a PDF of this article. - Journal of Invasive Cardiology

a PDF of this article. - Journal of Invasive Cardiology

Original Contribution
Predictors of Failure of Final Kissing-Balloon Inflation After
Mini-Crush Stenting in Non-Left Main Bifurcation Lesions:
Importance of the Main-Vessel Angle
Zafer Elbasan, MD, Rabia Eker Akıllı, MD, Gülhan Yüksel Kalkan, MD, Durmuş Yıldıray Şahin, MD,
Mustafa Gür, MD, Murat Çaylı, MD
FKBI success with this technique varies between 64%-92%.4-7 To
overcome this problem, the mini-crush stent technique was devised.
Although mini-crush stenting has a higher rate of FKBI success, it
still cannot be achieved in all patients.7 The exact causes of FKBI
failure during mini-crush stenting are not fully understood. The aim
of this study was to investigate the factors that contribute to FKBI
failure in mini-crush stenting.
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Abstract: Background. The majority of bifurcation lesions
are treated with crush stenting. However, the success of crush stenting depends on final kissing-balloon inflation (FKBI), which is potentially difficult. Although mini-crush stenting has a higher rate of
successful FKBI, it still cannot be achieved in some patients. The aim
of this study was to investigate the factors that contribute to failure
of FKBI in mini-crush stenting. Methods and Results. We included
173 consecutive patients who were treated with mini-crush stenting.
The patients were divided into FKBI and non-FKBI groups. The bifurcation angles were measured: (1) proximal bifurcation angle (angle
A, between proximal main vessel and side branch); (2) distal bifurcation angle (angle B, between distal main branch and side branch);
and (3) the main-vessel angle (angle C, between proximal main vessel
and distal main branch). FKBI could be performed in 153 patients.
Angle C and calcification were significantly lower and angle A and
mean stent diameter in the main vessel were significantly higher in the
FKBI group. Multivariate logistic regression analysis showed that only
Angle C was an independent predictor of FKBI failure. Conclusions.
Main-vessel angle was the only independent predictor of FKBI failure
in mini-crush stenting.
J INVASIVE CARDIOL 2013;25(3):118-122
Key words: mini-crush stenting, final kissing balloon inflation,
main-vessel angle
Bifurcation lesions still represent a technical challenge for the interventional cardiologist. Although different techniques have been
proposed, percutaneous coronary intervention (PCI) for bifurcation
lesions is still associated with lower procedural success rate, higher
major adverse cardiac event rate, and poor long-term outcomes
compared with non-bifurcation lesions, even in the drug-eluting
stent (DES) era.1-3
The majority of bifurcation lesions are treated with crush stenting in many clinics. However, the success of crush stenting depends
on a final kissing-balloon inflation (FKBI), which is potentially difficult, because wire and balloon have to cross double layers of stent
at the side-branch (SB) orifice. Early and long-term results after
PCI are not satisfactory in patients with FKBI failure.4 The rate of
From the Department of Cardiology, Adana Numune Education and Research Hospital,
Adana, Turkey.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest
regarding the content herein.
Manuscript submitted August 29, 2012, provisional acceptance given November 13,
2012, final version accepted December 7, 2012.
Address for correspondence: Dr Durmuş Y. Şahin, MD, Adana Numune Education
and Research Hospital, Department of Cardiology, Seyhan Application Center, Çukurova, Adana, 01170, Turkey. Email: [email protected]
118
Methods
Patients. Of the 4375 PCI procedures performed between January 2010 and May 2012 at Adana Numune Education and Research
Hospital in Adana, Turkey, we included 173 consecutive patients
(101 males and 72 females; mean age, 58.0 ± 10.5 years) who were
treated with the mini-crush stenting technique. Mini-crush stenting
cases were identified through cineangiogram and procedural report
review. Patients with acute myocardial infarction, left ventricular
dysfunction, left main (LM) coronary bifurcation lesion, as well as
those treated with crush stenting but had unsatisfactory cineangiograms, were excluded from the study. Demographic, angiographic,
and procedural variables were recorded. The Local Ethics Committee approved the study protocol.
