1. CYPHER® Clinical Evidence in Acute Myocardial Infarction (AMI)

2. Acute Myocardial Infarction
The Development of AMI
Plaque is subjected to erosion and/or disruption
Lipid-rich core exposed after rupture is highly thrombogenic
Causes platelet activation
Elicits the coagulation cascade
Thrombus formation
Sub-occlusive - unstable angina
Occlusive - AMI
A pro-inflammatory environment
Atherosclerotic
Plaque
Plaque
Rupture
Spontaneous or Post-Intervention
SUMMARY
Rupture of atherosclerotic plaque leads to the formation of thrombus. This thrombus can lead to a total occlusion, AMI, or partial occlusion, Unstable Angina.
Stenting is an effective method for obtaining flow restoration. However, there are significant risks involved with stenting in acute coronary syndromes.
Among these are distal embolization, “No-reflow”, increased thrombin generation, and most importantly, an increased risk of stent thrombosis.
Why is the risk for stent thrombosis increased in ACS?
Stenting is invasive, in nature, and will lead to the injury of the vessel wall. The body’s response to this is the activation of the coagulation cascade, covering the damaged intimal surface with platelets within hours.
This platelet activation will lead to thrombus formation. This additional thrombus formation in an already thrombotic environment significantly increases the odds for stent thrombosis.
Acute Myocardial Infarction
Unstable Angina

3. The Value of a Sirolimus-eluting Stent in AMI
Inflammatory cytokine levels are high in AMI
Neointimal hyperplasia following bare-metal stent implantation is an inflammatory response
CYPHER® Stent has been proven to significantly inhibit:
Strut-associated inflammation1
Neointimal hyperplasia1
1. Suzuki T, et al. Circulation. 2001;104:

4. Randomised Trials in AMI Show a Clinical Advantage for CYPHER® Stent vs BMS

5. Superiority of CYPHER® Stent in AMI: Randomised Controlled Trials
Study
Comparator Stent
Number of Patients
Late Loss in-stent (mm)
Binary restenosis
In-stent (%)
TLR (%)
MACE (%)
STRATEGY1
BMS
175
CYPHER®: -0.22
BMS: 0.6
CYPHER®: 7.5
BMS: 28
CYPHER®: 6
BMS: 20
CYPHER®: 18
BMS: 32
TYPHOON2
721
CYPHER®: 0.14
BMS: 0.83
CYPHER®: 3.5
BMS: 20.3
CYPHER®: 3.7
BMS: 12.6 -
SESAMI3
320
CYPHER®: 0.18
BMS: 0.85
CYPHER®: 9.3
BMS: 21.3
CYPHER®: 4.3
BMS: 11.2
CYPHER®: 6.8
BMS: 16.8
DI LORENZO4
BMS/Taxus
180
CYPHER®: 0.0
Taxus: 1.5
BMS: 15.6
CYPHER®: 6.4
Taxus: 8.1
BMS: 23.6
BASKET-AMI5
217
DES: 4.9
BMS: 8.1 (TVR)
DES 7.6
BMS: 16.7
MISSION!6
310
CYPHER®: 0.19
BMS: 0.95
CYPHER®: 2.3
BMS: 22.6
CYPHER®: 3.2
CYPHER®: 13.9
BMS: 26.3
DIAZ7
120
BMS: 5.7 (TVF)
CYPHER®: 6.7
BMS: 11.1
PROSIT8
Taxus
308
Taxus: 0.43
CYPHER®: 5.0
Taxus : 12.0
CYPHER®: 2.6
Taxus : 6.5
CYPHER®: 5.8
Taxus : 11.7
MULTISTRATEGY9
745
BMS: 10.2
CYPHER®: 7.8
BMS: 14.5
1. Valgimigli M, et al. JAMA. 2005;293(17): Spaulding C, et al. N Engl J Med. 2006;355(11): Menichelli M, et al. J Am Coll Cardiol. 2007;49(19): Di Lorenzo E, et al. ACC Scientific Sessions Presentation Pittl C, et al. Eur Heart J. 2006;27:650 (abstract suppl). 6. van der Hoeven BL, et al. J Am Coll Cardiol. 2008;51(6): Lee JH, et al. Catheter Cardiovasc Interv. 2008;72(1): Diaz L, et al. Am Heart J. 2007;154(1):164.e1 – 164.e6. 9. Valgimigli M, et al. JAMA 2008;299(15):

