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CYPHER® Clinical Evidence in Acute Myocardial Infarction (AMI)
The Development of AMI
UnstableAngina
AtheroscleroticPlaque
PlaqueRupture
Spontaneous orPost-Intervention
AcuteMyocardial Infarction
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
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;104:1188-93.
Randomised Trials in AMI Show a Clinical Advantage for
CYPHER® Stent vs BMS
Superiority of CYPHER® Stent in AMI: Randomised Controlled Trials
1. Valgimigli M, et al. JAMA. 2005;293(17):2109-17. 2. Spaulding C, et al. N Engl J Med. 2006;355(11):1093-104. 3. Menichelli M, et al. J Am Coll Cardiol. 2007;49(19):1924-30. 4. Di Lorenzo E, et al. ACC Scientific Sessions 2005. Presentation 2303. 5. 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):618-26. 5. Lee JH, et al. Catheter Cardiovasc Interv. 2008;72(1):25-32. 7. Diaz L, et al. Am Heart J. 2007;154(1):164.e1 – 164.e6. 9. Valgimigli M, et al. JAMA 2008;299(15):1788-99.
Study Comparator Stent
Number of Patients
Late Loss in-stent (mm)
Binary restenosisIn-stent (%)
TLR (%) MACE (%)
STRATEGY1 BMS 175 CYPHER®: -0.22BMS: 0.6
CYPHER®: 7.5BMS: 28
CYPHER®: 6 BMS: 20
CYPHER®: 18 BMS: 32
TYPHOON2 BMS 721 CYPHER®: 0.14BMS: 0.83
CYPHER®: 3.5BMS: 20.3
CYPHER®: 3.7 BMS: 12.6
-
SESAMI3 BMS 320 CYPHER®: 0.18 BMS: 0.85
CYPHER®: 9.3BMS: 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 BMS 217 - -DES: 4.9
BMS: 8.1 (TVR)DES 7.6
BMS: 16.7
MISSION!6 BMS 310 CYPHER®: 0.19 BMS: 0.95
CYPHER®: 2.3 BMS: 22.6
CYPHER®: 3.2 BMS: 11.2
CYPHER®: 13.9 BMS: 26.3
DIAZ7 BMS 120 - - CYPHER®: 0.0 BMS: 5.7 (TVF)
CYPHER®: 6.7 BMS: 11.1
PROSIT8 Taxus 308 CYPHER®: 0.19 Taxus: 0.43
CYPHER®: 5.0 Taxus : 12.0
CYPHER®: 2.6 Taxus : 6.5
CYPHER®: 5.8 Taxus : 11.7
MULTISTRATEGY9 BMS 745 - - CYPHER®: 3.2 BMS: 10.2
CYPHER®: 7.8 BMS: 14.5
TYPHOONStudy Design
Randomisation 1:1
Any Bare-Metal Stent(357 patients)
CYPHER® or CYPHER Select®
Sirolimus-eluting Stent(355 patients)
Patients Presenting within 12 hours after Onset of Symptomsof a First AMI Requiring Primary PCI of a Native Coronary Artery
Primary Endpoint: Target Vessel Failure (TVF) at 1 YearDefined 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;355:1093-104.
TYPHOONLower TVF Risk vs BMS
25
20
10
5
0
Pa
tie
nts
(%
)
15
0
60 120 180 240 300 360Time (days)
3.14.2
7.3
2.8
6.2
14.3
49%p=0.0036*
CYPHER® BMS
1º Endpoint: TVF at 1 year*
* Defined as ischaemia driven TVR, recurrent MI, or target vessel-related cardiac death
Spaulding C, et al. N Engl J Med. 2006;355:1093-104.
