Culotte stenting technique in coronary bifurcation disease: angiographic follow-up using

Transcription

CLINICAL RESEARCH
European Heart Journal (2008) 29, 2868–2876
doi:10.1093/eurheartj/ehn512
Interventional cardiology
Culotte stenting technique in coronary
bifurcation disease: angiographic follow-up using
dedicated quantitative coronary angiographic
analysis and 12-month clinical outcomes
Tom Adriaenssens†*, Robert A. Byrne, Alban Dibra, Raisuke Iijima, Julinda Mehilli,
Olga Bruskina, Albert Schömig, and Adnan Kastrati
Received 17 March 2008; revised 21 September 2008; accepted 23 October 2008; online publish-ahead-of-print 11 November 2008
This paper was guest edited by Prof. Christiaan J.M. Vrints, Department of Cardiology, University of Antwerp-University Hospital
Antwerp, Belgium.
See page 2831 for the editorial comment on this article (doi:10.1093/eurheartj/ehn385)
Aims
Percutaneous treatment of coronary bifurcation disease remains challenging. In patient subsets in which a two-stent
strategy is necessary, the culotte technique is a widely used method. We sought to examine the clinical and angiographic outcomes of patients treated in this manner at our institution. As quantitative coronary angiographic analysis
using standard measurement programmes is problematic, we used a dedicated bifurcation analysis system.
.....................................................................................................................................................................................
Methods
We prospectively enrolled patients undergoing culotte stenting with drug-eluting stents (Cypher, Endeavor, polymer-free
and results
rapamycin-eluting, Taxus) in two German centres. Lesions were classified according to the Medina classification. Angiographic follow-up was scheduled between 6 and 12 months post-index procedure. Clinical follow-up was available up to
12 months. Culotte technique was used in 134 lesions in 132 patients. Of these, 124 (92.5%) represented ‘true bifurcation’
lesion morphology. Kissing balloon inflation was used in 62% of patients. Procedural angiographic success was achieved in all
lesions. Follow-up coronary angiography was performed in 108 (81.8%) patients. Median (IQR) late lumen loss was 0.10
(20.04 – 0.38) mm in the proximal main vessel, 0.34 (0.03 – 0.66) mm in the distal main branch, and 0.30 (20.01 –
0.72) mm in the side branch. The incidence of binary angiographic restenosis was 22% for the whole bifurcation lesion,
0% in the proximal main vessel, 9.1% in the distal main branch, and 16% in the side branch. At 12 months, 28 of 132
(21%) patients had undergone target lesion revascularization. The incidence of stent thrombosis (at 1 year) was 1.5%. Predictors of angiographic restenosis were older age, increasing bifurcation angle, more severe distal main branch stenosis, and
smaller side branch reference diameter; kissing balloon post-dilatation tended to have a protective effect.
.....................................................................................................................................................................................
Conclusion
The culotte stenting technique is associated with high procedural success and a relatively low risk of angiographic
restenosis. Safety results in our cohort were favourable in terms of a low risk of stent thrombosis.
----------------------------------------------------------------------------------------------------------------------------------------------------------Keywords
Bifurcation † Double-stenting technique † Culotte technique † Percutaneous coronary intervention † In-stent
restenosis † Stent thrombosis † Quantitative coronary angiography
Introduction
Coronary bifurcation disease remains one of the complex coronary lesion subsets that pose a challenge for the interventional
cardiologist. The percutaneous treatment of bifurcations is
common, accounting for 15–20% of interventions.1,2 When compared with non-bifurcation interventions, bifurcation interventions
have a lower rate of procedural success, higher procedural costs,
†Present address. University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium.
* Corresponding author. Tel: þ32 16344235, Fax: þ32 16344240, Email: tom.adriaenssens@uzleuven.be
Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2008. For permissions please email: journals.permissions@oxfordjournals.org.
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Deutsches Herzzentrum München and 1. Klinikum rechts der Isar, Technische Universität, Lazarettstrasse 36, 80636 Munich, Germany
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Culotte stenting technique in coronary bifurcation disease
Methods
Study population
This prospective, observational study collected information on patients
undergoing culotte stenting in two German centres, the Deutsches
Herzzentrum München and Klinikum rechts der Isar, both in Munich,
Germany, between June 2003 and December 2005. Bifurcation interventions in the left main coronary artery were excluded from the
current analysis, since they are part of a larger, randomized trial. All
cases involving culotte stenting were included, both in situations
where the culotte technique was the outset strategy as well as the
de facto outcome following on from a provisional main-vessel-only
stenting strategy. The demographic data, patient history, coronary
risk factors, lesion location, morphology, and procedural strategy
were recorded. All patients provided written informed consent.