PCI procedure. All patients were previously treated with aspirin
and clopidogrel. If patients were not pretreated with clopidogrel, a
600 mg loading dose of clopidogrel was administered just before the
index procedure. The mini-crush stenting procedure was performed
using the technique described by Galassi et al.8 In our laboratory,
2-step FKBI is routinely performed whenever possible for all patients treated with crush or mini-crush stenting. Stepwise balloon
inflation, beginning from 1.5 mm in diameter to the optimal SB
stent dilatation was followed by FKBI. If the 1.5 mm balloon failed
to cross through the stent struts, we then used a 1.25 or 1.5 mm
Sprinter balloon to separate struts and allow a larger balloon to pass.
If the Sprinter balloon also failed to cross the SB, we then used the
proximal optimization technique (POT). In any case with difficulty
crossing into the SB, the POT became routine in our clinic by 2010.
Procedural time was defined from wiring of both vessels to FKBI.
If predilatation was performed, procedure time was started after the
predilatation. Based on the success of FKBI, the patients were divided into an FKBI group (n = 153) and a non-FKBI group (n = 20).
In this study, the Liberté bare-metal stent (Boston Scientific)
was used in 37 patients for treatment of the main vessel and in
46 patients for the treatment of a side branch. In other patients,
PCI was performed with the following DESs: Endeavor stents
(Medtronic Inc), Coraxel paclitaxel-eluting stents (Alvi Medica),
The Journal of Invasive Cardiology®
Main Vessel Angle in Mini-Crush Stenting
proximal main vessel and the
distal main branch.
Statistical
analysis.
All calculations were performed with the SPSS
version 13.0 (SPSS Inc).
Continuous variables were
Main vessel angle
Proximal bifurcation
(Angle C)
angle
tested for normality with
(Angle A)
the Kolmogorov–Smirnov
test. Continuous variables
were expressed as mean
± standard deviation and
compared using indepenDistal bifurcation angle
dent sample t-tests or anal(Angle B)
ysis of variance (ANOVA)
Figure 1. Wideness of stent strut cell at the side-branch ostium according to the main vessel angle. (A) Vessel with where appropriate. Catesteep angle: the stent strut cell at the side-branch ostium is wider and advancement of balloon into the side branch is gorical variables were comeasy. (B) Straight vessel: normal stent strut cell at the side-branch ostium. (C) Vessel with wider angle: the stent strut pared with the chi-square
cell at the side-branch ostium is narrowed and advancement of balloon into the side branch is extremely difficult.
test. Multiple logistic regression analysis with backCoracto sirolimus-eluting stents (Alvi Medica), Xience V stents (Ab- ward elimination process was used to identify predictors of FKBI
bott Vascular), and Promus stents (Boston Scientific).
failure. All significant parameters on univariate analysis, such as
All procedural cineangiograms were acquired digitally and stored lesion calcification, angle A, angle C, and mean stent diameter in
in Digital Imaging and Communication in Medicine standard for- the main vessel were selected in the multivariate model. A receivmat. Lesion morphology, stent type, and stent size were recorded in er operator characteristic (ROC) curve analysis was performed to
all patients. Three-dimensional reconstruction was performed off- identify the optimal cut-off point of MVA and PBA to predict
line by the same experienced operator (MG), blinded to individual the failure of FKBI. The area under the curve (AUC) value was
patient data and clinical outcome, using 3-dimensional software calculated. A P-value of <.05 was considered significant.
