Long-term effectiveness and safety of the sirolimus-eluting BiOSS LIM® dedicated bifurcation stent in the treatment of distal left main stenosis: an international registry

Aims:The aim of this study was to assess prospectively the effectiveness and safety of a new version of the dedicated bifurcation BiOSS stent, the sirolimus-eluting BiOSS LIM, for the treatment of distal left main (LM) stenosis. Methods and results:This was a prospective international registry which enrolled patients with NSTE-ACS or stable angina.Provisional T-stenting was the mandated strategy.The primary endpoint was the cumulative rate of cardiac death, myocardial infarction (MI) and target lesion revascularisation (TLR) at 12 months.Twelve-month quantitative coronary angiography endpoints included late lumen loss and percent diameter stenosis.A total of 74 patients with distal LM stenosis were enrolled.Seventy-three of the 74 patients (aged 67±9 years, 23% women, 20.3% NSTE-ACS, SYNTAX score 22.4±4.4)were successfully treated with the BiOSS LIM stent, with additional side branch placement of regular DES in 11 patients (14.9%).Periprocedural MI occurred in one (1.4%)patient.The 12-month MACE rate was 9.5% without cardiac death or definite stent thrombosis.TLR and MI rates were 6.8% (n=5) and 2.7% (n=2), respectively. Conclusions:The use of the BiOSS LIM dedicated bifurcation stent for the treatment of distal LM stenosis was feasible and safe, with promising long-term clinical effectiveness.