Assessment of vascular response to Bi<scp>OSS LIM</scp> C<sup>®</sup> stents vs Orsiro<sup>®</sup> stents in the porcine coronary artery model

Bil, Jacek; Gil, Robert; Pawłowski, Tomasz; Milewski, Krzysztof

doi:10.1111/1755-5922.12267

Cited by 8 publications

(7 citation statements)

References 19 publications

(37 reference statements)

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“…The result found in the porcine model with a BiOSS LIM C ® stent seemed to confirm our hope [29]. A total of seven BiOSS LIM C ® stents were implanted in normal non-atherosclerotic straight porcine coronary arteries using a 1.2 stent-to-artery ratio.…”

Section: Discussionsupporting

confidence: 74%

First-in-man study of dedicated bifurcation cobalt-chromium sirolimus-eluting stent BiOSS LIM C® — three-month results

Gil

Bil²,

Witkowski

et al. 2018

Kardiol Pol

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Section: Discussionsupporting

confidence: 74%

First-in-man study of dedicated bifurcation cobalt-chromium sirolimus-eluting stent BiOSS LIM C® — three-month results

Gil

Bil²,

Witkowski

et al. 2018

Kardiol Pol

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“…This difference might translate into better clinical outcomes. The results observed in the porcine model with the BiOSS LIM C stent seemed to confirm our hope [ 20 ]. Interestingly, Table VII presents numerical comparisons of clinical results between BiOSS LIM C, BiOSS LIM and BiOSS Expert.…”

Section: Discussionsupporting

confidence: 72%

“…This difference might translate into better clinical outcomes. The results observed in the porcine model with the BiOSS LIM C stent seemed to confirm our hope [20]. Interestingly, Table VI In the BiOSS LIM LM Registry the rate of MACE rate was 9.5% (n = 7), whereas the rate of clinically driven TLR was 6.8% (n = 5) [7].…”

Section: A B Discussionsupporting

confidence: 68%

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Twelve-month clinical results from the new cobalt-chromium sirolimus-eluting dedicated bifurcation stent BiOSS LIM C Registry

et al. 2020

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Introduction: Percutaneous coronary interventions (PCI) in bifurcations are still challenging and are associated with higher risks of periprocedural complications as well as restenosis and stent thrombosis. The aim of this paper was to summarize 12 months of clinical results of the prospective, first-inman registry assessing the BiOSS LIM C stent (Balton, Poland). Material and methods: In the prospective two-center registry we enrolled patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and stable coronary artery disease. Provisional T-stenting was the default treatment strategy. The primary endpoint was defined as the rate of cardiac death, myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) in 12-month follow-up. Results: The study population consisted of 95 patients (mean age 66.8 ±9.8 years, 17.9% were females). A BiOSS LIM C stent was implanted in the left main (LM) in 53 (55.8%) cases. There were 25.2% of patients with NSTE-ACS, 33.7% with diabetes, 90.5% with hypertension, and 53.7% had previous MI. The device success rate was 100%. An additional regular drug-eluting stent was deployed in the side branch in 18.9% of cases. Proximal optimization technique and final kissing balloon (FKB) technique were used in 53.7% and 30.5% of cases, respectively. MI type 4a was registered in four cases (4.2%). At 12 months the MACE rate was 9.5%, cardiac death 1.1%, MI 2.1% and clinically driven TLR 6.3%. All incidents, apart from one TLR, appeared in the LM subgroup. Conclusions: Our registry might suggest that PCI using the BiOSS LIM C in coronary bifurcations is feasible and might be an option for percutaneous revascularization.

