Five-year clinical follow-up of the STENTYS self-apposing stent in complex coronary anatomy: a single-centre experience with report of specific angiographic indications
Neth Heart J
Five-year clinical follow-up of the STENTYS self-apposing stent in complex coronary anatomy: a single-centre experience with report of specific angiographic indications
H. Lu 0
R. J. Bekker 0
M. J. Grundeken 0
P. Woudstra 0
J. J. Wykrzykowska 0
J. G. P. Tijssen 0
R. J. de Winter 0
K. T. Koch 0
0 Department of Cardiology, Academic Medical Center, University of Amsterdam , Amsterdam , The Netherlands
Objectives We sought to investigate angiographic indications for the use of the STENTYS technique and evaluated the long-term safety and clinical efficacy of the stent. Background Coronary lesions involving complex anatomy, including aneurysmatic, ectatic, or tapered vessel segments often carry a substantial risk of stent malapposition. The self-apposing stent technique may reduce the risk of stent malapposition and therefore improve clinical outcomes. Methods A total of 120 consecutive patients treated with the STENTYS stent were included (drug-eluting stent (DES) n = 101, bare-metal stent (BMS) n = 19). All lesions were scored for angiographic indications for the STENTYS stent, including aneurysms, ectasias, tapering, absolute diameters, bifurcation lesions, and saphenous vein grafts. Off-line quantitative coronary angiography analyses were performed pre-procedure and post-procedure. Five years follow-up was obtained including cardiac death, target vessel myocardial infarction (TV-MI), target vessel revascularisation, stent thrombosis, and the composite endpoint target vessel failure (cardiac death, TV-MI and target vessel revascularisation). Results Angiographic indications for STENTYS use were aneurysm (30%), ectasia (19%), tapering (27%), bifurcation lesions (8%), and saphenous vein graft lesions (16%) and absolute diameters (22%). Mean maximal diameter was 4.51 ± 0.99 mm. At 5-year follow-up target vessel failure rates were 24.1% in the total cohort (DES 22.8% vs. BMS 33%, p = 0.26). Definite stent thrombosis rate was 3.8% at 5-year follow-up in this cohort with complex and high-risk lesions (DES 4.5% vs. BMS 0%, p = 0.39). Conclusions Angiographic indications for the use of the self-apposing stent were complex lesions with atypical coronary anatomy. Our data showed reasonable stent thrombosis rates at 5-year follow-up, considering the high-risk lesion characteristics.
Stent designs; Complex lesions; Coronary artery disease
● At 5-year follow-up, overall stent thrombosis rate was
3.8%, which is reasonable considering the complexity of
this cohort where proper sizing with tubular
balloon-expandable stents could be difficult in vessel segments with
varying vessel diameters.
● The multi-centre enrolling SIZING registry will give us
insights into the performance of this device in lesions
with vessel diameter variance.
Percutaneous coronary intervention of coronary lesions
involving complex anatomy such as aneurysm, ectasia or
tapering, remains challenging in daily clinical practice. Due
to the varying vessel diameters within the target vessel,
optimal stent sizing can be difficult. Particularly in these
complex lesions, in-stent restenosis and late stent thrombosis
remain significant problems, even when we use a
contemporary drug-eluting stent (DES) [
]. When a stent/vessel
size mismatch occurs, incompletely apposed stent struts
could delay tissue coverage, and therefore predispose for
the occurrence of stent thrombosis [
]. Proper sizing
using balloon-expandable stents in lesions with varying
vessel diameters can be more difficult, since
balloon-expandable stents are tubular by nature and limited to a maximum
expansion diameter . The nitinol self-apposing
STENTYS stent (STENTYS SA, Paris, France) can adjust to
varying lumen diameters (Fig. 1). This technique might
improve clinical outcome after percutaneous coronary
intervention of vessels involving varying diameters due to its
superior strut apposition [
]. Moreover, large vessel diameters
often exceed the expansion capacity of currently available
balloon-expandable stents [
]. This stent can expand up to
6.0 mm which results in adequate apposition even in
absolute vessel diameters. In the present single-centre study,
we aimed to evaluate what the operator indication was for
the use of the self-apposing stent in daily clinical practice.
Fig. 1 Stent apposition in a
tapered aneurysmatic vessel. A
tapered aneurysmatic tube which
illustrates the stent
apposition of the WALLSTENT (a),
a balloon-expandable stent (b)
the STENTYS self-apposing
stent (c) and stent boost of the
STENTYS stent in an
aneurysmatic vessel in vivo (d)
We report the angiographic indication for the stent, with
angiographic and clinical outcomes up to 5-year follow-up.
Materials and methods
Study patients and setting
All consecutive patients treated with the STENTYS stent
since the introduction of the device in our centre from April
2010 until January 2016 were evaluated for this registry.
