion. Four centers that had a small number of patients were consolidated as one center for analysis. BA: Balloon angioplasty; CI: Confidence interval; PEB: Paclitaxel-eluting balloon.

Figure 3

Cumulative frequency distribution of MLD determined by quantitative coronary angiography. PEB vs. BA: Pre-procedure (pre), post-procedure (post), and at 9 months (follow-up). BA: Balloon angioplasty; MLD: Minimal lumen diameters; PEB: Paclitaxel-eluting balloon.

Figure 4

A patient treated with the PEB for a bifurcation lesion. (A) High-grade stenosis in the proximal first diagonal branch. (B) Final result after angioplasty and PEB. (C) Angiographic control after 9 months without any signs of restenosis. PCI: Percutaneous coronary interventions; PEB: Paclitaxel-eluting balloon.

Figure 5

Time-to-event curves for the composite endpoints of major adverse cardiac and cerebral events through 9 months in the intention-to-treat population. The event rates presented here were calculated by the Kaplan-Meier methodology and compared with the log-rank test. BA: Balloon angioplasty; PEB: Paclitaxel-eluting balloon.