(CardiOp-B system, version 2.1.0.151, Paieon Medical, Ltd).9,10
The software algorithm rendered an image as well as quantitative Results
information, including bifurcation angle measurement. All bifurcaThe index lesion location was the left anterior descending artery/
tion angle evaluations were performed before PCI in the absence of diagonal branch in 159 patients (91.9%), the circumflex artery/obthe guidewires in place (as these could modify the angle). All three tuse marginal branch in 12 patients (6.9%), and the right coronary
non-left main bifurcation angles were presented in accordance with artery/posterior descending artery/posterolateral branch in 2 patients
the European Bifurcation Club consensus definition (Figures 1 and (1.2%). Patients underwent PCI due to stable angina pectoris and
2).11 Angle A (proximal bifurcation angle) is defined as the angle be- unstable angina pectoris in 145 (83.8%) and 28 (16.2%), respectween the proximal main vessel and the SB; angle B (distal bifurca- tively. FKBI could be performed in 153 patients (88.4%). Baseline
tion angle) is defined as between the distal main branch and the SB; demographic characteristics of patients with FKBI and non-FKBI
and angle C (main-vessel angle) is defined as the angle between the were similar (Table 1).
A
B
C
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C
Figure 2. (A) Left anterior descending artery-diagonal bifurcation lesion in RAO projection. (B) Circumflex artery-obtuse marginal bifurcation
lesion in AP caudal projection. (C) Left anterior descending artery-diagonal bifurcation lesion in LAO projection.
Vol. 25, No. 3, March 2013
119
ELBASAN, et al.
1.0
Sensitivity
.8
AUC: 0.931
The cut-off value of MVA: 167
Sensitivity: 86.7%
Specificity: 89.2%
.5
.3
independent predictor of FKBI failure (odds ratio [OR], 0.80; 95%
confidence interval [CI], 0.73-0.88; P<.001). ROC curve analysis
was performed to evaluate the usefulness of angle C for predicting
FKBI failure. The AUC was 0.931 (95% CI, 0.874-0.987; P<.001)
and the cut-off value of angle C was 167° for predicting FKBI failure, with a sensitivity of 86.7% and a specificity of 89.2% (Figure 3).
The median angle C was 152°. The patients were divided into
three groups according to tertiles of angle C, which were defined as
angle Clow <141° (n = 57), angle Cmid = 141°-160° (n = 59), and
angle Chigh >160° (n = 57). Failure of FKBI, procedure time, and
contrast volume increased significantly from the angle Clow group to
the Angle Chigh group. Angiographic and procedural characteristics
of the patients according to the angle C tertiles are summarized in
Table 3.
Discussion
0.0
0.0
.3
.5
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1.0
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1 - Specificity
C
Figure 3. The receiver operating characteristic curve analysis of main
vessel angle for predicting the failure of final kissing-balloon inflation in
mini-crush stenting.
Table 1. Baseline clinical characteristics of groups.
FKBI Group
(n = 153)
Non-FKBI
Group (n = 20)
P
57.8 ± 10.7
59.6 ± 8.7
.4
89/64
12/8
.9
Hypertension
99 (64.7%)
12 (60.0%)
.7
Diabetes mellitus
30 (19.6%)
7 (35.0%)
.1
Smoking
73 (47.7%)
11 (55.0%)
.5
Hyperlipidemia
95 (62.1%)
13 (65.0%)
.8
Previous PCI
12 (11.8%)
3 (15.0%)
.6
Previous CABG
11 (7.2%)
1 (5.0%)
.7
ACS
24 (15.7%)
4 (20.0%)
.6
SAP
129 (84.3%)
16 (80.0%)
Age (years)
Sex (male/female)
PCI indication
FKBI = final kissing balloon inflation; PCI = percutaneous coronary
intervention; CABG = coronary artery bypass graft operation; ACS = acute
coronary syndrome; SAP = stable angina pectoris.