Patients were excluded if they presented with ST-segment
elevation myocardial infarction (STEMI) or were enrolled in
a randomised trial. All other clinical indications for
percutaneous coronary intervention were allowed. Percutaneous
coronary intervention involving the STENTYS device was
in the setting of routine clinical care. The choice for a
drugeluting stent or bare-metal stent (BMS) was at the discretion
of the operator. Pre-implantation sizing was done by visual
estimation. All patients provided written informed consent
for this registry. All patients were pre-loaded with aspirin
and a P2Y12 inhibitor, if not already on chronic therapy.
Patients received 5,000 IU of unfractionated heparin at the
start of the procedure. The use of peri-procedural
glycoprotein IIb/IIIa receptor inhibitors was left at the discretion of
The STENTYS stent is a new generation
self-expanding device, made of a nitinol platform, a biocompatible
nickel and titanium alloy. The stent is 6 French-compatible
and is delivered using a rapid-exchange delivery system
over a conventional 0.01400 guidewire. It is available in
3 lengths (17 mm, 22 mm and 27 mm), and in three
diameter sizes: small (2.5–3.0 mm), medium (3.0–3.5 mm),
and large (3.5–4.5 mm). The strut thickness is 102 microns
(small size) or 133 microns (medium and large sizes).
The large STENTYS can expand over 6.0 mm suitable for
Angiographic data acquisition and definitions
absolute vessel diameters of >4.5 mm. The stent is
available as bare-metal stent and drug-eluting stent (paclitaxel
or sirolimus). Since apposition is possible in large and
variable vessel diameters of, for example, proximal and
distal main branches, the stent can be used safely and
effectively in bifurcation lesions [
] and in saphenous
vein grafts [
]. Moreover, the nitinol platform can enlarge
further after implantation. Therefore, the STENTYS device
is extensively evaluated in patients with acute myocardial
infarction in the APPOSITION trials [
revealed lower rates of strut mal-apposition as compared with
balloon-expandable stents and favourable clinical results.
During the present study, the novel balloon-based delivery
system Xposition was not yet available for commercial use.
An experienced interventional cardiologist (KTK)
retrospectively reviewed the procedural report and procedural
angiograms of all lesions treated with STENTYS to
obtain lesion characteristics and to access the angiographic
indication for this device if it was not stated in the
report. The following angiographic indications were
specified; aneurysm; ectasias; tapering; absolute reference
vessel diameter 4.0–5.0 mm, bifurcation lesions and lesions
located in saphenous vein grafts. Aneurysm was defined as
localised or segmental dilatation which exceeds the
diameter of normal adjacent segments by 1.5 times .
Ectasia was defined as irregular diffuse dilatation (>1.5 times
the normal diameter) that involves more than one third of
the length of the coronary artery [
]. Tapering was
defined as a significant diameter change of ≥1 mm from
the proximal to the distal vessel segment. Offline
quantitative coronary angiography (QCA) analyses were performed
using dedicated software (QAngioXA version 7.3; Medis,
Leiden, the Netherlands). Standardised QCA methodology
was used including a bifurcation algorithm for bifurcation
lesions. Pre- and post-procedural reference vessel diameter,
minimal luminal diameter and percentage diameter stenosis
(%DS) were obtained. Pre-implantation D-max is obtained
to assess maximal luminal diameters at baseline. Acute
gain was defined as the difference between pre-procedural
and post-procedural minimal luminal diameter.
Longitudinal geographic mismatch on QCA was defined as the entire
length of the lesion (as defined by QCA) not completely
covered by the stent. Angiographic success was defined as
final residual stenosis of less than 20% by offline QCA and
thrombolysis in myocardial infarction (TIMI) 3 flow on the
final angiogram without geographic mismatch.
Follow-up and outcomes
Patients were contacted individually to obtain
followup data. Hospital records and coronary angiograms were
reviewed to complete information. Reported clinical
outcomes included cardiac death, target vessel myocardial
infarction (TV-MI), non-TV-MI, clinically indicated
target lesion revascularisation, target vessel revascularisation
(TVR), non-TVR, and definite/probable stent thrombosis
according to the Academic Research Consortium
]. Target vessel failure was defined as the
composite of cardiac death, TV-MI or TVR. Procedural success
was defined as angiographic success without in-hospital
target vessel failure.
Continuous variables were presented as mean ± standard
deviation, categorical variables as frequencies. We performed
comparisons of variables using the two-sided Student-t test,
chi-square or Fisher’s exact test, as appropriate. Event rates
were assessed by Kaplan-Meier estimates and compared
with the log-rank test. Follow-up was censored at 5 years
or at the last known date of follow-up, whichever came
first. We used the SPSS software package (version 24, IBM,
Chicago, IL, USA).
