Use of the Bifurcation Optimization Stent System in cardiological settings

2020 ◽  
Vol 16 (5) ◽  
pp. 397-404
Author(s):  
Dobrin Iotkov Vassilev ◽  
Niya Boykova Mileva ◽  
Robert J Gill
Keyword(s):  
Randomized Clinical Trials ◽  
Target Lesion ◽  
Side Branch ◽  
Major Adverse Cardiovascular Events ◽  
Drug Eluting Stent ◽  
Cobalt Chromium ◽  
Coronary Bifurcation ◽  
Stent System ◽  
Bifurcation Stent ◽  
Cobalt Chromium Stent

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.

Moving Towards Biomimicry – The Development of the Novel BioMime™ Sirolimus-eluting Coronary Stent System

2010 ◽  
Vol 6 (2) ◽  
pp. 78 ◽  
Author(s):  
Ashok Seth ◽  
Keyword(s):  
Time Course ◽  
Interventional Cardiology ◽  
Percutaneous Transluminal Coronary Angioplasty ◽  
Coronary Stent ◽  
Drug Eluting Stent ◽  
Cobalt Chromium ◽  
Cardiac Events ◽  
Stent System ◽  
Cobalt Chromium Stent ◽  
Transluminal Coronary Angioplasty

Since the first reported use of percutaneous transluminal coronary angioplasty (PTCA), advances in the interventional cardiology arena have been fast-paced. Within the last 10 years, these developments have been exponential. Developers and clinicians are fast adapting from the learning curve awarded by the time-course of drug-eluting stent (DES) evolution. The BioMime™ sirolimus-eluting coronary stent is a new step towards a biomimicry concept. The stent is built on an ultra-low strut thickness (65µm) cobalt–chromium stent platform using an intelligent hybrid of close and open cells allowing for morphology-mediated expansion, and employs a well-known antiproliferative – sirolimus – that elutes from a biodegradable co-polymer formulation in 30 days and ensures high coating integrity and a low coating thickness of 2µm. The resultant stent demonstrated almost 100% endothelialisation at 30 days in pre-clinical models and 0% major adverse cardiac events (MACE) at six months in the primary efficacy and safety clinical study.

P2693Late catch-up phenomenon and late-term target lesion revascularization of two-stenting for coronary bifurcation lesions between first and second generation drug-eluting stents

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K Okabe ◽  
M Ohya ◽  
K Matsushita ◽  
A Kuwayama ◽  
R Murai ◽  
...  
Keyword(s):  
Stent Implantation ◽  
Target Lesion ◽  
Side Branch ◽  
Drug Eluting Stent ◽  
Coronary Bifurcation ◽  
Coronary Bifurcation Lesions ◽  
Drug Eluting ◽  
Bifurcation Lesions ◽  
Catch Up

Abstract Background The second generation drug-eluting stent (G2-DES) has been reported as superior to the first generation drug-eluting stent (G1-DES) in mid-term outcomes. However, the late-term outcomes between G1-DES and G2-DES in two-stenting for coronary bifurcation lesions are not well studied. Purpose To evaluate the late catch-up phenomenon and late-term target lesion revascularization (TLR) of two-stenting for coronary bifurcation lesions between G1-DES and G2-DES. Methods This study included 1133 lesions in 1089 patients undergoing drug eluting stent implantation with two stenting from 2004 to 2016. These consisted of 496 G1-DES implanted lesions and 637 G2-DES implanted lesions. Late-term follow-up angiography was performed without in-stent restenosis (ISR) and TLR at mid-term follow-up in 582 lesions (242 G1-DES lesions and 340 G2-DES lesions). ISR was defined as more than 50% restenosis. Late catch-up phenomenon was defined as ISR without ISR within 1 year following index stent implantation. Late-term TLR was defined as from 1 to 5 year TLR. Bifurcation lesions were defined as the main branch ranging from the proximal stem to the distal main branch with boundaries defined by 5 mm proximal and distal to the stent-implanted area, and the side branch ranging from the bifurcation carina to the distal side branch with boundaries defined by the carina and 5 mm distal to the stent-implanted area. Results The median follow-up duration was 5.1 years (the first and third quarters, 3.2 and 7.1 years). The late-catch up phenomenon rate significantly differed between the G1-DES and G2-DES groups (16.9% vs 8.4%, p=0.001). A significant difference in late catch-up between the same two groups was also observed in bifurcation lesions of the main branch (5.0% vs 0.6%, p=0.001) and side branch (10.3% vs 5.6%, p=0.033), respectively. The 5-year cumulative rates also differed between the two groups in TLR (8.2% vs 3.7% log-rank p=0.001), and late-term TLR (7.0% vs 3.6% log-rank p=0.001). Conclusion Two-stenting using G2-DES, compared with G1-DES, significantly reduced late-term restenosis and TLR. The restenosis rate in bifurcation area may be associated with differences between two groups in late-term outcome.

