Restenosis Rates Following Bifurcation Stenting With
Sirolimus-Eluting Stents for De Novo Narrowings
Kengo Tanabe, MD, Angela Hoye, MB ChB, Pedro A. Lemos, MD, Jiro Aoki, MD,
Chourmouzios A. Arampatzis, MD, Francesco Saia, MD, Chi-hang Lee, MBBS,
Muzzafer Degertekin, MD, Sjoerd H. Hofma, MD, Georgios Sianos, MD, PhD,
Eugene McFadden, MB ChB, Pieter C. Smits, MD, PhD,
Willem J. van der Giessen, MD, PhD, Pim de Feyter, MD, PhD, Ron T. van Domburg, PhD,
and Patrick W. Serruys, MD, PhD
The percutaneous treatment of coronary bifurcation
stenoses is hampered by an increased rate of subse-
quent restenosis. The present study reports on the
outcomes of a consecutive series of 58 patients with
65 de novo bifurcation stenoses treated with siroli-
mus-eluting stent implantation in both the main vessel
and side branch. At 6 months, the incidence of major
adverse cardiac events was 10.3% (1 death and 5
target lesion revascularizations) with no episodes of
acute myocardial infarction or stent thrombosis.
2004 by Excerpta Medica, Inc.
(Am J Cardiol 2004;91:115–118)
P
ercutaneous coronary intervention of bifurcation
lesions is associated with lower procedural suc-
cess rates
1
and an increased subsequent rate of major
adverse cardiac events (MACEs) and restenosis. Var-
ious techniques and strategies have been applied in an
attempt to improve outcomes, including kissing bal-
loon dilatation and the use of stent implantation in
both branches.
2
The use of adjunctive atherectomy
was found to be disadvantageous in the Coronary
Angioplasty Versus Excisional Atherectomy Trial
(CAVEAT-I) trial.
3
Although there was an improved
initial angiographic result with less residual stenosis,
this was at the expense of a higher rate of side branch
occlusion and acute myocardial infarction. In the
long-term, results of angioplasty in bifurcations have
been hampered by problems of restenosis, particularly
after stent implantation within the side branch.
4,5
Re-
cently, sirolimus-eluting stents (SESs) have demon-
strated dramatically reduced restenosis rates in pa-
tients with relatively simple lesions.
6,7
We sought to
investigate the safety and efficacy of SESs in a con-
secutive series of unselected patients with de novo
bifurcation lesions enrolled in the Rapamycin-Eluting
Stent Evaluation At Rotterdam Cardiology Hospital
(RESEARCH) registry.
8
•••
Since April 2002, SES implantation (Cypher, John-
son & Johnson–Cordis, Miami, Florida) has been used
as the default strategy for all patients treated in our
institution, as part of the RESEARCH registry.
8
Briefly, this single-center registry aims to evaluate the
efficacy of SES implantation in the “real world” of
interventional cardiology. All consecutive patients
were enrolled, irrespective of clinical presentation and
lesion characteristics, and the incidence of MACEs
was prospectively evaluated during follow-up. At 6
months, a total of 563 consecutive patients were
treated solely with SESs. Of these, 58 patients
(10.3%) with de novo bifurcation lesions were treated
with SES implantation in both the main and side
branches; these patients comprise the present study
population. The patients’ informed written consent
was obtained in accordance with the rules of the
institutional ethics committee, which approved the
study.
All procedures were performed with standard in-
terventional techniques, except with the use of the
SES as the device of choice. The strategy of bifurca-
tion stenting employed and the use of kissing balloon
dilatation after procedure was at the operators’ discre-
tion. One of 4 methods of stenting was used: T-
stenting, culotte stenting, kissing stents, or the “crush”
technique. T-stenting and culotte stenting have been
previously described.
5,9
Kissing stents involved simul-
taneous implantation of the stents within both
branches, with the proximal edges alongside each
other, thereby bringing forward the point of diver-
gence. The crush technique involves positioning both
stents, with the proximal part of the side branch stent
lying well within the main vessel, while ensuring that
the edge of the stent in the main vessel is more
proximal than the side branch stent. The side branch
stent is deployed first, and the balloon and wire are
carefully withdrawn. The main vessel stent is then
deployed, thereby crushing the proximal part of the
side branch stent.
10
SESs were available in diameters
from 2.25 to 3.00 mm and lengths from 8 to 33 mm.
During the procedure, intravenous heparin was given
to maintain an activated clotting time of 250 sec-
onds. All patients were prescribed lifelong aspirin and
clopidogrel for 6 months. The use of glycoprotein
IIb/IIIa inhibitors was at the discretion of the operator.
Clinical and angiographic follow-up was per-
formed at 6 months. MACEs were predefined as
death, myocardial infarction, or target lesion revascu-
From the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Neth-
erlands. This study was supported by a grant from Cordis Corporation,
a Johnson & Johnson Company. Dr. Serruys’ address is: Thoraxcenter,
Bd 406, Erasmus MC, Dr Molewaterplein 40, 3015 GD Rotterdam,
The Netherlands. E-mail: p.w.j.c.serruys@erasmusmc.nl. Manuscript
received December 2, 2003; revised manuscript received and ac-
cepted March 19, 2004.
115 ©2004 by Excerpta Medica, Inc. All rights reserved. 0002-9149/04/$–see front matter
The American Journal of Cardiology Vol. 91 July 1, 2004 doi:10.1016/j.amjcard.2004.03.040