Literature DB >> 22829507

Dedicated paclitaxel-eluting bifurcation stent BiOSS® (bifurcation optimisation stent system): 12-month results from a prospective registry of consecutive all-comers population.

Robert J Gil1, Dobrin Vassilev, Aleksandra Michalek, Adam Kern, Radosław Formuszewicz, Sławomir Dobrzycki, Jarosław Wójcik, Maciej Lesiak, Piotr Kardaszewicz, Andrzej Lekston.   

Abstract

AIMS: Dedicated bifurcation stents seem to be the most promising solution for treating bifurcations. The aim of our study was to present the 12 months results of a new dedicated stent for coronary bifurcation lesions -the paclitaxel-eluting stent- BiOSS® Expert (Bifurcation Optimisation Stent System, Balton, Warsaw, Poland). METHODS AND
RESULTS: Sixty-three patients with 65 lesions were enrolled in the registry. Forty-six % of the patients were classified as NSTEMI or unstable angina, 27% were diabetics, 30% had previous myocardial infarction and 48% had a history of previous revascularisation. In addition, hypertension and dyslipidaemia were the most common risk factors (58% and 40%). Sixty-five stents were successfully implanted (100% device success rate). The analysis of 30 days follow-up for 63 patients revealed good clinical results showing lack of death, target lesion revascularisation procedures (TLR) and target vessel revascularisation procedures (TVR). There were six (9,5%) cases of in-hospital raised troponin, however, only one showed an additional increase in CK-MB levels and was qualified as non-Q myocardial infarction (MI). There was a need for percutaneous coronary intervention (PCI) in a non-index vessel in one patient due to exertional angina. The analysis of 12-month follow-up for 63 patients revealed good clinical results. There were two (3.2%) cases of death (three and 10 months after index procedure). The first patient, in good physical shape, drowned, while the second was found dead by his family. There were no incidents of MI or stroke in the rest of the population. At 12 months there were seven (10.8% per lesion; 11.1% per patient) cases of TLR and nine (13.8% per lesion; 14.3% per patient) TVR. There were also 15 (23.8%) cases of PCI on vessels not related to BiOSS® Expert stent implantation.
CONCLUSIONS: Our registry showed that bifurcation treatment with a single dedicated paclitaxel-eluting bifurcation stent, BiOSS® Expert is feasible and successful. The long-term clinical results are satisfactory in this high-risk patient population.

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Year:  2012        PMID: 22829507     DOI: 10.4244/EIJV8I3A50

Source DB:  PubMed          Journal:  EuroIntervention        ISSN: 1774-024X            Impact factor:   6.534


  4 in total

1.  Dedicated Bifurcation Drug-eluting Stent BiOSS® - A Novel Device for Coronary Bifurcation Treatment.

Authors:  Robert J Gil; Dobrin Vassilev; Jacek Bil
Journal:  Interv Cardiol       Date:  2013-03

2.  Rationale and design of the randomized, multicenter, open-label, controlled POLBOS 3 trial aimed to compare regular drug-eluting stents versus the dedicated coronary bifurcation sirolimus-eluting BiOSS LIM C stent.

Authors:  Robert J Gil; Tomasz Pawłowski; Jacek Legutko; Maciej Lesiak; Adam Witkowski; Mariusz Gąsior; Adam Kern; Jacek Bil
Journal:  Medicine (Baltimore)       Date:  2019-04       Impact factor: 1.817

3.  Comparative analysis of lumen enlargement mechanisms achieved with the bifurcation dedicated BiOSS) stent versus classical coronary stent implantations by means of provisional side branch stenting strategy: an intravascular ultrasound study.

Authors:  Robert J Gil; Jacek Bil; Aleksandra Michałek; Dobrin Vassiliev; Ricardo A Costa
Journal:  Int J Cardiovasc Imaging       Date:  2013-07-19       Impact factor: 2.357

4.  12-month intravascular ultrasound observations from BiOSS® first-in-man studies.

Authors:  Robert J Gil; Jacek Bil; Ricardo A Costa; Katarzyna E Gil; Dobrin Vassiliev
Journal:  Int J Cardiovasc Imaging       Date:  2016-06-17       Impact factor: 2.357

  4 in total

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