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

Gil, Robert; Bil, Jacek; Witkowski, Adam; Pawłowski, Tomasz

doi:10.5603/kp.a2017.0226

Cited by 10 publications

(8 citation statements)

References 24 publications

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“…The prevalence of death is less than 1%. 11,12 These numbers are similar to the results of our study. Therefore, the limitations of the different strategies for PCI treatment in bifurcations are not related to the early outcomes, but to late outcomes.…”

Section: Journal Of Transcatheter Interventionssupporting

confidence: 91%

Percutaneous coronary intervention in bifurcation lesions: independent predictors of in-hospital death

Oliveira¹,

Correia²,

Oliveira³

2019

J Transcat Intervent

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Background: Bifurcation lesions remain a challenge and little is known about the characteristics and outcomes of percutaneous coronary intervention over the last decade with the increasing use of drug-eluting stents. The objective of this study was to identify the patient profile and the in-hospital outcomes as well as the predictors of in-hospital death over time. Methods: An observational, retrospective study that evaluated patients undergoing percutaneous coronary intervention for bifurcation lesions between 2006 and 2016. Patients were divided into three groups: 2006-2008 (Group 1), 2009-2011 (Group 2), and 2012-2016 (Group 3). We used multiple logistic regression analysis to identify independent predictors of in-hospital death. Results: A total of 36,608 patients were included, and Group 3 patients were older, with a higher number of comorbidities, more stable clinical presentation and lesions treated with longer stent length and smaller stent size. The success of the procedure was higher (96.1% vs. 97.4% vs. 98.1%; p<0.0001) and the mortality lower (1.2% vs. 0.7% vs. 0.6%; p<0.0001) in the most recently treated group. In the multiple logistic regression analysis, female sex, left main coronary artery lesions, primary percutaneous coronary intervention, rescue percutaneous coronary intervention, procedures performed between 2006-2008 and use of glycoprotein IIb/IIIa inhibitors were variables independently associated with in-hospital mortality. Conclusions: Female sex, acute clinical presentation, emergency percutaneous coronary intervention, and greater anatomical complexity were associated with in-hospital mortality in patients undergoing coronary bifurcation treatment. Advances in contemporary treatment possibly contributed to the clinical outcome improvement in these patients.

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Section: Journal Of Transcatheter Interventionssupporting

confidence: 91%

Percutaneous coronary intervention in bifurcation lesions: independent predictors of in-hospital death

Oliveira¹,

Correia²,

Oliveira³

2019

J Transcat Intervent

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“…Clinically driven TLR was defined as the reintervention within the target lesion because of a symptomatic ≥ 50% diameter stenosis within 12 months after the index procedure. Further details were presented previously [16]. Table III.…”

Section: Endpointsmentioning

confidence: 99%

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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“…At present, mainly Non-Compliant balloon catheters are used for the pre-dilatation of heavily calcified lesions, post-dilatation of implanted stent to enhance the parameters of expansion, dealing with coronary bifurcation lesion through kissing balloon technique and management of cases with restenosis, particularly in previously implanted stents. [13][14][15] According to several studies, use of Non-Compliant (NC) balloon for Post Dilatation (PD) is found to be associated with optimal expansion hence higher frequency of optimal stent deployment, lower rates of Target Vessel Revascularization (TVR) and better clinical outcomes of the patients going through elective angioplasty. 16 This study focuses on the evaluation of impacts of PD performed with Non-Compliant balloon on angiographical outcome (that is TIMI flow grade) in patients who went through the primary PCI.…”

Section: Discussionmentioning

confidence: 99%

Effect of Post Dilatation on TIMI Flow in Patients Undergoing Primary Percutaneous Coronary Intervention

Abbasi

Samore²,

Ali³

et al. 2022

PAFMJ

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Objective: To evaluate the impact of post dilatation performed with Non- Compliant Balloon on Angiographical outcome (that is TIMI flow grade) in patients who underwent the primary percutaneous coronary intervention. Study Design: Retrospective cross-sectional study. Place and Duration of Study: At Tertiary Cardiac Care Center, Rawalpindi Pakistan from Nov 2020 to Apr 2021. Methodology: The retrospective data of the all the patients with STEMI was assessed via non-probability consecutive sampling technique and analyzed statistically. The study participants were classified into two categories based on whether they underwent post-dilatation or not, i.e., Category-I: patients who underwent post-dilatation with NC balloon and Category-II: patients who did not undergo post-dilatation. The primary study end-point was post-dilatation TIMI flow grade. Continuous study variables were expressed as Mean±S.D and categorical variables as frequencies and percentages. Chi square test was applied to find the association between study variables by keeping 95% CI and 5 % margin of error. p-value <0.05 was considered statistically significant. Results: The study included (n=410) eligible patients in total. Majority were males (n=303; 73.9%), 217 (52.9 %) patients underwent PD procedure. TIMI flow grade did not differ significantly between the two study categories (p-value > 0.05). Postprocedural success rate was 81.3% for patients with PD. Conclusion: The current study illustrates that PD does not adversely affect the final angiographic outcomes when performed after primary angioplasty.

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

Abstract: 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.

Cited by 10 publications

References 24 publications

Percutaneous coronary intervention in bifurcation lesions: independent predictors of in-hospital death

Percutaneous coronary intervention in bifurcation lesions: independent predictors of in-hospital death

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

Effect of Post Dilatation on TIMI Flow in Patients Undergoing Primary Percutaneous Coronary Intervention

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