Procedures and intervention medications
The culotte technique consists of stenting one of two branches of the
bifurcation lesion first, and after balloon dilatation of the stent meshes,
stenting the uncovered branch through the first stent and leaving the
proximal main vessel covered with two overlapped stents.11 Ideally,
the procedure is terminated by kissing balloon dilatation of both
branches, though this was at the discretion of the operator. Aspirin
and unfractionated heparin were administered per standard practice.
The use of IIb/IIIa inhibitors was left at the discretion of the operator.
After the procedure, patients were maintained on aspirin 100 mg twice
daily indefinitely, and clopidogrel 75 mg twice daily until discharge and
75 mg daily for at least 6 months. Other medicaments such as
b-blocker, statins, and angiotensin converting enzyme inhibitors were
given as indicated. After enrolment, patients remained at hospital for
at least 48 h. Electrocardiograms were recorded and blood was
collected for determination of creatine kinase and its MB isoenzyme
before intervention, and every 8 h for the first 24 h after intervention
and daily until hospital discharge.
Qualitative and quantitative angiographic
evaluation
All bifurcation lesions were classified according to the Medina classification (Table 3), a relatively new classification,12,13 in which a binary
value (1,0) is given, according to whether the parent vessel proximal
to the bifurcation, the main branch distal to the bifurcation or the
side branch is compromised (1) or not (0). Procedural angiographic
success was defined as a post-procedural final residual stenosis
,30% by visual analysis in the presence of Thrombolysis in Myocardial
Infarction (TIMI) flow grade 3 without death, occurrence of Q-wave
myocardial infarction (MI), or coronary bypass graft surgery (CABG).
Between 6 and 12 months after the index procedure, all patients
were invited back for angiographic follow-up. Coronary angiograms
were obtained in multiple views after intracoronary injection of
nitrates. QCA analysis was performed with the dedicated bifurcation
system QAngio XA 7.1 (MEDIS, Leiden, The Netherlands). This new
program analyses the main vessel and side branch in one single analysis.14 A minimal cost algorithm detects the contours of the proximal
main vessel, distal main branch and side branch. The lesion is then
divided into four fragments: a central fragment at the actual location
of the bifurcation, and three fragments around the bifurcation. Each
of the individual vessel fragments are combined with the central fragment to form three segments, so the actual bifurcation is taken into
account in all three individual measurements. The reference vessel
diameter, minimal lumen diameter (MLD), and percent diameter stenosis were measured pre- and post-procedurally and at follow-up
angiography. The late lumen loss was calculated as the difference
between the post-procedure and follow-up MLD for each of the
three segments. Binary restenosis was defined as the presence of
.50% diameter stenosis within the target lesion. The binary restenosis
rate was also calculated for the entire bifurcation lesion. The angiographic pattern of in-stent restenosis (ISR) was further classified
according to the classification proposed by Mehran et al.,15 with
pattern I including focal (,10 mm in length) lesions, pattern II
.10 mm within the stent, pattern III .10 mm extending outside the
stent, and pattern IV totally occluded ISR. Pattern I ISR was further
subdivided into Type I A (articulation or gap), Type I B (margin),
Type I C (focal body), and Type I D (multifocal).
All lesions were also classified according to the bifurcation angle
(BA)—defined as the angle between the axis of the distal main
vessel and the axis of the side-branch at its origin (in contradistinction
to the ‘access angle’, which represents that angle subtended by the
proximal main vessel and the side branch). The measurement was performed in the angiographic view with least foreshortening of the three
segments, usually the operator’s working view and the view in which
QCA measurements were done. The study population was divided
using the median BA (528) as the cut point into a low-angle group
(BA ,528) and a high-angle group (BA .528).
Clinical definitions and follow-up
Clinical follow-up by phone contact or office visit was obtained at 1
and 12 months and evaluated the rate of death, acute MI (AMI), or
target lesion revascularization (TLR). The diagnosis of MI required
the presence of new Q-waves in the electrocardiogram and/or
longer hospitalization, and a higher rate of clinical and angiographic
restenosis. The introduction of drug-eluting stents has resulted in a
lower event rate and reduction of main vessel restenosis, however
side branch ostial residual stenosis and long-term restenosis
remain a problem.3 – 6 Furthermore, bifurcation intervention represents one of the independent risk factors for stent thrombosis
in several analyses.7 – 10
Recent randomized comparisons between single- or
double-stent techniques did not find that stenting the side
branch decreases restenosis rate, thus providing support for a provisional side branch stenting strategy where possible. However,
one possible explanation for this may be the fact that using the
one-stent technique may actually represent a selection bias for
less complex lesions while more complex lesions need to be
treated with two stents. The high cross-over rate between the
single-stent and the double-stent group in most of these studies
underscored the need for safe and reliable double-stent techniques. In recent years, several fundamentally different
double-stent techniques have been described, the most widely
adopted being T-stenting technique, crush technique, culotte technique, V and kissing stent technique. The culotte technique is a
widely used method though there is a notable absence of published data on outcomes of patients treated in this manner. We
therefore undertook an examination of the clinical and angiographic outcomes of patients treated with the culotte technique
at our institution. As quantitative coronary angiographic (QCA)
analysis using standard measurement programmes is problematic,
we used a dedicated bifurcation software system for our angiographic analyses.