6. TYPHOON Study Design
Patients Presenting within 12 hours after Onset of Symptoms of a First AMI Requiring Primary PCI of a Native Coronary Artery
Randomisation 1:1
CYPHER® or CYPHER Select® Sirolimus-eluting Stent
(355 patients)
Any Bare-Metal Stent
(357 patients)
Primary Endpoint: Target Vessel Failure (TVF) at 1 Year
Defined as composite of ischaemia-driven Target Vessel Revascularization (TVR), recurrent Myocardial Infarction (MI), or Target Vessel-related Cardiac Death
Angiographic Substudy (200 pts): In-stent Late Loss at 8-Months
Dual APT recommended for  6 months (Clopidogrel: ~ 75% at 6 months and ~ 50% at 12 months)
Spaulding C, et al. N Engl J Med. 2006;355:

7. TYPHOON Lower TVF Risk vs BMS
Intention-to-Treat Analysis at 1 year
CYPHER®
BMS 25 20
1º Endpoint: TVF at 1 year*
14.3 15
Patients (%)
49%
p=0.0036* 10
6.2
7.3 5
3.1
4.2
2.8 60
120
180
240
300
360
Time (days)
* Defined as ischaemia driven TVR, recurrent MI, or target vessel-related cardiac death
Spaulding C, et al. N Engl J Med. 2006;355:

8. TYPHOON Significant Benefit without Angiographic F/U
TVF: Intention-to-Treat Analysis at 1 year 25 20
P = 0.034 15
12.7 10
6.8 5
N=251
N=251
CYPHER©
BMS
Spaulding C, et al. PCR 2006

9. TYPHOON Superior Clinical Outcomes vs BMS
Intention-to-Treat Analysis at 1 year
CYPHER®
BMS 30
p=0.004
Death
2.3
2.2
p=NS MI
1.1
1.4
p=NS
TVR
5.6
13.4
p<0.001 25 20
14.3
Patients (%) 15 10
7.3
p. 71 (table T61) 5
TVF*
Primary Endpoint
* Defined as ischaemia-driven TVR, recurrent MI, or target vessel-related cardiac death
Spaulding C, et al. N Engl J Med. 2006;355:

10. Diaz de la Llera Study Design
Consecutive patients with STEMI over the age of 18 years
Randomisation 1:1
CYPHER® Stent
plus abciximab
(60 patients)
BMS
plus abciximab
(60 patients)
Primary Endpoint: Composite of death, non-fatal MI and recurrent
myocardial ischaemia within 360 days after initial procedure
Diaz de la Llera LS, et al. Am Heart J. 2007;154:164.e.1-6.

11. Diaz de la Llera Better Event-Free Survival vs BMS at 1 year
Primary endpoint* Event-free survival at 360 days
Secondary endpoint Survival free from TVF
CYPHER©
Bare Metal Stents
1.0
CYPHER© stent 0.0%
BMS %
p=0.064
93.3
0.9
88.9
Event-free survival (%)
0.8
RR=1.75 (95% CI; 0.47 – 6.57) p=0.402
0.7
*Defined as composite of death, non-fatal MI and recurrent myocardial ischaemia within 360 days after initial procedure 60
120
180
240
300
360
Days after initial procedure
Diaz de la Llera LS, et al. Am Heart J. 2007;154:164.e.1-6.

