BiOSS LIM Research Articles

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.

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).

Clinical outcomes of a dedicated bifurcation stent system

IntroductionPercutaneous coronary intervention (PCI) of bifurcation lesions is technically challenging and associated with higher rates of complications such as stent thrombosis or in-stent restenosis. In this paper, we present the clinical outcomes of BiOSS LIM C (Balton, Poland), a dedicated bifurcation stent. MethodsIn this retrospective single-center study we analyzed the outcome of patients with bifurcation coronary artery disease treated with the BiOSS LIM C stent system. The primary endpoint was the cumulative rate of major adverse cardiac events (MACE) including cardiac death, myocardial infarction (MI) and target lesion revascularisation (TLR) at the longest available follow-up. ResultsThe study population consisted of 25 patients (mean age 73.6 ± 9.7 years, 25 % females). In 80 % of the cases (n = 20) BiOSS LIM C stent was implanted in the left main coronary artery. Intravascular imaging was used in 70 % of the cases and an additional regular drug-eluting stent (DES) was deployed in the side branch in 24 % of the cases. The device success rate was 100 % and we observed no in-hospital adverse events. At a median follow-up of 15 ± 6 months, the MACE rate was 56 %, cardiac death was 4 %, and clinically driven TLR was 55 %. One patient died in the LM subgroup, 5 months after the index PCI, due to NSTEMI complicated by cardiogenic shock. Two patients died due to non-cardiac causes. ConclusionsIn this consecutive series of patients treated with BiOSS LIM C in major coronary bifurcation lesions, mostly in the left main stem, the mid-term clinical outcomes demonstrated a high incidence of major adverse events, mainly caused by TLR, despite an adequate implantation technique.

EPIC03-BIOSS observational prospective study. Performance analysis of the BIOSS LIM C dedicated stent in coronary bifurcation lesion angioplasty

EPIC03-BIOSS observational prospective study. Performance analysis of the BIOSS LIM C dedicated stent in coronary bifurcation lesion angioplasty

6-year results of BiOSS stents in coronary bifurcation treatment.

The wide variation in bifurcation anatomy has generated an ongoing search for stents explicitly designed for coronary bifurcations, and to date, results have been underachieved. The POLBOS I and POLBOS II were international, multicentre, randomized, open-label, controlled trials. Patients were randomly assigned to BiOSS Expert (in POLBOS I, biodegradable polymer eluting paclitaxel)/BiOSS LIM (in POLBOS II, biodegradable polymer eluting sirolimus) stent implantation or regular drug-eluting stent (rDES) deployment. A provisional T-stenting strategy was the default treatment option. The primary endpoint of this pooled data study was the cumulative rate of major adverse cardiovascular events (MACE) consisting of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR). Telephone follow-up was performed annually up to 72months. (ClinicalTrials.gov Identifier: POLBOS I-NCT02192840, POLBOS II-NCT02198300). The total study population consisted of 445 patients, 222 patients in the BiOSS group and 223 patients in the rDES group. The follow-up rate was 93.7% in the BiOSS group and 91.9% in the rDES group. At 72months, there was no significant difference between BiOSS and rDES groups regarding MACE (25.7% vs 25.1%, HR 1.06, 95% CI 0.73-1.52), cardiac death (3.1% vs 4.0%, HR 0.94, 95% CI 0.43-2.34), MI (3.6% vs 4.9%, HR 0.76, 95% CI 0.32-2.89), TLR (18.9% vs 16.1%, HR 1.17, 95% CI 0.75-1.83) and stent thrombosis rates (0.9% vs 0.5%, HR 1.21, 95CI 0.75-2.09). At the 6-year follow-up, clinically significant clinical events did not differ between BiOSS stents and rDES.