Intention-to-Treat Analysis at 1 year
0
5
10
15
20
25
6.8
12.7
N=251N=251
P = 0.034
TYPHOONSignificant Benefit without Angiographic F/U
Spaulding C, et al. PCR 2006
TVF: Intention-to-Treat Analysis at 1 year
CYPHER© BMS
TYPHOONSuperior Clinical Outcomes vs BMS
30
Pa
tie
nts
(%
)
25
15
10
5
20
0
Death
2.3 2.2
p=NS
MI
1.1 1.4
p=NS
TVR
5.6
13.4
p<0.001
TVF*
7.3
14.3
PrimaryEndpoint
p=0.004
Intention-to-Treat Analysis at 1 year
* Defined as ischaemia-driven TVR, recurrent MI, or target vessel-related cardiac death
Spaulding C, et al. N Engl J Med. 2006;355:1093-104.
CYPHER® BMS
Diaz de la LleraStudy Design
Randomisation 1:1
BMSplus abciximab
(60 patients)
CYPHER® Stentplus abciximab
(60 patients)
Consecutive patients with STEMI over the age of 18 years
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.
Diaz de la LleraBetter Event-Free Survival vs BMS at 1 year
1.0
0.8
0.7
Ev
en
t-fr
ee
su
rviv
al
(%)
0.9
360300240180120600
CYPHER© stent 0.0% BMS 5.7%p=0.064
CYPHER© Bare Metal Stents
Days after initial procedure
Secondary endpointSurvival free from TVF
Primary endpoint*Event-free survival at 360 days
93.3
88.9
RR=1.75 (95% CI; 0.47 – 6.57)p=0.402
*Defined as 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.
MISSION!Study Design
Randomisation 1:1
Vision BMS (152 patients)
CYPHER® Stent(158 patients)
Patients with ECG-demonstrated STEMI with symptoms <9h before procedure
Primary Endpoint: In-segment late-lumen loss at 9 months
Refvan der Hoeven BL, et al. J Am Coll Cardiol. 2008;51(6):618-26.
MISSION!Lower Late Loss vs BMS
CYPHER® Stent 37.5%BMS 12.5%p < 0.001
An
gio
gra
ph
ic i
n-s
eg
me
nt
late
lo
ss
(m
m)
0.5
0.3
0.2
0.1
0.4
0
CYPHER© BMS
0.6
0.7
0.8
p<0.001
0.12
0.68
Primary endpointIn-segment late loss (9 months)
Secondary endpointLate stent malapposition at any site
(9 months)
Secondary endpointEvent- free survival (12 months)
CYPHER® Stent 86.0%BMS 73.6%p = 0.01
van der Hoeven BL, et al. J Am Coll Cardiol. 2008;51(6):618-26.
MULTISTRATEGYStudy Design
CYPHER® Stentplus abciximab
(186 patients)
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 12-24 hours
after onset with evidence of continuing ischaemia
Primary Endpoint (drug comparison): 50% recovery at 90 minutes Primary Endpoint (stent comparison): MACE at 8 months
CYPHER® Stentplus tirofiban(186 patients)
BMSplus abciximab
(186 patients)
BMSplus tirofiban(186 patients)
Randomisation 1:1:1:1
Valgimigli M, et al. JAMA. 2008;299(15):1788-99.
MULTISTRATEGYLower MACE* Rates vs BMS
20
10
5
0
15
60 100
160
180
200
260Days after randomisation
7.8%
14.5%
20 40 80 120
220
240
140
CYPHER® BMS
Uncoated Stent 372 351 342 326 318
CYPHER Stent 372 355 351 347 343
MA
CE
* (%
)
No. at risk
Adjusted HR: 0.53 (97.5% CI: 0.33-0.83); p=0.006p=0.0039 at Log-rank test
0
Valgimigli M, et al. JAMA. 2008;299(15):1788-99.
