Circulation. 1996;93:2114-2120
(Circulation. 1996;93:2114-2120.)
© 1996 American Heart Association, Inc.
Six-Month Clinical and Angiographic Outcome of the New, Less Shortening Wallstent in Native Coronary Arteries
Yukio Ozaki, MD, PhD;
David Keane, MB, MRCPI, PhD;
Peter Ruygrok, MD;
Willem J. van der Giessen, MD, PhD;
Pim de Feyter, MD, PhD;
Patrick W. Serruys, MD, PhD
From the Catheterization Laboratory, Thoraxcenter, Erasmus University,
Rotterdam, Netherlands.
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Abstract
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Background The new, less shortening, self-expanding
Wallstent
is characterized by longitudinal flexibility, a protective
membrane,
a low profile, and a customized range of diameters (3.5 to
6.0
mm). The recent modification of the braiding angle of the Wallstent
has
resulted in a new device with less shortening on expansion and
a
concomitant reduction in radial force. We hypothesized that
the
enforced mechanical remodeling produced by the selection
of an
oversized Wallstent might result in improved accommodation
of
subsequent reactive intimal hyperplasia and prevention of
chronic
recoil of the vessel.
Methods and Results To prove this hypothesis, we recently
implanted 44 new, less shortening Wallstents in 35 native
coronary arteries in 35 patients with acute or threatened
closure after balloon angioplasty, according to a strategy of
oversizing of Wallstent diameter and complete coverage of the lesion
length. The initial and 6-month follow-up angiograms were
analyzed with a computer-based quantitative
coronary angiography (QCA) system. Acute gain (minimal luminal
diameter [MLD] post minus MLD pre) and late loss (MLD post minus MLD
at follow-up) were examined. Stent deployment was successful in 44
of 44 attempts (100%). Nominal stent diameter used was 1.40 mm larger
than the maximal vessel diameter. One patient (3%) with a dilated but
unstented lesion proximal to the stented segment sustained a
subacute occlusion on day 1 associated with myocardial infarction.
Event-free survival at 30 days after stent implantation was 97%
(34 of 35 patients). Of the 34 patients eligible for 6-month
angiographic follow-up, 3 who were asymptomatic
declined repeat angiography. MLD (and percent diameter stenosis
[% DS]) changed from 0.83±0.50 mm (72%) pre through 3.06±0.48 mm
(15%) post to 2.27±0.74 mm (28%) at follow-up. Acute gain was
2.23±0.63 mm, and late loss was 0.78±0.61 mm. Angiographic
restenosis (>50% DS) was observed in 5 of 31 patients
(16%) at 6 months, all of whom underwent repeat angioplasty. Thus, the
overall event-free survival at 6-month follow-up was 83% (29
of 35 patients).
Conclusions The oversized Wallstent implantation with
complete coverage of the lesion length conveyed a favorable 6-month
clinical and angiographic outcome. The large acute gain obtained by the
Wallstent afforded greater accommodation of the subsequent late loss.
The enforced mechanical remodeling by oversized new Wallstents may
result in prevention of acute and chronic recoil of the vessel wall and
subsequently a lower restenosis rate at follow-up.
Key Words: arteries stents coronary disease restenosis angiography angioplasty
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Introduction
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The new, less
shortening, self-expanding Wallstent is characterized
by
longitudinal flexibility, a protective membrane, a low profile,
and a
customized range of diameters (3.5 to 6.0 mm) and lengths
(12 to 42
mm). The recent modification in braiding angle has
resulted in a new
device with less shortening on expansion and
a concomitant reduction in
radial force.
1 2 The fine mesh structure
of the Wallstent
provides maximal scaffolding to the vessel
wall, which has previously
encouraged extensive implantation
of the original Wallstent prototype
for the treatment of friable
coronary vein grafts and a limited
and less favorable implantation
experience in native coronary
arteries in the late 1980s.
3 4 5 6 7 8 However, the safety and
efficacy of implantation of
the new, less shortening Wallstent in
native coronary arteries
is unknown. While we have long
recognized that the greater the
gain, the greater the
loss,
9 we also recognize that achieving
a greater acute
luminal gain allows greater subsequent accommodation
of loss (in
accordance with simple geometry and percent tax
laws), and thus,
although the absolute loss is greater, the
net gain is also greater.
Additionally, a recent multicenter
stent study using a Palmaz-Schatz
stent matched to vessel size
demonstrated that the greater initial
luminal gain contributed
to a significantly lower
restenosis rate in the stented group
compared with the
balloon angioplasty group.
