1. DES Should be Used as the Default Stent in ACS!
Gregg W. Stone MD
Columbia University Medical Center Cardiovascular Research Foundation

2. Disclosures Gregg W. Stone MD
Advisory boards for and honoraria from Abbott Vascular and Boston Scientific
Consultant to Medtronic

3. Harmonizing Outcomes with Revascularization and Stents in AMI
UFH + GPI (n=1802)
Bivalirudin (n=1800)
Primary Medical Rx 193
Primary CABG 62
Deferred PCI 2
Index PCI, not eligible
- PTCA only 119
- Stented 220
3602 pts with STEMI R
1:1
3006 pts eligible for stent rand.
93.1% of all stented pts were randomized R
3:1
TAXUS DES
N=2257
EXPRESS BMS
N=749
Randomized 18 16
• • • Withdrew • • •
• • • Lost to FU • • • 7 13
1 year FU
N=2225 (98.6%)
N=730 (97.5%)
13 month angiographic FU
942 23 97
• • • Withdrew • • •
• • • Lost to FU • • • 8 34
307
3 year FU
N=2103 (93.2%)
N=687 (91.7%)

4. Primary Efficacy Endpoint: Ischemic TLR10
Diff [95%CI] =
-3.0% [-5.1, -0.9]
HR [95%CI] =
0.59 [0.43, 0.83]
P=0.002
TAXUS DES (n=2257) 9
EXPRESS BMS (n=749) 8
7.5% 7 6
Ischemic TLR (%) 5
4.5% 4 3 2 1 1 2 3 4 5 6 7 8 9 10 11 12
Time in Months
Number at risk
TAXUS DES
2257
2132
2098
2069
1868
EXPRESS BMS
749
697
675
658
603
Stone GW et al. NEJM 2009;360:

5. Binary Analysis Segment Restenosis at 13 Months Patient and Lesion Level Analysis*
RR [95%CI] =
0.44 [0.33, 0.57]
P<0.0001
RR [95%CI] =
0.44 [0.33, 0.57]
P<0.0001
Major 2 endpoint
* ITT: Includes all stent randomized lesions, whether or not a stent was implanted, and whether or not non study stents were placed
** Any lesion with restenosis  per pt restenosis
Stone GW et al. NEJM 2009;360:

6. Primary Efficacy Endpoint: Ischemic TLR
Routine angiographic FU
No routine angiographic FU
TAXUS DES (n=911)
TAXUS DES (n=1346)
EXPRESS BMS (n=293)
EXPRESS BMS (n=456) 2 24 22 18 16 14 12 8 6 20 10 4 2 24 22 18 16 14 12 8 6 20 10 4
1-yr HR [95%CI]=
0.58 [0.32, 1.04]
18.3%
P=0.06
1-yr HR [95%CI]=
0.64 [0.43, 0.95]
12.7%
Ischemic TLR (%)
Ischemic TLR (%)
P=0.02
10.3%
8.7%
3-yr HR [95%CI]=
3-yr HR [95%CI]=
0.53 [0.38, 0.75]
0.67 [0.48, 0.93]
P=0.001
P=0.01 3 6 9 12 15 18 21 24 27 30 33 36 3 6 9 12 15 18 21 24 27 30 33 36
Months
Months
Number at risk
Number at risk
PES
911
896
878
830
812
795
596
PES
1346
1208
1164
1112
1090
1051
681
BMS
293
282
274
237
234
229
157
BMS
456
394
381
361
353
338
215
Stone GW. TCT2010.

7. Primary Safety Endpoint: Safety MACE*
1928
634
2037
2094
684
2257
TAXUS DES 12 15 18 21 24 27 30 33 36
749
669
Months 3 6 9
Number at risk
EXPRESS BMS
1971
648
1875
615
412
1289
P=0.66
3-yr HR [95%CI]=
1.05 [0.84, 1.33]
12.9%
13.6%
Safety MACE (%) 2 4 8 10 14 16
TAXUS DES (n=2257)
EXPRESS BMS (n=749)
P=0.92
1-yr HR [95%CI]=
1.02 [0.76, 1.36]
8.1%
8.0%
* Safety MACE = death, reinfarction, stroke, or stent thrombosis
Stone GW. TCT2010.

