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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Article info
Publication history
Published online: December 24, 2014
Accepted:
December 23,
2014
Received:
August 9,
2014
Footnotes
See editorial by Shuvy and Strauss, pages 588-590 of this issue.
See page 677 for disclosure information.
Identification
Copyright
© 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
