The clinical outcome of percutaneous treatment of

Clinical research
European Heart Journal (2007) 28, 433–442
doi:10.1093/eurheartj/ehl539
Interventional cardiology
The clinical outcome of percutaneous treatment of
bifurcation lesions in multivessel coronary artery
disease with the sirolimus-eluting stent: insights
from the Arterial Revascularization Therapies
Study part II (ARTS II)
`vre3, Keith G. Oldroyd4, Victor Guetta5,
Keiichi Tsuchida1, Antonio Colombo2, Thierry Lefe
6
7
Giulio Guagliumi , Wolfgang von Scheidt , Witold Ruzyllo8, Christian W. Hamm9, Marco Bressers10,
Hans-Peter Stoll11, Kristel Wittebols11, Dennis J. Donohoe11, and Patrick W. Serruys1*
1
Thoraxcenter, Ba 583, Erasmus Medical Center, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands; 2EMO Centro
Cuore Columbus and San Raffaele Hospital, Milan, Italy; 3Institut Cardiovasculaire Paris Sud, Massy, France; 4Lanarkshire
Acute Hospitals, Glasgow, UK; 5Chaim Sheba Medical Center, Tel Hashomer, Israel; 6Azienda Ospedaliera Ospedali Riunitit di
Bergamo, Bergamo, Italy; 7Klinikum Augsburg, Augsburg, Germany; 8Institute of Cardiology Warsaw, Warsaw, Poland;
9
Kerckhoff Klinik, Kardiologie, Bad Nauheim, Germany; 10Cardialysis, B.V., Rotterdam, The Netherlands; and 11Cordis
Corporation, Miami Lakes, FL, USA
See page 383 for the editorial comment on this article (doi:10.1093/eurheartj/ehl252)
KEYWORDS
Bifurcation lesion;
Multivessel disease;
Stent;
Sirolimus;
Multicentre trial
Aims Little is known about the impact of treating bifurcations on the overall outcome of multivessel
coronary artery disease treated with stenting. This analysis was made to investigate the 1 year clinical
outcome of the treatment of bifurcation lesions using sirolimus-eluting stents (SES) in patients with
multivessel disease.
Methods and results Among a total of 607 patients (2160 lesions) in the Arterial Revascularization
Therapies Study part II (ARTS II), there were 324 patients in whom at least one bifurcation lesion was
treated (465 lesions). Patients with bifurcations were compared with those without bifurcations in
terms of baseline characteristics and major adverse cardiac and cerebrovascular events (MACCE).
Patients with ‘true’ (200 patients) vs. ‘partial’ bifurcations (124 patients) and usage of a one- (263
patients) vs. two-stent strategy (61 patients) were also evaluated. The bifurcation group was associated
with more complex lesion and procedural characteristics than the non-bifurcation group. However,
there was no significant difference in 1 year MACCE rates between the bifurcation group and the
non-bifurcation group (13.3 vs. 11.0%, P ¼ 0.46). MACCE in patients with true bifurcations was 13.0
vs. 13.7% for partial bifurcations (P ¼ 0.87) and 14.1 vs. 9.8% for one- vs. two-stent strategy (P ¼ 0.53).
Conclusions In this trial without angiographic follow-up, the presence of bifurcations did not affect 1
year outcomes after SES implantation. The outcomes in true vs. partial bifurcations and using one vs.
two stents were similar when the treatment strategies were left to the operator’s discretion.
Introduction
Percutaneous coronary intervention (PCI) in bifurcation
lesions remains problematic. Even in the modern era of
PCI with stent implantation, treatment of bifurcations is
hampered by a higher event rate1–3 and requires longer
procedure time, more radiation exposure, and higher
volumes of contrast material4 compared with non-bifurcation
lesions. The interventional approach is more complicated and
may include initial adjunctive debulking, double guidewire
* Corresponding author. Tel: þ31 10 463 5260; fax: þ31 10 436 9154.
E-mail address: [email protected]
placement, re-crossing of stent struts towards the side
branch (SB), and final kissing balloon inflation. Therefore, in
the treatment of multivessel disease, bifurcation lesions can
become a crucial obstacle to complete revascularization,
with a potentially negative impact on long-term outcomes.
Numerous pivotal randomized trials have now shown that
PCI using drug-eluting stents (DES) significantly reduces the
need for repeat revascularization in patients with coronary
artery disease.5–8 The efficacy of sirolimus-eluting stents
(SES) in multivessel disease9,10 and bifurcation lesions11,12
has recently been reported. Nevertheless, these trials
have focused on the treatment of single-discrete lesions
& The European Society of Cardiology 2007. All rights reserved. For Permissions, please e-mail: [email protected]
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Received 15 May 2006; revised 13 January 2007; accepted 22 January 2007; online publish-ahead-of-print 31 January 2007
434
with relatively simple morphology.5–7 In spite of this recent
progress, the presence of bifurcation lesions in multivessel
disease may still be seen as a reason to prefer surgical revascularization. Interestingly, a retrospective angiographic
analysis of 158 coronary bypass operations revealed that
multivessel stenting would have been technically feasible
in 77 (49%) of patients with bifurcation lesions.13 However,
the practical impact of DES utilization on bifurcation
lesions in patients with multivessel disease has not been
assessed.
The objective of the analysis of the Arterial Revascularization Therapies Study part II (ARTS II)14,15 was to investigate
the 1 year clinical outcome of patients with bifurcation
lesions treated with SES and to compare it with the
outcome of non-bifurcation lesions, without having mandated or pre-specified a particular treatment strategy.