10 We hypothesized
that
implantation of the oversized new Wallstents in native
coronary
arteries (a policy of resetting the vessel size into
undiseased
condition) would produce enforced mechanical remodeling
of the
coronary vessel with subsequent reduction in subacute
occlusion
and improved accommodation of reactive intimal
hyperplasia.
To test this hypothesis, we recently implanted 44 Wallstents into 35
native coronary arteries in 35 patients with acute or
threatened closure post coronary balloon angioplasty.
Wallstents were selected to produce oversizing of the stent diameter
and complete coverage of the lesion length. QCA measurements were made
pre primary balloon angioplasty and post Wallstent implantation and the
follow-up angiogram by use of a QCA analysis system (CAAS
II).
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Methods
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Study Patients
To determine the feasibility and safety of deployment of the
oversized
new, less shortening Wallstent, we deployed 44 Wallstents in
35
native coronary arteries in 35 patients. Patients who had
acute
or threatened closure post coronary intervention with a
dissected
lesion length of >18 mm, an MVD of >3.0 mm, absence of
significant
disease in the major side branches, and absence of clinical
contraindication
to anticoagulation were included in the study.
Study End Points and Definition
The primary clinical end point of the study was the occurrence
of any of the following adverse cardiac events: acute or subacute
stent thrombosis, repeat coronary intervention,
coronary bypass surgery, myocardial infarction, or death.
Procedural success was defined as technically successful deployment of
the stent in the absence of an adverse cardiac event. Angiographic
success was defined as a <30% residual diameter stenosis
after final deployment of the stent. Stent thrombosis was defined as a
clinical event leading to catheterization that
identified stent thrombosis within 14 days of deployment. Long-term
clinical outcome included all cardiovascular events
occurring within 6 months of stent deployment. Angiographic
restenosis was defined as luminal narrowing
50% diameter
stenosis at follow-up.
Criteria of Acute and Threatened Vessel Closure
Post balloon angioplasty (primary coronary angioplasty),
lesion morphology was categorized according to the dissection criteria
proposed by Huber et al,11 and coronary flow
distal to the lesion was classified according to the TIMI
criteria.12 Acute occlusion was defined as TIMI 0 flow.
Threatened closure was defined as TIMI 1, 2, or 3 flow with visible
dissection type C, D, E, or F or as dissection type A or B and TIMI 1,
2, or 3 flow with a residual diameter stenosis of
>50%.11 12
Stent Implantation
Balloon angioplasty and stent deployment were performed
according to standard clinical practice by the femoral approach at the
Thoraxcenter (Rotterdam, Netherlands). Recent intracoronary
ultrasound studies reported that atherosclerotic plaque is frequently
present even in angiographically normal proximal reference segments
in patients with significant coronary
stenosis.13 14 We therefore used the MVD from
on-line QCA, which would be expected to be closer to the original
vessel diameter in the nondiseased condition compared with the more
traditional use of the IRD for stent sizing. After determination of the
MVD on the diameter function of the on-line QCA analysis
system (in millimeters), a Wallstent with a nominal diameter of 1.0 mm
greater than the MVD and nominal length 5 to 10 mm longer than the
lesion length was selected (see Fig 1
). Of the 44 stents
used in 35 lesions, 3 were 4 mm in diameter, 11 were 4.5 mm in
diameter, 10 were 5 mm in diameter, 15 were 5.5 mm in diameter, and 5
were 6 mm in diameter. Of the 44 stents, 3 were 18 mm long, 26 were 23
to 28 mm long, 8 were 35 mm long, and 7 were 42 mm long. Twenty-two
patients received a single Wallstent, 7 received two Wallstents, and 1
had three Wallstents implanted. During the primary balloon angioplasty,
the balloon diameter was 3.0±0.6 mm and the maximum inflation pressure
was 10.6±3.1 atm. After delivery of the stent, high-pressure
intrastent balloon inflations (14.2±3.3 atm) using balloon diameters
of 4.0±0.6 mm to optimize stent expansion were performed in all 35
patients.

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Figure 1. QCA of the right coronary artery revealed
that MLD was 0.97 mm, MVD was 4.26 mm, and lesion length was 30.0 mm
(left). A Wallstent (5.5 mm in diameter and 35 mm long) that was 1.24
mm greater than the MVD was deployed, and partial contrast
extravasation caused by balloon rupture was observed (middle). At
6-month follow-up, MLD decreased to 2.58 mm associated with a 14%
residual DS; however, the extravasation was restored and
restenosis was not observed (right).