Angiographic and procedural variables of the FKBI and non-FKBI groups were compared in Table 2. Lesion calcification (14.5% vs
35.0%; P=.04) and angle C (148.4 ± 14.7 vs 175.0 ± 10.3; P<.001)
were significantly lower in the FKBI group than in the non-FKBI
group. Angle A (154.3 ± 14.2 vs 130.7 ± 16.4; P<.001) and the
mean stent diameter in the main vessel were significantly higher in
the FKBI group than in the non-FKBI group (3.37 ± 0.42 vs 3.16 ±
0.41; P=.04) . As expected, the procedure time and contrast volume
were significantly higher in the non-FKBI group. However, there
were no significant differences in angle B, the need for predilatation,
stent type, or the stent length between the two groups. Multivariate logistic regression analysis showed that only angle C was an
120
To the best of our knowledge, this is the first article investigating the reasons for FKBI failure during mini-crush stenting. We
found that only angle C was an independent predictor of FKBI
failure. We also showed that increased angle C is associated with a
higher incidence of FKBI failure, longer procedure time, and more
contrast volume.
The Achilles’ heel of true bifurcation lesion PCI is restenosis in
the SB ostium. One of the most important reasons of SB ostial restenosis is incomplete coverage.12 Colombo et al13 described the crush
stenting technique, which offers complete coverage of SB ostium,
in 2003. Using this technique, SB restenosis was reduced to about
13%-26%.7,14-16 However, three stent layers in the proximal part of
the bifurcation lesion in crush stenting predisposes to incomplete
stent apposition and potentially leads to thrombotic complications.
Furthermore, the success of crush stenting depends on achievement
of FKBI, which is potentially difficult because the wire and balloon
have to cross double layers of stent at the SB orifice.4 The rate of
FKBI success with this technique varies between 64%-92%.4-7 The
mini-crush stent technique was devised to improve the success rate
of FKBI. Although the success rate of FKBI while using the minicrush stent technique is significantly improved, it still cannot be
achieved in approximately 12% of patients.7 The exact reasons for
FKBI failure remain unknown. In our study, the failure rate of FKBI
was 11.6%, which was consistent with the literature.
Previous studies have researched the effect of bifurcation angles
on clinical outcome and the success of FKBI.2,17 Dzavik et al16 investigated the effects of bifurcation angle on the performance of FKBI
in 133 patients with crush stenting. They divided the patients into
four groups according to quartiles of the bifurcation angle and reported that the success rate of FKBI was similar in all groups. In
addition, Chen et al2 recently showed that there is no influence of
angle B on the success of FKBI. In our study, there was also no relation between angle B and FKBI failure, and only angle C was an
independent predictor of FKBI failure. We also showed that when
angle C was increased, FKBI failure and procedural difficulty were
increased. A possible explanation of these findings is that the stent
strut cell at the SB ostium is relatively narrowed in patients with wider angle C and advancement of the balloon into the SB is extremely
difficult. However, patients with lower angle C have relatively larger
strut cells at the SB ostium with easier advancement of balloons into
the SB to facilitate FKBI (Figure 1).
The Journal of Invasive Cardiology®
Main Vessel Angle in Mini-Crush Stenting
Table 2. Angiographic and procedural characteristics of groups.
FKBI Group
(n = 153)
Non-FKBI
Group (n = 20)
Lesion location
P
.4
LAD-D
141 (92.2%)
18 (90.0%)
CX-OM
10 (6.5%)
2 (10.0%)
Right coronary artery
2 (1.3%)
0 (0.0%)
2 (1.3%)
1 (5.0%)
.8
22 (14.5%)
7 (35.0%)
.04
154.3 ± 14.2
130.7 ± 16.4
<.001
Lesion characteristics
Restenosis
Calcification
Bifurcation angles
Angle A
Angle B
57.3 ± 10.0
54.4 ± 11.3
.2
Angle C
148.4 ± 14.7
175.0 ± 10.3
<.001
Predilatation
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35 (22.9%)
6 (30.0%)
.5
Side branch
28 (18.3%)
4 (20.0%)
.9
C
Main vessel
Main-vessel stent type
.8
Liberte
32 (20.9%)
5 (25.0%)
Endeavor
24 (15.7%)
3 (15.0%)
Coraxel
21 (13.7%)
4 (20.0%)
Coracto
39 (25.5%)
3 (15.0%)
Xience V
22 (14.4%)
2 (10.0%)
Promus
15 (9.8%)
3 (15.0%)
Side-branch stent type
.6
Liberté
40 (26.1%)
6 (30.0%)
Endeavor
26 (17.0%)
2 (10.0%)
Coraxel
27 (17.6%)
4 (20.0%)
Coracto
29 (19.0%)
2 (10.0%)
Xience V
17 (11.1%)
2 (10.0%)
Promus
14 (9.2%)
4 (20.0%)
Main vessel
3.37 ± 0.42
3.16 ± 0.41
.04
Side branch
2.78 ± 0.36
2.75 ± 0.23
.5
Main vessel
19.6 ± 5.4
21.9 ± 5.4
.08
Side branch
15.3 ± 5.3
17.2 ± 5.4
.1
Procedural time (min)
27.9 ± 11.1
65.0 ± 9.5
<.001
Contrast volume (mL)
120.7 ± 34.4
204.0 ± 38.2
<.001
Stent diameter (mm)
Stent length (mm)
FKBI = final kissing-balloon inflation; LAD-D = left anterior descending artery and
diagonal branch; CX-OM = circumflex coronary artery and obtuse marginal branch.