12. MISSION! Study Design
Patients with ECG-demonstrated STEMI with symptoms <9h
before procedure
Randomisation 1:1
CYPHER® Stent
(158 patients)
Vision BMS
(152 patients)
Primary Endpoint: In-segment late-lumen loss at 9 months
van der Hoeven BL, et al. J Am Coll Cardiol. 2008;51(6):
Ref

13. MISSION! Lower Late Loss vs BMS
Primary endpoint In-segment late loss (9 months)
Secondary endpoint Event- free survival (12 months)
0.8
CYPHER® Stent 86.0%
BMS % p = 0.01
0.7
p<0.001
0.68
0.6
0.5
Secondary endpoint Late stent malapposition at any site (9 months)
Angiographic in-segment late loss (mm)
0.4
0.3
0.2
0.12
CYPHER® Stent 37.5%
BMS %
p < 0.001
0.1
CYPHER©
BMS
van der Hoeven BL, et al. J Am Coll Cardiol. 2008;51(6):

14. MULTISTRATEGY Study Design
Patients with (1) chest pain > 30 mins with an ECG ST-segment elevation
of 1 mm 2 or more leads, or with a new left bundle-branch block,
and (2) admission within 12 h of symptom onset or hours
after onset with evidence of continuing ischaemia
Randomisation 1:1:1:1
CYPHER® Stent
plus abciximab
(186 patients)
CYPHER® Stent
plus tirofiban
(186 patients)
BMS
plus abciximab
(186 patients)
BMS
plus tirofiban
(186 patients)
Primary Endpoint (drug comparison):  50% recovery at 90 minutes
Primary Endpoint (stent comparison): MACE at 8 months
Valgimigli M, et al. JAMA. 2008;299(15):

15. MULTISTRATEGY Lower MACE* Rates vs BMS
CYPHER®
BMS 20
No prespecified angiographic F/U
Broad inclusion criteria 15
14.5%
MACE* (%) 10
7.8% 5
Adjusted HR: 0.53 (97.5% CI: ); p=0.006
p= at Log-rank test 20 40 60 80
100
120
140
160
180
200
220
240
260
No. at risk
Days after randomisation
Uncoated Stent
CYPHER Stent
Dual APT recommended for ≥ 3 months
(Clopidogrel: ~ 90% at 1 month and ~ 20% at 8 months)
*Death, MI, or TVR
Valgimigli M, et al. JAMA. 2008;299(15):

16. CYPHER® Stent vs BMS: No difference in Stent Thrombosis Summary of CYPHER® Stent vs BMS Trials
p=NS for all trials
8-month
1-year
1-year
1-year
2-year
2-year 10 8
6.0
Patients (%) 6
4.7
4.6
4.0
3.6 4
3.4
3.4
2.7
2.0
1.8
p. 71 (table T61) 2
1.3
1.2
MULTI
STRATEGY
Diaz
MISSION
TYPHOON
SESAMI
STRATEGY
n=745
n=120
n=308
n=712
n=320
n=175
Dual APT
Recommendation
3 months
9 months
12 months
6 months
12 months
6 months
Definitions of ST vary by trial: ARC Def/Probable used when possible

17. Randomised Trials in AMI
Show a Clinical Advantage for CYPHER® Stent vs Taxus®

18. Taxus in AMI PASSION Study Design
STEMI patients with chest pain > 20mn and ST-elevation in
≥2 contiguous leads; infarct related artery with a de novo lesion
Randomisation 1:1
Taxus Express2 or Liberte Stent
(n=309)
BMS
(n=310)
Primary Endpoint: Composite of death, recurrent MI, or target lesion (within 5 mm of stent edges) revascularization (TLR) at one year
Laarman, GJ et al. N Engl J Med. 2006;355:

19. No prespecified angiographic F/U
Not all DES are created equal: PASSION Primary Endpoint* at 1 Year Follow-up Not Met
Taxus
BMS
No prespecified angiographic F/U
12.6 10
8.7
MACE (%) 5
PRIMARY ENDPOINT NOT ACHIEVED
HR=0.68 ( ) p=0.12
120
240
360
Days
Dual APT recommended for ≥ 6 months (Clopidogrel: Median Duration of 9 months)
*Cardiac Death, MI, or TLR
Laarman, GJ et al. N Engl J Med. 2006;355: 19

20. Not all DES are created equal: PASSION 2-Year Outcomes
Taxus
BMS
OR (95% CI: )
OR (95% CI: )
OR 0.60 (95% CI: ) 20
p =0.12
15.4 15
p=0.09
11.1
% of Patients
9.9
p =0.32 10
7.2
6.0
5.6 5
MACE
Cardiac Death
TLR
Dirksen MT. Presented at ESC 2007.