Methods
Patient population
stenosis involving a main branch (MB) and/or contiguous SB with a
diameter of 2.0 mm by visual estimate. An SB was required to
be within a distance that was less than three times the diameter
of the reference vessel of the SB measured from the branching
point. ‘True’ bifurcation lesions were defined as lesions with significant stenoses present in both the MB and the ostium of the SB.
‘Partial’ bifurcation lesions were defined as lesions in which a
branch vessel did not have significant ostial stenosis. The SYNTAX
Score was used to classify the lesions in more detail (Figure 1).16
Both the MB and the SB needed to have at least a Thrombolysis in
Myocardial Infarction (TIMI) flow grade 1 pre-procedure. A total of
324 patients with 465 bifurcation lesions met the criteria for
inclusion in this analysis (210 patients with one bifurcation lesion;
114 patients with two or more bifurcation lesions) and were compared with the remaining 283 patients without bifurcations. We
also analysed two additional subgroups on the basis of lesion morphology and stenting strategy and compared (i) 200 patients with
at least one true bifurcation vs. 124 with only partial bifurcations
and (ii) 263 patients treated with a one-stent strategy (stenting
only MB or SB) in any of the bifurcations vs. 61 treated with a
two-stent strategy (stenting in both branches) in at least one of
the bifurcations.
Procedure
All the lesions were treated with an SES (Cypherw; Cordis Corp.,
Johnson & Johnson, Warren, NJ, USA) with a diameter of 2.5–
3.5 mm and a length of 13–33 mm, without restriction on the
total length of stents implanted in an overlapping manner. The
decision to choose a specific strategy of stent implantation in
the bifurcation lesions was left to the operators’ discretion:
one-stent strategy, or two-stent strategy using any of the four
main techniques (T-, V-, culotte-, and crush-stenting techniques).17,18 Recommendations concerning the antiplatelet
regimen have been described previously.14,15
Angiographic analysis of bifurcation lesions
The following baseline lesion and procedural characteristics were
evaluated by angiography: plaque distribution; take-off angle of
the SB; stenting techniques; significant stenosis (50% diameter stenosis) remaining in the SB left post-procedure in true bifurcations;
Figure 1 SYNTAX Score bifurcation classification. Type A, pre-branch stenosis not involving the ostium of the SB; type B, post-SB stenosis of the main vessel not
involving the origin of the SB; type C, stenosis encompassing the SB but not involving its ostium; type D, stenosis involving the main vessel and ostium of the SB;
type E, stenosis involving only the ostium of the SB; type F, stenosis directly involving the main vessel (pre-SB) and the ostium of the SB; and type G, stenosis
directly involving the main vessel (post-SB) and the ostium of the SB.
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Principal inclusion and exclusion criteria of the ARTS II study have
been described previously.14,15 Clinical manifestations of coronary
artery disease were stable angina (Canadian Cardiovascular
Society class I, II, III, or IV), unstable angina (Braunwald class IB,
IC, IIB, IIC, IIIB, or IIIC), or silent myocardial ischaemia.14,15 Patients
were required to have multivessel disease, with a need for treatment of the left anterior descending (LAD) artery and at least one
other significant lesion (.50% diameter stenosis by visual estimate)
in another major epicardial coronary artery.14,15 Patients with any
previous coronary intervention, left main coronary disease, overt
congestive heart failure, or a left ventricular ejection fraction of
,30% were excluded. A total of 607 patients with 2160 lesions
were treated with SES. The patient selection and recruitment procedures and associated patient numbers were described in the
main manuscript.15 All 607 patients gave written informed
consent. Of these patients, 602 were treated with PCI, and the
remaining five patients underwent bypass surgery. Finally, 1 year
follow-up analyses were performed in 601 patients (99.0%). In this
analysis, bifurcation lesions were defined as a lesion 50% diameter
K. Tsuchida et al.
Multivessel stenting and bifurcation lesions
435
Table 1 Baseline patient demographics and clinical characteristics (n ¼ 607 patients) of the non-bifurcation group and the bifurcation
group
Variables
Non-bifurcation (n ¼ 283)
Bifurcation (n ¼ 324)
P-value
Age, years
Body mass index, kg/m2
Male, % (n)
Diabetes mellitus, % (n)
Hypertension, % (n)
Hypercholesterolaemia, % (n)
History of cerebrovascular accident
Family history of MI/sudden death ,55 years, % (n)
Peripheral vascular disease, % (n)
Previous MI, % (n)
Previous PCI, % (n)
Previous carotid surgery, % (n)
Chronic obstructive pulmonary disease, % (n)
Smoking history, % (n)
Previous
Current
Unstable angina, % (n)
Stable angina, % (n)
Silent ischaemia, % (n)
62.5 + 9.9
27.5 + 4.0
76.7 (217/283)
24.4 (69/283)
65.0 (184/283)
73.1 (207/283)
1.1 (3/283)
31.0 (87/281)
8.5 (24/283)
36.0 (102/283)
0.7 (2/283)
0.7 (2/283)
4.9 (14/283)
63.2 + 9.5
27.5 + 4.2
76.5 (248/324)
27.8 (90/324)
69.1 (224/324)
74.5 (240/322)
0.6 (2/323)
40.2 (130/323)
5.6 (18/323)
33.0 (107/324)
0.3 (1/324)
1.9 (6/323)
2.5 (8/323)
0.37
0.90
1.00
0.36
0.30
0.71
0.67
0.022
0.20
0.44
0.60
0.29
0.13
42.4
21.6
38.5
50.5
11.0
39.5 (128/324)
17.3 (56/324)
34.6 (112/324)
55.6 (180/324)
9.9 (32/324)
0.51
0.22
0.35
0.22
0.69
(120/283)
(61/283)
(109/283)
(143/283)
(31/283)
CABG, coronary artery bypass graft; MI, myocardial infarction.
