sirolimus-eluting stents: present and future
DESCRIPTION
Sirolimus-eluting Stents: Present and Future. Dr Steve Fearn Director of Health Economics and Medical Affairs Cordis UK. Conflict of Interest. I am employed by Cordis. Topics. Update of Cypher in STEMI. Update of Cypher in diabetic patients. NEVO™ Sirolimus-eluting Stent. Cypher in STEMI. - PowerPoint PPT PresentationTRANSCRIPT
Sirolimus-eluting Stents:Present and Future
Dr Steve Fearn
Director of Health Economics and Medical Affairs
Cordis UK
Conflict of Interest
I am employed by Cordis.
Topics
Update of Cypher in STEMI.
Update of Cypher in diabetic patients.
NEVO™ Sirolimus-eluting Stent.
Cypher in STEMI
Cypher in STEMI Dataset
• Total of 10 RCTs, 3,639 patients.
9 trials, 2,769 patients
Cypher in STEMI: All-cause Mortality to 12m
Study name Outcome Time point Statistics for each study Events / Total MH odds ratio and 95% CI
MH odds Lower Upper ratio limit limit Cypher BMS
STRATEGY Death 12m 0.88 0.30 2.53 7 / 87 8 / 88
TYPHOON Death 12m 1.01 0.37 2.71 8 / 355 8 / 357
SESAMI Death 12m 0.42 0.11 1.64 3 / 160 7 / 160
MISSION Death 12m 0.47 0.09 2.63 2 / 158 4 / 152
Diaz et al Death 12m 1.37 0.22 8.52 3 / 60 2 / 54
Di Lorenzo Death 12m 0.31 0.08 1.19 3 / 90 9 / 90
BASKET AMI Death 12m 0.47 0.11 1.96 3 / 75 6 / 74
Pasceri et al Death 12m 3.19 0.13 81.25 1 / 32 0 / 33
DEBATER Death 12m 1.16 0.49 2.76 11 / 424 10 / 446
MULTISTRATEGYDeath 8m 0.73 0.33 1.60 11 / 372 15 / 372
0.75 0.52 1.08 52 / 1813 69 / 1826
0.1 0.2 0.5 1 2 5 10
Favours Cypher Favours BMS
Meta Analysis
p (overall effect) = 0.11Heterogeneity (I2) = 0.0%, p = 0.78
RR = 0.76 (95% CI 0.53 to 1.08)
Update of De Luca et al J Thromb Thrombolysis 2009 ; 28: 200-210
Cypher in STEMI: Further MI to 12m
Study name Outcome Time point Statistics for each study Events / Total MH odds ratio and 95% CI
MH odds Lower Upper ratio limit limit Cypher BMS
STRATEGY MI 12m 0.74 0.25 2.23 6 / 87 8 / 88
TYPHOON MI 12m 0.80 0.21 3.01 4 / 355 5 / 357
SESAMI MI 12m 1.00 0.20 5.03 3 / 160 3 / 160
MISSION MI 12m 0.60 0.25 1.42 9 / 158 14 / 152
Diaz et al MI 12m 0.90 0.05 14.72 1 / 60 1 / 54
Di Lorenzo MI 12m 0.55 0.16 1.95 4 / 90 7 / 90
BASKET AMI MI 12m 0.48 0.09 2.70 2 / 75 4 / 74
Pasceri et al MI 12m 0.33 0.01 8.49 0 / 32 1 / 33
DEBATER MI 12m 0.56 0.27 1.15 12 / 424 22 / 446
MULTISTRATEGYMI 8m 0.70 0.33 1.48 12 / 372 17 / 372
0.64 0.45 0.91 53 / 1813 82 / 1826
0.1 0.2 0.5 1 2 5 10
Favours Cypher Favours BMS
Meta Analysis
p (overall effect) = 0.01Heterogeneity (I2) = 0.0%, p = 1.00
RR = 0.65 (95% CI 0.47 to 0.92)
Update of De Luca et al J Thromb Thrombolysis 2009 ; 28: 200-210
Cypher in STEMI: Stent Thrombosis to 12m
Study name Outcome Time point Statistics for each study Events / Total MH odds ratio and 95% CI
MH odds Lower Upper ratio limit limit Cypher BMS
STRATEGY Stent thrombosis12m 0.24 0.03 2.23 1 / 87 4 / 88
TYPHOON Stent thrombosis12m 0.93 0.42 2.06 12 / 355 13 / 357
SESAMI Stent thrombosis12m 2.01 0.18 22.42 2 / 160 1 / 160
MISSION Stent thrombosis12m 0.64 0.10 3.86 2 / 158 3 / 152
Diaz et al Stent thrombosis12m 1.83 0.16 20.74 2 / 60 1 / 54
Di Lorenzo Stent thrombosis12m 0.33 0.01 8.20 0 / 90 1 / 90
BASKET AMI Stent thrombosis12m 1.50 0.24 9.25 3 / 75 2 / 74