21. PROSIT Study Design
Acute STEMI 12 hrs or persistent ischaemia hrs
(n = 231)
Randomisation 1:1
Taxus
(n=115)
CYPHER®
(n=116)
Primary Endpoint: In-segment late loss at 6 months
Secondary Endpoints: MACE at 30 days and 9 months and
angiographic in-segment restenosis at 6 months
Lee JH, et al. Catheter Cardiovasc Interv. 2008;72(1):25-32.

22. Other endpoints Angiographic binary restenosis
PROSIT Superior Angiographic Outcomes vs Taxus
CYPHER©
Taxus
In-segment Late Loss
(6 months)
p=0.002
0.33
Late Loss (mm)
0.3
0.2
0.1
0.09
0.4
0.5
Other endpoints Angiographic binary restenosis
(6 months)
In-segment
CYPHER® %
Taxus %
p= 0.03
In-stent
CYPHER® %
Taxus %
p= 0.09
Lee JH, et al. Catheter Cardiovasc Interv. 2008;72(1):25-32.

23. PROSIT Improved Clinical Outcome (MACE & TLR) vs Taxus
CYPHER©
Taxus
MACE
(12 months)
P=0.07
11.7
Patients (%) 15 10 5
5.8 20
TLR
P=0.17
6.5
7.5
2.5
2.6
Lee JH, et al. Catheter Cardiovasc Interv. 2008;72(1):25-32.

24. Meta-analyses Confirm
the Value of DES in AMI

25. Meta-analysis of DES trials in AMI DES vs BMS in STEMI Patients1
Study
No. of patients
Mean age (years)
Type of DES
Primary endpoint
Length of thienopyridine therapy (months)
Mean length of follow-up (months)
BASKET-AMI2
216
62.2
PES SES
Cardiac death, myocardial infarction, or reintervention 6
18.0
Di Lorenzo3
270
64.0
Death, myocardial infarction, or reintervention
12.0
HAAMU-STENT4
164
63.0
PES
Angiographic late lumen loss 12
16.7
MISSION5
310
59.2
SES
PASSION6
619
60.8
SESAMI7
320
61.6
Angiographic binary restenosis
12.3
STRATEGY8
175
62.6
Death, myocardial infarction, stroke, or angiographic binary restenosis 3
24.2
TYPHOON9
712
59.3
12.1
1. Kastrati A, et al. Eur Heart J. 2007;28: Pittl C, et al. Eur Heart J. 2006;27:650 (abstract suppl). 3. Di Lorenzo E, et al. ACC Scientific Sessions Presentation HAAMU-STENT trial. Available at wwwcardiosourcecom/pops/trialSumasp?trialID= Accessed 5 March van der Hoeven BL, et al. J Am Coll Cardiol. 2008;51(6): Laarman GJ et al. N Engl J Med. 2006; 355: Menichelli M, et al. J Am Coll Cardiol. 2007;49(19): Valgimigli M, et al. JAMA. 2005;293(17): Spaulding C, et al. N Engl J Med. 2006;355(11):

26. Probability of reintervention (%) Months after randomization
Meta-analysis of DES trials in AMI* Lower Rate of Reintervention with DES
DES
BMS 20
2786 patients 15
HR: 0.38 (95% CI, 0.29–0.50)
p< 0.001
Probability of reintervention (%) 10 5 1 2 3 4 5 6 7 8 9 10 11 12
Months after randomization
*Trials included were: BASKET; di Lorenzo; HAAMU-STENT; MISSION; PASSION; SESAMI; STRATEGY; TYPHOON
Kastrati A, et al. Eur Heart J. 2007;28:

