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First-in-man study of dedicated bifurcation cobalt-chromium sirolimus-eluting stent BiOSS LIM C – 3-month results.

First-in-man study of dedicated bifurcation cobalt-chromium sirolimus-eluting stent BiOSS LIM C – 3-month results.
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Gil RJ, Bil J, Kern A, Pawłowski T,


Gil RJ, Bil J, Kern A, Pawłowski T, (click to view)

Gil RJ, Bil J, Kern A, Pawłowski T,

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Kardiologia polska 2017 12 01() doi 10.5603/KP.a2017.0226
Abstract
BACKGROUND
The optimal approach to coronary bifurcations treatment by PCI is still a subject of debate and the dedicated bifurcation stents are one of proposed solutions.

AIM
The aim of this report was to assess effectiveness and safety profile of a new dedicated bifurcation stent – sirolimus-eluting BiOSS® LIM C (Balton, Poland) at the first 3 months of the 12-month Registry.

METHODS
This is the two-center registry, which enrolls patients with NSTE-ACS and stable angina. Provisional T-stenting is the obligatory strategy of the treatment. Angiographic control is planned at 12 months. The primary endpoint is the cumulative rate of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR) at 12 months.

RESULTS
A total of 48 patients with lesions in coronary bifurcations were enrolled (mean age 67.9±8.9 years, 14.6% of female). There were 20.8% of patients with NSTE-ACS, 93.8% with hypertension, 35.4% with diabetes, 52.1% had previous MI, and 47.9% and 14.6% underwent prior PCI and CABG, respectively. The device success rate was 100%. The side branch was treated with an additional classical DES implantation in 18.8% of cases. The periprocedural MI (MI type 4a) was observed in two cases (4.2%). At 3 months there was one case (2.1%) of TLR. No death, MI or stent thrombosis were observed.

CONCLUSION
Bifurcation treatment with a single dedicated bifurcation stent (BiOSS LIM C) is feasible and highly successful (100% implantation success rate). The short-term clinical results are very promising, also in distal left main stenosis. The 12-month observations are pending.

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