Regular drug-eluting stents versus the dedicated coronary bifurcation sirolimus-eluting BiOSS LIM® stent: the randomised, multicentre, open-label, controlled POLBOS II trial

Abstract

MACE rates as well as TLR rates were comparable between the BiOSS LIM and rDES. At 12 months, cumulative MACE incidence was similar in both groups (11.8% vs. 15%), as was the TLR rate (9.8% vs. 9%). Significantly lower rates of restenosis were observed in the FKBI subgroup of the BiOSS group.

Assessment of vascular response to BiOSS LIM C® stents vs Orsiro® stents in the porcine coronary artery model

“…It achieved acceptable results both in in vivo studies and in clinical trials. However, clinical results of BiOSS Expert and BiOSS LIM were not very different that was caused mainly by high late lumen loss values in case of BiOSS LIM . Therefore, the idea to reduce the late lumen loss and as a result TLR rate using thinner struts appeared…”

“…Nevertheless, the optimal approach for true coronary bifurcations is still a subject of discussion, especially when the side branch is large, narrowed by a long plaque or not simply accessible . The role of dedicated devices in this setting remains unclear compared to the provisional approach as shown in the Tryton IDE study or POLBOS I and II trials …”

Outcomes of the Tryton‐dedicated bifurcation stent for the treatment of true coronary bifurcations: Individual‐patient‐data pooled analysis

“…A meta‐analysis incorporating the results of 9 RCTs including 2,569 patients reported that a two‐stent strategy had similar clinical safety (cardiac death and stent thrombosis) and efficacy (TLR, target vessel revascularization) compared with the PS strategy. Moreover, studies evaluating the performance of dedicated bifurcation devices, such as the BiOSS LIM stent also showed similar clinical outcomes in comparison to PS approach …”

Is it possible to further improve clinical results with coronary bifurcation stenting, or what is more important — the technique or the stent?

“…No randomised study has given results for this type of stent compared to regular DESs. A BIOSS Lim stent is a dedicated device demonstrating clinical efficacy in a recently published randomised POLBOS II trial [53]. At 12 months, the cumulative MACE incidence was similar in both groups (11.8% [BiOSS] vs. 15%…”