Cairo University
The use of DES or BMS in pts
undergoing primary PCI had been an
unanswered question in the past few years.
Stent thrombosis, a major safety
concern, remains elusive and problematic
event.
‣ Evidence from RCTs
‣ Safety as regards stent thrombosis
‣ 8 randomized trials DES vs BMS
‣ 2,786 patients with STEMI
‣ Follow-up 12.0-24.22 months
‣ Primary efficacy endpoint: TLR
‣ Primary safety endpoint: Stent thrombosis
Kastrati A et al: Euro Heart J 2007; 28:2706-2713
Mean
DUAL
Patients age Type therapy F-U
Study (no.) (yr) of DES (mo) (mo)
BASKET-AMI 216 62.2 PES 6 18.0
SES
Di Lorenzo 270 64.0 PES 6 12.0
SES
HAAMU-STENT 164 63.0 PES 12 16.7
MISSION 310 59.2 SES 12 12.0
PASSION 619 60.8 PES 6 12.0
SESAMI 320 61.6 SES 12 12.3
STRATEGY 175 62.6 SES 3 24.2
TYPHOON 712 59.3 SES 6 12.1
Kastrati A et al: Eur Heart J 28:2706, 2007
CP1299198-1
DES
BMS
P =0.006 P
DES
BMS
All P = NS
8.0%
9.0%
65% 6.5%
4.3%
4.6%
2.3% 2.2%
1.8%
STRATEGY 8 mo
(n = 175)
TYPHOON 12 mo
(n = 700)
SESAMI 12 mo
(n = 320)
PASSION 12 mo
(n = 619)
• Evidence from RCTs
• Safety as regards stent t thrombosis
s
10
DES
BMS\
Cumu lative incid dence (%)
8
6 p = 0.511
4
2
0
0 200 400 600 800 1000 1200
Kereiakes DJ. ACC 2010
Days
10
DES
BMS
Cumu lative incid dence (%)
8
6 p
4
2
p = 0.296
0
0 200 400 600 800 1000 1200
Kereiakes DJ. ACC 2010
Days
Group Rate of MACE (%)
Number DES BMS
All 626 11.5 18.2
Age < 63 315 9.4 19.4
Age 63 311 13.7 17.1
Male 458 11.8 16.1
Female 168 10.6 24.1
Diabetes mellitus 65 13.8 22.2
No diabetes mellitus 561 11.3 17.7
Ref D > 3.1 mm 317 9.6 15.6
Ref D 31mm 3.1 299 12.0 20.8
Visible thrombus 458 11.6 15.9
No visible thrombus 168 11.1 24.1
Stent length > 18 mm 309 12.9 17.8
Stent length 18 mm 310 9.5 17.9
LAD 258 14.8 20.6
CX/RCA 368 9.4 16.4
Kereiakes DJ. ACC 2010
DES
better
Odds Ratio (95% CI)
0 0.5 1.0 0.5 2.0
BMS
better
Group Rate of MACE (%)
Number DES BMS
All 626 11.5 18.2
Age < 63 315 9.4 19.4
Age 63 311 13.7 17.1
Male 458 11.8 16.1
Female 168 10.6 24.1
Diabetes mellitus 65 13.8 22.2
No diabetes mellitus 561 11.3 17.77
Ref D > 3.1 mm 317 9.6 15.6
Ref D 3.1 mm 299 12.0 20.8
Visible thrombus 458 11.6 15.9
No visible thrombus 168 11.1 24.1
Stent length > 18 mm 309 12.9 17.8
Stent length 18 mm 310 9.5 17.9
LAD 258 14.8 20.6
CX/RCA 368 9.4 16.4
Kereiakes DJ. ACC 2010
DES
better
Odds Ratio (95% CI)
0 0.5 1.0 0.5 2.0
BMS
better
Group Rate of MACE (%)
Number DES BMS
All 626 11.5 18.2
Age < 63 315 94 9.4 19.4
Age 63 311 13.7 17.1
Male 458 11.8 16.1
Female 168 10.6 24.1
Diabetes mellitus 65 13.8 22.2
No diabetes mellitus 561 11.3 17.7
Ref D > 3.1 mm 317 9.6 15.6
Ref D 3.1 mm 299 12.0 20.8
Visible thrombus 458 11.6 15.9
No visible thrombus 168 11.1 24.1
Stent length > 18 mm 309 12.9 17.8
Stent length 18 mm 310 95 9.5 17.9
LAD 258 14.8 20.6
CX/RCA 368 9.4 16.4
Kereiakes DJ. ACC 2010
Odds Ratio (95% CI)
DES
0 05 0.5 10 1.0 05 0.5 20 2.0
