cypher endeavor stent
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CYPHER STENTCYPHER STENT
Interventional ConferenceInterventional Conference
How does it work?How does it work?
PathwayPathway
Stent DesignStent Design
Drug DiffusionDrug Diffusion
SIRIUSSIRIUS
Higher rate of incomplete stent Higher rate of incomplete stent apposition (18% vs 9%), but no apposition (18% vs 9%), but no clinical eventsclinical events
No difference in stent thrombosis No difference in stent thrombosis (0.8% in both group)(0.8% in both group)
5 yr followup5 yr followup
Pooled Analysis of 5-Year Follow-Up From 4
Randomized, Controlled CYPHER® vs. Bare-Metal
Stent Trials
The CYPHERThe CYPHER®® Stent Trials: Methodology Stent Trials: Methodology
Patient-level databases of pivotal RCTs were obtained from Patient-level databases of pivotal RCTs were obtained from Cordis Corporation by the Cardiovascular Research Cordis Corporation by the Cardiovascular Research Foundation with permission for unrestricted analysesFoundation with permission for unrestricted analyses RAVEL, SIRIUS, E-SIRIUS, C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, C-SIRIUS
5-year data available for all trials5-year data available for all trials
Analysis Plan (performed by M. Fahy, Sr. Biostatistician)Analysis Plan (performed by M. Fahy, Sr. Biostatistician) EndpointsEndpoints
Safety:Safety: Death (overall, cardiac, non-cardiac); MI (all, QWMI); compositesDeath (overall, cardiac, non-cardiac); MI (all, QWMI); composites Stent thrombosis: ARC definitions; per protocolStent thrombosis: ARC definitions; per protocol
Efficacy:Efficacy: TLR and TVR TLR and TVR
Survival analyses utilizedSurvival analyses utilized to maximally utilize all available FU to maximally utilize all available FU information, compared by log-rank test (exact LR if <5 events)information, compared by log-rank test (exact LR if <5 events)
Kirtane A.J., et al., TCT 2007; Oral Presentation.
Death through 5 years:Death through 5 years:Pooled Analysis of 4 SES vs. BMS RCT’s*Pooled Analysis of 4 SES vs. BMS RCT’s*
0%
5%
10%
15%
20%
0 365 730 1095 1460 1825
DaysNumber at risk
BMS
CYPHER
870
878
857
863
843
842
824
817
795
792
694
703
* RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS
HR 1.10 [0.79,1.52]
p=0.578.9% (76)
8.2% (69)
Kirtane A.J., et al., TCT 2007; Oral Presentation.
CYPHER Stent (n=878)Bare Metal Stent (n=870)CYPHER Stent (n=878)Bare Metal Stent (n=870)
DaysNumber at risk
BMS
CYPHER
870
878
857
863
843
842
824
817
795
792
694
703
HR 1.16 [0.72,1.85]
p=0.55
4.4% (37)3.9% (32)
0%
5%
10%
15%
20%
0 365 730 1095 1460 1825
Kirtane A.J., et al., TCT 2007; Oral Presentation.* RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS
CYPHER Stent (n=878)Bare Metal Stent (n=870)CYPHER Stent (n=878)Bare Metal Stent (n=870)
Cardiac Death through 5 years:Cardiac Death through 5 years:Pooled Analysis of 4 SES vs. BMS RCT’s*Pooled Analysis of 4 SES vs. BMS RCT’s*
DaysBMS
CYPHER
868
873
824
832
806
807
782
779
751
751
652
660
Number at risk
HR 1.15 [0.81,1.63]
p=0.44
7.9% (67)
6.8% (58)
0%
5%
10%
15%
20%
0 365 730 1095 1460 1825
Kirtane A.J., et al., TCT 2007; Oral Presentation.* RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS
Myocardial Infarction (MI) through 5 years:Myocardial Infarction (MI) through 5 years:Pooled Analysis of 4 SES vs. BMS RCT’s*Pooled Analysis of 4 SES vs. BMS RCT’s*
