DES Versus BiOSS LIM - POLBOS II Study

Overview

Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary interventions (PCI) and are associated with higher rates of periprocedural complications as well as higher rates of in-stent restenosis and stent thrombosis. Provisional T-stenting (PTS) is the best treatment strategy at the moment. However, the optimal approach to coronary bifurcations treatment is still a subject of debate, especially when the side branch is large, not easily accessible and narrowed by a long lesion. One of the proposed alternatives are dedicated bifurcation stents (DBS). However, there is large scarcity of randomized trials with DBS. POLBOS II study is continuation of POLBOS I (POLish Bifurcation Optimal Stenting) study, in which paclitaxel-eluting stent BiOSS Expert® (Balton, Poland) was assessed. Now performance of sirolimus-eluting stent BiOSS LIM® (Balton, Poland) is verified.

After signing the informed consent patients were randomly assigned to one of two treatment strategies: BiOSS LIM® stent implantation or rDES implantation (envelope randomization, 1:1). If the patient was enrolled to rDES Group there was a second randomization: with or without final kissing ballooning (FKB). Clinical follow-up was performed with office visits or telephone contacts at 1 and 12 months after intervention. Adverse events were monitored throughout the study period. Follow-up coronary angiography was performed at 12 months unless clinically indicated earlier.

Conditions