Variables
Angiographic characteristics
Number of vessels with a lesion .50% DS
Number of lesions .50% DS
Ejection fraction, %
Vessel territory with stenosis, % (n)
RCA
LAD
LCX
Diffuse lesion (lesion length .20 mm), % (n)
Small vessels (1.5 mm and ,2.5 mm), % (n)
Lesion angulation, % (n)
Moderate
Severe
Irregular contour, % (n)
Ostial lesion, % (n)
Calcification: moderate to heavy, % (n)
Thrombus containing lesions, % (n)
Chronic total occlusion, % (n)
Lesion classification, % (n)
Type A
Type B1
Type B2
Type C
Procedural characteristics
Post-procedural hospital stay, days
Duration of procedure, min
Number of stents implanted
Number of stented lesions
Average stent length, mm
Total stent length, mm
Usage of glycoprotein IIb/IIIa inhibitor, %
Total number of bifurcation lesions
LCX, left circumflex; RCA, right coronary artery.
Non-bifurcation (283 patients,
909 lesions)
Bifurcation (324 patients,
1251 lesions)
P-value
2.5 + 0.5
3.2 + 1.2
59.4 + 11.7
2.6 + 0.5
3.9 + 1.2
60.9 + 11.5
0.008
,0.001
0.15
30.9 (281/909)
40.5 (368/909)
28.6 (260/909)
8.7 (75/867)
7.0 (64/909)
27.7
42.3
30.0
14.2
10.8
(347/1251)
(529/1251)
(375/1251)
(170/1199)
(135/1251)
0.11
0.43
0.50
,0.001
0.003
10.5 (91/867)
0.1 (1/867)
9.0 (78/864)
4.6 (40/866)
32.6 (282/865)
0.7 (6/878)
3.1 (28/900)
12.3 (147/1197)
0.1 (1/1197)
8.1 (97/1191)
4.1 (49/1199)
30.1 (361/1198)
0.4 (5/1221)
1.8 (22/1239)
0.24
1.00
0.52
0.58
0.25
0.54
0.058
8.1 (73/900)
26.8 (241/900)
53.6 (482/900)
11.6 (104/900)
5.9 (73/1239)
20.9 (259/1239)
57.6 (714/1239)
15.6 (193/1239)
0.046
0.002
0.06
0.008
3.5 + 3.2
76.5 + 41.3
3.3 + 1.4
2.9 + 1.1
19.2 + 3.5
64.1 + 27.0
27.6
—
3.3 + 2.1
92.6 + 43.5
4.0 + 1.6
3.4 + 1.1
19.8 + 3.5
79.7 + 34.3
36.7
465
0.50
,0.001
,0.001
,0.001
0.024
,0.001
0.019
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Table 2 Baseline lesion and procedural characteristics (n ¼ 607 patients) of the non-bifurcation group and the bifurcation group
436
K. Tsuchida et al.
significant plaque shift (50% diameter stenosis) into the SB (or MB)
in partial bifurcations; final kissing balloon inflation; angiographic
success in lesion, MB, as well as SB; persistent major dissection in
SB after procedure; and final TIMI flow grade in SB.
Plaque distribution was described on the basis of SYNTAX Score
bifurcation lesion types.16 Take-off angle of SB was measured as
the angle between MB distal to the branching point and SB by
visual assessment in a non-foreshortened projection (Figure 1). Significant plaque shift was defined as 50% diameter stenosis in ostia
of SBs (or MBs) subsequent to stenting in partial bifurcations. Angiographic success was defined as a residual stenosis of ,50% of the
luminal diameter by visual assessment with TIMI 3 flow in the MB,
SB, or lesion (both branches).
Endpoints and clinical definitions
Statistical analysis
Patients with bifurcation lesions (bifurcation group) were compared
with those without bifurcation lesions (non-bifurcation group) with
respect to clinical, lesion, and procedural characteristics, as well
as the freedom from MACCE. Additional subgroup comparisons
were also performed between patients with true vs. partial bifurcations and between patients treated with the one-stent vs.
two-stent strategy. Continuous variables were expressed as
mean + SD. Categorical variables were presented as frequency
(%). Patient demographics and procedural characteristics of the
groups were compared with the Student’s t-test and with the x2
test or the Fisher’s exact test for categorical variables. Kaplan–
Meier analyses and survival rates between groups were compared
using the log-rank test. A two-sided P-value , 0.05 was considered
statistically significant. Analyses were performed using SAS version
8.02 (SAS Institute, Inc., Cary, NC, USA).
Results
Baseline patient demographics and clinical
characteristics: the non-bifurcation group vs. the
bifurcation group
Table 1 shows the patient baseline demographics and clinical
characteristics of the non-bifurcation and the bifurcation
groups. None of the clinical characteristics except for
family history differed between the non-bifurcation and
the bifurcation groups.
