Clinical outcomes of a dedicated bifurcation stent system

Percutaneous coronary intervention (PCI) of bifurcation lesions is technically challenging and associated with higher rates of complications such as stent thrombosis or in-stent restenosis. In this paper, we present the clinical outcomes of BiOSS LIM C (Balton, Poland), a dedicated bifurcation stent.

In this retrospective single-center study we analyzed the outcome of patients with bifurcation coronary artery disease treated with the BiOSS LIM C stent system. The primary endpoint was the cumulative rate of major adverse cardiac events (MACE) including cardiac death, myocardial infarction (MI) and target lesion revascularisation (TLR) at the longest available follow-up.

The study population consisted of 25 patients (mean age 73.6 ± 9.7 years, 25 % females). In 80 % of the cases (n = 20) BiOSS LIM C stent was implanted in the left main coronary artery. Intravascular imaging was used in 70 % of the cases and an additional regular drug-eluting stent (DES) was deployed in the side branch in 24 % of the cases. The device success rate was 100 % and we observed no in-hospital adverse events. At a median follow-up of 15 ± 6 months, the MACE rate was 56 %, cardiac death was 4 %, and clinically driven TLR was 55 %. One patient died in the LM subgroup, 5 months after the index PCI, due to NSTEMI complicated by cardiogenic shock. Two patients died due to non-cardiac causes.

In this consecutive series of patients treated with BiOSS LIM C in major coronary bifurcation lesions, mostly in the left main stem, the mid-term clinical outcomes demonstrated a high incidence of major adverse events, mainly caused by TLR, despite an adequate implantation technique.