27. Months after randomisation Months after randomisation
Meta-analysis of DES trials in AMI* Similar Low Rates of Death, Recurrent MI
DES
BMS
DES
BMS 10 10
HR: 0.76 (95% CI, ) p=0.14
HR: 0.72 (95% CI, ) p=0.11 8 8 6 6
Probability of recurrent myocardial infarction (%)
Probability of death (%) 4 4 2 2 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12
Months after randomisation
Months after randomisation
*Trials included were: BASKET; di Lorenzo; HAAMU-STENT; MISSION; PASSION; SESAMI; STRATEGY; TYPHOON
Kastrati A, et al. Eur Heart J. 2007;28: 27

28. Probability of stent thrombosis (%) Months after randomisation
Meta-analysis of DES trials in AMI* Similar Low Rates of Stent Thrombosis
DES
BMS 5
HR: 0.80 (95% CI, ) p=0.43 4
2786 patients 3
Probability of stent thrombosis (%) 2 1 1 2 3 4 5 6 7 8 9 10 11 12
Months after randomisation
*Trials included were: BASKET; di Lorenzo; HAAMU-STENT; MISSION; PASSION; SESAMI; STRATEGY; TYPHOON
Kastrati A, et al. Eur Heart J 2007;28:

29. Long-term RCT Data
Support the Use of
CYPHER® Stent in AMI

30. Secondary Endpoints: TLR, TVR, MACE and TVF at 1 year
SESAMI Study Design
Patients >18 years, with symptoms of acute MI for ≥30min but ≤12h and had ≥1mm ST-segment elevation in at least 2 contiguous leads or left bundle-branch block (n=320)
Randomisation
BMS
(n=160)
CYPHER®
(n=160)
Primary Endpoint: binary restenosis at the 1-year angiographic follow-up
Secondary Endpoints: TLR, TVR, MACE and TVF at 1 year
Menichelli M, et al. J Am Coll Cardiol 2007;49:

31. SESAMI at 2 years Significantly Lower TLR and TVR Rates vs BMS
CYPHER®
BMS 17
p<0.05
p=0.022 16
14.0 14
12.7 12 10
8.7
Patients (%) 8
6.0 6 4 2
TLR
TVR
Menichelli M, et al. SESAMI 2 year results. Presented at TCT 2007.

32. SESAMI at 2 years Lower Death and Re-AMI rates vs BMS
CYPHER®
BMS 10
8.0 8
6.0 6
4.7
4.7
Patients (%)
3.3 4
2.7 2
Death
Re-AMI
Stent Thrombosis *
*ARC definitions (Definite/Probable)
Menichelli M, et al. SESAMI 2 year results. Presented at TCT 2007.

33. Inclusion Criteria: STEMI
STRATEGY Study Design
Inclusion Criteria: STEMI
(n = 175)
Randomisation 1:1
abciximab plus
BMS
(n=88)
tirofiban plus
CYPHER®
(n=87)
Primary Endpoint: Freedom, at 8 months after randomisation, from death, non-fatal MI, stroke and binary restenosis
Secondary Endpoints: Freedom, at day 30 and month 8, from major cardiac or cerebrovascular adverse events defined as the composite of death, reinfarction , stroke and repeat TVR
Valgimigli M, et al. JAMA 2005;293(17):

34. STRATEGY Lower 3-Year MACE rates vs BMS
abciximab + BMS
tirofiban + SES 50
41% 40 30
29%
Probability of Events(%) 20
Hazard Ratio 0.64
[95% CI: ]; p=0.089 10
200
400
600
800
1000
1200
1400
Days after Randomization
BMS = bare metal stent, CI = confidence interval, SES = sirolimus-eluting stent, TVR = target vessel revascularization 34

35. STRATEGY Similar Low Rates of Death and MI at 3 Years
abciximab + BMS
tirofiban + SES 50 45 40 35 30
Probability of Events(%) 25
23% 20
20% 15 10
P=0.57 at log rank test 5
200
400
600
800
1000
1200
1400
Days after Randomization
BMS = bare metal stent, SES = sirolimus-eluting stent 35