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Anticoagulant Therapy
At the beginning of the procedure, patients were given an
intravenous bolus dose of 10 000 IU heparin and
subsequently 5000 IU as required to maintain the activated
clotting time >300 seconds throughout the procedure. All patients
received 100 mg/d aspirin. The postintervention anticoagulant regimen
was conventional15 : 1 hour after removal of the femoral
sheath, an intravenous heparin infusion was commenced to
maintain the activated partial thromboplastin time between 70
and 90 seconds until oral anticoagulant therapy (warfarin) had achieved
a prothrombin time international normalized ratio of 2.5 to 3.5.
Warfarin was prescribed for 3 months post stent implantation, and
aspirin indefinitely.16
QCA Analysis
The new version of the computer-based CAAS (CAAS
II)16 was used to perform both the on-line QCA
analysis (for immediate guidance of stent sizing in the
catheterization laboratory) as well as the subsequent
off-line cinefilm analysis. In the CAAS analysis,
which has previously been described elsewhere,17 18 19 20 21 22 23 the
entire cineframe, 18x24 mm, is digitized at a resolution of 1329x1772
pixels. Correction for pincushion distortion is performed before
analysis. Boundaries of a selected coronary segment are
detected automatically. The absolute diameter of the stenosis
(in millimeters) is determined by use of the guiding catheter as
a scaling device.24 To standardize the method of
analysis of the initial and follow-up angiograms, the
following measures were taken: all study frames selected for
analysis were end-diastolic to minimize motion
artifact, and arterial segments were measured between the
same identifiable branch points after the administration of isosorbide
dinitrate.25 26
QCA Parameters
Acute gain and late loss represent the improvement in
MLD achieved at intervention (MLD post stenting minus MLD pre) and the
changes at follow-up (MLD post stenting minus MLD at
follow-up), respectively. Net gain (gain minus loss), net gain
index (net gain divided by IRD pre), relative loss (loss divided by IRD
pre), and loss index (loss divided by gain) were studied. Acute stent
recoil (MLD during intrastent balloon inflation minus final MLD post
stenting) and percent acute stent recoil (acute recoil divided by MLD
during intrastent balloon inflation) were measured.27
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Results
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Clinical Characteristics
The baseline clinical characteristics of the 35 patients are
provided
in Table 1

. Thirty of the patients were men,
and the mean age
was 60±9 years (range, 40 to 76 years).
Twenty-seven
patients had stable angina, and 8 had unstable
angina.
28 Of
the 8 patients with unstable angina, 5 had
Braunwald type II
and 3 had type III.
28
Angiographic Characteristics
The angiographic characteristics of the treated lesions are
given in Table 2
. Of 35 lesions, 22 were in the right
coronary artery, 11 were in the left anterior descending
coronary artery, and the remaining 2 were in the circumflex
coronary artery. Seven of the lesions were ostial, and 16 were
at sites of a bifurcation. Pre balloon angioplasty, the lesions were
categorized according to the American College of
Cardiology/American Heart Association Task Force
criteria.29 Of the 35 lesions, 1 was type A, 22 were type
B, and the remaining 12 were type C. Post primary balloon angioplasty
and before Wallstent implantation, 1 lesion had a type A dissection, 6
a type B dissection, 24 a type C dissection, 2 a type D dissection, and
2 a type F dissection.11 TIMI flow12 was
grade 0 in 2 lesions, grade 2 in 1 lesion, and grade 3 in 32 lesions.
Intracoronary thrombus (intraluminal filling defect on
angiography) was evident in 8 lesions.30
Clinical Outcome
Stent deployment was successful in 44 of 44 stents (100%) in 35
patients. Fig 2
shows the clinical outcome of the 35
patients. One patient with a dilated but unstented lesion proximal to
the stented segment sustained a subacute occlusion on day 1
associated with a Q-wave myocardial infarction (creatine phosphokinase,
1840 IU/L) and was subsequently treated by proximal implantation of a
Palmaz-Schatz stent. The event-free survival at 30-day
follow-up was 97% (34 of 35 patients). Of the 34 patients eligible
for 6-month angiographic follow-up, 3 who were
asymptomatic declined repeat angiography. Angiographic
restenosis (>50% DS) was observed in 5 of 31 patients
(16%) at 6 months, all of whom underwent repeat angioplasty. Thus, the
overall event-free survival at 6-month follow-up was 83% (29
of 35 patients).

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Figure 2. Flow chart of outcome after Wallstent implantation
in native coronary arteries. pt indicates patient; F-up,
follow-up angiogram.