Table 3 Clinical endpoints and stent thrombosis at 30 days and 1 year: the non-bifurcation group vs. the bifurcation group
Variables
Thirty day outcome, % (n)
Death
CVA
Non-fatal MI
Q-wave MI
Non Q-wave MI
Death/CVA/MI
Revascularization
CABG
PCI
MACCE
Stent thrombosis
One year outcome
Death
CVA
Non-fatal MI
Q-wave MI
Non-Q-wave MI
Death/CVA/MI
Revascularization
CABG
PCI
MACCE
Stent thrombosis
CVA, cerebrovascular accident.
Non-bifurcation (n ¼ 283 patients)
Bifurcation (n ¼ 324 patients)
P-value
0.0 (0/283)
0.0 (0/283)
2.5 (7/283)
0.7 (2/283)
2.1 (6/283)
2.5 (7/283)
2.5 (7/283)
2.1 (6/283)
0.4 (1/283)
4.2 (12/283)
0.4 (1/283)
0.0 (0/324)
0.3 (1/324)
5.2 (17/324)
0.9 (3/324)
4.3 (14/324)
5.6 (18/324)
2.5 (8/324)
0.6 (2/324)
1.9 (6/324)
6.2 (20/324)
1.2 (4/324)
1.00
0.10
1.00
0.17
0.07
1.00
0.15
0.13
0.36
0.38
1.1 (3/283)
0.7 (2/283)
2.8 (8/283)
0.7 (2/283)
2.5 (7/283)
4.2 (12/283)
7.8 (22/283)
2.8 (8/283)
4.9 (14/283)
11.0 (31/283)
0.7 (2/283)
0.9 (3/324)
0.9 (3/324)
5.9 (19/324)
0.9 (3/324)
4.9 (16/324)
7.1 (23/324)
9.0 (29/324)
1.5 (5/324)
7.7 (25/324)
13.3 (43/324)
1.5 (5/324)
1.00
1.00
0.08
1.00
0.14
0.16
0.66
0.40
0.19
0.46
0.46
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The primary endpoint of this analysis was freedom from any major
adverse cardiac and cerebrovascular event (MACCE) at 30 days
and 1 year, defined as death from any cause, cerebrovascular accident, documented non-fatal myocardial infarction, and any revascularization by percutaneous intervention or surgery after the
index procedure. Because this analysis does not compare patients
undergoing PCI using SES (ARTS II) with the historical surgical
cohort in ARTS I,15,19 the incidence of myocardial infarction was
determined as follows: in the first 7 days after the intervention, a
definite diagnosis of myocardial infarction was made if there was
documentation of new abnormal Q-waves (according to the Minnesota code) and either a ratio of serum creatine kinase MB (CK-MB)
isoenzyme to total cardiac enzyme that was greater than 0.1 or a
CK or CK-MB value that was three times the upper limit of
normal,20 whereas five times the upper limit of normal was used
as the diagnostic threshold in the main report of this study14,15,19
to enable comparison with the surgical cohort. Serum CK and
CK-MB isoenzyme concentrations were measured 6, 12, and 18 h
after the intervention. Apart from MACCE, we reported the
occurrence of stent thrombosis at bifurcation lesions, which was
defined as either angiographic documentation of a complete
occlusion (TIMI flow 0 or 1) or angiographic documentation of a
flow-limiting thrombus (TIMI flow 1 or 2). Stent thrombosis was
categorized depending on the timing of occurrence into acute
(peri-procedure), subacute (post-procedure to 30 days), and late
(.30 days).
Multivessel stenting and bifurcation lesions
437
Overall lesion and procedural characteristics: the
non-bifurcation group vs. the bifurcation group
The bifurcation group had more extensive disease and more
complex lesion characteristics compared with the nonbifurcation group [diffuse lesion, P , 0.001 (95% CI 2.8–8.2);
type C lesion, P ¼ 0.008 (95% CI 1.1–6.9)] (Table 2). There
was a concomitant increase in procedural complexity in the
bifurcation group as reflected by a higher number of stents
implanted [P , 0.001 (95% CI 0.5–1.0)], longer total stent
length per patient [P , 0.001 (95% CI 10.5–20.6)], or longer
procedural time [P , 0.001 (95% CI 9.4–23.0)] (Table 2).
Thirty day and 1 year outcomes and incidence of
stent thrombosis: the non-bifurcations vs. the
bifurcations
MACCE and the incidence of stent thrombosis at 30 days and
at 1 year are shown in Table 3. The MACCE rate at each time
point was not significantly different between the bifurcation
group and the non-bifurcation group (6.2 vs. 4.2% at 30 days,
P ¼ 0.36; 13.3 vs. 11.0% at 1 year, P ¼ 0.46).
Five stent thromboses (subacute four and late one)
occurred in the bifurcation group vs. two (one subacute
and one late) in the non-bifurcation group up to 1 year.
Among the five events in the bifurcation group, four subacute thromboses (two patients on day 1; one on day 22;
one on day 28) were related to bifurcation lesions and one
late thrombosis developed in a non-bifurcation lesion. Of
these four bifurcation lesions, three were stented only in
the MB. The remaining one stent thrombosis was associated
with a lesion treated with stenting in both the LAD artery
and the diagonal branch (provisional T-stenting without
kissing balloon inflation). One patient who had never been
placed on aspirin therapy developed subacute thrombosis
22 days after the index PCI.