8. Three-Year Stent Thrombosis (ARC Definite or Probable)6
TAXUS DES (n=2238)
EXPRESS BMS (n=744) 5
4.8%
4.3% 4
3.4%
Stent Thrombosis (%)
3-yr HR [95%CI]= 3
3.1%
1.10 [0.74, 1.65] 2
P=0.63
1-yr HR [95%CI]=
0.92 [0.58, 1.45] 1
P=0.72 3 6 9 12 15 18 21 24 27 30 33 36
Months
Number at risk
TAXUS DES
2238
2108
2066
2013
1980
1932
1341
EXPRESS BMS
744
695
683
664
654
637
425
Stone GW. TCT2010.

9. Stent Randomization: Aspirin and Thienopyridine Use
Regular* aspirin use (%)
Regular* thieno. use (%)
TAXUS DES (n=2257)
EXPRESS BMS (n=749)
99.1%
98.3%
98.3%
99.4%
97.5%
98.7%
97.5%
95.8%
94.6%
98.5%
98.9%
98.6%
97.4%
97.1%
97.8%
96.3%
95.7%
72.8%
87.5%
P<0.001
Antiplatelet agent use (%)
63.6%
All P=NS
P<0.001
36.7%
28.3%
30.5%
P=0.004
22.5%
P=0.003
*Taken >50% of days since last visit
Stone GW. TCT2010.

10. Three-Year All-Cause Mortality
P=0.31
3-yr HR [95%CI]=
0.84 [0.60, 1.17]
5.6%
6.6%
All-Cause Mortality (%) 1 2 3 4 5 6 7 8
TAXUS DES (n=2257)
EXPRESS BMS (n=749)
P=0.97
1-yr HR [95%CI]=
0.99 [0.64, 1.55]
2072
674
2138
2170
713
2257
TAXUS DES 12 15 18 21 24 27 30 33 36
749
702
Months 9
Number at risk
EXPRESS BMS
2097
683
2026
657
443
1409
3.5%
Stone GW. TCT2010.

11. Adapted from Ziada KM et al. JACC CI Int 2011;4;39-41
Long-term (3-5 year) FU after DES vs. BMS in AMI N=6,026 pts from 8 randomized trials
 Study N
Type of DES
Clinical FU (mos)
Angio FU
DEDICATION
626
SES, PES and ZES
Median 42 No
PASEO
270
SES and PES
Mean 41
STRATEGY
175
SES 60
SESAMI
320 36
MISSION
304
Yes
TYPHOON
712 48
PASSION
619
PES
HORIZONS-AMI
3,006
Adapted from Ziada KM et al. JACC CI Int 2011;4;39-41

12. Adapted from Ziada KM et al. JACC CI Int 2011;4;39-41
Long-term (3-5 year) FU after DES vs. BMS in AMI Stent thrombosis (N=6,026 pts)
 Stent thrombosis
DES
BMS
OR [95%CI] P
DEDICATION
2.9%
3.2%
0.90 [0.36, 2.24]
0.82
PASEO
1.1%
2.2%
0.49 [0.07, 3.57]
0.48
STRATEGY
6.9%
7.9%
0.86 [0.28, 2.66]
0.79
SESAMI
5.1%
1.00 [0.37, 2.73]
1.00
MISSION
3.1%
2.0%
1.69 [0.40, 7.20]
TYPHOON
5.3%
5.5%
0.90 [0.42, 2.00]
0.83
PASSION
4.2%
3.4%
1.19 [0.52, 2.69]
0.68
HORIZONS-AMI
4.4%
1.15 [ ]
0.50
META-ANALYSIS
1.06 [ ]
0.67
1.15 ( )
Adapted from Ziada KM et al. JACC CI Int 2011;4;39-41