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elevation of creatine kinase or its MB isoenzyme at least three times
the upper limit of normal in at least two blood samples. TLR was
defined as either surgical or percutaneous reintervention driven by significant (.50%) luminal diameter narrowing either within the stent or
the 5 mm borders proximal and distal to the stent and was undertaken
in the presence of either anginal symptoms or objective evidence of
ischaemia. Stent thrombosis was assessed based on the definitions of
the Academic Research Consortium (ARC) into definite, probable,
or possible stent thrombosis.16 Stent thrombosis was also categorized
according to the timing of the event into: intra-procedural, early
(between 0 and 30 days after the index procedure), and late (.30
days after the index procedure).
Statistical analysis
Results
The culotte stenting procedure was the dominant two-stent strategy
at our institution during the study time period. Of 1103 treated
lesions where a coronary bifurcation was involved, 422 required
intervention in both the main vessel and side branch (252 balloon
angioplasty in the side arm, 36 non-culotte 2-stent interventions,
and 134 culotte interventions). The 134 culotte treated lesions
occurred in 132 patients. In these 132 patients, a total of 239
lesions were treated with DES during the index intervention, including 105 non-bifurcational lesions which are not analysed here. The
overall mean number of lesions treated per patient was 1.8 + 0.8.
Baseline patient characteristics are listed in Table 1. Median
patient age was 65.5 (57.9, 73.1) years. Patients underwent percutaneous coronary intervention because of stable coronary heart
disease in 61.4%, unstable angina pectoris/non-ST-elevation myocardial infarction (NSTEMI) in 32.6%, and STEMI in 6.1%. Baseline
angiographic and procedural characteristics are shown in Table 2.
The target bifurcation lesion was the left anterior descending/diagonal branch in 91 patients, left circumflex/obtuse marginal branch
in 30, and distal right coronary artery in 13 of the 134 lesions.
Two patients had two bifurcation lesions stented during the
same intervention. Defined according to the Medina classification
(1,1,1), (1,0,1) or (0,1,1), 124 (92.5%) lesions represented a ‘true
bifurcation’ lesion morphology (Table 3). Four different types of
drug-eluting stents were implanted. The Cypher sirolimus-eluting
Table 1 Baseline demographic and clinical
characteristics of the patients
Variable
Patients
(n ¼ 132)
................................................................................
Age, years
64.0 + 10.8
Women, n (%)
Diabetes mellitus, n (%)
30 (22.7)
22 (16.7)
Current smoker, n (%)
19 (14.4)
Arterial hypertension, n (%)
Hypercholesterolaemia, n (%)
88 (66.7)
87 (65.9)
Single-vessel disease
34 (25.8)
Multivessel disease
Stable angina, n (%)
98 (74.2)
81 (61.4)
Unstable angina/non-ST elevation myocardial
infarction, n (%)
43 (32.6)
Acute myocardial infarction, n (%)
8 (6.1)
Prior myocardial infarction, n (%)
Prior aortocoronary bypass surgery, n (%)
37 (28.0)
8 (6.1)
Left ventricular ejection fraction, %
55.0 + 10.5
Data are presented as mean+SD or number (percentages).
stent in 45 lesions (33.6%), the Taxus paclitaxel-eluting stent in
27 (20.1%), the Endeavor zotarolimus-eluting stent in 7 (5.2%),
and the polymer-free rapamycin-eluting stent in 55 (41%) of
lesions.17 Procedural angiographic success was achieved in all
lesions.
