two-year clinical outcomes yan li md., phd. on behalf of fireman investigators associated professor...
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Two-Year Clinical Outcomes
Yan Li MD., PhD. On behalf of FIREMAN Investigators
Associated Professor of Department of Cardiology of Xijing Hospital
Fourth Military Medical UniversityXi’an, China
Background: FIREMAN at 1-Year
Study Design
FIREMAN RegistryProspective, Multicenter and Nationwide
45 Medical Centers
Patient Eligibility
Study Algorithm Patient enrollment (2006.09-2007.07)
n = 1078
Excluded pts due to hybrid stenting, n=49 (4.5%)
Clinical follow-up Angiographic follow-up
12months 97.2% (1001/1029 pts)
8 months 51% (517/1013pts)
Primary End Point : MACE@ 12months Secondary End Point ： Binary Restenosis, Late loss at 8months, TVR, Stent thrombosis, Stroke
1029 pts Enrolled
Diabetes 22.8%
24months 97.7% (1005/1029 pts ）
Frequency of Complex Coronary Lesions Criteria*
50.459.18
5.6
31.6
15.8
1.86.1 3
7.4
0
20
40
60
80
100
Multi-vessel Long lesionCTO Ostial Small vessel BifurcationUnprotected left main disease Severe angulationRestenosis
%
* Criteria are not mutually exclusive.
MACE @ 24 months
(10) (12) (40) (36) (60)(2)
0.6
3.4
0.1 0.19
3.5
5.83
1.07
2.82
4.96
0.97 1.17
3.89
0
2
4
6
8
12mo 24mo
12mo 0.6 1.07 3.4 0.1 2.82 4.96
24mo 0.97 1.17 3.89 0.19 3.5 5.83
Cardiac death non-fatal MI TLR-PCI TLR_CABG TVR MACE
MACE-free Survival Rate 1.00
0
0.96
0.98
0.94
0.92
0.90
150 300 450 600
Mac
e-fr
ee S
urv
ival
rat
e,%
Days after Procedure
94.2%
TLR-free Survival Rate
0.92
0.90
1.00
0.94
0.92
0.98
0 600 750450300150
TL
R-f
ree
Su
rviv
al
rate
%
Days after Procedure
95.9%
MI-
free
Su
rviv
al R
ate,
%
Days after Procedure
1.00
0.92
0.94
0.96
0
0.90
0.98
450300150 750600
98.8%
MI-free Survival Rate
Car
dia
c d
eath
-fre
e S
urv
ival
Rat
e,%
Days after Procedure
1.00
0.98
0.96
0.94
0.92
0.90
1500 450300 750600
99.0%
Cardiac death-free Survival Rate
Stroke @ 2-Year%
0.680.58
1.171.17
0.58
1.75
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
2
ischemic stroke hemorrage stroke total
12mo 24mo
Dual Anti-platelet Therapy
99.6
98.4
98.3
96.8
97.8
70.8
95.8
29.4
94.75
18.83
0
20
40
60
80
100
ASA Clopidogrel
30d 6mo 12mo 18mo 24mo
%
Stent Thrombosis @ 2-Year
0.92
0.90
1.00
0.94
0.92
0.98
0 600 750450300150
Ste
nt
Th
rom
bo
sis
-fre
e
Su
rviv
al
rate
, %
Days after Procedure
98.1%
4 cases ST were due to prematurely stopping dual anti-platelet therapy before 12 months.
1 case of VLST due to prematurely stopping dual anti-platelet therapy before 12 months.
286 79
165 200
132 233
15 350
0 100 200 300 400
Case 4
Case 3
Case 2
Case 1
371 359
351 379
84 646
520 16
0 100 200 300 400 500 600 700 800
Case 4
Case 3
Case 2
Case 1
Dual ASA alone
Cumulative Incidence of Stent Thrombosis
3
0
5
2
1
4
0 720540360180Ste
nt
Th
rom
bo
sis
Cu
mu
lati
ve
inci
den
ce,
%
Days after Procedure
1.55%
0.39%
Subgroup Analysis
Subgroup Analysis
Subgroup Analysis
Predictors of Cumulative Stent Thrombosis
By Cox Regression AnalysisVariables HR(95%CI) P value
Clinical variables
Pre-MI 2.776(1.007 ~8.329) 0.211
Pre-PCI 1.837(0.421~5.522) 0.669
Hypercholesterima 0.642(0.398~3.074) 0.328
hypertension 2.189(0.833~4.578) 0.851
Diabetes 8.651(2.393~21.543) 0.008
Lesion characteristics
Multi-vessel 0.724 (0.152~2.299) 0.416
Diffuse long 2.023(0.898~6.244) 0.347
Small vessel 6..262(1.699~15.458) 0.026
CTO 5.171(1.881~12.369) 0.035
J-Cypher TaxusVI EndeavorIV FIREMAN
DES
Events
Cypher Taxus Endeavor Firebird
Death 1.70 0.5 1.5 0.97
MI 3.60 8.8 2.0 1.17
TVR - 13.9 8.9 3.50
TLR 7.9 9.7 5.9 4.08
ST 2.43 0.5 0.1 1.94
Total MACE
- 21.3 9.8 5.83
Comparison with other DES
Conclusions (1)
2-Year Efficacy ： 2-Year outcomes showed that FIREBIRD 2-Year outcomes showed that FIREBIRD
SES was effective and safe in the SES was effective and safe in the treatment of selectively complex lesions. treatment of selectively complex lesions.
2-Year Safety ： No significant increase in very late stent No significant increase in very late stent
thrombosis at 2 Years. thrombosis at 2 Years.
Conclusions (2)
Very Late Stent ThrombosisAlthough the study population was a
selective complex subsets, very late stent thrombosis was low at 0.39% .
Diabetes, small vessel and CTO are still strongest predictors of stent thrombosis.
There was one case of VLST event in patients due to discontinuation of DAPT before 12 months ..