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QCA Analysis
Table 3
shows the relationship between the nominal
diameter and length of the Wallstents selected and QCA analysis
results. The average nominal diameter of the Wallstents used was 1.40
mm greater than the MVD and 9.4 mm longer than the lesion length. Fig 3
provides an example of the serial angiographic outcome
in an individual patient; Fig 4
displays the results of
serial luminal diameter changes measured by QCA analysis for
the study population. MLD was 0.83±0.50 mm pre intervention. Post
stent implantation, high-pressure intrastent balloon dilatation of
14.2±3.3 atm with balloons 4.0±0.6 mm in diameter was performed in
all lesions. Implantation of the Wallstent increased the MLD to
3.06±0.48 mm.

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Figure 3. Coronary angiography of the right
coronary artery in a patient with dissection after primary
balloon angioplasty. Pre balloon angioplasty, the MLD was 0.71 mm, the
IRD was 3.61 mm associated with 80% DS, and the MVD was 4.07 mm (A).
Post balloon angioplasty, the lumen had enlarged; however, a type C
dissection with TIMI 3 flow was present (B). A Wallstent (nominal
diameter of 5.0 mm and 23 mm long) that was nearly 1.0 mm greater than
the MVD was deployed, and the radiopaque stent markers can be seen
during the deployment (C). Post stent balloon dilatation (4.0 mmx20
mm) at 16 atm was performed (D). Post Wallstent deployment, MLD was
3.71 mm, which was greater than IRD pre deployment (3.61 mm) associated
with 9% residual diameter stenosis (E). Six-month
follow-up angiography revealed no restenosis, with an
MLD of 3.43 mm associated with a 19% DS (F).
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Figure 4. Changes of MLD and IRD in 35 lesions from pre
procedure through stent implantation to 6-month follow-up. Post
stent delivery, high-pressure intrastent balloon inflation
(14.2±3.3 atm) was performed in all 35 lesions.
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Acute stent recoil and percent acute stent recoil were 0.52±0.31 mm
and 14±8%. Acute gain was 2.23±0.63 mm, late loss 0.78±0.61 mm, net
gain 1.47±0.92 mm, net gain index 0.55±0.37, relative loss
0.29±0.23, and loss index 0.38±0.37. Angiographic success (<30%
residual diameter stenosis) was achieved in all lesions
(100%). Of the 31 patients who underwent follow-up angiography, 5
had angiographic restenosis, yielding an angiographic
restenosis rate of 16% (5 of 31 patients). Fig 5
shows the sequential changes in % DS for the study
population. Average % DS decreased significantly from 72% pre
intervention to a final residual value of 28% at follow-up.

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Figure 5. Changes in % DS from pre procedure to post stent
implantation in 35 lesions. The % DS was 28% at follow-up.
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Discussion
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The novel findings of this study were as follows. (1)
Delivery
of the new, less shortening Wallstent to the target lesion can
be
achieved in a high proportion of cases (44 of 44 stents). (2)
After
delivery of the stent, angiographic success as defined
by <30%
residual diameter stenosis can be achieved with
high-pressure
intrastent balloon inflations in a high
proportion of cases
(35 of 35 lesions). (3) Despite the bailout
indication, oversizing
of the stent diameter and complete coverage
of the lesion length
resulted in a low risk of subacute stent
thrombosis (3%) and
subsequently conveyed a low restenosis
rate at 6-month follow-up
(16%).
Procedural Outcome
The high successful delivery rate of the Wallstent may be
attributed to a number of factors. First, the 1.57-mm profile of the
unexpanded Wallstent delivery system compares favorably with that of
other stents, and thus, an intraprocedural exchange of the guiding
catheter should rarely be necessary.2 Second, the
unconnected junctions of each filament of the Wallstent enhance the
longitudinal flexibility of the stent to aid the negotiation of
tortuous vessels. Third, the protective rolling membrane of the
Wallstent prevents dislodgment of the stent off the delivery system
during the delivery process to the target lesion. Fourth, the operators
who implanted the stents have extensive previous experience with the
Wallstent delivery system, which relative to other stents is
user-unfriendly and has a longer learning curve.
Early Outcome
Previous studies of bailout stenting have been reported for the
Gianturco-Roubin stent,31 32 33 34 35 the Palmaz-Schatz
stent,36 37 38 39 40 the original Wallstent
prototype,7 8 and the new AVE Microstent.41
These have been associated with a deployment success rate of 89% to
100%, a myocardial infarction rate of 4% to 43%, a coronary
bypass surgery rate of 0% to 60%, and a subacute thrombosis rate
of 7% to 16%. In the present study, 34 of 35 lesions had
dissection types B, C, D, E, and F, with a lesion length of >18 mm
after primary angioplasty; however, stenting was effective in tacking
back the dissection flap and restoring TIMI 3 flow in all 35 lesions.