Clinical outcomes
Clinical follow-up data at 12 months were available in all patients
included in the study (Table 4). Twenty-six of 132 (19%) patients
underwent TLR. The incidence of stent thrombosis (at 1 year)
was 1.5% (one patient suffered stent thrombosis 40 days after
the procedure, 1 week after he had stopped clopidogrel treatment;
the other patient suffered stent thrombosis 47 days after the procedure, while on dual antiplatelet therapy). According to the ARC
criteria, both stent thromboses were classified as definite and late
(occurring between 30 days and 1 year after the procedure). There
were no probable or possible stent thromboses and no periprocedural or early stent thromboses (occurring between 0 and 30 days
post intervention). There were no deaths and the incidence of MI
at 1 year follow-up was 8.2%. Of the 10 cases of MI during 12month clinical follow-up, two were caused by stent thrombosis
(one NSTEMI, one STEMI), both of which were treated successfully with balloon dilatation. There were two other NSTEMI
(one subtotal occlusion in a vessel distal to the bifurcation lesion
and another subtotal occlusion in a vessel other than the initial
bifurcation lesion). Both were treated successfully with percutaneous intervention. The others were small peri-interventional
MIs with only minimal enzyme elevation.
Quantitative angiographic analysis
Follow-up coronary angiography was performed in 108 (81.8%)
patients. Data from control angiography after 6–8 months are
Discrete variables are presented as numbers (percentages). Continuous variables are expressed as median (IQR) or mean+standard deviation. Confidence intervals for incidences were calculated using the
Poisson exact method. A logistic regression model was established
to investigate independent predictors of restenosis. Based on prior
clinical trial experiences the following clinical variables were chosen
as likely meaningful variables and only these were entered into the
analysis model as explanatory variables: age, diabetes, gender,
Medina classification, restenotic lesion, angle of bifurcation, calcified
lesion, reference diameter of the proximal main vessel, stenosis of
the proximal main vessel, reference diameter of the distal main
branch, stenosis of the distal main branch, reference diameter of the
side branch, stenosis of the side branch, and kissing balloon postdilatation (KBP). Explanatory variables were assumed to be independent and error-free. The model was assessed for goodness-of-fit
using R 2. All tests were two-sided unless explicitly indicated and a
P-value of ,0.05 was considered statistically significant. Formal correction to account for multiple testing was not employed.
T. Adriaenssens et al.
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Table 2 Angiographic and procedural data
Variable
Table 3 Medina classification of the lesions
Lesions (n ¼ 134)
................................................................................
Target vessel
0,0,1
2 (1.5)
30 (22.4)
0,1,0
1,0,0
5 (3.7)
0 (0)
13 (9.7)
0,1,1
27 (20.2)
126 (94.0)
7 (5.2)
3 (2.2)
90 (67.2)
Left anterior descending coronary artery, n (%)
91 (67.9)
Left circumflex coronary artery, n (%)
Right coronary artery, n (%)
................................................................................
Chronic total occlusions, n (%)
4 (3)
1,0,1
1,1,0
In-Stent restenosis lesion, n (%)
21 (16)
1,1,1
Calcified lesions, n (%)
96 (71.6)
Complex (type B2/C) lesions, n (%)
Lesions, n ¼ 134 (%)
Variable
................................................................................
................................................................................
Baseline vessel size, mm
Proximal main vessel
3.02 (2.85, 3.30)
Distal main branch
2.79 (2.48, 2.96)
Side branch
2.50 (2.32, 2.74)
................................................................................
1.86 (1.33, 2.44)
Distal main branch
1.12 (0.90, 1.58)
Side branch
1.09 (0.75, 1.47)
Table 4 Clinical outcomes of the patients
Outcome
Initial diameter stenosis, %
38.9 (18.9, 57.2)
Distal main branch
56.9 (46.0, 67.2)
Side branch
55.9 (41.9, 70.8)
................................................................................
Lesion length, mm
5.50 (3.44, 7.75)
Distal main branch
8.32 (5.5, 12.8)
Side branch
8.13 (5.83, 11.6)
................................................................................
Maximal balloon pressure, atm
Main vessel
15.0 (12.0, 17.0)
Side branch
16.0 (12.0, 17.0)
................................................................................
2.25 –4.50a
Side branch
2.00 –4.00a
................................................................................
Stent length, mm
Main vessel
23.0 (18.0, 28.0)
a
Side branch
18.0 (16.0, 25.0)
b
................................................................................
Target lesion revascularization
at 30 days
1
Stent thrombosis at 30 days
0
0.0 (0.03)b
Death at 30 days
Myocardial infarction at 30
days
Death or myocardial infarction
at 30 days
MACE at 30 days
0
6
0.0 (0.03)b
4.5 (1.7– 9.9)
6
4.5 (1.7– 9.9)
7
5.3 (2.1– 10.9)
Target lesion revascularization
at 1 year
28
21.2 (14.1–30.7)
Stent thrombosis at 1 year
Stent diameter, mm
Main vessel
Percentage (CI)a
................................................................................
................................................................................