No prespecified angiographic F/U
Broad inclusion criteria
Dual APT recommended for ≥ 3 months(Clopidogrel: ~ 90% at 1 month and ~ 20% at 8 months)
*Death, MI, or TVR
CYPHER® Stent vs BMS: No difference in Stent Thrombosis Summary of CYPHER® Stent vs BMS Trials
Pa
tie
nts
(%
)
10
6
4
2
MULTISTRATEGY
2.7
8-month
Diaz
3.4
1.8
MISSION
1.32.0
TYPHOON
3.4 3.6
SESAMI
4.7
6.0
STRATEGY
1.2
4.6
8
0
1-year 1-year 1-year 2-year 2-year
4.0
Definitions of ST vary by trial: ARC Def/Probable used when possible
Dual APTRecommendation
n=745
3 months
n=120
9 months
n=308
12 months
n=712
6 months
n=320
12 months
n=175
6 months
p=NS for all trialsCYPHER® BMS
Randomised Trials in AMI Show a Clinical Advantage for
CYPHER® Stent vs Taxus®
Taxus in AMIPASSION Study Design
Randomisation 1:1
BMS(n=310)
Taxus Express2 or Liberte Stent(n=309)
STEMI patients with chest pain > 20mn and ST-elevation in ≥2 contiguous leads; infarct related artery with a de novo lesion
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;355:1105-13.
Not all DES are created equal: PASSION Primary Endpoint* at 1 Year Follow-up Not Met
MA
CE
(%
)
10
0 120 240 360
5
0
Taxus BMS
Laarman, GJ et al. N Engl J Med. 2006;355:1105-13.
Days
PRIMARY ENDPOINT NOT ACHIEVEDHR=0.68 (0.41-1.10)
p=0.12
8.7
12.6No prespecified angiographic F/U
Dual APT recommended for ≥ 6 months (Clopidogrel: Median Duration of 9 months)
*Cardiac Death, MI, or TLR
Not all DES are created equal: PASSION 2-Year Outcomes
p =0.12
p =0.32
p=0.09
OR 0.70 (95% CI: 0.45-1.09)
OR 0.78 (95% CI: 0.41-1.44)
OR 0.60(95% CI: 0.34-1.09)
Dirksen MT. Presented at ESC 2007.
15.4
7.2
9.911.1
5.6 6.0
0
5
10
15
20
MACE Cardiac Death TLR
% o
f P
ati
en
ts
Taxus BMS
PROSITStudy Design
Acute STEMI 12 hrs or persistent ischaemia 12-24 hrs (n = 231)
Randomisation 1:1
CYPHER®
(n=116)
Taxus(n=115)
Primary Endpoint: In-segment late loss at 6 months
Secondary Endpoints: MACE at 30 days and 9 months andangiographic in-segment restenosis at 6 months
Lee JH, et al. Catheter Cardiovasc Interv. 2008;72(1):25-32.
PROSITSuperior Angiographic Outcomes vs Taxus
CYPHER© Taxus
In-segment Late Loss(6 months)
p=0.002
0.33
La
te L
os
s (
mm
)
0.3
0.2
0.1
0
0.09
0.4
0.5
In-segmentCYPHER® 5.9%Taxus 14.8%p= 0.03
In-stentCYPHER® 5.0%Taxus 12.0%p= 0.09
Lee JH, et al. Catheter Cardiovasc Interv. 2008;72(1):25-32.
Other endpointsAngiographic binary restenosis
(6 months)
PROSITImproved Clinical Outcome (MACE & TLR) vs Taxus
CYPHER© Taxus
MACE(12 months)
P=0.07
11.7
Pa
tie
nts
(%
)
15
10
5
0
5.8
20
TLR(12 months)
P=0.17
6.5
Pa
tie
nts
(%
)
7.5
5
2.5
0
2.6
10
Lee JH, et al. Catheter Cardiovasc Interv. 2008;72(1):25-32.