Baseline and procedural characteristics: true vs.
partial bifurcations and one-stent vs. two-stent
strategy
In terms of patient characteristics, only hypertension was
significantly more frequent in patients with true vs. partial
Table 4 Baseline lesion and procedural characteristics: true or partial bifurcation and one- or two-stent strategy
Variables
a
Partial
bifurcation
(124 patients)b
62.9 + 9.0
77.5 (5/200)
27.0 (54/200)
73.5 (147/200)
77.4 (154/199)
40.7 (81/199)
63.6 + 10.2
75.0 (93/124)
29.0 (36/124)
62.1 (77/124)
69.9 (86/123)
39.5 (49/124)
0.49
0.69
0.70
0.036
0.15
0.91
63.2 + 9.6
76.4 (201/263)
28.9 (76/263)
67.7 (178/263)
72.4 (189/261)
38.5 (101/261)
63.0 + 9.1
77.0 (47/61)
23.0 (14/61)
75.4 (46/61)
83.6 (51/61)
47.5 (29/61)
0.87
1.00
0.43
0.28
0.07
0.25
34.0 (68/200)
19.0 (38/200)
33.0 (66/200)
57.0 (114/200)
10.0 (20/200)
31.5 (39/124)
14.5 (18/124)
37.1 (46/124)
53.2 (66/124)
9.7 (12/124)
0.72
0.36
0.47
0.57
1.00
33.5 (88/263)
17.1 (45/263)
36.5 (96/263)
53.2 (140/263)
10.3 (27/263)
31.1 (19/61)
18.0 (11/61)
26.2 (16/61)
65.6 (40/61)
8.2 (5/61)
0.76
0.85
0.14
0.09
0.81
264
4.3 + 1.4
0.001
810
4.1 + 1.3
441
3.6 + 1.1
P-value
,0.001
987
3.8 + 1.2
Two-stent
strategy (n ¼ 61
patients)d
P-value
25.9 (210/810)
43.7 (354/810)
30.4 (246/810)
31.1 (137/441)
39.7 (175/441)
29.3 (129/441)
0.055
0.19
0.70
28.7 (283/987)
41.7 (412/987)
29.6 (292/987)
24.2 (64/264)
44.3 (117/264)
31.4 (83/264)
0.16
0.48
0.60
6.1 (49/801)
20.8 (167/801)
57.1 (457/801)
16.0 (128/801)
96.0 + 44.0
4.1 + 1.6
3.6 + 1.2
81.9 + 34.5
36.0
5.5 (24/438)
21.0 (92/438)
58.7 (257/438)
14.8 (65/438)
87.3 + 42.5
3.8 + 1.5
3.2 + 1.0
76.1 + 33.9
37.9
0.71
0.94
0.59
0.62
0.08
0.08
0.002
81.9 + 34.5
36.0
5.8 (57/979)
21.0 (206/979)
57.1 (559/979)
16.0 (157/979)
86.1 + 38.2
3.7 + 1.3
3.2 + 1.0
74.3 + 30.0
34.6
6.2 (16/260)
20.4 (53/260)
59.6 (155/260)
13.8 (36/260)
121.1 + 53.4
5.3 + 1.9
4.2 + 1.3
102.5 + 42.1
45.9
0.88
0.86
0.48
0.44
,0.001
,0.001
,0.001
,0.001
0.11
Patients with at least one true bifurcation lesion.
Patients with only partial bifurcation lesions.
c
Patients whose bifurcation lesions treated only with one-stent strategy.
d
Patients whose at least one of the bifurcation lesions treated with two-stent strategy.
b
One-stent
strategy (n ¼ 263
patients)c
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Baseline patient characteristics
Age, years
Male, % (n)
Diabetes mellitus, % (n)
Hypertension, % (n)
Hypercholesterolaemia, % (n)
Family history of MI/sudden
death , 55 years, % (n)
Previous MI, % (n)
Current smoking, % (n)
Unstable angina, % (n)
Stable angina
Silent ischaemia, % (n)
Lesion and procedural
characteristics
Number of overall lesions
Number of lesions . 50% DS
Vessel territory with stenosis,
% (n)
RCA
LAD
LCX
Lesion classification, % (n)
Type A
Type B1
Type B2
Type C
Duration of procedure, min
Number of stents implanted
Number of stented lesions
Total stent length, mm
Usage of glycoprotein IIb/IIIa
inhibitor, %
True
bifurcation
(200 patients)a
438
K. Tsuchida et al.
bifurcations (Table 4). Patients with true bifurcations and
two-stent strategy also had a significantly higher number
of lesions than the corresponding companion subgroup.
Patients treated with two-stent strategy had more
complex procedural characteristics with longer procedural
time, a higher number and longer length of stents used
than those with one stent (P , 0.001). The procedural
characteristics did not differ between patients with true
or partial bifurcations except for the number of stented
lesions (3.6 vs. 3.2, P ¼ 0.002) (Table 4).
two-stent strategy and final kissing balloon, are described
in Figure 2.
The angiographic success (,50% residual stenosis) of the
MB was 98.1% (456/465), whereas the SB angiographic
success rate was only 51.2% (238/465). Nevertheless,
the final patency of the SB with TIMI 3 flow was 92.9% (432/
465). In the non-true bifurcations (types A, B, C, and E,
Figure 1), significant narrowing of the SB was present after
the procedure in 28.5% (63/221), whereas the percentage
was 64.3% (157/244) in the SB of true bifurcations.
Thirty day and 1 year outcome: true vs. partial
bifurcations and one-stent vs. two-stent strategy
Discussion
There was no difference in any of the endpoints that were
evaluated between the two groups, including stent thrombosis (Table 5).