Number of
patients, n
0.75 (0.02–4.2)
2
1.5 (0.2– 5.5)
Death at 1 year
Myocardial infarction at 1 year
0
11
0.0 (0.03)b
8.3 (4.1– 14.9)
Death or myocardial infarction
at 1 year
MACE at 1 year
11
8.3 (4.1– 14.9)
35
26.5 (18.5–36.9)
CI, Poisson exact confidence intervals.
One-sided 97.5% confidence interval.
Type of DES implanted
Cypher
45 (33.6)
Endeavor
7 (5.2)
Polymer-free rapamycin-eluting
55 (41)
Taxus
27 (20.1)
................................................................................
Minimal lumen diameter after procedure, mm
2.98 (2.70, 3.23)
Distal main branch
2.42 (2.15, 2.72)
Side branch
2.14 (1.96, 2.42)
................................................................................
Diameter stenosis after procedure, %
4.3 (1.0, 9.5)
Distal main branch
12.5 (8.1, 21.4)
Side branch
15.8 (9.0,24.4)
................................................................................
Kissing balloon post-dilatation, n (%)
83 (62.0)
Data are presented as median (IQR) or number (percentages).
a
Indicates range provided rather than median (IQR).
presented in Table 5. Late lumen loss was 0.15 + 0.40 mm in the
proximal main vessel, 0.37 + 0.55 mm in the distal main branch,
and 0.38 + 0.64 mm in the side branch. The incidence of binary
angiographic restenosis at 6 months was 22% for the whole bifurcation lesion, 0% in the proximal main vessel, 9.1% in the distal
main branch, and 16% in the side branch. With regard to the angiographic pattern of restenosis, restenotic lesions in the main vessel
(n ¼ 10) occurred only in the part distal to the bifurcation point,
with five classified as pattern I C (focal body), 1 pattern I D multifocal, and 4 pattern II (diffuse intrastent). Of restenotic lesions in
the side branch (n ¼ 18), there were seven pattern I C (focal
body; five of which at the ostium), seven pattern II (diffuse intrastent), two pattern III (diffuse proliferative), and two pattern IV
(total occlusions).
We tried to identify predictors of restenosis after culotte DES
bifurcation intervention and examined the impact of the severity
Initial minimal lumen diameter, mm
Data are presented as number (percentages). The components of the three-digit
score refer to the proximal main vessel, distal main vessel, and side branch vessel,
respectively.12
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Table 5 Quantitative coronary angiography
Variable
Lesions (n ¼ 134)
................................................................................
Late lumen loss in-stent, mm
Table 6 Logistic regression model
Variable
Odds ratio (95% CI)
P-value
................................................................................
Age increase by 10 years
2.38 (1.21–4.96)
0.01
Distal main branch
0.10 (20.04, 0.38)
0.34 (0.03, 0.66)
Diabetes
Male sex
3.43 (0.71–16.60)
0.62 (0.15–2.53)
0.13
0.51
Side branch
0.30 (20.01, 0.72)
Medina classification
0.42 (0.13–1.32)
0.14
Restenotic lesion
Bifurcation angle increase by 108
0.52 (0.12–2.24)
1.53 (1.04–2.23)
0.38
0.03
Calcified lesion
0.53 (0.12–2.24)
0.39
Reference vessel diameter
decrease by 1 mm
4.55 (0.17–123.36)
0.37
0.91 (0.67–1.23)
0.54
decrease by 1 mm
0.10 (0.00–3.17)
0.19
Baseline stenosis increase by 10%
1.47 (1.03–2.09)
0.03
31.83 (1.71–592.77)
0.02
0.97 (0.82–1.15)
0.75
0.37 (0.13–1.10)
0.07
................................................................................
Minimal lumen diameter in-stent, mm
2.83 (2.51, 3.12)
Distal main branch
2.08 (1.84, 2.42)
Side branch
1.81 (1.53, 2.12)
................................................................................
Diameter stenosis in-segment, %
8.6 (1.7, 15.3)
................................................................................
Distal main branch
24.5 (41.1, 34.6)
................................................................................
Side branch
28.0 (18.7, 40.2)
Distal main vessel
Angiographic restenosis in-segment, n (%)
Bifurcation lesion
Distal main branch
Side branch
24 (22.0)
0
10 (9.1)
18 (16.0)
Data are presented as median (IQR) or number (percentages).
................................................................................
Side branch vessel
decrease by 1 mm
................................................................................