Meta-analyses Confirm the Value of DES in AMI
Meta-analysis of DES trials in AMI DES vs BMS in STEMI Patients1
Study No. of patients
Mean age (years)
Typeof DES Primary endpoint
Length of thienopyridine
therapy (months)
Mean length of follow-up (months)
BASKET-AMI2 216 62.2 PESSES
Cardiac death, myocardial infarction, or reintervention 6 18.0
Di Lorenzo3 270 64.0 PESSES
Death, myocardial infarction, or reintervention 6 12.0
HAAMU-STENT4 164 63.0 PES Angiographic late lumen loss 12 16.7
MISSION5 310 59.2 SES Angiographic late lumen loss 12 12.0
PASSION6 619 60.8 PES Cardiac death, myocardial infarction, or reintervention 6 12.0
SESAMI7 320 61.6 SES Angiographic binary restenosis 12 12.3
STRATEGY8 175 62.6 SESDeath, myocardial infarction,
stroke, or angiographic binary restenosis
3 24.2
TYPHOON9 712 59.3 SES Cardiac death, myocardial infarction, or reintervention 6 12.1
1. Kastrati A, et al. Eur Heart J. 2007;28:2706-2713. 2. Pittl C, et al. Eur Heart J. 2006;27:650 (abstract suppl). 3. Di Lorenzo E, et al. ACC Scientific Sessions 2005. Presentation 2303. 4. HAAMU-STENT trial. Available at wwwcardiosourcecom/pops/trialSumasp?trialID=1492. Accessed 5 March 2007. 5. van der Hoeven BL, et al. J Am Coll Cardiol. 2008;51(6):618-26. 6. Laarman GJ et al. N Engl J Med. 2006; 355:1105-13. 7. Menichelli M, et al. J Am Coll Cardiol. 2007;49(19):1924-30. 8. Valgimigli M, et al. JAMA. 2005;293(17):2109-17. 9. Spaulding C, et al. N Engl J Med. 2006;355(11):1093-104.
Meta-analysis of DES trials in AMI*Lower Rate of Reintervention with DES
20
10
5
Pro
ba
bil
ity
of
rein
terv
en
tio
n (
%)
15
0
11 12Months after randomization
109876543210
2786 patients
DES BMS
HR: 0.38 (95% CI, 0.29–0.50)p< 0.001
*Trials included were:BASKET; di Lorenzo; HAAMU-STENT; MISSION;
PASSION; SESAMI; STRATEGY; TYPHOON Kastrati A, et al. Eur Heart J. 2007;28:2706-2713.
Meta-analysis of DES trials in AMI*Similar Low Rates of Death, Recurrent MI
10
Pro
ba
bil
ity
of
de
ath
(%
) 8
4
6
2
0
HR: 0.76 (95% CI, 0.53-1.10)p=0.14
Months after randomisation0 1 2 3 4 5 6 7 8 9 10 11 12
10
8
4
6
2
0
HR: 0.72 (95% CI, 0.48-1.08)p=0.11
Months after randomisation0 1 2 3 4 5 6 7 8 9 10 11 12
Pro
ba
bil
ity
of
rec
urr
en
tm
yo
ca
rdia
l in
farc
tio
n (
%)
*Trials included were:BASKET; di Lorenzo; HAAMU-STENT; MISSION;
PASSION; SESAMI; STRATEGY; TYPHOON
DES BMSDES BMS
Kastrati A, et al. Eur Heart J. 2007;28:2706-2713.
Meta-analysis of DES trials in AMI*Similar Low Rates of Stent Thrombosis
5
4
2
1
0
Pro
ba
bil
ity
of
ste
nt
thro
mb
os
is (
%)
3
0
1 2 4 8 11 12Months after randomisation
DES BMS
106 9753
2786 patients
*Trials included were:BASKET; di Lorenzo; HAAMU-STENT; MISSION;
PASSION; SESAMI; STRATEGY; TYPHOON
HR: 0.80 (95% CI, 0.46-1.39)p=0.43
Kastrati A, et al. Eur Heart J 2007;28:2706-2713.
Long-term RCT Data Support the Use of
CYPHER® Stent in AMI
SESAMIStudy Design
Randomisation
CYPHER®
(n=160)
BMS(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;49:1924-1930.