Lesion and procedural demographics of 465
bifurcation lesions
Bifurcation lesions in multivessel disease
The expanded use of PCI to multivessel disease has raised
the issue of how to handle complex lesions in terms of complete revascularization. The restenosis risk of patients with
Table 5 Clinical endpoints and stent thrombosis at 30 days and 1 year: true or partial bifurcation and one- or two-stent strategy
True bifurcation
(n ¼ 200 patients)a
Thirty day outcome,
% (n)
Death
CVA
Non-fatal MI
Q-wave MI
Non-Q-wave MI
Death/CVA/MI
Revascularization
CABG
PCI
MACCE
Stent thrombosis
One year outcome,
% (n)
Death
CVA
Non-fatal MI
Q-wave MI
Non-Q-wave MI
Death/CVA/MI
Revascularization
CABG
PCI
MACCE
Stent thrombosis
a
Partial bifurcation
(n ¼ 124 patients)b
P-value
Two-stent strategy (n ¼ 61)d
P-value
0.0 (0/200)
0.5 (1/200)
5.5 (11/200)
0.5 (1/200)
5.0 (10/200)
6.0 (12/200)
3.0 (6/200)
0.5 (1/200)
2.5 (5/200)
7.0 (14/200)
1.5 (3/200)
0.0 (0/124)
0.0 (0/124)
4.8 (6/124)
1.6 (2/124)
3.2 (4/124)
4.8 (6/124)
1.6 (2/124)
0.8 (1/124)
0.8 (1/124)
4.8 (6/124)
0.8 (1/124)
1.00
1.00
0.56
0.58
0.80
0.72
1.00
0.41
0.49
1.00
0.0
0.4
5.7
1.1
4.6
6.1
2.7
0.8
1.9
6.8
1.1
(0/263)
(1/263)
(15/263)
(3/263)
(12/263)
(16/263)
(7/263)
(2/263)
(5/263)
(18/263)
(3/263)
0.0
0.0
3.3
0.0
3.3
3.3
1.6
0.0
1.6
3.3
1.6
(0/61)
(0/61)
(2/61)
(0/61)
(2/61)
(2/61)
(1/61)
(0/61)
(1/61)
(2/61)
(1/61)
1.00
0.75
1.00
1.00
0.54
1.00
1.00
1.00
0.39
0.57
0.5 (1/200)
1.0 (2/200)
6.0 (12/200)
0.5 (1/200)
5.5 (11/200)
6.5 (13/200)
9.0 (18/200)
1.5 (3/200)
8.0 (16/200)
13.0 (26/200)
2.0 (4/200)
1.6 (2/124)
0.8 (1/124)
5.6 (7/124)
1.6 (2/124)
4.0 (5/124)
8.1 (10/124)
8.9 (11/124)
1.6 (2/124)
7.3 (9/124)
13.7 (17/124)
0.8 (1/124)
0.56
1.00
1.00
0.56
0.61
0.66
1.00
1.00
1.00
0.87
0.65
1.1
0.8
6.1
1.1
4.9
7.2
9.9
1.9
8.4
14.1
1.5
(3/263)
(2/263)
(16/263)
(3/263)
(13/263)
(19/263)
(26/263)
(5/263)
(22/263)
(37/263)
(4/263)
0.0
1.6
4.9
0.0
4.9
6.6
4.9
0.0
4.9
9.8
1.6
(0/61)
(1/61)
(3/61)
(0/61)
(3/61)
(4/61)
(3/61)
(0/61)
(3/61)
(6/61)
(1/61)
1.00
0.47
1.00
1.00
1.00
1.00
0.32
0.59
0.59
0.53
1.00
Patients with at least one true bifurcation lesion.
Patients with only non-true bifurcation lesions.
c
Patients whose bifurcation lesions treated only with one-stent strategy.
d
Patients whose at least one of the bifurcation lesions treated with two-stent strategy.
b
One-stent strategy
(n ¼ 263)c
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Table 6 summarizes lesion and procedural characteristics of
the 465 bifurcation lesions. Figure 2 delineates the profile of
the 465 lesions. Lesions located in the LAD/diagonal branching point were the most frequent. True bifurcations (types
D, F, and G, Figure 1) accounted for 52.5% (244/465).
Overall, a double guidewire technique was used in 39.8%
(185/465), whereas in true bifurcations, the use was 53.7%
(131/244). The other technical aspects, such as the use of
The main findings of this analysis are (i) SES implantation to
treat bifurcation lesions in patients with multivessel disease
yields similar outcomes as in those with non-bifurcation
lesions; (ii) there is no difference in outcome between
patients with true bifurcation lesions and partial bifurcation
lesions and in patients treated with a one-stent vs.
two-stent strategy; (iii) these excellent results were
obtained despite the fact that many SBs were left with a
significant narrowing at the end of the procedure.
