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

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.

Angiographic Restenosis in Coronary Bifurcations Treatment with Regular Drug Eluting Stents and Dedicated Bifurcation Drug-Eluting BiOSS Stents: Analysis Based on Randomized POLBOS I and POLBOS II Studies.

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.

The carina angle-new geometrical parameter associated with periprocedural side branch compromise and the long-term results in coronary bifurcation lesions with main vessel stenting only.

BACKGROUND: The two main problems unresolved in coronary bifurcation stenting are periprocedural side branch compromise and higher restenosis at long term. The purpose of this study is to reveal the link between periprocedural side branch compromise and long-term results after main vessel stenting only in coronary bifurcations. METHODS: Eighty-four patients formed the study population. The inclusion criteria were good-quality angiograms, with maximal between-branch angle opening, no overlap, permitting accurate angiographic analysis. Carina angle (alpha)-the distal angle between main vessel (MV) before bifurcation and side branch (SB)-was measured pre- and poststenting. Clinical follow-up 9-12 months was obtained with coronary angiography if needed. RESULTS: The patient population was high-risk with 33% diabetics and 84% two- and three-vessel disease. Ninety-five stents were implanted in 92 lesions, with three T-stenting cases. Drug-eluting stents were implanted in 54%. Kissing-balloon (KBI) or sequential inflation was performed in 35%. SB functional closure occurred in 17.4%, with independent predictors alpha < 40 degrees and diameter ratio MB/SB >1.22. After 12+/-4 months there were five myocardial infarctions (6%) and 13 (15%) target lesion revascularization procedures. Independent predictors of major cardiovascular events were carina angle <40 degrees , MB lesion length >8 mm, negative change of between-branch angle, DES usage, and KBI. CONCLUSIONS: Smaller carina angle with straightening of MV-main branch from stent implantation in coronary bifurcations predicted higher SB compromise, restenosis, and MACE rates during follow-up of 1 year.

Comparison of dedicated BIOSS bifurcation stents with regular drug-eluting stents for coronary artery bifurcated lesions: Pooled analysis from two randomized studies.

BACKGROUND: Coronary bifurcation treatment poses a therapeutic challenge. The aim of this study was to analyze pooled data of two randomized clinical trials, POLBOS I and POLBOS II, to compare 1-year follow-up results and identify possible prognostic factors. METHODS: In POLBOS trials dedicated bifurcation BiOSS® stents were compared with regular drug eluting stents (rDES) in patients with stable coronary artery disease or non ST-segment elevation acute coronary syndrome (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. The primary endpoint was major adverse cardiovascular events (MACE) rate defined as the rate of cardiac death, myocardial infarction (MI) or target lesion revascularization (TLR). RESULTS: 445 patients, with 222 patients in the BiOSS group and 223 patients in the rDES group, were analyzed. In 26.7% cases procedures were performed within distal left main, and true bifurca-tions which accounted for 81.6% of treated lesions. At 12 months the whole population exhibited no statistical differences in terms of MACE, TLR, MI or cardiac death between rDES and BiOSS groups. In multivariate analysis odds for MACE decreased with female sex (OR 0.433, 95% CI 0.178-0.942, p = 0.047) and with proximal optimization technique use (OR 0.208, 95% CI 0.097-0.419, p < 0.001), whereas the odds for MACE increased with main vessel predilatation (OR 2.191, 95% CI 1.042-5.066, p = 0.049) and diabetes mellitus treated with insulin (OR 2.779, 95% CI 1.1-6.593, p = 0.024). CONCLUSIONS: Pooled data showed no significant difference between MACE and TLR rates for BiOSS® group vs. rDES group.

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

AIMS: 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. METHODS AND RESULTS: 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). CONCLUSIONS: 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.

Regular Drug-Eluting Stent vs Dedicated Coronary Bifurcation BiOSS Expert Stent: Multicenter Open-Label Randomized Controlled POLBOS I Trial.

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.

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

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.

First-in-man study of paclitaxel-eluting stent BiOSS (Bifurcation Optimisation Stent System) dedicated for coronary bifurcation stenoses: three months results.

BACKGROUND: The best treatment strategy for coronary bifurcation stenosis is still unknown. Dedicated bifurcation stents are the most promising solution. AIM: To evaluate the safety and short-term efficacy of a new stent dedicated for coronary bifurcation stenosis. METHODS: A new bifurcation optimisation stent system (BiOSS, Balton, Poland) is made of 316L stainless steel and is coated with a mixture of biodegradable lactate polymer and paclitaxel (1 µg/mm(2)). The stent consists of two parts, with different diameters according to Murray law connected by two 1.5 mm long bridges. BiOSS is mounted on a dedicated bifurcation balloon (Bottle, Balton, Poland) with markers of the proximal and the distal stent edge, and a third marker at the mid part showing the proximal end of its smaller distal part. The stent delivery is a rapid exchange system. Provisional T-stenting is the obligatory strategy. In order to optimise the result, Bottle balloon (nominal pressure: 10 atm) is inflated with mid marker positioned at the side branch ostium. Double antiplatelet therapy was planned for 12 months. Forty five patients with non-left main bifurcation stenosis (the n-LMB group), as well as 15 patients with left main (LM) bifurcation stenosis (the LMB group), were included in the prospective, feasibility and safety assessment registry. An intravascular ultrasound control is obligatory for all LM patients and strongly recommended for the remaining patients. Patients with ST-elevation myocardial infarction (STEMI) and Medina type 001 bifurcation lesions were excluded from the registry. The primary end-points of the study were: death, MI, in-stent thrombosis and target lesion revascularisation (in-hospital and one, three, six, and 12 months after the intervention). An angiographic control is planned at nine months in all patients. Here, we present the results of a three-month follow-up. RESULTS: The average age of the enrolled patients (63% males) was 67 ± 11 years. Thirty five (58%) patients had hypertension, and 16 (27%) were diabetic (five on insulin treatment). Almost half of the patients (29, 48%) had previous non-ST- -elevation acute coronary syndrome treated with percutaneous coronary intervention. Six (10%) patients had previous coronary artery bypass grafting. In the LMB group (n = 15), there were: six with Medina type 111; five with type 010; three with type 110; and one with type 011 bifurcation lesions. In the n-LMB group (n = 45), the dominant vessel was left anterior descending (n = 26, 58%), followed by left circumflex (n = 15, 33%) and right coronary artery (n = 4, 9%). Medina type 111 lesions were present in 48% of patients. Intravascular ultrasound was performed in 37 (62%) cases. All BiOSS stents were implanted successfully (avg. pressure 12 atm), without any periprocedural complications. There were only seven (14%) cases with a second stent implanted within a side branch. There were four periprocedural increases of troponin interpreted as MI. At one month and at three months, all patients were uneventful (out-of hospital MACE rate 0%). CONCLUSIONS: The BiOSS bifurcation dedicated stent is a feasible device, with promising safety and short-term clinical effectiveness/profile.