better
BMS
better
Group Rate of MACE (%)
Number DES BMS
All 626 11.5 18.2
Age < 63 315 9.4 19.4
Age 63 311 13.7 17.1
Male 458 11.8 16.11
Female 168 10.6 24.1
Diabetes mellitus 65 13.8 22.2
No diabetes mellitus 561 11.3 17.77
Ref D > 3.1 mm 317 9.6 15.6
Ref D 3.1 mm 299 12.0 20.8
Visible thrombus 458 11.6 15.9
No visible thrombus 168 11.1 24.1
Stent length > 18 mm 309 12.9 17.8
Stent length 18 mm 310 9.5 17.9
LAD 258 14.8 20.6
CX/RCA 368 9.4 16.4
Odds Ratio (95% CI)
Kereiakes DJ. ACC 2010 DES 0 0.5 1.0 0.5 2.0
better
BMS
better
The safety and efficacy of CYPHER ® in AMI is
supported by comprehensive clinical evidence
De Luca meta-analysis:
Involving 9 clinical i l ti trials with 2769 patients
t
randomised to CYPHER or BMS.
The safety and efficacy of CYPHER was
compared with BMS.
The outcome in patients with STEMI was
examined.
De Luca, G., et al. J Thromb Thrombolysis 2009;28:200-10.
CYPHER ® shows a trend towards reduced Re-MI vs.
BMS in AMI
Re-MI occurrence with CYPHER Select ® Plus vs. BMS: 3.0% vs. 4.3% (p = 0.06),
at 1 year
Study name
STRATEGY
TYPHOON
SESAMI
MISSION
Diaz et al
Di Lorenzo
Outco
me
Re-MI
Re-MI
Re-MI
Re-MI
Re-MI
Re-MI
BASKET AMI
Re-MI
Pasceri et al
MULTISTRATE
GY
Re-MI
Time
point
12
months
12
months
12
months
12
months
12
months
12
months
12
months
12
months
Statistics for each study
MH odds
ratio
Lower
limit
Upper
limit
Events/total
CYPHE
R ®
BMS
0.88 0.30 2.53 7/87 8/88
0.80 0.21 3.01 4/355 5/357
1.00 0.20 5.03 3/160 3/160
0.60 0.25 1.42 9/158 14/152
0.90 0.05 14.72 1/60 1/54
0.55 0.16 1.95 4/90 7/90
048 0.48 009 0.09 270 2.70 2/75 4/74
0.33 0.01 8.49 0/32 1/33
Re-MI 8 months 070 0.70 033 0.33 148 1.48 12/372 17/372
0.68 0.46 1.02 43/1389 60/1380
MH odds ratio and 95% CI
0.1 0.2 0.5 1 2 5 10
Favours CYPHER Select ® Plus Favours BMS
p (overall effect) = 0.06
Heterogeneity (I 2 ) = 0.0%
RR = 0.70 (95% CI 0.48 to 1.02) Adapted from De Luca, G., et al. J Thromb Thrombolysis 2009;28:200-10.
CYPHER ® and BMS demonstrate similar incidence
of stent thrombosis in AMI
No difference in ST with CYPHER Select ® Plus vs. BMS at 12 months
Study name
STRATEGY
TYPHOON
SESAMI
MISSION
Diaz et al
Di Lorenzo
BASKET AMI
MULTISTRATE
GY
Outco
me
ST
ST
ST
ST
ST
ST
ST
p (overall effect) = 0.60
Heterogeneity (I 2 ) = 0.0%
RR = 0.88 (95% CI 0.55 to 1.42)
Time
point
12
months
12
months
12
months
12
months
12
months
12
months
12
months
Statistics for each study
MH odds Lower Upper CYPHE
ratio limit limit R
®
Events/total
BMS
0.20 0.01 4.18 0/87 2/88
0.93 0.42 2.06 12/355 13/357
2.01 0.18 22.42 2/160 1/160
0.64 0.10 3.86 2/158 3/152
1.83 0.16 20.74 2/60 1/54
0.33 0.01 8.20 0/90 1/90
1.50 0.24 9.25 3/75 2/74
ST 8 months 0.81 0.33 1.99 9/372 11/372
0.88 0.54 1.43 30/1389 34/1380
MH odds ratio and 95% CI
0.1 0.2 0.5 1 2 5 10
Favours CYPHER Select ® Plus
Favours BMS
Adapted from De Luca, G., et al. J Thromb Thrombolysis 2009;28:200-10.