Multivessel stenting and bifurcation lesions
439
Table 6 Lesion and procedural characteristics of bifurcation lesions
Variables
Repeat
revascularization
(n ¼ 28)
No repeat
revascularization
(n ¼ 437)
5.6 (26/465)
53.8 (250/465)
29.9 (139/465)
6.2 (29/465)
4.5 (21/465)
14.3 (4/28)
53.6 (15/28)
28.5 (8/28)
0
3.6 (1/28)
5.0 (22/437)
53.8 (235/437)
30.0 (131/437)
6.6 (29/437)
4.6 (20/437)
43.0 (200/465)
17.6 (82/465)
15.7 (73/465)
7.3 (34/465)
7.1 (33/465)
7.1 (33/465)
2.2 (10/465)
52.5 (244/465)
47.5 (221/465)
64.9 (302/465)
22.2 (103/465)
46.4 (13/28)
21.4 (6/28)
25.0 (7/28)
0
3.6 (1/28)
3.6 (1/28)
0
46.4 (13/28)
53.6 (15/28)
85.7 (24/28)
42.9 (12/28)
42.8 (187/437)
17.4 (76/437)
15.1 (66/437)
7.8 (34/437)
7.3 (32/437)
7.3 (32/437)
2.3 (10/437)
52.9 (231/437)
47.1 (206/437)
62.7 (274/437)
20.8 (91/437)
39.8 (185/465)
14.6 (68/465)
35.7 (10/28)
10.7 (3/28)
40.0 (175/437)
14.9 (65/437)
45.6 (31/68)
4.4 (3/68)
22.0 (15/68)
26.5 (18/68)
1.5 (1/68)
78.9 (367/465)
6.5 (30/465)
4
0
2
0
0
85.7 (24/28)
3.6 (1/28)
27
3
13
18
1
78.5 (343/437)
6.6 (29/437)
12.3 (57/465)
12.9 (60/465)
0.9 (4/465)
7.1 (2/28)
14.3 (4/28)
0
12.6 (55/437)
12.8 (56/437)
0.9 (4/437)
64.3 (157/244)
25.0 (7/28)
34.3 (150/437)
28.5 (63/221)
10.7 (3/28)
13.7 (60/437)
98.1 (456/465)
51.2 (238/465)
49.9 (232/465)
85.7 (24/28)
50.0 (14/28)
42.9 (12/28)
98.9 (432/437)
51.3 (224/437)
50.3 (220/437)
3.4 (16/465)
3.7 (17/465)
92.9 (432/465)
1.7 (8/465)
3.6 (1/28)
10.7 (3/28)
85.7 (24/28)
0
3.4 (15/437)
3.2 (14/437)
93.4 (408/437)
1.8 (8/437)
a
RCA with right ventricular branch, 8; LAD with major septal branch, 6; LAD with intermediate artery, 5; RCA with acute marginal branch, 2.
multivessel interventions is higher if a companion lesion
develops restenosis, regardless of the presence or absence
of conventional patient risk factors or lesion complexity.21
The existence of inter-lesion dependence for the risk of
restenosis in multilesion stenting has been hypothesized.21
However, the impact of bifurcation lesions in multivessel
intervention remains to be determined.
A few studies in the bare metal stent era demonstrated
that treatment of bifurcation lesions resulted in a lower
success rate and higher late adverse event rate than nonbifurcation lesions.1–3 However, these studies included not
only multivessel intervention but also single-vessel treatment (target lesion per patient, 1.4),2,3 and stents were
only used in 70% of patients.1–3 Because patients in the
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Baseline lesion characteristics, % (n)
Lesion location
LAD/left circumflex
LAD/diagonal
Left circumflex/marginal
Distal RCA
Othersa
Plaque distribution (SYNTAX Score class)
Type
D
B
C
G
A
E
F
True bifurcations (types D, F, and G)
Partial bifurcations (types A, B, C, and E)
Take-off angle of SB , 70 degree
Calcification: moderate to heavy
Procedural characteristics, % (n)
Double guidewires
Stenting in both the MB and the SB
Two-stent strategies
T-stenting
Culotte
V-stenting
Crush
Not classifiable
Stenting only in MB
Stenting only in SB
Post-dilatation technique
Kissing balloon inflation
Post-dilatation only in SB
Sequential dilatation of both branches
Post-procedural lesion characteristics, % (n)
Remaining significant stenosis of SB in true
bifurcations (types D, F, and G) after procedure
Remaining significant plaque shift into SB
(or MB) after stenting in MB (or SB) in partial bifurcations
(types A, B, C, and E) after procedure
Angiographic success in
MB
SB
Lesion
Final TIMI flow grade in SB
0 or 1
2
3
Major dissection in SB persisted after procedure
Bifurcation lesions
(n ¼ 465)
440
K. Tsuchida et al.
present study underwent multivessel treatment with SES as
a default strategy, these results may not be directly comparable with those of previous studies.1–3 Nevertheless, in the
light of the promising results from major randomized
trials,5,6 it could be hypothesized that the SES could potentially equalize the treatment risk between patients with
bifurcation lesions and those without bifurcation lesions.
Changing impact of bifurcation lesions in DES era
Our findings seem to contradict a number of prior
studies12,22–24 evaluating DES in bifurcation lesions where a
high target lesion revascularization (TLR) rate was found
for the SB and in many instances when two stents were
implanted. We believe that a number of the TLRs reported
in these studies12,22–24 were triggered by the stenoses
detected during protocol-mandated angiographic follow-up.
The ARTS I and ARTS II studies are clinical outcome trials
without any mandatory angiographic investigation at
follow-up, thereby reflecting the natural course of the
disease and its treatment and avoiding the so-called
‘oculo-stenotic reflex’, as illustrated in the BENESTENT II
trial.25 This reflex may be even more pronounced when
treating bifurcation lesions.2 The fact that residual stenoses
in the SB were left untreated and did not result in recurrent
angina or other clinical events at follow-up speaks to the
benign nature of these persisting SB stenoses. This view is
supported by the findings that only 51% of the SBs had an
optimal result after the procedure (Table 6). Moreover,
according to a fractional flow reserve analysis, it appears
that many of the SB lesions that seem to be angiographically
significant may not be haemodynamically significant.26 It is
also worth noting that our results were obtained with a conservative usage of a two-stent strategy, even in true bifurcations. We cannot ignore the fact that this approach
accepts a certain level of incomplete revascularization on
many SBs, which were probably correctly judged by the
interventionalists as being clinically unimportant, provided
that they showed TIMI 3 flow (92.9%) (Table 6). Therefore,
even the concept of ‘incomplete revascularization’ needs
to be revisited.
