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

Gil, Robert; Bil, Jacek; Witkowski, Adam; Garcia, Luis A Iñigo; Formuszewicz, Radoslaw; Dobrzycki, Sławomir; Vassilev, Dobrin; Segiet, Agnieszka

doi:10.5603/cj.a2017.0098

Cited by 10 publications

(10 citation statements)

References 22 publications

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“…Some have shown promising results and for many investigators may represent the device of choice for future treatment of bifurcation stenoses. [20][21][22][23] Although there are promising studies on the role of intravascular ultrasound, optical coherence tomography, and fractional flow reserve in the context of percutaneous treatment of bifurcations, these modalities have not been routinely incorporated into clinical practice yet. 24 The main limitations of the study were its retrospective nature, inclusion of patients conditioned to the decision of the operator, with potential selection bias, non-identification of the PCI techniques used, and the adjunct pharmacotherapy in use by the patients.…”

Section: Journal Of Transcatheter Interventionsmentioning

confidence: 99%

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 Interventionsmentioning

confidence: 99%

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

Oliveira¹,

Correia²,

Oliveira³

2019

J Transcat Intervent

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“…The aim of our study was to propose a modified Mehran restenosis classification adapted to bifurcation lesions and preliminarily assess its value in the 4-year follow-up on data from two randomized studies, POLBOS I and POLBOS II, that compared dedicated bifurcation BiOSS stents with regular drug-eluting stents (rDES) [ 4 – 6 ].…”

Section: Aimmentioning

confidence: 99%

Mehran in-stent restenosis classification adapted for coronary bifurcations: the impact on 4-year follow-up from randomized clinical studies POLBOS I and II

Bil

Gil

Witkowski

et al. 2018

pwki

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“…We previously reported 12 months follow-up of pooled data form POLBOS I and POLBOS II trials [3]. e aim of this study is to analyze the angiographic restenosis prevalence and patterns and predictors of di erent patterns in dedicated bifurcation BiOSS® vs. current generation drug-eluting stents implanted in coronary bifurcation lesions.…”

Section: Introductionmentioning

confidence: 99%

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

Gil

Bil

Witkowski³

et al. 2020

Cardiovascular Therapeutics

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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.

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

Abstract: Pooled data showed no significant difference between MACE and TLR rates for BiOSS® group vs. rDES group.

Cited by 10 publications

References 22 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

Mehran in-stent restenosis classification adapted for coronary bifurcations: the impact on 4-year follow-up from randomized clinical studies POLBOS I and II

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

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