CYPHER ® shows superior efficacy vs.
BMS demonstrated by lower TVR rates
There was a 64% reduction in TVR with CYPHER Select ® Plus vs. BMS at 1 year
Study name
Outcom
e
Time
point
Statistics for each study
Events/total
STRATEGY
TVR
12
months
MH odds
ratio
Lower
limit
Upper
limit
CYPHER ®
BMS
0.32 0.13 0.78 8/87 21/88
MH odds ratio and 95% CI
TYPHOON
TVR
12
months
0.38 0.22 0.66 20/355 48/357
SESAMI
TVR
12
months
0.32 0.13 0.78 7/160 20/160
MISSION
TVR
12
months
0.26 0.09 0.72 5/158 17/152
Diaz et al
TVR
12
months
0.12 0.01 2.41 0/60 3/54
Di Lorenzo
TVR
12
months
020 0.20 006 0.06 074 0.74 3/90 13/90
BASKET AMI
TVR
12
months
0.52 0.16 1.62 5/75 9/74
Pasceri et al
TVR
12
months
0.30 0.06 1.61 2/32 6/33
0.1 0.2 0.5 1 2 5 10
MULTISTRAT
EGY
TVR 8 months 0.29 0.15 0.57 12/372 38/372
Favours CYPHER Select ® Plus
Favours BMS
p (overall effect) < 0.001
Heterogeneity (I 2 ) = 0.0%
RR = 0.36 (95% CI 0.27 to 0.47)
0.32 0.24 0.43 62/1389 175/1380
Adapted from De Luca, G., et al. J Thromb Thrombolysis 2009;28:200-10.
CYPHER ® demonstrates an advantage in longterm
mortality rates vs. BMS in AMI
A trend towards better mortality rates with CYPHER Select ® Plus vs.
BMS at 2–3 years
Study name
Outco
me
Time
point
Statistics for each study
Events/total
MH odds ratio and 95% CI
MH
odds
ratio
Lower Upper CYPHE
limit limit R ® BMS
BASKET AMI
Death
36
months
0.47 0.11 1.96 3/75 6/74
Pasceri et al
Death
36
months
319 3.19 013 0.13 81.25 1/32 0/33
STRATEGY
Di Lorenzo
Death
Death
24
months
24
months
0.82 0.34 2.02 10/87 12/88
0.1 0.2 0.5 1 2 5 10
0.42 0.12 1.41 4/90 9/90 Favours CYPHER Select ® Plus Favours BMS
p (overall effect) = 0.17
Heterogeneity (I 2 ) = 0.0%
RR = 0.68 (95% CI 0.39 to 1.19)
0.65 0.35 1.20 18/284 27/285
Adapted from De Luca, G., et al. J Thromb Thrombolysis 2009;28:200-10.
Safety and efficacy of CYPHER ® in AMI vs.
BMS is confirmed at 5 years
TVR to 5 years
STRATEGY confirms long-term
superior efficacy of
CYPHER Select ® Plus vs. BMS
No difference in safety risk vs.
BMS at 5-years follow-up in
STEMI patients
Penzo C. Oral presentation on the STRATEGY Study EuroPCR 2009.
‣ Rapid restoration of blood by 1ry PCI is the
most important factor determining the clinical
outcome after STEMI.
‣ DES use in pts with STEMI reduces the rate of
MACE when compared with BMS.
‣ The rate of stent t thrombosis is not significantly
ifi higher in pts with DES and is balanced by the
reduction in events associated with decrease
TLR.
‣ Avoid the use of DES in non complaint pts or
those likely to need surgery in less than one
year.
Change language