Effect of paclitaxel-coated balloon angioplasty on side branch lesion and cardiovascular outcomes in patients with de novo true coronary bifurcation lesions undergoing percutaneous coronary intervention

2021 ◽  
Author(s):  
Youmei Li ◽  
Qi Mao ◽  
Huanyun Liu ◽  
Denglu Zhou ◽  
Jianhua Zhao
Keyword(s):  
Percutaneous Coronary Intervention ◽  
De Novo ◽  
Coronary Intervention ◽  
Side Branch ◽  
Cardiovascular Outcomes ◽  
Major Adverse Cardiovascular Events ◽  
Coronary Bifurcation ◽  
Percutaneous Coronary ◽  
Bifurcation Lesions

Abstract Purpose To compare the effects of paclitaxal-coated balloon (PCB) versus conventional balloon (CB) on side branch (SB) lesion and cardiovascular outcomes in patients with de novo true bifurcation lesions. Methods In total, 219 patients with de novo true bifurcation lesions were enrolled and divided into PCB group (102 cases) and CB group (117 cases) according to angioplasty strategy in SB. Drug-eluting stent (DES) was implanted in main vessel (MV) for each subject. All subjects underwent a 12-month follow-up for late lumen loss (LLL), restenosis and major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI). MACEs included cardiac death, nonfatal myocardial infarction and angina pectoris. Results There were no differences in diameter, minimum lumen diameter (MLD) and stenosis for bifurcation lesions between the two groups before and immediately after PCI (P > 0.05). After 12-month follow-up, no differences occurred in MV-MLD and MV-LLL between the two groups (P > 0.05); SB-MLD in PCB group was higher than that in CB group (1.97 ± 0.36 mm vs. 1.80 ± 0.43 mm, P = 0.007); SB-LLL in PCB group was lower than that in CB group (0.11 ± 0.18 mm vs. 0.19 ± 0.25 mm, P = 0.024). Multivariate COX analyses indicated that PCB group had lower MACE risk than CB group (HR = 0.480, 95%CI 0.244–0.941, P = 0.033). Conclusion PCB could decrease SB-LLL and MACE risk in patients with de novo true coronary bifurcation lesion 12 months after single-DES intervention.

Outcome of patients treated by a novel thin-strut cobalt-chromium stent in the drug-eluting stent era: Results of the SKICE (Skylor in real world practice) registry

2009 ◽  
Vol 73 (4) ◽  
pp. 457-465 ◽  
Author(s):  
Francesco Burzotta ◽  
Carlo Trani ◽  
Daniel Todaro ◽  
Mario Attilio Mazzari ◽  
Italo Porto ◽  
...  
Keyword(s):  
Real World ◽  
Drug Eluting Stent ◽  
Cobalt Chromium ◽  
Drug Eluting ◽  
Cobalt Chromium Stent

Abstract 12311: Side Branch Angle Influences the Neointimal Coverage of Drug-Eluting Stent in Coronary Bifurcation Lesions: An Optical Coherence Tomography Study

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Makoto Watanabe ◽  
Shiro Uemura ◽  
Youko Dote ◽  
Yu Sugawara ◽  
Yutaka Goryo ◽  
...  
Keyword(s):  
Stent Implantation ◽  
Side Branch ◽  
Drug Eluting Stent ◽  
Coronary Bifurcation ◽  
Coronary Bifurcation Lesions ◽  
Branch Angle ◽  
Bifurcation Lesion ◽  
Drug Eluting ◽  
Bifurcation Lesions ◽  
Neointimal Coverage