It is also worth noting that the threshold criteria for
enzyme elevation used to define non-Q-wave myocardial
infarction applied in this analysis, namely three times CK
or CKMB elevation, are similar to that used routinely in
other studies.22–24 However, it is more sensitive than five
times CK or CKMB elevation described in the ARTS I and II
original protocols14,15,19 that was used to enable comparison
of the results of PCI with surgery for multivessel disease.19
The occurrence of stent thrombosis did not differ between
the bifurcation and non-bifurcation groups. Three out of the
four bifurcation lesions that developed stent thrombosis had
a poor angiographic result at the end of the procedure (only
one bifurcation achieved lesion success). Recently, bifurcation lesions were reported as one of the independent predictors of stent thrombosis of DES.27,28 The relatively small
number of patients evaluated in this analysis and the low
overall frequency of thromboses in this study do not allow
for any definitive statement with respect to these observations by other investigators.
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Figure 2 Bifurcation lesion profile (n ¼ 465). Asterisk denotes SYNTAX Score lesion classification. KB, final kissing balloon inflation; Seq, sequential postdilatation of both the MB and the SB; three lesions (2, true; 1, partial) underwent prior debulking (rotational atherectomy in all cases).
Multivessel stenting and bifurcation lesions
441
Study limitation
3.
4.
5.
6.
7.
8.
9.
Conclusions
This analysis of treating bifurcation lesions in multivessel
disease with SES showed that these lesions were associated
with increased procedural complexity but not with more
adverse events compared with non-bifurcation lesions. In
contemporary interventional practice, when operators are
allowed to decide the best strategy to employ, which
resulted in a conservative implantation of two stents, no
difference in outcome was found among different types of
bifurcations. The suboptimal angiographic results in the SB
did not increase the risk of MACCE. However, this result
may warrant further investigation in a larger, appropriately
designed study in the light of the trend towards a higher rate
of myocardial infarction in the bifurcation group.
Acknowledgements
This study was supported by Cordis Corporation, a Johnson &
Johnson Company. A complete list of investigators and committees
of the ARTS II has been previously reported.15 We are indebted to
Brian G. Firth, Marco Valgimigli, and Neville Kukreja for their
careful review of the manuscript and constructive comments, and
to He
´ctor M. Garcı´a-Garcı´a for his assistance with statistical analysis. H.-P.S., K.W., and D.J.D. are employees of Cordis.
10.
11.
12.
13.
14.
15.
16.
Conflict of interest: none declared.
17.
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Online publish-ahead-of-print 4 September 2006
Periaortitis complicating chronic aortic dissection
* Corresponding author. Tel:
þ 44 2890633703; fax: þ 44 2890634821. E-mail address: [email protected]
A 34-year-old man with Marfan’s syndrome was admitted
with fever, weight loss, night sweats, low-back pain,
and altered bowel habit. Three years earlier, he had suffered a type A aortic dissection involving the entire length
of his aorta. He required aortic root replacement and resuspension of his aortic valve and was being followed-up
with moderate aortic regurgitation. Infective endocarditis was excluded. A CT scan of the aortic graft was
normal, but there was considerable soft tissue surrounding the entire abdominal aorta and there were mild
back-pressure changes on the left kidney (Panel A). The
appearance was in keeping with periaortitis. A PET scan
demonstrated extensive, abnormal FDG uptake in a
‘cuff’ of soft tissue around the abdominal aorta, extending from the level of the renal hila to the aortic bifurcation (Panels B and C). He developed progressive
dilatation of his left kidney and significant impairment
of renal function. He was commenced on high-dose oral
steroids (60 mg prednisolone), resulting in a rapid
improvement in both renal function and inflammatory
markers. However, a MAG3 isotope scan demonstrated
an obstructed left kidney with associated functional
loss, and consequently, a ureteric stent was placed percutaneously. Periaortitis has been characterized as an exaggerated inflammatory response to advanced atherosclerosis. This
is the first report of this condition in a patient with a chronic aortic dissection. This case demonstrates the clinical presentation of periaortitis, the utility of PET scanning and the major complication of obstructive uropathy, which can be
managed with steroids and ureteric stenting.
Panel A. A contrast-enhanced CT scan of the abdomen demonstrating a dissection flap in the abdominal aorta (solid
arrow), a cuff of tissue surrounding the aorta (dotted arrow), and dilatation of the left renal pelvis.
Panel B. A coronal maximum intensity projection (MIP) of the PET scan. There is abnormal uptake of FDG to the right of
the ascending aorta graft and extensive, abnormal FDG uptake in a cuff of soft tissue around the abdominal aorta,
extending from the level of the renal hila to the aortic bifurcation (arrow).
Panel C. A transaxial MIP of the PET scan. There is abnormal uptake of FDG in a cuff of soft tissue around the abdominal
aorta (arrow).
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Paul W. Johnston*, Peter T. Kennedy, and Paul H. Blair
Regional Medical Cardiology Centre, First Floor, West Wing, Royal Victoria Hospital, Grosvenor Road, Belfast BT12 6BA, UK
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