Kissing balloon post-dilatation
of the baseline lesion (expressed via the Medina classification), the
angle between main branch and side branch and the use of KBP or
not. It appeared that the more severe bifurcation lesions, with
Medina score (0,1,1), (1,0,1), (1,1,0) and the most severe lesions
with Medina score (1,1,1) had a clearly elevated restenosis risk
of 29 and 20.3%, respectively, where no restenosis was seen in
the very small number of patients with less complex bifurcation
lesions with Medina score (0,0,1), (0,1,0), and (0,0,1). As to the
use of KBP, restenosis occurred in 11 of 71 (15.5%) of patients
with vs. 13/39 (33.3%) of patients without KBP. With respect to
the angle of the bifurcation lesion, an angle over the mean of
528 correlated with a higher rate of restenosis (13 of 54 or
24.1% of lesions) compared with lesions with smaller BAs ,528
(restenosis in 11 of 56 or 19.6% of lesions). There was a
numeric trend towards an excess of restenosis with Endeavor
and Taxus stents though an interaction between stent type and
binary restenosis rates was not statistically significant [Cypher 7
(18.0%), Endeavor 2 (28.6%), polymer-free rapamycin-eluting 6
(15.8%), Taxus 9 (34.6%); P ¼ 0.12].
By logistic regression analysis (see Table 6), the predictors for
angiographic restenosis were older age, increasing BA, more
severe stenosis in the distal main branch, and a smaller reference
diameter of the side branch. The use of KBP seemed to have a protective effect on the occurrence of restenosis in the bifurcation
lesion, although not statistically significant (odds ratio 0.37; 95%
CI 0.13 –1.10; P ¼ 0.07).
Discussion
The strengths of this report are that it is the largest report on the
use of culotte technique with DES and the largest report on the
Predictors of binary restenosis. CI, confidence interval.
use of a dedicated bifurcation QCA system for angiographic analysis. It shows that the culotte technique is associated with favourable safety outcomes in terms of a low risk for stent thrombosis.
While the risk of restenosis remains significant compared with
more straightforward DES interventions, this may be regarded as
acceptable considering the lesion complexity. In addition, while
previous reports have identified predictors of restenosis in bifurcation interventions, this is the first report to do so for the
culotte technique and indicates that completing the procedure
with KBP could be associated with better long-term results.
Bifurcation approaches
The optimal treatment strategy for coronary bifurcation lesions
remains to be defined. There is consensus that drug-eluting
stents are superior to bare metal stents in this lesion subset.17
Recent studies lend support to a strategy of provisional side
branch stenting when confronted with the need for coronary bifurcation intervention.18,19 However, there is agreement among many
interventional cardiologists that in several situations (e.g. severe
ostial disease of the side branch, dissection or diminished flow, a
large territory at risk in the side branch etc.), there is need for a
safe and reliable double-stenting technique. In this regard, different
technical options are available to the operator. The T-stenting
technique is limited by a need for extremely precise stent positioning to ensure complete coverage of the side branch ostium.
An alternative technique, crush stenting, is relatively easy to
perform, though KBP is mandatory to achieve acceptable rates of
restenosis of the side branch.20,21
................................................................................
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Stent thrombosis
Since there are no published randomized trials comparing different
double-stent techniques for the treatment of coronary bifurcation
lesions, one can only compare the results of the current study
with historical controls of other treatment strategies. In particular,
recent data on outcomes of patient cohorts treated with the
crush technique using DES has raised concern regarding rates of
stent thrombosis with bifurcation stenting. Analysing 241 lesions,
Hoye et al.25 noted a stent thrombosis rate at 9 months of 4.3%.
In a smaller number of patients, Ge et al.20 reported a stent thrombosis rate (combined intra-procedural and post-procedural) of 3.5%
at 9 months. Costa et al.26 suggest an association between incomplete apposition of crushed stent struts against the main vessel
wall and the development of stent thrombosis as a possible explanation. The most extensive information on T-stenting with
drug-eluting stents was published by Colombo.4 He compared a
single stent (22 lesions) with a double-stent strategy (60 of 63
lesions treated with T-stenting technique). At 6 months, the incidence of stent thrombosis was 4.8%, when one sudden death was
also considered, the combined incidence of sudden death and
stent thrombosis rose to 6.3% in the double-stent group. Conversely, a later paper from the same group compared crush and Tstenting techniques and reported lower rates of stent thrombosis
in the T-stenting group (3.3 vs. 0%).21 Our incidence rate (at 1
year)—utilizing ARC criteria—was notably lower at 1.5% and
more in keeping with the two smaller culotte series previously
discussed.23,24 Superior stent apposition with the culotte technique
(in comparison with crush and t-stenting) is a possible explanation.
