RT Journal Article
T1 Regular drug-eluting stents versus the dedicated coronary bifurcation sirolimus-eluting BiOSS LIM (R) stent: the randomised, multicentre, open-label, controlled POLBOS II trial
A1 Gil, Robert J.
A1 Bil, Jacek
A1 Grundeken, Maik J.
A1 Kern, Adam
A1 Inigo Garcia, Luis A.
A1 Vassilev, Dobrin
A1 Pawlowski, Tomasz
A1 Formuszewicz, Radoslaw
A1 Dobrzycki, Slawomir
A1 Wykrzykowska, Joanna J.
A1 Serruys, Patrick W.
K1 BiOSS LIM r
K1 dedicated bifurcation stent
K1 sirolimus-eluting stent
K1 Strut thickness
K1 Lesions
K1 Restenosis
K1 Classification
K1 Consensus
K1 Registry
K1 Disease
K1 Impact
AB Aims: The aim of the POLBOS II randomised trial was to compare any regular drug-eluting stents (rDES) with the dedicated bifurcation sirolimus-eluting stent BiOSS LIM for the treatment of coronary bifurcation lesions. The secondary aim was to study the effect of final kissing balloon inflation (FKBI) on clinical outcomes.Methods and results: Between December 2012 and December 2013, 202 patients with stable coronary artery disease or non-ST-segment elevation acute coronary syndrome were randomly assigned 1:1 to treatment of the coronary bifurcation lesions either with the BiOSS LIM stent (n=102) or with an rDES (n=100). Coronary re-angiography was performed at 12 months. The primary endpoint was the composite of cardiac death, myocardial infarction (MI), and target lesion revascularisation (TLR) at 12 months. The target vessel was located in the left main in one third of the cases (35.3% in BiOSS and 38% in rDES). Side branch treatment was required in 8.8% (rDES) and 7% (BiOSS). At 12 months, the cumulative MACE incidence was similar in both groups (11.8% [ BiOSS] vs. 15% [rDES, p=0.08]), as was the TLR rate (9.8% vs. 9% [p=0.8]). The binary restenosis rates were significantly lower in the FKBI subgroup of the BiOSS group (5.9% vs. 11.8%, p
PB Europa edition
SN 1774-024X
YR 2016
FD 2016-12-01
LK https://hdl.handle.net/10668/26751
UL https://hdl.handle.net/10668/26751
LA en
DS RISalud
RD Apr 8, 2025