PMID- 29192951
OWN - NLM
STAT- MEDLINE
DCOM- 20181211
LR  - 20181211
IS  - 1897-4279 (Electronic)
IS  - 0022-9032 (Linking)
VI  - 76
IP  - 2
DP  - 2018
TI  - First-in-man study of dedicated bifurcation cobalt-chromium sirolimus-eluting 
      stent BiOSS LIM C(R) - three-month results.
PG  - 464-470
LID - 10.5603/KP.a2017.0226 [doi]
AB  - BACKGROUND: The optimal approach to coronary bifurcation treatment by 
      percutaneous coronary intervention (PCI) is still a subject of debate, and 
      dedicated bifurcation stents are one of the proposed solutions. AIM: The aim of 
      this report was to assess the effectiveness and safety profile of a new dedicated 
      bifurcation stent - sirolimus-eluting BiOSS LIM C(R) (Balton, Poland) at the first 
      three months of a 12-month registry. METHODS: This is a two-centre registry, 
      which enrolled patients with non-ST elevation acute coronary syndrome (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 revas-cularisation (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% 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 coronary artery bypass grafting, respectively. The device 
      success rate was 100%. The side branch was treated with an additional classical 
      drug-eluting stent implantation in 18.8% of cases. The periprocedural MI (MI type 
      4a) was observed in two (4.2%) cases. At three months there was one (2.1%) case 
      of TLR. No death, MI, or stent thrombosis were observed in the follow-up period. 
      CONCLUSIONS: Bifurcation treatment with a single dedicated bifurcation stent 
      (BiOSS LIM C(R)) is feasible and highly successful (100% implantation success 
      rate). The short-term clinical outcomes are very promising, also in distal left 
      main stenosis. The 12-month observations are pending.
FAU - Gil, Robert J
AU  - Gil RJ
AD  - Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of 
      Interior and Administration, Warsaw, Poland; Mossakowski Medical Research Centre, 
      Polish Academy of Science, Warsaw, Poland. scorpirg@gmail.com.
FAU - Bil, Jacek
AU  - Bil J
FAU - Kern, Adam
AU  - Kern A
FAU - Pawlowski, Tomasz
AU  - Pawlowski T
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20171201
PL  - Poland
TA  - Kardiol Pol
JT  - Kardiologia polska
JID - 0376352
RN  - 0R0008Q3JB (Chromium)
RN  - 3G0H8C9362 (Cobalt)
RN  - W36ZG6FT64 (Sirolimus)
SB  - IM
MH  - Acute Coronary Syndrome/drug therapy/surgery
MH  - Aged
MH  - Angina, Stable/drug therapy/surgery
MH  - Chromium
MH  - Cobalt
MH  - Coronary Stenosis/drug therapy/*surgery
MH  - *Drug-Eluting Stents
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Percutaneous Coronary Intervention
MH  - Poland
MH  - Registries
MH  - Sirolimus/therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - BiOSS LIM C(R)
OT  - dedicated bifurcation stent
OT  - sirolimus-eluting stent
EDAT- 2017/12/02 06:00
MHDA- 2018/12/12 06:00
CRDT- 2017/12/02 06:00
PHST- 2017/08/22 00:00 [received]
PHST- 2017/10/05 00:00 [accepted]
PHST- 2017/10/03 00:00 [revised]
PHST- 2017/12/02 06:00 [pubmed]
PHST- 2018/12/12 06:00 [medline]
PHST- 2017/12/02 06:00 [entrez]
AID - VM/OJS/KP/11611 [pii]
AID - 10.5603/KP.a2017.0226 [doi]
PST - ppublish
SO  - Kardiol Pol. 2018;76(2):464-470. doi: 10.5603/KP.a2017.0226. Epub 2017 Dec 1.