CYPHER Stent (n=878)Bare Metal Stent (n=870)CYPHER Stent (n=878)Bare Metal Stent (n=870)
DaysBMS
CYPHER
869
877
852
854
837
832
816
804
786
780
685
693
Number at risk
HR 1.54 [0.77,3.09]
p=0.22
2.4% (20)1.6% (13)
0%
5%
10%
15%
20%
0 365 730 1095 1460 1825
Kirtane A.J., et al., TCT 2007; Oral Presentation.* RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS
Q-wave MI through 5 years:Q-wave MI through 5 years:Pooled Analysis of 4 SES vs. BMS RCT’s*Pooled Analysis of 4 SES vs. BMS RCT’s*
CYPHER Stent (n=878)Bare Metal Stent (n=870)CYPHER Stent (n=878)Bare Metal Stent (n=870)
DaysNumber at risk
BMS
CYPHER
868
873
824
832
806
807
782
779
751
751
652
660
HR 1.12 [0.88,1.45]
p=0.36
15.1% (130)
13.6% (115)
0%
5%
10%
15%
20%
0 365 730 1095 1460 1825
Kirtane A.J., et al., TCT 2007; Oral Presentation.* RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS
Death or MI through 5 years:Death or MI through 5 years:Pooled Analysis of 4 SES vs. BMS RCT’s*Pooled Analysis of 4 SES vs. BMS RCT’s*
CYPHER Stent (n=878)Bare Metal Stent (n=870)CYPHER Stent (n=878)Bare Metal Stent (n=870)
DaysNumber at risk
BMS
CYPHER
868
873
824
832
806
807
782
779
751
751
652
660
HR 1.13 [0.84,1.51]
p=0.4311.1% (94)9.8% (83)
0%
5%
10%
15%
20%
0 365 730 1095 1460 1825
Kirtane A.J., et al., TCT 2007; Oral Presentation.* RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS
Cardiac Death or MI through 5 years:Cardiac Death or MI through 5 years:Pooled Analysis of 4 SES vs. BMS RCT’s*Pooled Analysis of 4 SES vs. BMS RCT’s*
CYPHER Stent (n=878)Bare Metal Stent (n=870)CYPHER Stent (n=878)Bare Metal Stent (n=870)
DaysNumber at risk
BMS
CYPHER
870
878
853
858
839
836
820
811
791
785
690
697
Protocol ST Definitions do not count ST after intervening TLR
HR 2.19 [0.76,6.32]
p=0.131.3% (11)
0.6% (5)
0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
3.0%
0 365 730 1095 1460 1825
6 vs. 0, p=0.02After 1 yearAfter 1 year
Kirtane A.J., et al., TCT 2007; Oral Presentation.
Protocol-defined ST through 5 years:Protocol-defined ST through 5 years:Pooled Analysis of 4 SES vs. BMS RCT’s*Pooled Analysis of 4 SES vs. BMS RCT’s*
* RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS
CYPHER Stent (n=878)Bare Metal Stent (n=870)CYPHER Stent (n=878)Bare Metal Stent (n=870)
DaysNumber at risk
BMS
CYPHER
870
878
853
859
838
837
818
811
789
784
688
695
HR 1.62 [0.67,3.91]
p=0.28 1.6% (13)
1.0% (8)
0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
3.0%
0 365 730 1095 1460 1825
9 vs. 4, p=0.19After 1 yearAfter 1 year
Kirtane A.J., et al., TCT 2007; Oral Presentation.* RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS
ARC Definite ST through 5 years:ARC Definite ST through 5 years:Pooled Analysis of 4 SES vs. BMS RCT’s*Pooled Analysis of 4 SES vs. BMS RCT’s*
CYPHER Stent (n=878)Bare Metal Stent (n=870)CYPHER Stent (n=878)Bare Metal Stent (n=870)
0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
3.0%
0 365 730 1095 1460 1825
DaysNumber at risk
BMS
CYPHER
870
878
848
858
834
835
813
809
784
783
683
694
0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
3.0%
0 365 730 1095 1460 1825
DaysNumber at risk
BMS
CYPHER
870
878
848
858
834
835
813
809
784
783
683
694
HR 0.99 [0.51,1.95]
p=0.99 2.1% (17)2.0% (17)
11 vs. 6, p=0.23After 1 yearAfter 1 year
Kirtane A.J., et al., TCT 2007; Oral Presentation.
