open access

Vol 25, No 3 (2018)
Original articles — Interventional cardiology
Published online: 2017-08-24
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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

Robert J. Gil, Jacek Bil, Adam Kern, Luis A. Iñigo Garcia, Radosław Formuszewicz, Sławomir Dobrzycki, Dobrin Vassilev, Agnieszka Segiet
DOI: 10.5603/CJ.a2017.0098
·
Pubmed: 28840591
·
Cardiol J 2018;25(3):308-316.

open access

Vol 25, No 3 (2018)
Original articles — Interventional cardiology
Published online: 2017-08-24

Abstract

 

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 bifurca­tions 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.

Abstract

 

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 bifurca­tions 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.

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Keywords

coronary bifurcation, drug eluting stent, proximal optimization technique, left main, diabetes mellitus

About this article
Title

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

Journal

Cardiology Journal

Issue

Vol 25, No 3 (2018)

Pages

308-316

Published online

2017-08-24

DOI

10.5603/CJ.a2017.0098

Pubmed

28840591

Bibliographic record

Cardiol J 2018;25(3):308-316.

Keywords

coronary bifurcation
drug eluting stent
proximal optimization technique
left main
diabetes mellitus

Authors

Robert J. Gil
Jacek Bil
Adam Kern
Luis A. Iñigo Garcia
Radosław Formuszewicz
Sławomir Dobrzycki
Dobrin Vassilev
Agnieszka Segiet

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