Superiority Of A Simple Stenting Strategy
For Coronary Bifurcation Lesions In The
Drug-Eluting Stent Era: Evidence From A
Meta-Analysis Of 1141 Patients
G. Biondi-Zoccai,1 C. Moretti,1 P. Agostoni,2 P. Omedé,1
F. Sciuto,1 M. Lotrionte,3 A. Abbate,4 T. Lefevre,5 and I. Sheiban1
1University
of Turin, Turin, Italy ([email protected]); 2AZ
Middelheim, Antwerp, Belgium; 3Catholic University, Rome, Italy;
4Virginia
Commonwealth University, Virginia, USA; 5Institut
Hospitalier Jacques Cartier, Massy, France
1
BACKGROUND
• Coronary bifurcation lesions (especially
true biforcations) remain challenging even
in the drug-eluting stent (DES) era.
• Several studies have tried to compare a
simple stenting strategy (with provisional
main branch stenting) versus a more
complex stenting strategy (with systematic
stenting of both main and side branches).
2
BACKGROUND AND AIM
• Many studies were however too small to
reach reliable conclusions, and there is
still debate on the most appropriate
management for bifurcations.
• We thus performed a comprehensive
meta-analysis of randomized trials
comparing simple versus complex DES
strategies in patients with coronary
bifurcation lesions.
3
METHODS
• Pertinent randomized trials were searched in
several databases and recent conference
proceedings (updated May 2008).
• The primary end-point of the study was the midterm rate of major adverse cardiac events
(MACE, ie death, myocardial infarction, or repeat
revascularization), but binary restenosis and
stent thrombosis were also appraised.
• Data were abstracted and pooled to generate
Peto fixed-effect odds ratios (OR) with 95%
confidence intervals.
4
INCLUDED STUDIES
Pts on simple Pts on complex Specific
Study
Year
strategy
strategy
strategy
BBK
2007
101
101
T
BIFURCATION 2004
22
63
Crushing
CACTUS
2008
173
177
Crushing
NORDIC
2004
207
206
T
Pan et al
2004
47
44
T
5
RESULTS
• We retrieved 5 trials, enrolling 1141 patients,
550 treated according to a simple DES strategy
and 591 managed according to a complex DES
strategy (mostly by means of T stenting).
• Angiographic follow-up, available after a median
of 7 months in 350 subjects, disclosed similar
rates of binary angiographic restenosis in both
main branch (odds ratio=1.13 [0.65-1.95],
p=0.66) and side branch (odds ratio=1.05 [0.731.51], p=0.80).
6
RESULTS
• Clinical follow-up, available after a median of 6
months in 1141 patients, showed equal rates of
MACE (odds ratio=0.83 [0.54-1.28], p=0.40).
• Similarly, no significant differences between
simple and complex DES strategies were found
for the risk of death (odds ratio=1.25 [0.42-3.77],
p=0.69) or target lesion revascularization (TLR)
(odds ratio=1.0 [0.58-1.71], p=0.99).
7
RESULTS
• Conversely, a simple stenting strategy was
associated with a statistically significant
reduction in the rate of myocardial infarctions
(odds ratio=0.60 [0.36-0.98], p=0.04).
• Moreover, a simple stenting strategy tended to
prevent as much as one half of definite stent
thromboses in comparison to a complex stenting
strategy (odds ratio=0.56 [0.18-1.72], p=0.31).
8
RISK OF BINARY RESTENOSIS –
MAIN BRANCH
Study
or sub-category
BIFURCATION
Pan et al
NORDIC
BBK
CACTUS
Simple strategy
n/N
1/21
1/47
7/151
7/101
12/173
Complex strategy
n/N
Peto OR
95% CI
3/55
4/44
9/156
3/101
8/177
Peto OR
95% CI
0.87
0.27
0.80
2.31
1.56
493
533
Total (95% CI)
Total events: 28 (Simple strategy), 27 (Complex strategy)
Test for heterogeneity: Chi² = 4.74, df = 4 (P = 0.31), I² = 15.7%
Test for overall effect: Z = 0.43 (P = 0.66)
[0.09,
[0.04,
[0.29,
[0.65,
[0.63,
8.16]
1.60]
2.17]
8.21]
3.85]
1.13 [0.65, 1.95]
0.01
0.1
1
10
100
Favours simple Favours complex
9
RISK OF BINARY RESTENOSIS –
SIDE BRANCH
Study
or sub-category
BIFURCATION
Pan et al
NORDIC