Baseline patient characteristics and procedural characteristics
Between April 2010 and January 2016, 120 patients were
included in our registry including 19 STENTYS bare-metal
stents, and 101 STENTYS drug-eluting stents. We report
the outcome separately. Baseline clinical characteristics are
summarised in Table 1 of the online supplementary
material. Mean age was 65 ± 12 years in the group with a
drugeluting stents vs. 67 ± 13 in the group with a bare-metal
stent. In the group with a drug-eluting stent, 46% of patients
had stable angina, 16% unstable angina and 39%
non-STsegment elevation myocardial infarction (NSTEMI). In the
group with a bare-metal stent, 53% of patients had stable
angina, 26% unstable angina and 21% NSTEMI.
Lesion and procedural characteristics are shown in
Table 2 of the online supplementary material. A total of
124 lesions were treated (study lesions). Of this total,
104 lesions were treated with the STENTYS drug-eluting
stent and 20 with the STENTYS bare-metal stent. D-max
was 4.51 ± 0.99 mm in the group with a drug-eluting stent
and 4.63 ± 1.05 mm in the group with a bare-metal stent
(p = 0.64). A considerable number of patients had a
L = 20
implantation D-max of ≥4.0 to 5.0 mm (38% vs. 37%
respectively, p = 0.95). In both groups, there was even a
preimplantation D-max of ≥5.0 mm in approximately one third
of cases (28% vs. 37% respectively, p = 0.42). Geographic
mismatch occurred in 2% in the group with a drug-eluting
stent vs. 5% in the group with a bare-metal stent (p = 0.46).
Angiographic success was 69% in the group with a
drugeluting stent vs. 68% in the group with a bare-metal stent
(p = 0.94), similar to the procedural success due to no
inhospital target vessel failure.
Angiographic indications and results
Angiographic indications for operators to choose the
STENTYS stent, were aneurysm (30%), ectasia (19%), tapering
(27%), bifurcation lesions (8%), saphenous vein graft
lesions (16%) and absolute target vessel diameters (22%)
(Tab. 1). More than 1 angiographic indication could apply,
for example, tapering and absolute target vessel diameter
(Fig. 2). QCA results are summarised in Tab. 2. Reference
vessel diameter, %DS and the minimal luminal diameter
of all angiographic indications are shown separately
illustrating the angiographic differences between the groups. In
tapering, the reference vessel diameter of the proximal edge
is remarkably larger than the reference vessel diameter in
the distal edge of the treated segment. Angiographic
outcomes for the bifurcation lesions are shown in Table 3 of
the online supplementary material.
Clinical follow-up was obtained for all patients with a
median follow-up of 51 months (IQR 42–60). One patient was
lost to follow-up due to emigration to Suriname 2 years
after baseline percutaneous coronary intervention and is
censored from the date of emigration. Target vessel
failure was observed in 25 patients (24.1%), 19 (22.8%) in
the group with a drug-eluting stent vs. 6 (33%) in the
group with a bare-metal stent (Tab. 3). Landmark analysis
at 2-year up to 5-year follow-up revealed an incremental
target vessel failure rate of 13.3% in the group with a
drugeluting stent and 15.2% in the group with a bare-metal
stent (p = 0.73) (Fig. 3). In the total cohort, definite stent
thrombosis occurred in 4 cases (3.8%). Stent thrombosis
characteristics are shown in Table 4 of the online
supplementary material. Individual clinical endpoints are shown
in Tab. 3 and Fig. 4. Clinical outcomes per angiographic
indication are shown in Table 5 of the online supplementary
material. Comparison between the bare-metal stent group
and the drug-eluting stent group should be interpreted with
caution due to the non-randomised design and the small
This study evaluates the angiographic indications for the
use of the STENTYS device according to experienced
interventionalists with the report of 5-year clinical outcome
in a subgroup of complex patients. Indications for
STENTYS use was coronary aneurysm, ectasia, tapering, absolute
vessel diameters, bifurcation lesions and lesions located in
saphenous vein grafts. Our QCA data demonstrates that this
device is effective in large variable reference vessel
diameters in a cohort with high-risk complex coronary anatomy.
Clinical experience with the STENTYS stent
Several theoretic advantages of the nitinol self-apposing
platform were previously evaluated in selected cohorts.