The absolute numbers of stent thrombosis events in all studies are in
fact very small, and the validity of comparison between these heterogeneous patient groups is limited. Nevertheless, given the huge
impact on morbidity and mortality of stent thrombosis, these differences may have clinical relevance and warrant further investigation.
Although, a specific analysis of the length of stent overlap in this
current study is not available, the discrepancy between lesion
length and stent length as reported in Table 2 can be interpreted
as evidence of considerable proximal main vessel stent overlap—
an inherent technical characteristic of the culotte technique,
which may be postulated to optimize stent apposition and coverage at the carina. Whether the resultant DES double-layer results
in significant differences with respect to drug dosing effects compared with the triple-layer coverage seen with the crush technique
is not known.
Anti-restenotic efficacy
In terms of anti-restenotic efficacy, late lumen loss and restenosis
rates in main vessel and side branch in our patient population
compare well to the results of these historical controls
(Figure 1).4,20,21,23,24 While rates of re-intervention on the target
lesion remain significant (21% at 1 year), this may be regarded as
acceptable in a high-risk patient cohort—67.7% of lesions being
classified as Medina (1,1,1), 74.2% of patients having multivessel
disease, and 16% of lesions being ISR lesions. The presence of
AMI, severely depressed left ventricular function or renal insufficiency were not exclusion criteria for our analysis. In comparison
with the other reports, our study has the longest clinical follow-up
(12 months compared with only 6 or 9 months in most of the
other series). In terms of predictors of reduced anti-restenotic efficacy, our study confirmed the previously reported negative impact
of a higher BA.27 It is hypothesized that the achievement of an
effective post-dilatation of the side branch may be more challenging as the BA approaches 908, resulting in some degree of side
branch or main vessel stent underexpansion.28 The overall relatively high residual stenosis in the side branch post-intervention
(median 15.8%, IQR 9.0 –24.4%) may also be consistent with a
degree of ostial side branch stent deformation in certain cases
and is in keeping with the fact that no two-stent technique can
completely eliminate excess metal from the carina. In line with
several reports on crush stenting,20,25 our study demonstrated a
beneficial effect of KBP on restenosis (total restenosis rate of
33% in lesions without KBP vs. 15% in lesions treated with KBP).
Quantitative coronary angiography
Conventional QCA algorithms are designed to detect vessel contours assuming minimal vessel tapering. Since there is, also in the
non-diseased state, a step down in the reference diameter of
the main vessel from proximal to distal and from main vessel to
side branch, the reference vessel dimensions measured with
these standard algorithms are inherently inaccurate when applied
to bifurcation lesions. Because the percentage diameter stenosis
is derived from the reference diameter, the percentage diameter
stenosis of a bifurcation lesion will be either underestimated or
overestimated as a result of the systematic errors in reference
The culotte technique has several major advantages. First, it
allows the operator to start the intervention using a provisional
side branch stenting approach. The culotte technique offers the
advantage over the crush technique of having only two and not
three stent layers in the proximal part of the bifurcation lesion,
potentially leading to a lower risk of incomplete stent apposition.
From a technical point of view, final re-wiring into the side
branch, with the aim of performing KBP, is easier after culotte
than after crush stenting. Finally, the result after properly performed culotte stenting and KBP leads to optimal bifurcation coverage, least recoil at the ostium site, least residual stenosis, and less
stent distortion in comparison with other techniques. These considerations are supported by the work of Ormiston et al.22 in a
bench testing model of coronary bifurcation interventions.
Relatively few outcome data on the culotte technique are available in the literature. It was first described one decade ago,11
before the advent of drug-eluting stents, though only two small
studies report on the culotte technique in the DES era. Hoye
et al.23 report on 24 lesions, with no cases of stent thrombosis,
and one repeat revascularization procedure at 8 month follow-up.
In this series of lesions, late loss was 0.48 mm for the main vessel
and 0.53 mm for the side branch. Kaplan et al.,24 performed a nonrandomized comparison in a limited number of patients (n ¼ 80),
between the culotte technique and the T-stenting technique. In
the group of patients treated with culotte stenting, 45 in total,
TLR rate was 8.9% while stent thrombosis occurred in only one
patient (2.2%). Interestingly, the culotte technique yielded significantly better immediate angiographic result at the side branch
ostium, and better clinical outcomes at 9 months, when compared
with T-stenting.
