A prospective randomized open-label trial of sirolimus versus paclitaxel-coated balloons for the side branch of de novo coronary bifurcation lesion.

BACKGROUND

Drug-coated balloons (DCBs) are commonly used in small coronary arteries. A recent trial reported similar outcomes between paclitaxel-coated balloons (PCBs) and sirolimus-coated balloons (SCBs) in side branch (SB) stenosis after stenting main branch (MB). This trial investigated whether SCBs and PCBs produce similar effects in de novo bifurcation lesions.

METHODS

In this prospective, multicenter, randomized, non-inferiority clinical trial, patients with de novo non-left main coronary bifurcation lesions undergoing provisional stent of SB were randomly assigned in a 1:1 ratio to receive either SCBs or PCBs in SB. The primary efficacy endpoint was the percentage of target lesion stenosis (TLS) in the SB observed on angiogram 9 months after treatment. Secondary endpoints included efficacy and safety endpoints. The former included restenosis of target lesions and the latter included adverse events (AEs) and serious adverse events (SAEs).

RESULTS

During June 2021 and October 2023, a total of 241 patients (SCB 121 vs. PCB 120) were included at 10 centers in China (mean age 63.92±9.48 years; 32% female). At the 9-month follow-up, the difference in the primary efficacy endpoint between the SCB (26.8%±14.4%) and PCB (30.6%±17.1%) groups was -3.8% (95% confidence interval: -7.9% to 0.2%, P<0.05 for non-inferiority margin of 7%). The secondary efficacy endpoints were similar between the two groups, including restenosis of target lesions (7.2% vs. 7.8%, P=0.88), late lumen loss (LLL) (0.21 vs. 0.26 mm, P=0.69), target lesion revascularization (TLR) (0.84% vs. 0.85%, P>0.99), target vessel revascularization (TVR) (0.84% vs. 0.85%, P>0.99), target lesion failure (TLF) (0.84% vs. 0.85%, P>0.99), major adverse cardiac event (MACE) (4.2% vs. 2.0%, P=0.43), and major adverse cardiac and cerebral event (MACCE) (0.84% vs. 1.71%, P=0.62) at 9 months. The secondary safety endpoints were also similar between the groups.

CONCLUSIONS

In patients with de novo non-left main coronary bifurcation lesions treated with provisional stenting in the SB, SB dilation with SCB was non-inferior to PCB in terms of percentage of TLS at 9-month follow-up.Trial Registration: This study was registered at the National Research Registration and Filing Information System (https://www.medicalresearch.org.cn/, MR-12-24-007528).