Naber et al. observed a definite stent thrombosis rate of
1% at 6-month and 0% at 12-month follow-up in
bifurcation lesions [
]. A large STEMI registry with STENTYS
bare-metal stent and paclitaxel-eluting stent (PES) revealed
definite stent thrombosis rates of 3.3% at 2-year
]. Less data is available for the stent performance in
all-comer populations. An evaluation of a small real-world
cohort reveals that interventionalists chose the STENTYS
device in a comparable selection of angiographic situations,
including bifurcation lesions, acute coronary syndrome and
ectatic coronaries, with a stent thrombosis rate of 2.5%
at 21 ± 13 months [
]. Another real-world single-centre
experience with both STENTYS bare-metal stent and
paclitaxel-eluting stent from Italy reported a stent thrombosis
rate of 1.8% at 23.6 ± 12.6 months [
]. A larger multicentre
cohort reported stent thrombosis rates of 2.6% at 2.5 years
in all-comer patients, based on usage of STENTYS
Target vessel failure
Cardiac death, TV-MI and TVR
Target Vessel Failure between 2 and 5 years
Cardiac death, TV-MI and TVR
Other composite endpoints
Cardiac death and TV-MI
Cardiac death, TV-MI and TLR
Components of composite endpoints
Clinically indicated TLR
MI not related to target vessel
Values are n (number of patients) with event rates calculated using the Kaplan-Meier method
BMS bare-metal stent, DES drug-eluting stent, MI myocardial infarction, TV-MI target vessel myocardial infarction, TVR target vessel revascularisation,
TLR target lesion revascularisation
metal stent, paclitaxel-eluting stent and sirolimus-eluting
]. In the present study, we observed a geographic
mismatch in 2% in the group with a drug-eluting stent and
5% in the group with a bare-metal stent (p = 0.46), and
overall stent thrombosis rate of 3.8% at 5-year follow-up.
Considering the complexity of our cohort including both
STENTYS bare-metal stent and paclitaxel-eluting stent,
these indicators for device performance are acceptable. The
low angiographic success rates of 69% in the group with
a drug-eluting stent and 68% in the group with a bare-metal
stent is partly explained by the fact the we incorporated
a geographic mismatch and measured the residual stenosis
on off-line QCA. These success rates should be interpreted
with caution since QCA analyses might overestimate
residual stenosis in aneurysmatic and ectatic lesions.
Comparison with contemporary balloon expandable stents
It is well-known that complex target lesion anatomy is
associated with an increased risk of adverse outcome [
Using the SYNTAX score, an angiographic scoring system
quantifying the complexity of coronary artery disease, it
is possible to identify high-risk patients based on
angiographic characteristics [
]. Unprotected left main,
multi-vessel disease, longer lesions, bifurcation or
trifurcation lesions and large thrombus load are incorporated
and considered more complex. A recent pooled analysis
evaluating new-generation balloon-expandable drug-eluting
stents, including stents eluting everolimus and zotarolimus,
and biodegradable polymer stents eluting biolimus and
sirolimus, demonstrated a definite stent thrombosis rate of
1.0% at 2-year follow-up in patients with a higher coronary
complexity (SYNTAX score > 11) [
]. The RESOLUTE
all-comers trial comparing the Resolute zotarolimus-eluting
stent with the Xience V everolimus-eluting stent revealed
definite stent thrombosis rates of 1.2% vs. 0.4% (p = 0.14)
respectively in a pre-specified subgroup of complex patients
at 1-year follow-up [
]. The same trial reported definite
stent thrombosis rates of 1.6% vs. 0.8% (p = 0.08)
respectively at 5-year follow-up in an all-comers population [
Our observations of much higher stent thrombosis rates
could partially be explained by the atypical complexities
including aneurysms, ectasia and large tapering. Moreover,
the patients were treated with the STENTYS bare-metal
stent or paclitaxel-eluting stent delivered with the
conventional delivery system. The Xposition delivery system
with the sirolimus-eluting STENTYS device, where precise
stent delivery is made possible by a delivery balloon which
is retracted after stent delivery, might improve clinical
outcome in complex coronary anatomy [
This study is limited by its observational design. It is
a small, single-centre cohort study of complex lesions.
A matched control group with such atypical anatomical
high-risk lesions treated with balloon-expandable stents
was not available. The STENTYS use, including the choice
for STENTYS drug-eluting stent or bare-metal stent was
at the discretion of the operator. The angiograms were
reviewed by a single expert only. No routine angiographic
follow-up was performed in these patients. Finally, clinical
outcomes were not adjudicated by an independent clinical
This single-centre registry showed that operators tend to
choose this stent technique in complex lesions.
Considering the high-risk lesion characteristics, stent thrombosis
rates are reasonable at 5-year follow-up. The STENTYS
platform seems safe and effective in patients with an
atypical anatomy. The enrolling SIZING registry will give us
insights into the performance of this device in lesions with
vessel diameter variance [
Funding The authors received no specific funding for this work.
Conflict of interest H. Lu, R.J. Bekker, M.J. Grundeken, P. Woudstra,
J.J. Wykrzykowska, J.G.P. Tijssen, R.J. de Winter and K.T. Koch
declare that they have no competing interests.
Open Access This article is distributed under the terms of the
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link to the Creative Commons license, and indicate if changes were
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