Comparison of overexpansion capabilities and thrombogenicity at the side branch ostia after implantation of four different drug eluting stents

Interventions in bifurcation lesions often requires aggressive overexpansion of stent diameter in the setting of long tapering vessel segment. Overhanging struts in front of the side branch (SB) ostium are thought to act as a focal point for thrombi formation and consequently possible stent thrombosis. This study aimed to evaluate the overexpansion capabilities and thrombogenicity at the SB ostia after implantation of four latest generation drug-eluting stents (DES) in an in-vitro bifurcation model. Four clinically available modern DES were utilized: one bifurcation dedicated DES (Bioss LIM C) and three conventional DES (Ultimaster, Xience Sierra, Biomime). All devices were implanted in bifurcation models with proximal optimization ensuring expansion before perfusing with porcine blood. Optical coherence tomography (OCT), immunofluorescence (IF) and scanning electron microscope analysis were done to determine thrombogenicity and polymer coating integrity at the over-expanded part of the stents. Computational fluid dynamics (CFD) was performed to study the flow disruption. OCT (p = 0.113) and IF analysis (p = 0.007) demonstrated lowest thrombus area at SB ostia in bifurcation dedicated DES with favorable biomechanical properties compared to conventional DES. The bifurcated DES also resulted in reduced area of high shear rate and maximum shear rate in the CFD analysis. This study demonstrated numerical differences in terms of mechanical properties and acute thrombogenicity at SB ostia between tested devices.

Predictors of long-term outcomes of coronary bifurcation stenting: 6-year results from international, randomized POLBOS I and POLBOS II clinical trials

Abstract Introduction Bifurcation lesions pose a therapeutic challenge during percutaneous coronary intervention (PCI). Results of regular drug-eluting stents (rDESs) in bifurcation treatment are not optimal. Purpose The aim of this study was to analyze the 6-year follow-up of BiOSS (Balton, Poland) stents in patients enrolled into two randomized clinical trials POLBOS I (NCT02192840) and POLBOS II NCT02198300). Methods The BiOSS stent is a coronary dedicated bifurcation balloon expandable stent made of 316L stainless steel and coated with a biodegradable polymer as well as the drug. The stent consists of two parts with different diameters connected with two struts of 1.9 - 2.5 mm length each. The aim of randomized POLBOS trials was to compare the BiOSS stents with regular drug eluting stents (rDES) in patients with stable CAD or NSTE-ACS (POLBOS I: paclitaxel eluting BiOSS Expert vs rDES; POLBOS II: sirolimus eluting BiOSS LIM vs rDES). Provisional T-stenting was the default strategy. Angiographic control was performed at 12 months in all patients. The primary end-point was composed MACE defined as cardiac death, myocardial infarction or target lesion revascularization (TLR). Clinical assessment was performed every year after index procedure. Results In POLBOS I trial BiOSS Expert was implanted in 120 patients (49.4%), and rDES was implanted in 123 patients. The target vessel was the left anterior descending (LAD) artery (52% vs 70%) followed by the left main stem (LMS) coronary artery (22% vs 15%). In rDES group, 38.2% of patients received paclitaxel-eluting stents. Side branch treatment with rDES was required in 10% of cases in both groups. At 12 months, the incidence of cumulative major adverse cardiovascular events (MACE) was similar in both groups: 13.3% vs 12.2% (P=0.7). The TLR rate was significantly higher in the BiOSS Expert group compared with rDES group (11.5% vs 7.3%; P=0.02). Significantly lower rates of restenosis were observed in final kissing balloon (FKB) subgroups of both the BiOSS Expert (8.1% vs 13.2%; P<0.05) and rDES groups (4.9% vs 9.5%; P<0.05). In POLBOS II 202 patients were randomly assigned 1:1 to treatment of the coronary bifurcation lesions either with the BiOSS LIM stent (n=102) or with rDES (n=100). The target vessel was the LAD (44% vs 43%) followed by the LMS (35.3% vs 38%). 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<0.05). At the time of ESC Congress 2020 we will present data from 6-year follow-up from POLBOS I trial and POLBOS II trial focusing on LM stenting and patients with diabetes. Conclusions BiOSS® stents provided satisfactory 1-year results which seemed comparable with rDES. Long-term data are pending. Funding Acknowledgement Type of funding source: None

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

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-in-man registry assessing the BiOSS LIM C stent (Balton, Poland). 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. 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 4 (4.2%) cases. 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. Our registry might suggest that PCI using the BiOSS LIM C in coronary bifurcations is feasible and might be an option for percutaneous revascularization.