BBK
CACTUS
Simple strategy
n/N
3/21
2/47
29/151
7/101
25/173
Complex strategy
n/N
Peto OR
95% CI
12/55
6/44
18/156
12/101
23/177
Peto OR
95% CI
0.63
0.31
1.80
0.56
1.13
493
533
Total (95% CI)
Total events: 66 (Simple strategy), 71 (Complex strategy)
Test for heterogeneity: Chi² = 8.01, df = 4 (P = 0.09), I² = 50.0%
Test for overall effect: Z = 0.26 (P = 0.80)
[0.18,
[0.07,
[0.97,
[0.22,
[0.62,
2.19]
1.33]
3.35]
1.44]
2.08]
1.05 [0.73, 1.51]
0.01
0.1
1
10
100
Favours simple Favours complex
10
RISK OF MACE
Study
or sub-category
BIFURCATION
Pan et al
NORDIC
BBK
CACTUS
Simple strategy
n/N
3/22
2/47
6/207
14/101
15/173
Complex strategy
n/N
Peto OR
95% CI
12/63
3/44
7/206
12/101
21/177
550
Total (95% CI)
Total events: 40 (Simple strategy), 55 (Complex strategy)
Test for heterogeneity: Chi² = 1.14, df = 4 (P = 0.89), I² = 0%
Test for overall effect: Z = 0.83 (P = 0.40)
Peto OR
95% CI
0.69
0.61
0.85
1.19
0.71
591
[0.20,
[0.10,
[0.28,
[0.52,
[0.36,
2.45]
3.69]
2.56]
2.71]
1.41]
0.83 [0.54, 1.28]
0.1 0.2
0.5 1
2
5
10
Favours simple Favours complex
11
RISK OF DEATH
Study
or sub-category
BIFURCATION
Pan et al
NORDIC
BBK
CACTUS
Simple strategy
n/N
Complex strategy
n/N
0/22
1/47
2/207
3/101
1/173
550
Total (95% CI)
Total events: 7 (Simple strategy), 6 (Complex strategy)
Test for heterogeneity: Chi² = 2.44, df = 4 (P = 0.66), I² = 0%
Test for overall effect: Z = 0.40 (P = 0.69)
Peto OR
95% CI
1/63
1/44
3/206
1/101
0/177
Peto OR
95% CI
0.26
0.94
0.66
2.76
7.56
591
[0.00,
[0.06,
[0.11,
[0.38,
[0.15,
22.78]
15.21]
3.87]
19.88]
381.19]
1.25 [0.42, 3.77]
0.001 0.01 0.1
1
10 100 1000
Favours simple Favours complex
12
RISK OF MYOCARDIAL INFARCTION
Study
or sub-category
BIFURCATION
Pan et al
NORDIC
BBK
CACTUS
Simple strategy
n/N
2/22
2/47
8/153
1/101
13/173
Complex strategy
n/N
Peto OR
95% CI
7/63
1/44
18/126
2/101
16/177
496
Total (95% CI)
Total events: 26 (Simple strategy), 44 (Complex strategy)
Test for heterogeneity: Chi² = 3.55, df = 4 (P = 0.47), I² = 0%
Test for overall effect: Z = 2.02 (P = 0.04)
Peto OR
95% CI
0.81
1.85
0.34
0.51
0.82
511
[0.17,
[0.19,
[0.15,
[0.05,
[0.38,
3.89]
18.27]
0.77]
4.96]
1.75]
0.60 [0.36, 0.98]
0.001 0.01 0.1
1
10 100 1000
Favours simple Favours complex
13
RISK OF TLR – ANY BRANCH
Study
or sub-category
BIFURCATION
Pan et al
NORDIC
BBK
CACTUS
Simple strategy
n/N
1/22
1/47
4/207
11/101
10/173
Complex strategy
n/N
Peto OR
95% CI
7/63
3/44
2/206
9/101
10/177
550
Total (95% CI)
Total events: 27 (Simple strategy), 31 (Complex strategy)
Test for heterogeneity: Chi² = 2.88, df = 4 (P = 0.58), I² = 0%
Test for overall effect: Z = 0.01 (P = 0.99)
Peto OR
95% CI
0.47
0.33
1.95
1.25
1.02
591
[0.09,
[0.05,
[0.39,
[0.50,
[0.42,
2.44]
2.44]
9.78]
3.13]
2.52]
1.00 [0.58, 1.71]
0.1 0.2
0.5 1
2
5
10
Favours simple Favours complex
14
RISK OF STENT THROMBOSIS
Study
or sub-category
BIFURCATION
Pan et al
NORDIC
BBK
CACTUS
Simple strategy
n/N
Complex strategy
n/N
0/22
0/47
1/207
1/101
2/173
550
Total (95% CI)
Total events: 4 (Simple strategy), 9 (Complex strategy)
Test for heterogeneity: Chi² = 2.63, df = 4 (P = 0.62), I² = 0%
Test for overall effect: Z = 1.01 (P = 0.31)
Peto OR
95% CI
3/63
1/44
0/206
2/101
3/177
Peto OR
95% CI
0.25
0.13
7.35
0.51
0.68
591
[0.02,
[0.00,
[0.15,
[0.05,
[0.12,
3.43]
6.38]
370.59]
4.96]
3.98]
0.56 [0.18, 1.72]
0.01
0.1
1
10
100
Favours simple Favours complex
15
CONCLUSIONS
• In patients with coronary bifurcation lesions a
simple strategy provides equivalent results in
terms of MACE and angiographic restenosis
rates in comparison to a more complex
technique.
• Moreover, a simple stenting strategy appears
safer and intrinsically more cost-effective than a
complex one, with significantly fewer infarctions.
16
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