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Canadian Journal of Cardiology

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

Published:December 24, 2014DOI:https://doi.org/10.1016/j.cjca.2014.12.024

      Abstract

      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.

      Résumé

      Introduction

      Les résultats sur les endoprothèses médicamentées habituelles (EMh) dans le traitement des bifurcations ne sont pas optimaux. Le but de l’essai POLBOS I (Polish Bifurcation Optimal Stenting I) était de comparer le traitement des bifurcations au moyen de toute EMh vs à l’endoprothèse spécialisée à élution de paclitaxel de BiOSS Expert (Balton, Pologne). Le second but était d’étudier l’effet du « final kissing balloon » sur les résultats cliniques.

      Méthodes

      Entre octobre 2010 et janvier 2013, les patients souffrant de coronaropathie stable ou de syndrome coronarien aigu sans sus-décalage du segment ST étaient répartis selon un rapport 1:1 à 1 des 2 stratégies de traitement : l’implantation de l’endoprothèse BiOSS Expert ou d’une EMh. L’angiographie coronarienne était réalisée après 12 mois. Le critère de jugement principal était un critère combiné de la mortalité d’origine cardiaque, de l’infarctus du myocarde (IM) et de revascularisation de lésions cibles (RLC) après 12 mois.

      Résultats

      La BiOSS Expert était implantée chez 120 patients (49,4 %) et une EMh était implantée chez 123 patients. Le vaisseau cible était l’artère interventriculaire antérieure (52 % vs 70 %) suivie du tronc commun de l’artère coronaire gauche (22 % vs 15 %). Dans le groupe qui subissait l’implantation d’une EMh, 38,2 % recevaient des endoprothèses à élution de paclitaxel. Trois échecs d’implantation d’endoprothèses étaient observés (2 dans le groupe d’EMh et 1 dans le groupe d’endoprothèses BiOSS Expert). Le traitement de la branche latérale au moyen de l’EMh était nécessaire dans 10 % des cas dans les 2 groupes. Après 12 mois, le nombre d’événements cardiovasculaires indésirables majeurs (ECIM) était similaire dans les 2 groupes : 13,3 % vs 12,2 % (P = 0,7). Le taux de RLC était significativement plus élevé dans le groupe d’endoprothèses BiOSS Expert que dans le groupe d’EMh (11,5 % vs 7,3 %; P = 0,02). Des taux significativement plus faibles de resténose étaient observés dans les sous-groupes « final kissing balloon » des groupes d’endoprothèses BiOSS Expert (8,1 % vs 13,2 %; P < 0,05) et d’EMh (4,9 % vs 9,5 %; P < 0,05).

      Conclusions

      Les taux d’ECIM étaient comparables entre les 2 groupes. Cependant, le taux de RLC était plus élevé dans le groupe d’endoprothèses BiOSS Expert. Un protocole plus rigoureux donnait de meilleurs résultats angiographiques et cliniques.
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