Sirolimus-eluting BiOSS LIM dedicated bifurcation stent in the treatment of unprotected distal left main stenosis.

Proximal optimization technique (POT) has been proposed to adapt the conventional drug-eluting stent (DES) with the fractal anatomy of the bifurcation. However, only few DES are labeled for post-expansion beyond 5.0 mm. Furthermore, recrossing in the side branch (SB) through the main vessel (MV) stent cells may be challenging. To compare the sirolimus-eluting, balloon-expandable dedicated bifurcation stent BiOSS LIM DES versus the second generation DES in the treatment of distal unprotected left main coronary arteries (ULMCAs) lesions. Forty-two consecutive patients with distal ULMCA lesions were treated with the BiOSS LIM (BiOSS LIM group) in our center. A matched-group of patients treated with second-generation DES was selected from our database (Control group). The primary endpoint was the procedural complication rate, including (a) SB occlusion, defined as intraprocedural TIMI flow grade <3 immediately after MV stenting; and/or (b) trouble in SB access, defined as the need of ≥2 guidewires or a failure to recross in the SB trough the MV stent cells. The need of POT in the two groups was also analyzed. The primary endpoint occurred in four (9.5%) patients in the BiOSS LIM group and in 13 (31%) in the Control group (p = 0.028; OR = 4.25; 95% confidence interval: 1.25-14.43). POT was performed more often in the Control group (71% vs. 35%; p = 0.004). Compared to conventional DES, the BiOSS LIM stent (1) facilitates SB recrossing and (2) fits well with the fractal anatomy of the left main bifurcation.

TCT-585 First-in-man study of the new dedicated bifurcation BiOSS LIM C: 9-month interim results with OCT analysis.

The aim of this first-in-man study is to assess effectiveness and safety of dedicated bifurcation cobalt-chromium sirolimus-eluting stent BiOSS LIM C (Balton, Poland) in patients with stable coronary artery disease (CAD) and NSTE-ACS. BiOSS LIM C is a coronary dedicated bifurcation sirolimus-

The approach to coronary bifurcation treatment and its outcomes in Poland: The single center experience.

Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary interventions. The aim of this study was to analyze the strategy of coronary bifurcation treatment and associated angiographic as well as clinical outcomes in a large hospital in Northern Poland. Between January 2012 and January 2014 patients with stable coronary artery disease or non-ST-elevation acute coronary syndrome (NSTE-ACS) were treated with regular drug-eluting stents (rDES) or dedicated bifurcation stents (BiOSS Expert® or BiOSS LIM®). Clinical and angiographic controls were planned at 12 months. The primary endpoint was major adverse cardiovascular events (MACE) rate composed of cardiac death, myocardial infarction, and target lesion revascularization (TLR) at 12 months. In total, 152 patients were enrolled in whom 158 stents were deployed (99 BiOSS stents and 59 rDES). Left anterior descending artery (50%) was the dominant target vessel followed by left circum¬flex (25%). There was no stent implantation failure. In 10 (6.3%) patients rDES was required within the side branch. At 12 months MACE rate was 11.2%, whereas TLR rate was 7.9%. In the logistic regression analysis final kissing balloon technique was the prognostic factor for better clinical outcome, whereas NSTE-ACS and true bifurcations were risk factors of a poor outcome. Percutaneous coronary bifurcation treatment is a safe and effective procedure, and pro¬visional T-stenting is the preferred technique. Both rDES as well as dedicated bifurcation stents enabled a simple and fast bifurcation treatment option with comparable MACE and TLR rates. (Cardiol J 2017; 24, 6: 589-596).