36. STRATEGY Similar Low Rates of Stent Thrombosis at 3 Years
abciximab + BMS
tirofiban + SES 50 40 30
Probability of Stent Thrombosis
(ARC classification) 20
P=0.76 10
6.8%
5.7%
200
400
600
800
1000
1200
1400
Days after Randomization
BMS = bare metal stent, SES = sirolimus-eluting stent. 36

37. TYPHOON Study Design
Patients Presenting within 12 hours after Onset of Symptoms of a First AMI Requiring Primary PCI of a Native Coronary Artery
Randomisation 1:1
CYPHER® or CYPHER Select® Sirolimus-eluting Stent
(355 patients)
Any Bare-Metal Stent
(357 patients)
Primary Endpoint: Target Vessel Failure (TVF) at 1 Year
Defined as composite of ischaemia-driven Target Vessel Revascularization (TVR), recurrent Myocardial Infarction (MI), or Target Vessel-related Cardiac Death
Angiographic Substudy (200 pts): In-stent Late Loss at 8-Months
Dual APT recommended for  6 months (Clopidogrel: ~ 75% at 6 months and ~ 50% at 12 months)
Spaulding C, et al. N Engl J Med. 2006;355:

38. TYPHOON Death and MI at 3 Year Follow-up
Q and non-Q MI
CYPHER®
BMS
CYPHER®
BMS
100
100 95 95
Freedom of events (%) 90
Freedom of events (%) 90
p=0.69
p=0.99 85 85
Error bars indicate a point-wise two-sided 95% confidence interval ( stand. err.)
Standard Error based on the Greenwood Formula
Error bars indicate a point-wise two-sided 95% confidence interval ( stand. err.)
Standard Error based on the Greenwood Formula 80 80
180
360
540
720
900
1080
180
360
540
720
900
1080
Time (days from initial procedure)
Time (days from initial procedure)
Non adjudicated events
Spaulding C, presented at EuroPCR 2008.

39. TYPHOON Freedom from Revascularisation at 3 Year Follow-up
Revascularisation (PCI, CABG, TVR and non-TVR)
CYPHER®
BMS
100 95 90 85
Freedom of events (%) 80 75 70 65
Error bars indicate a point-wise two-sided 95% confidence interval ( stand. err.)
Standard Error based on the Greenwood Formula
p=0.045 60 60
120
180
200
240
300
360
420
480
540
600
680
720
780
900
960
1,020
1,080
Time (days from initial procedure)
Non adjudicated events
Spaulding C, et al. N Engl J Med. 2006;355:

40. Long-term Registries Data the CYPHER® Stent in AMI
Support the Use of
the CYPHER® Stent in AMI

41. Summary of DES vs. BMS STEMI Registries with Long-term Follow-up
2-year New Jersey State Registry (MIDAS) n = 5,174
Mortality Significantly Favours DES ( )
2-year Massachusetts n = 2,629
Mortality Significantly Favours DES
p=0.002; -2.7% [-4.5%, 0%]
2-year GRACE n = 2,298
Mortality Significantly Favours BMS 8.6% DES vs. 1.6% BMS; p< 0.001
3-year RESEARCH n = 369
No Difference in Mortality 11.5% vs. 13.3%; p=NS
3-year Minnesota Heart n=858
Significant Difference
Favouring SES and PES vs. BMS
in freedom from mortality
4-year Nakamura n = 1,542
No significant differences in mortality between DES and BMS

42. MIDAS NJ State Registry 2-Year Mortality and CV Mortality
Cox Adjusted Hazard Ratios for 2-Year All-Cause and CV Mortality Comparing STEMI Patients with DES to BMS
AMI Setting
DES
BMS
All Cause Mortality
CVD Death
STEMI
141 (n=2,217)
323 (n=2,957)
( )
88 (n=2,217)
191 (n=2,957)
0.67 ( )
N-values refer to number of patients at baseline
Vagonescu T, et al. MIDAS Registry. Presented at TCT 2007.