Background: Stent implantation for coronary bifurcation is intrinsically accompanied with inappropriate strut apposition around side branch (SB), which has potential risk for future development of stent thrombosis. Previous experimental studies indicated that side branch angle (SBA) influences the local flow turbulence and wall shear stress. The purpose of this study was to investigate the relation between SBA and the neointimal coverage of drug-eluting stent (DES) which were implanted in coronary bifurcation lesions. Methods: Forty-seven bifurcation lesions treated with DES were evaluated with FD-OCT in 39 patients (mean age; 65.7±13.9 y.o) at follow-up angiography. Each lesions were divided into the bifurcation lesions without kissing balloon technique (KBT) after stent implantation (non-KBT group; 28 lesions) and those with KBT (KBT group; 19 lesions). Neointimal coverage was assessed based on cross-sectional OCT images containing SB at 0.4mm interval, and separately evaluated in terms of jailing struts over the SB ostium (SO) and non-jailing struts attaching to the vessel wall (VW). BA was measured on the longitudinal reconstruction images of FD-OCT before stent implantation. Incidence of uncovered struts and neointimal thickness were measured. Results: In non-KBT group, the percentage of uncovered struts was significantly higher in lesions with SBA≦60°compared with those with SBA>60°at both SO and VW region (56.9±39.8% vs. 25.6±26.8%, p<0.05; 10.6±7.6% vs. 3.3±4.4%, p<0.01, respectively) and significant negative correlation was found between SBA and the percentage uncovered struts at both SO and VW regions (r=–0.55, p<0.01; r=–0.47, p<0.05, respectively). In KBT group, the percentage of uncovered struts was not significant difference between lesions with SBA≦60°and those with SBA>60°at both SO and VW region (36.7±35.3% vs. 36.6±34.8%; 10.9±10.4% vs. 8.6±12.7%, respectively) and no correlation was found between SBA and the percentage of uncovered struts at both SO and VW region. Conclusions: The neointimal coverage of DES was affected by in bifurcation lesion without KBT, but is not affected in bifurcation lesion with KBT. KBT has potential benefit for neointimal coverage of DES at coronary bifurcation lesion with narrow SBA.

scholarly journals One-Year Outcomes of the Paclitaxel-Eluting, Self-Expanding Stentys Stent System in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia

2017 ◽  
Vol 24 (3) ◽  
pp. 311-316 ◽  
Author(s):  
Marc Bosiers ◽  
Joren Callaert ◽  
Koen Keirse ◽  
Jeroen M. H. Hendriks ◽  
Patrick Peeters ◽  
...  
Keyword(s):  
Limb Salvage ◽  
Critical Limb Ischemia ◽  
Duplex Ultrasound ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Primary Patency ◽  
Drug Eluting Stent ◽  
Lesion Length ◽  
Imaging Data ◽  
Stent System

Purpose: To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long. Methods: The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0–58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI). Results: Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months. Conclusion: In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.

scholarly journals Study on the Safety and Effectiveness of Drug-coated Balloons in Patients with Acute Myocardial Infarction

2021 ◽  
Author(s):  
Xiaojiao Hao ◽  
Damin Huang ◽  
Zhaoxia Wang ◽  
Jinchun Zhang ◽  
Hongqiang Liu ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Treatment Group ◽  
Target Lesion ◽  
Major Adverse Cardiovascular Events ◽  
Drug Eluting Stent ◽  
Stent Group ◽  
Significant Difference ◽  
Drug Coated Balloon

Abstract Background：Drug-coated balloon (DCB) is a new technology that has emerged in recent years, and it has been proven to be effective and safe in the treatment of restenosis in the stent. The purpose of this article is to observe the safety and effectiveness of drug-coated balloons in patients with acute myocardial infarction. Methods: A total of 80 patients who were admitted to our department due to STEMI from January 2018 to December 2019 were selected. The subjects were randomly divided into drug-coated balloon treatment group (balloon group, n=38) and drug-eluting stent (DES) treatment group (stent group, n=42). The patients were followed up for 1 year to understand the incidence of major adverse cardiovascular events (MACEs) at 1 month, 6 months and 1 year after operation. Coronary angiography was reexamined at 1 year after operation to understand the late lumen loss (LLL) of the two groups. Results: At the 1-year follow-up, the target lesion LLL in the balloon group was (−0.12±0.46) mm, while the target lesion in the stent group was (0.14±0.37) mm (P<0.05). Within 1 year, the incidence of MACEs in the balloon group was 11%, and the incidence of MACEs in the stent group was 12%. There was no significant difference between the two groups. Conclusion: DCB therapy alone is safe and effective when PCI is performed for STEMI, and it shows good clinical results during the 1-year follow-up period.

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