Twelve-month clinical outcomes after coronary stenting
with the Genous Bio-engineered R Stent in patients
with a bifurcation lesion: from the e-HEALING
(Healthy Endothelial Accelerated Lining Inhibits
Neointimal Growth) registry
Marcel A. Beijk
a
, Peter Damman
a
, Margo Klomp
a
, Pier Woudstra
a
,
Sigmund Silber
e
, Manfred Grisold
c
, Expedito E. Ribeiro
d
,
Harry Suryapranata
b
, Jaroslaw Wo ´ jcik
f
, Kui Hian Sim
g
, Jan G.P. Tijssen
a
and
Robbert J. de Winter
a
on behalf of the e-HEALING investigators
Background The e-Healthy Endothelial Accelerated
Lining Inhibits Neointimal Growth (e-HEALING) registry
was designed to capture clinical data on the use of the
endothelial progenitor cell capture stent (ECS) in routine
clinical practice. In this analysis, we investigated the
12-month clinical outcomes in patients treated with
an ECS for a bifurcation lesion.
Methods The worldwide, prospective, nonrandomized
e-HEALING registry aimed to enrol 5000 patients treated
for coronary artery disease with one or more ECS between
October 2005 and October 2007. Clinical follow-up was
obtained at 1, 6, and 12 months. The primary endpoint
was target vessel failure (TVF), defined as the composite
of cardiac death, myocardial infarction, and target vessel
revascularization at 12 months.
Results A total of 573 patients were treated for at least
one bifurcation lesion and were assessed in the current
analysis. Baseline characteristics showed a median age
of 65 years; 21% were diabetic patients and 36% had
unstable angina. A total of 63% of the bifurcation lesions
were located in the left artery descending and the mean
stent length was 20.7 ± 12.6 mm. At 12 months, TVF was
12.7% and target lesion revascularization was 7.5%.
Definite or probable stent thrombosis occurred in 1.7%
of the patients. Moreover, one or more stents per lesion
[hazard ratio (HR): 2.79, 95% confidence interval (CI):
1.60–4.86, P < 0.001], predilatation (HR: 0.39, 95% CI:
0.17–0.87, P = 0.023), and lesions located in the right
coronary artery (HR: 4.56, 95% CI: 1.07–19.5, P = 0.041)
were independent predictors of TVF.
Conclusion In the e-HEALING registry, coronary
bifurcation stenting with the ECS results in favorable
clinical outcomes and low incidences of repeat
revascularization and stent thrombosis. Coron Artery Dis
23:201–207 c 2012 Wolters Kluwer Health | Lippincott
Williams & Wilkins.
Coronary Artery Disease 2012, 23:201–207
Keywords: bifurcation lesion, e-Healthy Endothelial Accelerated Lining
Inhibits Neointimal Growth, endothelial progenitor cell capture stent,
Genous
a
Department of Cardiology, Academic Medical Center – University of
Amsterdam, Amsterdam,
b
Isala Klinieken, Locatie Weezenlanden, Zwolle, The
Netherlands,
c
Klinische Abteilung fur Kardiologie, Medizinische Universitatsklinik,
Graz, Austria,
d
Incor, The Heart Institute of the University of Sa ˜ o Paulo, Sa ˜ o Paulo,
Brazil,
e
Kardiologische Praxis und Praxisklinik, Munich, Germany,
f
Department
of Cardiology, Medical University of Lublin, Lublin, Poland and
g
Sarawak General
Hospital, Jalan Tun Ahmad Zaidi Adruce, Sarawak, Malaysia
Correspondence to Robbert J. de Winter, MD, PhD, FESC, Department of
Cardiology, Academic Medical Center – University of Amsterdam, B2-137,
Meibergdreef 9, PO Box 22660, 1105 AZ Amsterdam, The Netherlands
Tel: + 31 205 669 111; fax: + 31 206 962 609; e-mail: r.j.dewinter@amc.uva.nl
Marcel A. Beijk, Peter Damman, and Margo Klomp contributed equally to the
writing of this article.
Received 18 August 2011 Revised 25 December 2011
Accepted 2 January 2012
Introduction
The endothelial progenitor cell capture stent (ECS) is a
novel stent technology with a ‘prohealing’ approach. The
stent struts are coated with a biocompatible matrix with
murine, monoclonal, antihuman CD34
+
antibodies that
are covalently attached. These antibodies specifically target
the surface antigens present on circulating endothelial pro-
genitor cells (EPC), thereby creating an immune affinity
surface for preferentially capturing these circulating cells.
After the EPCs are immobilized on the stent surface, it is
hypothesized that these cells rapidly differentiate into a
functional endothelial layer. This ‘prohealing’ technology
may effectively inhibit stent-related thrombus formation
and neointimal hyperplasia. The clinical safety and efficacy
of the ECS was demonstrated in the Healthy Endothelial
Accelerated Lining Inhibits Neointimal Growth (HEAL-
ING) First-In-Man [1] and HEALING II study [2,3] in
noncomplex, de-novo coronary lesions with only 1 month of
dual antiplatelet therapy (DAPT) prescribed. At 1 year, both
studies showed favorable clinical outcomes.
Several randomized studies evaluating different treatment
strategies of bifurcation lesions have provided valuable
insights. However, clinical outcomes after stenting of
Therapy and prevention 201
0954-6928 c 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins DOI: 10.1097/MCA.0b013e328351550f
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