13. Adapted from Ziada KM et al. JACC CI Int 2011;4;39-41
Long-term (3-5 year) FU after DES vs. BMS in AMI Mortality (N=6,026 pts)
 DEATH
DES
BMS
OR [95%CI] P
DEDICATION
10.5%
6.4%
1.73 [0.97, 3.08]
0.06
PASEO
8.3%
12.2%
0.65 [0.29, 1.49]
0.31
STRATEGY
18.4%
15.9%
1.19 [0.54, 2.62]
0.66
SESAMI
3.2%
5.0%
0.61 [0.20, 1.92]
0.40
MISSION
4.4%
6.6%
0.69 [0.25, 1.85]
0.46
TYPHOON
4.0%
0.61 [0.27, 1.36]
0.23
PASSION
8.9%
11.5%
0.75 [0.45, 1.27]
0.29
HORIZONS-AMI
5.6%
0.84 [ ]
0.33
META-ANALYSIS
0.88 [ ]
0.27
Adapted from Ziada KM et al. JACC CI Int 2011;4;39-41

14. Long-term (3-5 year) FU after DES vs. BMS in AMI TVR (N=6,026 pts)
OR [95%CI] P
DEDICATION
8.9%
19.8%
0.40 [0.25, 0.64]
<0.01
PASEO
6.1%
21.1%
0.24 [0.11, 0.54]
STRATEGY
10.3%
26.1%
0.33 [0.14, 0.75]
0.01
SESAMI
8.3%
16.0%
0.46 [0.23, 0.92]
0.03
MISSION
15.8%
0.54 [0.27, 1.09
0.09
TYPHOON
11.9%
21.5%
0.49 [0.30, 0.80]
PASSION
7.7%
10.5%
0.73 [0.42, 1.26]
0.26
HORIZONS-AMI
12.5%
17.7%
0.67 [ ]
0.001
META-ANALYSIS
0.50 [ ]
<0.001
Adapted from Ziada KM et al. JACC CI Int 2011;4;39-41

15. Should all pts with STEMI receive DES
Should all pts with STEMI receive DES? Multivariable predictors of 12-month ischemic TLR among patients randomized to BMS
Variable
HR [95% CI]
P-value
Risk strata points
Insulin-treated diabetes
3.12 [1.23, 7.87]
0.02 1
Baseline RVD ≤3.0 mm
2.89 [1.56, 5.34]
0.0007
Total lesion length ≥30 mm
2.49 [1.33, 4.68]
0.004
Stone GW et al. JACC 2010;56:

16. 12 Month Ischemic TLR According to Risk Strata
Bare metal stent
Paclitaxel-eluting stent
HR [95%]
0.39 [0.21, 0.74]
Pint = 0.01
P=0.003
HR [95%]
0.58 [0.37, 0.92]
HR [95%]
0.99 [0.43, 21.7]
Ischemic TLR at 12 months (%)
P=0.02
P=0.93
Low (score = 0)
N = 947 (32.2%)
Intermediate (score = 1)
N = 1583 (53.9%)
High (score = >2)
N = 409 (13.9%)
Risk score for restenosis
Stone GW et al. JACC 2010;56:on-line

17. 13 Month Binary Angiographic Restenosis According to Risk Strata
Bare metal stent
Paclitaxel-eluting stent
HR [95% CI]=
0.42 [0.26, 0.66]
RR [95% CI]=
0.44 [0.31, 0.63]
P=0.0005
P<0.0001
RR [95% CI]=
0.44 [0.21, 0.95]
Angiographic restenosis at 13 months (%)
P=0.03
Low (score = 0)
N = 422 (29.6%)
Intermediate (score = 1)
N = 722 (50.7%)
High (score = >2)
N = 280 (19.7%)
Risk score for restenosis
Stone GW et al. JACC 2010;56:on-line

18. ► DES should be used as the default stent in. patients with ACS
► DES should be used as the default stent in patients with ACS They are safe and effective in reducing clinical and angiographic restenosis in this setting ► If a DES is not used in ACS, there should be a good reason. Either: BMS is likely to be as effective (non diabetic and RVD >3 mm and lesion length <30 mm), or Adherence with 1-year of DAPT is uncertain
Conclusions