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)
SESAMI at 2 yearsSignificantly Lower TLR and TVR Rates vs BMS
Pa
tie
nts
(%
) 10
6
4
2
TLR TVR
8
0
CYPHER® BMS
12
14
16
p<0.05
Menichelli M, et al. SESAMI 2 year results. Presented at TCT 2007.
p=0.022
12.7
8.7
6.0
14.0
17
SESAMI at 2 yearsLower Death and Re-AMI rates vs BMS
Pa
tie
nts
(%
)
10
6
4
2
Death Re-AMI
8
0
CYPHER® BMS
Menichelli M, et al. SESAMI 2 year results. Presented at TCT 2007.
8.0
2.7
4.73.3
Stent Thrombosis *
*ARC definitions (Definite/Probable)
4.7
6.0
STRATEGYStudy Design
Randomisation 1:1
tirofiban plusCYPHER®
(n=87)
abciximab plusBMS
(n=88)
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):2109-2117
Inclusion Criteria: STEMI(n = 175)
50
40
20
10
0
30
0
200 400 600 1000 14001200800
BMS = bare metal stent, CI = confidence interval, SES = sirolimus-eluting stent, TVR = target vessel revascularization
STRATEGYLower 3-Year MACE rates vs BMS
Pro
ba
bil
ity
of
Ev
en
ts(%
)
Days after Randomization
tirofiban + SESabciximab + BMS
Hazard Ratio 0.64[95% CI: 0.39-1.07]; p=0.089
41%
29%
50
40
20
10
0
30
0
200 400 600 1000 14001200800
BMS = bare metal stent, SES = sirolimus-eluting stent
STRATEGYSimilar Low Rates of Death and MI at 3 Years
Pro
ba
bil
ity
of
Ev
en
ts(%
)
Days after Randomization
tirofiban + SESabciximab + BMS
P=0.57 at log rank test5
15
25
35
45
23%20%
50
40
20
10
0
30
0
200 400 600 1000 14001200800
BMS = bare metal stent, SES = sirolimus-eluting stent.
STRATEGYSimilar Low Rates of Stent Thrombosis at 3 Years
Pro
ba
bil
ity
of
Ste
nt
Th
rom
bo
sis
(AR
C c
las
sif
ica
tio
n)
Days after Randomization
tirofiban + SESabciximab + BMS
P=0.76
6.8%5.7%
TYPHOONStudy Design
Randomisation 1:1
Any Bare-Metal Stent(357 patients)
CYPHER® or CYPHER Select®
Sirolimus-eluting Stent(355 patients)
Patients Presenting within 12 hours after Onset of Symptomsof a First AMI Requiring Primary PCI of a Native Coronary Artery
Primary Endpoint: Target Vessel Failure (TVF) at 1 YearDefined 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;355:1093-104.
TYPHOONDeath and MI at 3 Year Follow-up
100
90
80
95
85
p=0.69
CYPHER®
Death
BMS
Time (days from initial procedure)
Fre
ed
om
of
ev
en
ts (
%)
100
90
80
95
85
p=0.99
CYPHER® BMS
Time (days from initial procedure)
Fre
ed
om
of
ev
en
ts (
%)
Q and non-Q MI
Non adjudicated events
Error bars indicate a point-wise two-sided 95% confidence interval (1.98 + stand. err.)Standard Error based on the Greenwood Formula
Error bars indicate a point-wise two-sided 95% confidence interval (1.98 + stand. err.)Standard Error based on the Greenwood Formula
0 180 360 540 720 900 1080 0 180 360 540 720 900 1080
Spaulding C, presented at EuroPCR 2008.
TYPHOONFreedom from Revascularisation at 3 Year Follow-up
Non adjudicated events
100
80
70
0
Fre
ed
om
of
ev
en
ts (
%)
90
60
120 200 300 540 900 1,080Time (days from initial procedure)
p=0.045
BMSCYPHER®
680420
65
75
85
95
Error bars indicate a point-wise two-sided 95% confidence interval (1.98 + stand. err.)Standard Error based on the Greenwood Formula
60 180 240 360 480 600 720 780 960 1,020
Revascularisation (PCI, CABG, TVR and non-TVR)
Spaulding C, et al. N Engl J Med. 2006;355:1093-104.
