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Background: 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., Methods: 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 72 months. (ClinicalTrials.gov Identifier: POLBOS I-NCT02192840, POLBOS II-NCT02198300)., Results: 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 72 months, 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)., Conclusions: At the 6-year follow-up, clinically significant clinical events did not differ between BiOSS stents and rDES., (© 2021 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.)

Aims: Optimal percutaneous coronary intervention (PCI) strategy for coronary left main (LM) bifurcation lesions remains controversial. We performed systematic review and meta-analysis comparing one and 3-year clinical outcomes of 1- and 2- stent strategies using modern drug eluting stents (DESs) for revascularization of LM bifurcation disease., Methods: We systematically identified all investigations published between January 2015 and February 2020 comparing the use of single versus double-stent strategies for the revascularization of LM bifurcation lesions. The primary endpoint was 1- and 3-years all-cause mortality. Secondary outcomes included target lesion revascularization (TLR), target lesion failure (TLF), major adverse cardiovascular vents (MACEs) and cardiovascular (CV) mortality while the tertiary outcome was overall occurrence of stent thrombosis (ST) at 1- and 3-years., Results: No significant differences were observed between the two groups in terms of all-cause mortality rate both at 1 and 3-year follow-up. Single stent strategy was associated with a significantly lower risk of TLR (OR 0.78, 95% CI 0.62- 0.97, p = 0.03, I 2  = 61%) as well as of MACEs (OR 0.78, 95% CI 0.63-0.97, I 2  = 24%) compared to 2-stent strategy. Conversely no significant differences between the two groups were observed in terms of TLF, CV mortality and ST during the same follow-up period., Conclusions: In patients with LM bifurcation disease, single stent strategy demonstrated lower rate of MACEs and TLR but was not superior to 2-stent strategy in terms of CV mortality, TLF and ST at 1 and 3-year follow-up.

The bifurcation optimization stent system (BiOSS) LIM (Balton, Warsaw, Poland) stent is a dedicated coronary bifurcation stent. Its unique construction is developed in accordance with the anatomy of the coronary bifurcations, thus eliminating the carina displacement as a mechanism of side branch ostium compromise. Since its development in 2008, the BiOSS stent underwent several changes with the latest version created of sirolimus eluting cobalt-chromium stent. Results from registries and randomized clinical trials showed that implantation of the BiOSS stent is safe and effective with comparable results for major adverse cardiovascular events (MACE) and target lesion revascularisation rates between the BiOSS and regular drug-eluting stent groups. This stent provides alternative for coronary bifurcation treatment, especially when there is a large difference in diameter between the main vessel and the main branch.

Aim: The marked variation in bifurcation anatomy has brought about an ongoing search for stents specifically constructed for coronary bifurcations. This study aimed to analyze the angiographic restenosis prevalence and patterns and predictors of different patterns in dedicated bifurcation BiOSS® vs. current generation drug-eluting stents implanted in coronary bifurcation lesions based on data from two clinical trials POLBOS I and II., Methods: Dedicated bifurcation BiOSS® stents were compared with drug-eluting stents (DES) in patients with stable coronary artery disease (CAD) or nonST elevation acute coronary syndrome (NSTE-ACS) (POLBOS I: paclitaxel eluting BiOSS® Expert vs. DES; POLBOS II: sirolimus eluting BiOSS® LIM vs. DES). Provisional T-stenting was the default treatment. Morphological pattern of in-stent restenosis according to the modified Mehran classification adopted for bifurcation lesions was assessed with bifurcation dedicated quantitative coronary angiographic software (CAAS 5.11, Pie Medical Imaging BV, the Netherlands)., Results: In total, 445 patients (222 patients in BiOSS group and 223 patients in DES group) were included into the analysis. In BiOSS group 24 cases of angiographic restenosis (10.8%) were recorded, and in DES group-17 cases (7.6%) at 12 months follow-up (angiographic control rate at follow-up-90.3%). In the BiOSS group most frequent medina classification in restenotic cases was 0.0.1 (25%), whereas in DES-0.0.1 and 0.1.1 (23.5% each). In multivariate regression analysis proximal optimization technique was associated with the lowest chance for restenosis (OR 0.15, 95% CI 0.06-0.33), whereas diabetes on insulin was associated with the highest risk of restenosis (OR 4.21, 95% CI 1.48-11.44)., Conclusions: The angiographic restenosis pattern and rate was similar between BiOSS stents and DES in coronary bifurcation lesions., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2020 Robert J. Gil et al.)

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., Competing Interests: RJG declares no conflict of interest, JB declares no conflict of interest, RC declares no conflict of interest, KEG declares no conflict of interest, DV declares no conflict of interest. Ethical approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent Informed consent was obtained from all individual participants included in the study.

Background: Results of regular drug-eluting stents (rDESs) in bifurcation treatment are not optimal. The aim of the Polish Bifurcation Optimal Stenting I (POLBOS I) trial was to compare bifurcation treatment with any rDES vs the dedicated bifurcation paclitaxel-eluting stent BiOSS Expert (Balton, Poland). The second aim was to study the effect of final kissing balloon (FKB) inflation on clinical outcomes., Methods: Between October 2010 and January 2013 patients with stable coronary artery disease or non-ST-elevation acute coronary syndrome were assigned 1:1 to 1 of 2 treatment strategies: BiOSS Expert stent or rDES implantation. Coronary angiography was performed at 12 months. The primary end point was a composite of cardiac-related death, myocardial infarction (MI), and target lesion revascularization (TLR) at 12 months., Results: The BiOSS Expert was implanted in 120 patients (49.4%), and an 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 the rDES group, 38.2% received paclitaxel-eluting stents. There were 3 stent implantation failures (2 in the rDES group and 1 in the BiOSS Expert group). Side branch treatment with an 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 the rDES group (11.5% vs 7.3%; P = 0.02). Significantly lower rates of restenosis were observed in 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)., Conclusions: MACE rates were comparable between the 2 groups; however, the TLR rate was higher in the BiOSS Expert group. A more aggressive protocol yielded better angiographic and clinical outcomes., (Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)