It has been reported that another possible reason for FKBI
failure in crush stenting is a long main-vessel stent, which can
have a higher probability for malapposition, resulting in the incorrect advancement of the guidewire.18 In this study, we could
Vol. 25, No. 3, March 2013
not see any relationship between main-vessel stent length and
FKBI failure. We think that usage of POT in patients with
FKBI failure has decreased malapposition in the bifurcation
region. In addition, we found a weak correlation between
FKBI failure and both stent diameter in the main vessel and
lesion calcification on univariate analysis. However, multivariate logistic regression analysis showed that only angle C
was an independent predictor of FKBI failure.
It is well known that bifurcation treatment with two
stenting techniques modifies bifurcation angle19-21 and that
modification may influence FKBI performance.22 Importantly, Godino et al19 reported that change in bifurcation angle is
most pronounced after the crush stenting technique. Interestingly, they found no significant difference comparing angle C at baseline and after stenting.19 This angle appears to be
the least affected by the different types of stenting technique.
In this study, we measured bifurcation angle only before PCI
without the guidewires in place and found that only angle C
was an independent predictor of FKBI failure.
Stent design is another factor that may potentially affect
FKBI performance. Open-cell stent designs with a large cell
size should be used in the treatment of coronary bifurcation
lesions. When the cell size is large, the access to the SB is facilitated. Maximal achievable cell diameters of the studied stent
designs differ considerably, with values varying between 3.0
and 6.3 mm.23 These stent cell sizes play an important role
during coronary bifurcation treatment.24,25 All of the stents
used in this study were open-cell design with large cell size. In
addition, stent types were similar in the FKBI and non-FKBI
groups. Furthermore, the patients who were divided into three
groups according to angle C tertile also had similar stent types.
Impact of bifurcation angles on outcomes. It has been
known that angle A has an influence on the accessibility of
the SB, which is frequently the main reason for selecting a
double-stent technique, and that angle B has an impact on
the risk of SB occlusion during main-vessel stenting. This
angle appears to be the most influenced by the choice of bifurcation stenting technique.19 Our study suggests that angle
C is related to the success rate of FKBI when using the minicrush stent technique.
Study limitations. We studied the effect of angle C on
procedure success only in patients who underwent minicrush stenting. It can be further investigated in other bifurcation techniques, such as culotte stenting or provisional
stenting. In this study, we showed the effect of angle C on
the success rate of FKBI during mini-crush stenting. The relationship between angle C and long-term clinical outcomes
must be investigated by further research.
Conclusions
In this study, we found that angle C was the only independent predictor of FKBI failure in patients who underwent
mini-crush stenting. Patients with lower angle C have relatively larger strut cells at the SB ostium with easier advancement of balloons into the SB to facilitate FKBI. Increased angle
C is associated with difficulty of procedure, FKBI failure, more
procedure time, and more contrast used.
121
ELBASAN, et al.