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

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. The aim of this report was to assess the effectiveness and safety profile of a new dedicated bifurcation stent - sirolimus-eluting BiOSS LIM C® (Balton, Poland) at the first three months of a 12-month registry. 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. 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. Bifurcation treatment with a single dedicated bifurcation stent (BiOSS LIM C®) 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.

Comparative assessment of three drug eluting stents with different platforms but with the same biodegradable polymer and the drug based on quantitative coronary angiography and optical coherence tomography at 12-month follow-up

The aim of this study was to compare neointima proliferation in three drug-eluting stents (DES) produced by the same company (Balton, Poland) which are covered with a biodegradable polymer and elute sirolimus (concentration: 1.0 and 1.2 µg/mm2), but have different stent platforms and strut thickness: stainless steel Prolim® (115 µm) and BiOSS LIM® (120 µm) and cobalt-chromium Alex® (70 µm). We analyzed data of patients with quantitative coronary angiography (QCA) and optical coherence tomography (OCT) at 12 months from BiOSS LIM Registry, Prolim Registry and Alex OCT clinical trial. There were 56 patients enrolled, in whom 29 Prolim® stents were deployed, in 11—BiOSS LIM® and in 16—Alex stents. The late lumen loss was the smallest in Prolim® subgroup (0.26 ± 0.17 mm) and did not differ from Alex® subgroup (0.28 ± 0.47 mm). This parameter was significantly bigger in BiOSS® subgroup (0.38 ± 0.19 mm; p < 0.05). In OCT analysis there was no statistically significant difference between Prolim® and Alex® subgroups in terms of mean neointima burden (24.6 ± 8.6 vs. 19.27 ± 8.11%) and neointima volume (28.16 ± 15.10 vs. 24.51 ± 17.64 mm3). In BiOSS® group mean neointima burden (30.9 ± 6.2%) and mean neointima volume (44.9 ± 4.9 mm3) were significantly larger. The morphological analysis revealed that in most cases in all groups the neointima was homogenous with plaque presence only around stent struts. In the QCA and OCT analysis regular DES (Prolim® and Alex®) obtained similar results, whereas more pronounced response from the vessel wall was found in the BiOSS® subgroup.

Regular drug-eluting stents versus the dedicated coronary bifurcation sirolimus-eluting BiOSS LIM® stent: the randomised, multicentre, open-label, controlled POLBOS II trial.

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. 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<0.05). MACE rates as well as TLR rates were comparable between the BiOSS LIM and rDES. At 12 months, cumulative MACE incidence was similar in both groups (11.8% vs. 15%), as was the TLR rate (9.8% vs. 9%). Significantly lower rates of restenosis were observed in the FKBI subgroup of the BiOSS group.

Long-term effectiveness and safety of the sirolimus-eluting BiOSS LIM® dedicated bifurcation stent in the treatment of distal left main stenosis: an international registry.

The aim of this study was to assess prospectively the effectiveness and safety of a new version of the dedicated bifurcation BiOSS stent, the sirolimus-eluting BiOSS LIM, for the treatment of distal left main (LM) stenosis. This was a prospective international registry which enrolled patients with NSTE-ACS or stable angina. Provisional T-stenting was the mandated strategy. The primary endpoint was the cumulative rate of cardiac death, myocardial infarction (MI) and target lesion revascularisation (TLR) at 12 months. Twelve-month quantitative coronary angiography endpoints included late lumen loss and percent diameter stenosis. A total of 74 patients with distal LM stenosis were enrolled. Seventy-three of the 74 patients (aged 67±9 years, 23% women, 20.3% NSTE-ACS, SYNTAX score 22.4±4.4) were successfully treated with the BiOSS LIM stent, with additional side branch placement of regular DES in 11 patients (14.9%). Periprocedural MI occurred in one (1.4%) patient. The 12-month MACE rate was 9.5% without cardiac death or definite stent thrombosis. TLR and MI rates were 6.8% (n=5) and 2.7% (n=2), respectively. The use of the BiOSS LIM dedicated bifurcation stent for the treatment of distal LM stenosis was feasible and safe, with promising long-term clinical effectiveness.