43. Massachusetts State Registry 2-Year Outcome in Matched MI Patients
BMS
DES
BMS
DES 30
Time after initial procedure (days)
Cumulative incidence (%)
Recurrent MI
180
365
730 30 20 10
DES
2,629 2,604 2,483 2,368 2,263
No. at risk
BMS
2,629 2,592 2,430 2,285 2,192
Death 20
Cumulative incidence (%) 10 30
180
365
730
Time after initial procedure (days)
DES
2,629 2,618 2,550 2,484 2,433
No. at risk
BMS
2,629 2,614 2,512 2,431 2,373
DES
2,629 2,624 2,427 2,243 2,127
No. at risk
BMS
2,629 2,618 2,372 2,091 1,957
Cumulative incidence (%)
Revascularisation
180
365
730 30 20 10
Time after initial procedure (days)
DES
2,629 2,624 2,492 2,380 2,291
No. at risk
BMS
2,629 2,618 2,443 2,250 2,148
Cumulative incidence (%)
TVR
180
365
730 30 20 10
Time after initial procedure (days)
Log Rank P value 0.26
Mauri L, et al. Presented at ACC 2008.

44. GRACE Registry 2-Year Mortality
BMS
DES 20 15
Patients (%)
p<0.0001
p=0.5 10
8.6
3.9 5
2.9
1.6
n=1,729
n=569
n=569
n=1,729
STEMI
NST EMI/UA
*2-year GRACE: note this registry has incomplete follow-up, baseline characteristics were not equal between groups, inclusion criteria are not known and is currently unpublished data
Steg PG, et al. Presented at ESC 2007

45. RESEARCH 3-Year Mortality
3-year Registry
SES
BMS
PES 20
p=NS for all 15
13.3
12.4
11.5
Patients (%) 10 5
n=183
n=186
n=136
RESEARCH
Daemen J, et al. Am J Cardiol. 2007;99:

46. Minnesota Heart Experience 3-Year Mortality
Up to 3-years Registry
1.0
SES
BMS
PES
0.8
0.6
Log-rank test: Overall: p < BMS vs. SES: p < BMS vs. PES: p = SES vs. PES: p =
Survival probability
0.4
0.2
200
400
600
800
1000
1200
Minnesota Heart Experience
Henry T, et al. FDA Panel (FDA.gov).

47. Nakamura 4-year Event-free Survival from MACE*
STEMI Patients
SES
BMS
PES
100 80
p<0.0001 60 40 20 6 12 18 24 30 36 42 48
Time (months)
*Death, MI, CABG, TVR, TVF
Nakamura. Presented at ACC 2007 (i2 Summit).

48. CYPHER® Stent in AMI
Conclusions

49. DES During Primary PCI for AMI
Primary PCI for AMI saves lives
Recommendations:
Reduce door to balloon delays
Proper pharmacological regimen
Perform thromboaspiration
Inject nitrates and assess the size of the artery
“Best candidate” for DES in AMI:
early onset
high risk of restenosis
after thromboaspiration and pre-dilatation
DES if patient’s compliance for double antiplatelet therapy is assured
Spaulding C. Presented at EuroPCR 2008

50. Impact of Thrombus Burden on Mortality after use of DES in STEMI
Large thrombus burden
Small thrombus burden 25 20 15
12.9%
11.6%
Cumulative mortality (%)
12.9%
9.8% 10
7.8%
9.4%
7.2%
6.2% 5
p=0.076
p=0.048
p=0.025
p=0.074 1 3 6 9 12 15 18 21 24
Follow-up (months)
Sianos G, et al. JACC 2007;50:

51. CYPHER® Stent in AMI
Lesion site following plaque rupture is highly pro- inflammatory
The CYPHER® Sirolimus-eluting Stent is proven to reduce inflammation and neointimal hyperplasia
RCTs in AMI show that CYPHER® Stent significantly reduces:
Reintervention risk
Major adverse coronary events
CYPHER® Select Plus Stent obtained CE Mark for the treatment of AMI in July 2008