6. Chue CD, Routledge HC, Ludman PF, et al. 3-year
follow-up of 100 consecutive coronary bifurcation
lesions treated with Taxus stents and the crush techAngle Clow
Angle Cmid
Angle Chigh
P
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(n = 57)
(n = 59)
(n = 57)
7. Galassi AR, Tomasello SD, Capodanno D, Barrano
Lesion location
.2
G, Ussia GP, Tamburino C. Mini-crush versus Tprovisional techniques in bifurcation lesions: clinical
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54 (94.7%) 55 (93.2%) 50 (87.7%)
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CX-OM
3 (5.3%)
4 (6.8%)
5 (8.8%)
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Right coronary artery
0 (0.0%)
0 (0.0%)
2 (3.5%)
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Bifurcation angles
of drug-eluting stents with the “mini-crush technique.”
Catheter Cardiovasc Interv. 2007;69(7):976-983.
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165.6 ± 6.2 153.5 ± 10.2 135.6 ± 14.3 <.001
9. Schlundt C, Kreft JG, Fuchs F, Achenbach S, Daniel
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61.5 ± 6.8
55.3 ± 10.1 54.1 ± 11.4
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WG, Ludwig J. Three-dimensional on-line reconstruction of coronary bifurcated lesions to optimize
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132.8 ± 6.1 151.2 ± 5.1 170.3 ± 8.3 <.001
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Main-vessel stent type
.6
10. Gollapudi RR, Valencia R, Lee SS, Wong GB, Teirstein
Liberté
13 (22.8%) 11 (18.6%) 13 (22.8%)
PS, Price MJ. Utility of three-dimensional reconstruction of coronary angiography to guide percutaneous
Endeavor
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8 (13.6%)
9 (15.8%)
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2007;69(4):479-482.
Coraxel
9 (15.8%)
7 (11.9%)
9 (15.8%)
11. Louvard Y, Thomas M, Dzavik V, et al. Classification of coronary artery bifurcation lesions and treatCoracto
17 (29.8%) 12 (20.3%) 13 (22.8%)
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Xience V
4 (7.0%)
11 (18.6%)
9 (15.8%)
2008;71(2):175-183.
12. Ge L, Iakovou I, Cosgrave J, et al. Treatment of bifurPromus
4 (7.0%)
10 (16.9%)
4 (7.0%)
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and clinical follow up of crush versus T stenting. Heart.
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12 (21.1%) 16 (27.1%) 18 (31.6%)
13. Colombo A, Stankovic G, Orlic D, et al. Modified
T-stenting technique with crushing for bifurcation leEndeavor
7 (12.3%)
13 (22.0%)
8 (14.0%)
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8 (13.6%)
10 (17.5%)
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8 (13.6%)
9 (15.8%)
2005;6(6):475-488.
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5 (8.8%)
8 (13.6%)
6 (10.5%)
graphic outcome after implantation of drug-eluting
stents in bifurcation lesions with the crush stent techPromus
6 (10.5%)
6 (10.2%)
6 (10.5%)
nique: importance of final kissing balloon post-dilaMain-vessel stent diameter (mm)
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.7
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2.78 ± 0.40 2.78 ± 0.36 2.78 ± 0.29
.9
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19.8 ± 4.8
20.7 ± 5.7
.2
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Side-branch stent length (mm)
15.0 ± 5.9
15.3 ± 4.7
16.1 ± 5.4
.5
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long-term outcome after crush stenting of coronary biFKBI
57 (100.0%) 57 (96.6%) 39 (68.4%) <.001
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Procedural time (min)
19.8 ± 4.7
29.3 ± 9.9
47.4 ±16.9 <.001
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Contrast volume (mL)
96.2 ± 10.7 137.9 ± 45.1 156.5 ± 41.6 <.001
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an intravascular ultrasound analysis. J Am Coll Cardiol.
LAD-D = left anterior descending artery and diagonal branch; CX-OM = circumflex coronary artery
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Table 3. Angiographic and procedural characteristics of the patient groups.
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References
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