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

The aim of this study was to analyze the difference in neointima pattern assessed by intravascular ultrasound (IVUS) between two dedicated bifurcation stents, BiOSS® Expert and BiOSS® LIM at 12-month follow-up. This manuscript reports IVUS findings obtained from the analysis of patients enrolled into first-in-man registries initially assessing the BiOSS Expert® (paclitaxel) and BiOSS LIM® (sirolimus) stents. Quantitative angiographic analysis was performed pre, post-stenting, and at follow-up. IVUS examination was performed at 12 months. There were analyzed 34 cases (BiOSS Expert® 11 patients, BiOSS LIM® 23 patients). Procedural characteristics in the two groups were similar, except for rates of main vessel predilatation and FKB/POT, which were higher in BiOSS® LIM group, 54.5 % vs 73.9 % (P < 0.05) and 0 % vs 39.1 % (P < 0.05), respectively. When comparing late lumen loss (LLL) for both stents there were significantly bigger values for main vessel and main branch in the BiOSS® Expert group, but not in side branch. Intravascular ultrasound examination showed that in the BiOSS LIM® group comparing with the BiOSS Expert® group there was lower neointima burden in the whole stent (24.7 ± 7.5 % vs 19.4 ± 8.6 %, P < 0.05) as well as in main vessel (22.8 ± 5.6 % vs 16.9 ± 6.1 %, P < 0.05) and main branch (36.1 ± 6.5 % vs 27.6 ± 8.7 %, P < 0.05), but not at the level of bifurcation (15.1 ± 3.8 % vs 13.6 ± 5.4 %, P = NS). In addition, we found that final kissing balloon/proximal optimization technique (FKB/POT) was associated with significantly smaller value of LLL in main vessel (0.24 ± 0.09 mm vs 0.32 ± 0.14 mm, P < 0.05), which in IVUS analysis resulted in smaller neointima burden in main vessel (13.7 ± 3.9 % vs 18.9 ± 4.45 %, P < 0.05) as well as at the bifurcation site (12.6 ± 4.1 % vs 14.1 ± 2.4 %, P < 0.05). The obtained results suggest that neointima proliferation was the largest in main branches of both stents assessed in quantitative angiography (LLL) as well as in IVUS (neointima burden) and the neointima increase was smaller in BiOSS LIM® stents than in BiOSS Expert® stents. Moreover, the middle part of the stent seems to not to be associated with excessive neointima proliferation and more aggressive protocol of implantation with the use FKB/POT seems to decrease this process.Electronic supplementary materialThe online version of this article (doi:10.1007/s10554-016-0926-9) contains supplementary material, which is available to authorized users.

First-in-man study of dedicated bifurcation sirolimus-eluting stent: 12-month results of BiOSS LIM® Registry.