Although 7 of the lesions had angiographic evidence of
intracoronary thrombus before stenting, deployment of the
Wallstent without the administration of intracoronary
thrombolytic therapy resulted in a low subacute
thrombosis rate (3%). Complete coverage of the dissection flaps
(average stent length, 35.6 mm) and optimal stent expansion by
high-pressure intrastent balloon inflation (14.2±3.3 atm) of the
oversized new, self-expanding Wallstent are all factors that may
have contributed to the low rate of subacute thrombosis and a low
risk of early clinical events.42
Late Outcome
While the reported angiographic restenosis rates
(
50% DS at follow-up) have ranged from 21% to 53% for the
Gianturco-Roubin stent,31 32 33 34 35 43 13% to 38% for the
Palmaz-Schatz stent,10 36 37 38 39 40 44 45 and 14% to 34% for
the original Wallstent prototype,3 4 5 the angiographic
restenosis rate in this study was 16%. In our study, the
oversized Wallstent resulted in larger MLD post stenting (3.06 mm) that
was even greater than the reference vessel diameter pre intervention
(2.92 mm). While in previous stent studies, acute luminal gain at stent
implantation has ranged from 1.40 to 1.95 mm and late loss at
follow-up from 0.65 mm to 0.92 mm associated with
restenosis rates ranging from 22% to
38%,10 16 39 44 in our study, acute luminal gain at the
stent implantation was 2.23 mm and late loss at follow-up was 0.78
mm associated with a restenosis rate of 16%. The low loss
index of 0.38 and large net gain index of 0.55 indicate that our policy
of oversizing of the new Wallstent results in sufficient mechanical
remodeling of the vessel to enable accommodation of the limited luminal
loss and resultant low restenosis rate. Although the
presence of dissection has not been found to convey a more favorable
angiographic outcome after balloon angioplasty,46 the
vessels in which the internal elastic lamina has been disrupted before
stent placement may be more predisposed to a greater initial luminal
gain post stenting. The increased arterial distensibility
resulting from significant dissections might also contribute to an
improved long-term angiographic outcome in a stented vessel
compared with a stented vessel without significant dissection. This may
be one of the elements contributing to our more favorable loss index
compared with that recently reported for elective stenting in the
BENESTENT and STRESS studies.10 16 It should be
acknowledged that adoption of an oversizing policy with more rigid
balloon-expandable stents such as the Palmaz-Schatz stent may be
entirely inappropriate and unsafe, and the implications of our study
should be limited to the self-expanding new Wallstent. Furthermore,
it remains to be seen (a multicenter trial with the new Wallstent has
been initiated) whether such a policy can be safely executed at other
centers with less experience with the Wallstent.
Study Limitations
The number of patients reported in this early single-center
experience is small, and further multicenter experience with this new
stent design will be required before our policy of oversizing of the
new, less shortening Wallstent can be recommended.
Conclusions
Despite the indication of bailout management and the selection of
long, dissected lesions, implantation of the oversized new Wallstent
conveys a favorable acute and 6-month clinical and angiographic
outcome. The enforced mechanical remodeling by the oversized
self-expanding Wallstent may result in prevention of subacute
occlusion and chronic recoil of the vessel and subsequently improved
restenosis rates at follow-up.
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Selected Abbreviations and Acronyms
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| CAAS |
= |
coronary angiography analysis system |
| % DS |
= |
percent diameter stenosis |
| IRD |
= |
interpolated reference diameter |
| MLD |
= |
minimal luminal diameter |
| MVD |
= |
maximal vessel diameter |
| QCA |
= |
quantitative coronary angiography |
|
 |
Acknowledgments
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Dr Ozaki is a recipient of a grant from Takeda Medical Research
(Taisha
Ijo) Foundation, Osaka, Japan. Dr Keane is a recipient of a
travel
grant from the Peel Medical Research Trust, London, UK. We
gratefully
acknowledge Dr Masakiyo Nobuyoshi for his helpful advice. We
thank
Marie-Angèle Morel for her preparation of the figures.
 |
Footnotes
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Reprint requests to Patrick W. Serruys, MD, PhD, FESC, FACC,
Professor of Interventional Cardiology, Thoraxcenter, Erasmus
University, PO Box 1738, 3000 DR Rotterdam, The Netherlands.
Received September 5, 1995;
revision received December 28, 1995;
accepted January 2, 1996.
 |
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