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.