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“…After both successful preclinical testing and a first-in-human study of the BiOSS LIM C stent, a randomized study (POLBOS 3) was designed [11][12][13].…”

Section: Introductionmentioning

confidence: 99%

The Randomized, Multicenter, Open-Label, Controlled POLBOS 3 Trial Comparing Regular Drug-Eluting Stents and the Sirolimus-Eluting BiOSS LIM C Dedicated Coronary Bifurcation Stent: Four-Year Results

Gil,

Kern,

Bojko

et al. 2024

Biomedicines

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This multicenter, randomized study aimed to compare the sirolimus-eluting BiOSS LIM C dedicated coronary bifurcation stent with second-generation -limus drug-eluting stents (rDESs) in the treatment of non-left main (non-LM) coronary bifurcation. The deployment of a single stent in the main vessel–main branch across a side branch was the default strategy in all patients. The primary endpoint was the rate of major cardiovascular events (cardiac death, myocardial infarction, and target lesion revascularization) at 48 months. We enrolled 230 patients, allocating 116 patients to the BiOSS LIM C group and 114 patients to the rDES group. Most procedures were elective (BiOSS vs. rDES: 48.3% vs. 59.6%, p = 0.09) and performed in bifurcations within the left anterior descending/diagonal branch (BiOSS vs. rDES: 51.7% vs. 61.4%, p = 0.15). At 48 months, there were no statistically significant differences between the BiOSS and rDES groups in terms of major adverse cardiovascular events (MACE), cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR) as follows: MACEs—18.1% vs. 14.9%, HR 1.36, 95% CI 0.62–2.22, and p = 0.33; cardiac death—4.3% vs. 3.5%, HR 1.23, 95% CI 0.33–4.56, and p = 0.75; MI—2.6% vs. 3.5%, HR 0.73, 95% CI 0.17–3.23, and p = 0.68; and TLR—11.2% vs. 7.9%, HR 1.66, 95% CI 0.75–3.71, and p = 0.21. The implantation success rate of the BiOSS LIM C stent was very high, and the cumulative MACE rates were promising. The POLBOS 3 trial sets an important benchmark for treating non-LM coronary bifurcations (ClinicalTrials.gov NCT03548272).

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Assessment of vascular response to BiOSS LIM C^® stents vs Orsiro^® stents in the porcine coronary artery model

Abstract: The novel BiOSS LIM C stent demonstrates good short-term vascular effects in a porcine coronary bifurcation model which are comparable with Orsiro stents.

Cited by 8 publications

References 19 publications

First-in-man study of dedicated bifurcation cobalt-chromium sirolimus-eluting stent BiOSS LIM C® — three-month results

First-in-man study of dedicated bifurcation cobalt-chromium sirolimus-eluting stent BiOSS LIM C® — three-month results

Twelve-month clinical results from the new cobalt-chromium sirolimus-eluting dedicated bifurcation stent BiOSS LIM C Registry

The Randomized, Multicenter, Open-Label, Controlled POLBOS 3 Trial Comparing Regular Drug-Eluting Stents and the Sirolimus-Eluting BiOSS LIM C Dedicated Coronary Bifurcation Stent: Four-Year Results

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Assessment of vascular response to BiOSS LIM C® stents vs Orsiro® stents in the porcine coronary artery model

Abstract: The novel BiOSS LIM C stent demonstrates good short-term vascular effects in a porcine coronary bifurcation model which are comparable with Orsiro stents.

Cited by 8 publications

References 19 publications

First-in-man study of dedicated bifurcation cobalt-chromium sirolimus-eluting stent BiOSS LIM C® — three-month results

First-in-man study of dedicated bifurcation cobalt-chromium sirolimus-eluting stent BiOSS LIM C® — three-month results

Twelve-month clinical results from the new cobalt-chromium sirolimus-eluting dedicated bifurcation stent BiOSS LIM C Registry

The Randomized, Multicenter, Open-Label, Controlled POLBOS 3 Trial Comparing Regular Drug-Eluting Stents and the Sirolimus-Eluting BiOSS LIM C Dedicated Coronary Bifurcation Stent: Four-Year Results

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Assessment of vascular response to BiOSS LIM C^® stents vs Orsiro^® stents in the porcine coronary artery model