DEBATER Stent thrombosis12m 0.99 0.50 1.95 17 / 424 18 / 446
MULTISTRATEGYStent thrombosis8m 0.66 0.29 1.48 10 / 372 15 / 372
0.85 0.58 1.25 49 / 1781 58 / 1793
0.1 0.2 0.5 1 2 5 10
Favours Cypher Favours BMS
Meta Analysis
p (overall effect) = 0.42Heterogeneity (I2) = 0.0%, p = 0.90
RR = 0.86 (95% CI 0.59 to 1.24) Note: Pasceri et al not shown, OR not estimable
Update of De Luca et al J Thromb Thrombolysis 2009 ; 28: 200-210
Cypher in STEMI: TVR to 12m
Study name Outcome Time point Statistics for each study Events / Total MH odds ratio and 95% CI
MH odds Lower Upper ratio limit limit Cypher BMS
STRATEGY TVR 12m 0.29 0.11 0.77 6 / 87 18 / 88
TYPHOON TVR 12m 0.38 0.22 0.66 20 / 355 48 / 357
SESAMI TVR 12m 0.33 0.14 0.77 8 / 160 22 / 160
MISSION TVR 12m 0.35 0.15 0.83 8 / 158 20 / 152
Diaz et al TVR 12m 0.12 0.01 2.41 0 / 60 3 / 54
Di Lorenzo TVR 12m 0.20 0.06 0.74 3 / 90 13 / 90
BASKET AMI TVR 12m 0.52 0.16 1.62 5 / 75 9 / 74
Pasceri et al TVR 12m 0.30 0.06 1.61 2 / 32 6 / 33
DEBATER TVR 12m 0.63 0.38 1.04 26 / 424 42 / 446
MULTISTRATEGYTVR 8m 0.29 0.15 0.57 12 / 372 38 / 372
0.38 0.30 0.50 90 / 1813 219 / 1826
0.1 0.2 0.5 1 2 5 10
Favours Cypher Favours BMS
Meta Analysis
p (overall effect) < 0.0001Heterogeneity (I2) = 0.0%, p = 0.68
RR = 0.42 (95% CI 0.33 to 0.53)
Update of De Luca et al J Thromb Thrombolysis 2009 ; 28: 200-210
Cypher in Diabetic Patients
3-way Meta-analysis
BMS
Cypher Taxus
35 Trials3,852 diabetics
10,947 non-diabetics
16 trials1,413 diabetics 8 trials
915 diabetics
10 trials1,371 diabetics
1 x 3-way trial153 diabetics
Stettler et al BMJ 2008
Restricted network8 trials
800 patients
Cypher in Diabetes: All-cause Mortality
Adapted from Stettler et al BMJ 2008
0.0 0.5 1.0 1.5 2.0
DAPT >/= 6m
All trials 1.14 (0.74 to 1.60)
0.88 (0.55 to 1.30)
Favours Cypher Favours BMS
Hazard Ratio (95% CI)
Cypher in Diabetes: MI
Adapted from Stettler et al BMJ 2008
0.0 0.5 1.0 1.5
DAPT >/= 6m
All trials 0.68 (0.44 to 1.05)
0.68 (0.43 to 1.22)
Favours Cypher Favours BMS
Hazard Ratio (95% CI)
Cypher in Diabetes: ARC Definite Stent Thrombosis
Adapted from Stettler et al BMJ 2008
0.0 0.5 1.0 1.5
DAPT >/= 6m
All trials 0.46 (0.15 to 1.42)
0.33 (0.09 to 1.09)
Favours Cypher Favours BMS
Hazard Ratio (95% CI)
Cypher in Diabetes: TLR
Adapted from Stettler et al BMJ 2008
0.0 0.2 0.4 0.6 0.8 1.0
DAPT >/= 6m
All trials 0.29 (0.22 to 0.39)
0.29 (0.19 to 0.45)
Favours Cypher Favours BMS
Hazard Ratio (95% CI)
Cypher in Diabetes: TLR
Adapted from Stettler et al BMJ 2008
0.0 0.2 0.4 0.6 0.8 1.0
No Diabetes
Diabetes 0.29 (0.19 to 0.45)
0.29 (0.19 to 0.42)
Favours Cypher Favours BMS
Hazard Ratio (95% CI)
Cypher Summary
• Cypher is safe and effective in STEMI and diabetic patients.
• Further MI is reduced in STEMI patients treated with Cypher in year 1.
• Trend to reduction in MI in diabetic patients.
• TLR Treatment effect versus BMS is the same in diabetics and non-diabetics.
Don’t assume any ‘...limus stent’ = a sirolimus stent
NEVO™: Same Drug, New Technology
A sirolimus-eluting stent.
Reservoir technology.
75% less polymer.
Polymer-free after ~90 days.
Cypher-like drug release profile and tissue content.
Flexible and conformable CoCr stent.
Bridge elements
Reservoirs
Ductile Hinges