The aim was to assess the effectiveness and safety profile of a new dedicated bifurcation stent - sirolimus-eluting BiOSS LIM® (Balton, Poland) in 12-month Registry. The optimal approach to coronary bifurcations treatment by percutaneous coronary intervention (PCI) has been still a subject of debate. Dedicated bifurcation stents are one of the proposed solutions. This was the international, 3-center registry, which enrolled patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and stable angina. Provisional T-stenting was the obligatory strategy of the treatment. Angiographic control was planned at 12 months. The primary endpoint was cumulative rate of death, myocardial infarction (MI) and target lesion revascularization (TLR) at 12 months. A total of 60 patients with coronary bifurcations were enrolled (mean age 66.4 ± 11 years, 28.3% of female). There were 21.7% of patients with NSTE-ACS, 78.3% with hypertension, 38.3% with diabetes, 28.3% had previous MI, and 46.7% and 10% underwent prior revascularization, respectively, PCI and coronary artery bypass graft. The device success rate was 100%. Side branch was treated with an additional classical drug-eluting stent implantation in 23.3% of cases. At 12 months, the cumulative major adverse cardiovascular events rate was 11.7%. During follow-up (11 ± 1 months) there was 1 non-cardiac death (1.7%), 1 non-ST-elevated myocardial infarction (1.7%) due to restenosis and no case of stroke or in-stent thrombosis. Overall TLR was 8.3% (clinically driven TLR - 1.7%, angiographically driven - 6.6%). Mean late lumen loss was as follows: In main vessel - 0.35 ± 0.33 mm, in main branch - 0.34 ± 0.27 mm and in side branch - 0.18 ± 0.38 mm. Dedicated bifurcation stent BiOSS® LIM proved to be feasible device, with promising safety and long-term clinical effectiveness in the treatment of coronary bifurcation lesions, including distal left main stem stenosis.

TCT-405 Regular Drug Eluting Stent versus Dedicated Bifurcation Sirolimus Eluting Stent BiOSS LIM in Coronary Bifurcation Treatment - POLBOS II Randomized Study

The provisional T-stenting (PTS) is the recommended strategy for the coronary bifurcation treatment. However, results obtained with use of regular drug eluting stents (DES) are not optimal and relatively often associated with a side branch compromise and restenosis. Dedicated bifurcation stents are

First in man study of dedicated bifurcation sirolimus eluting stent:complete 6 months clinical results of BiOSS LIM Registry

First in man study of dedicated bifurcation sirolimus eluting stent:complete 6 months clinical results of BiOSS LIM Registry

Dedicated bifurcation stents or regular drug eluting stents in distal left main stenosis: A retrospective study.

In the distal left main (LM) atherosclerosis mainly develops within bifurcation or trifur-cation. The aim of this study was to analyze the strategy of distal LM stenosis treatment and associated clinical outcomes in a large hospital in Northern Poland. The study population consisted of consecutive patients with stable coronary artery disease or acute coronary syndrome (ACS) and distal LM stenosis who were hospitalized between June 2012 and June 2013. Patients were treated with regular drug-eluting stents (rDES), including bioresorbable vascular scaffolds, or dedicated bifurcation stents (BiOSS LIM®). Clinical outcomes were analyzed at 12, 24 and 36 months. Primary endpoint was cumulative major adverse cardiovascular events (MACE) inducing rate of cardiac death, myocardial infarction, and target lesion revascularization (TLR) after 36 months. One hundred and two patients were identified, 90 of whom were treated with percutaneous coronary intervention (56 rDES, including 9 Absorb, and 34 BiOSS) with no stent implantation fail-ure. In 15 (16.7%) patients rDES was required within side branch (SB). After 36 months MACE rate was 19.0% (BiOSS: 18.8% vs. rDES 19.2%), whereas TLR rate was 10.7% (BiOSS 12.5% vs. rDES 9.6%). In logistic regression for 36-month TLR rate proximal optimization technique (OR 0.311, 95% CI 0.211-0.644) was a prognostic factor of better clinical outcome, whereas non-ST-elevation ACS (OR 2.211, 95% CI 1.642-5.110), ST-elevation myocardial infarction (OR 2.771, 95% CI 1.325-7.209) and SB stenting (OR 1.141, 95% CI 1.002-1.881) were risk factors of poor outcome. Regular drug-eluting stents as well as dedicated bifurcation BiOSS LIM® stents enabled a simple and fast distal LM treatment option with a single stent. Both resulted in comparable MACE and TLR rates.