Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Biolimus-Eluting StenT For de-novo coRonary artery dIsease
in patiENts with Diabetes mellituS: the BESTFRIENDS
multicentre registry
Emanuele Meliga
a,b,c,d,e,f,g
, Alessandro Lupi
a,b,c,d,e,f,g
, Azeem Latib
a,b,c,d,e,f,g
,
Andrea Gagnor
a,b,c,d,e,f,g
, Giacomo Boccuzzi
a,b,c,d,e,f,g
,
Marco Alcantara
a,b,c,d,e,f,g
, Primiano Lombardi
a,b,c,d,e,f,g
,
Alessandro Sticchi
a,b,c,d,e,f,g
, Tiziana C. Aranzulla
a,b,c,d,e,f,g
,
Innocenzo Scrocca
a,b,c,d,e,f,g
, Ferdinando Varbella
a,b,c,d,e,f,g
,
Mauro De Benedictis
a,b,c,d,e,f,g
, Antonio Colombo
a,b,c,d,e,f,g
and Maria Rosa Conte
a,b,c,d,e,f,g
Aims Coronary inflammation and healing influence
outcomes of diabetic patients treated with Percutaneous
coronary revascularization (PCI). Stents covered with
biodegradable polymers (bp) may offer advantages over
nonerodible polymer ones, because polymer reabsorption
extinguish coronary inflammation and favours healing. Aim
of our study was to assess the safety and efficacy of bp-
biolimus-eluting stent (bp-BES) in a large series of
consecutive diabetic patients.
Methods From 2009 to 2013 we retrospectively enrolled
consecutive diabetic patients treated with PCI and bp-BES
implantation. Primary end points were target lesion
revascularization (TLR) and stent thrombosis rates.
Results Study cohort counted 747 patients. Multivessel
disease was present in 48.2% with a mean stent/patient
ratio of 1.860.78. During the hospital stay no stent
thrombosis occurred. At 3-year follow-up we observed
a 1.5% cumulative incidence of cardiac death, 1.1% of
myocardial infarction and 6.3% of TLR. Stent thrombosis
occurred in 1.1% of patients, all in the first 2 years of follow-
up. Kaplan–Meier analysis showed a TLR-free survival at
1 and 3 years of 97.2 and 96.1%, respectively.
Conclusion PCI with bp-BES seems to be well tolerated
and effective in a large unselected population of diabetic
patients. The good results observed were maintained at
3 years of follow-up.
J Cardiovasc Med 2016, 16:000–000
Keywords: biolimus-eluting stent, diabetic patients, percutaneous coronary
interventions
a
Mauriziano: Meliga, Aranzulla, Scrocca, De Benedictis, Conte,
b
Maggiore: Lupi,
c
San Raffaele: Latib, Sticchi, Colombo,
d
Degli Infermi: Gagnor, Varbella,
e
SG
Bosco: Boccuzzi,
f
Centro Medico: Alcantara and
g
Cardinal Massaia: Lombardi
Correspondence to Emanuele Meliga, MD, PhD, FESC, Interventional Cardiology
Unit, Mauriziano Hospital, Largo Filippo Turati 62, Turin 10128, Italy.
Tel: +39 011 508 50 38/39; fax: +39 011 508 24 37;
e-mail: emeliga@gmail.com
Received 21 January 2015 Revised 20 April 2015
Accepted 11 August 2015
Introduction
Diabetes is associated with diffuse and rapidly progres-
sive coronary artery disease (CAD) and has been shown to
be an important predictor of death and myocardial infarc-
tion (MI).
1–4
Percutaneous Coronary Intervention (PCI) revasculari-
zation in patients with diabetes mellitus, even in the
drug-eluting stent (DES) era, is associated with worse
outcomes, in comparison with nondiabetic patients, both
in terms of increased in-stent restenosis with need for
repeat revascularizations
5,6
and stent thrombosis.
7,8
The
adverse outcomes after PCI in patients with diabetes
have been attributed to small calibre of the target vessels,
severe and diffuse vascular inflammation, exuberant
neointimal proliferation, prothrombotic state and
clustering of cardiovascular risk factors.
5–8
In this
peculiar clinical subset, biodegradable polymer-covered
DES (bp-DES) may offer an advantage over durable
polymer-covered DES (dp-DES) as they may improve
coronary inflammation and healing with the gradual
reabsorption of the proinflammatory polymer covering
the metal stent struts of Bp-DES.
9,10
The more studied
and employed bp-DES is the biolimus-eluting stent
(BES). However, information about postmarketing effi-
cacy and safety of this stent in an all-comers population of
patients with diabetes are limited.
11,12
Thus, with the present study we aimed to evaluate the
short-term and long-term clinical outcomes of bp-BES
(Biomatrix, Biosensors International Ltd., Singapore and
Original article
1558-2027 Copyright ß 2016 Wolters Kluwer Health, Inc. All rights reserved. DOI:10.2459/JCM.0000000000000335