Long-term Registries Data Support the Use of
the CYPHER® Stent in AMI
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 DES0.60 (0.50-0.73)
2-year Massachusetts
n = 2,629
Mortality Significantly Favours DESp=0.002; -2.7% [-4.5%, 0%]
2-year GRACE
n = 2,298
Mortality Significantly Favours BMS8.6% DES vs. 1.6% BMS; p< 0.001
3-year RESEARCH
n = 369
No Difference in Mortality11.5% vs. 13.3%; p=NS
3-year Minnesota Heart
n=858
Significant Difference Favouring SES and PES vs. BMS
in freedom from mortality
4-yearNakamuran = 1,542
No significant differences in mortality between DES and BMS
MIDAS NJ State Registry2-Year Mortality and CV Mortality
AMI Setting DES BMS All Cause Mortality DES BMS CVD Death
STEMI 141(n=2,217)
323(n=2,957)
0.60 (0.50-0.73)
88(n=2,217)
191(n=2,957)
0.67(0.52-0.86)
Cox Adjusted Hazard Ratios for 2-Year All-Cause and CV Mortality Comparing STEMI Patients with DES to BMS
N-values refer to number of patients at baseline
Vagonescu T, et al. MIDAS Registry. Presented at TCT 2007.
Massachusetts State Registry 2-Year Outcome in Matched MI Patients
BMS DES
Time after initial procedure (days)
Cu
mu
lati
ve
in
cid
en
ce
(%)
Death
0 180 365 730
30
20
10
030
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
Cu
mu
lati
ve
in
cid
en
ce
(%)
Revascularisation
0 180 365 730
30
20
10
030
Time after initial procedure (days)
BMS DES
Time after initial procedure (days)
Cu
mu
lati
ve
in
cid
en
ce
(%)
Recurrent MI
0 180 365 730
30
20
10
030
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
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
Cu
mu
lati
ve
in
cid
en
ce
(%)
TVR
0 180 365 730
30
20
10
030
Time after initial procedure (days)
Mauri L, et al. Presented at ACC 2008.
GRACE Registry 2-Year Mortality
Steg PG, et al. Presented at ESC 2007
Pa
tie
nts
(%
)
p<0.0001
15
10
5
STEMI
1.6
NST EMI/UA
3.92.9
20
0
8.6
DESBMS
p=0.5
n=1,729 n=569 n=569 n=1,729
*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
RESEARCH3-Year Mortality
Daemen J, et al. Am J Cardiol. 2007;99:1027-32.
Pa
tie
nts
(%
)
15
10
5
RESEARCH
11.512.4
20
0
13.3
n=183 n=186 n=136
p=NS for all
3-year Registry
SES BMS PES
Minnesota Heart Experience
3-Year Mortality
Henry T, et al. FDA Panel (FDA.gov). Minnesota Heart Experience
Up to 3-years Registry
Log-rank test:Overall: p < 0.0001BMS vs. SES: p < 0.0001BMS vs. PES: p = 0.002SES vs. PES: p = 0.1924S
urv
iva
l p
rob
ab
ilit
y
0.8
0.6
0.2
1.0
0
0.4
0 200 400 600 800 1000 1200
SES
BMS
PES
Nakamura4-year Event-free Survival from MACE*
100
60
40
20
0
80
0
Time (months) 6 1
218
24
30
36
42
48
p<0.0001
Nakamura. Presented at ACC 2007 (i2 Summit).
SES BMS PES
STEMI Patients
*Death, MI, CABG, TVR, TVF
CYPHER® Stent in AMIConclusions
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
Impact of Thrombus Burden on Mortalityafter use of DES in STEMI
25
Cu
mu
lati
ve m
ort
alit
y (%
)
15
10
5
0
9.8%
p=0.076
20
0
Follow-up (months)
1 3 6 9 12
15
18
21
24
p=0.074p=0.025p=0.048
6.2%
11.6%
7.2%
12.9%
7.8%
12.9%
9.4%
Large thrombus burden Small thrombus burden
Sianos G, et al. JACC 2007;50:573-83.
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
Recommended