2874
Figure 1 The culotte technique for coronary bifurcation stenting. (A) Baseline angiogram with significant stenosis of the left anterior descending (LAD)/second diagonal bifurcation. (B) After wiring and pre-dilatation of both vessels, a first stent is positioned in the LAD, overstenting the
ostium of the side branch. (C) The wire is removed from the LAD, the stent is crossed with this wire into the diagonal branch which is then
dilated. (D) The second stent is then positioned covering the whole lesion in the diagonal branch and expanded with overlap in the proximal
vessel (LAD). (E) After rewiring into the left anterior descending, kissing balloon post-dilatation is performed. (F) Final result.
diameter measurement. Furthermore, in the bifurcation lesion,
there are different segments of interest that cannot be described
by a single measure of percentage diameter stenosis for the
entire bifurcation lesion. With the new program, the lesion is
divided into four fragments: a central fragment at the actual
location of the bifurcation, and three fragments around the
bifurcation. Each of the individual vessel fragments is combined
with the central fragment to form three segments. This segmental
analysis provides a more thorough insight into the precise location
of treatment failure or restenosis at follow-up (A. Lansky, personal
communication, 2007). In a comparison with the use of the
conventional and this new QCA software for bifurcation lesions,
Goktekin et al.14 found that the new system could be consistently
applied to the analysis of bifurcation lesions before and after
angioplasty, with an intra- and interobserver reproducibility equal
to or better than the conventional analysis system.
2875
Limitations
Although our study is the largest to date on culotte stenting,
patient numbers remain relatively low. This is a feature of many
bifurcation analyses. Meaningful comparison against prior reports
on strategies in lesions requiring a two-stent technique is limited
both due to the small number of patients, heterogeneity of
patient groups and the inherent historical nature of such comparisons. Neither was meaningful comparison against non-culottetreated lesions at our institution available. In addition, a variety
of drug-eluting stents, with differing anti-restenotic efficacy, as
well as variable strut characteristics and stent cell designs and
dimensions (which may be of particular relevance in a
through-the-strut two-stent technique such as that described),
was used in our study.
8.
9.
10.
11.
12.
13.
Conclusions
14.
15.
16.
17.
Funding
T.A. was supported by a fellowship in interventional cardiology from
the European Society of Cardiology. R.A.B. received support from
the Irish Board for Training in Cardiovascular Medicine sponsored by
A. Menarini Pharmaceuticals (Ireland).
18.
Conflict of interest: A.K. reports having received lecture fees
from Bristol-Meyers, Cordis, Lilly and sanofi-aventis. No other
conflicts of interest declared.
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2876
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CLINICAL VIGNETTE
doi:10.1093/eurheartj/ehn282
Online publish-ahead-of-print 17 June 2008
.............................................................................................................................................................................
Gérald Gahide1*, Richard Gervasoni2, and Francois Roubille2
1
Service d’Imagerie Cardiovasculaire et Thoracique, Hopital A de Villeneuve, Centre Hospitalo-Universitaire de Montpellier, Avenue du Doyen Gaston Giraud, 34000
Montpellier, France and 2Fédération de Cardiologie, CHU de Montpellier, France
* Corresponding author. Tel: þ33 467 335 987, Fax: þ33 467 336 088, Email: geraldgahide@hotmail.com
A 33-year-old patient was admitted in our institution
with acute chest pain. The day before, he was a
healthy martial art teacher. He had no medical past
history and strictly no cardiovascular risk factors. Laboratory tests demonstrated a troponin elevation to
16 ng/mL and no inflammatory syndrome. ECG
depicted a concave-upward widespread ST-segment
elevation. Myocarditis was suspected and MR scan
was performed within the 24 h after his admittance.
It demonstrated a hypersignal on TSE-T2 in the apicolateral territory. Delayed enhancement with IRFlash sequence showed a bright subepicardial
enhancement with pericardial thickening (Panel A,
small white arrows) and a limited contiguous transmural myocardial enhancement (Panel A, large
white arrow). A complementary CT scan showed
multiple coronary aneurysms involving the left
anterior descending artery (Panel C), the circumflex
artery, and the right coronary artery. Those findings
were confirmed on DSA coronarography (Panel D).
Follow-up MR imaging performed 12 months later
demonstrated a typical aspect of myocardial infarction with a subendocardial enhancement and resolution of the subepicardial enhancement (Panel B).
Diagnosis of myocardial infarction in aneurismal coronary artery disease was achieved.
Subepicardial or mid-wall enhancement on MR
imaging is usually synonym of inflammatory lesions.
In our case, the initial subepicardial enhancement likely corresponded to a post-infarction acute pericarditis. The pitfall was to misdiagnose the myocardial infarction in this difficult clinical and imaging context.
Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2008. For permissions please email: journals.permissions@oxfordjournals.org.
Predominant subepicardial enhancement on magnetic resonance
imaging corresponding to a post-infarction acute pericarditis
in an athletic young patient

Culotte stenting technique in coronary bifurcation disease: angiographic follow-up using

Transcription

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