First-in-man study of dedicated bifurcation cobalt-chromium sirolimus-eluting stent BiOSS LIM C® — three-month results

Abstract

Background: The optimal approach to coronary bifurcation treatment by percutaneous coronary intervention (PCI) is still a subject of debate, and dedicated bifurcation stents are one of the proposed solutions.

Aim: The aim of this report was to assess the effectiveness and safety profile of a new dedicated bifurcation stent — sirolimus-eluting BiOSS LIM C^® (Balton, Poland) at the first three months of a 12-month registry.

Methods: This is a two-centre registry, which enrolled patients with non-ST elevation acute coronary syndrome (NSTE-ACS) and stable angina. Provisional T-stenting is the obligatory strategy of the treatment. Angiographic control is planned at 12 months. The primary endpoint is the cumulative rate of cardiac death, myocardial infarction (MI), and target lesion revas­cularisation (TLR) at 12 months.

Results: A total of 48 patients with lesions in coronary bifurcations were enrolled (mean age 67.9 ± 8.9 years, 14.6% female). There were 20.8% of patients with NSTE-ACS, 93.8% with hypertension, 35.4% with diabetes, 52.1% had previous MI, and 47.9% and 14.6% underwent prior PCI and coronary artery bypass grafting, respectively. The device success rate was 100%. The side branch was treated with an additional classical drug-eluting stent implantation in 18.8% of cases. The periprocedural MI (MI type 4a) was observed in two (4.2%) cases. At three months there was one (2.1%) case of TLR. No death, MI, or stent thrombosis were observed in the follow-up period.

Conclusions: Bifurcation treatment with a single dedicated bifurcation stent (BiOSS LIM C^®) is feasible and highly successful (100% implantation success rate). The short-term clinical outcomes are very promising, also in distal left main stenosis. The 12-month observations are pending.