ARC Definite/Probable ST through 5 years:ARC Definite/Probable ST through 5 years:Pooled Analysis of 4 SES vs. BMS RCT’s*Pooled Analysis of 4 SES vs. BMS RCT’s*
CYPHER Stent (n=878)Bare Metal Stent (n=870)CYPHER Stent (n=878)Bare Metal Stent (n=870)
* RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS
DaysNumber at risk
BMS
CYPHER
870
877
680
827
659
797
632
766
603
732
518
645
HR 0.35 [0.27,0.45]
p<0.0001
9.6% (80)
23.9% (205)
0%
5%
10%
15%
20%
25%
30%
0 365 730 1095 1460 1825
Kirtane A.J., et al., TCT 2007; Oral Presentation.
TLR through 5 years:TLR through 5 years:Pooled Analysis of 4 SES vs. BMS RCT’s*Pooled Analysis of 4 SES vs. BMS RCT’s*
CYPHER Stent (n=878)Bare Metal Stent (n=870)CYPHER Stent (n=878)Bare Metal Stent (n=870)
* RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS
DaysNumber at risk
BMS
CYPHER
869
876
660
812
635
779
603
737
569
697
479
603
HR 0.44 [0.36,0.55]
p<0.0001
15.2% (127)
29.4% (250)
0%
5%
10%
15%
20%
25%
30%
0 365 730 1095 1460 1825
Kirtane A.J., et al., TCT 2007; Oral Presentation.* RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS
CYPHER Stent (n=878)Bare Metal Stent (n=870)CYPHER Stent (n=878)Bare Metal Stent (n=870)
TVR through 5 years:TVR through 5 years:Pooled Analysis of 4 SES vs. BMS RCT’s*Pooled Analysis of 4 SES vs. BMS RCT’s*
From this independent, patient-level meta-analysis from the From this independent, patient-level meta-analysis from the 4 principal CYPHER4 principal CYPHER®® Stent trials it may be concluded that at Stent trials it may be concluded that at 5-year follow-up of patients with single de novo native 5-year follow-up of patients with single de novo native coronary lesions 2.5 – 3.5 mm in diameter and ≤30 mm in coronary lesions 2.5 – 3.5 mm in diameter and ≤30 mm in length, polymer-based sirolimus-eluting stents compared to length, polymer-based sirolimus-eluting stents compared to otherwise equivalent bare metal stents result in:otherwise equivalent bare metal stents result in: No significant increase in stent thrombosisNo significant increase in stent thrombosis
No significant increase in late stent thrombosis by ARC definitionsNo significant increase in late stent thrombosis by ARC definitions
No significant differences in death or myocardial infarction at any No significant differences in death or myocardial infarction at any time periodtime period
Sustained reduction in target lesion and target vessel Sustained reduction in target lesion and target vessel revascularizationrevascularization
Kirtane A.J., et al., TCT 2007; Oral Presentation.
On-Label CYPHEROn-Label CYPHER®® Stent Trials: Stent Trials:Conclusions through 5-year Follow-upConclusions through 5-year Follow-up
SES in AMISES in AMI
TYPHOON STUDYTYPHOON STUDY
SES in DMSES in DM
SES in small VesselSES in small Vessel
MVDMVD
Cypher vs TaxusCypher vs Taxus
All type: SES vs PES All type: SES vs PES all comersall comers
All type: SES vs PESAll type: SES vs PESall comersall comers
SES vs PESSES vs PESDM patientsDM patients
SES vs PESSES vs PESIn-stent restenosisIn-stent restenosis
SES vs PESSES vs PESlong lesionslong lesions
Meta-analysis: SES vs PESMeta-analysis: SES vs PES16 trials16 trials
Couple of precautionsCouple of precautions
Plavix?: follow up after 6 month of plavix
JACC-Meta Analysis for ST JACC-Meta Analysis for ST ’06’06
9-12 month follow-up9-12 month follow-up
DES vs BMS : MORTALITY/MI DES vs BMS : MORTALITY/MI benefit?????benefit?????
Comprehensive Meta-Analysis Comprehensive Meta-Analysis
of DES vs. BMS Randomized of DES vs. BMS Randomized
Trials and RegistriesTrials and Registries
Ajay J. Kirtane, M.D., S.M.Ajay J. Kirtane, M.D., S.M. Gregg W. Stone, M.D.Gregg W. Stone, M.D.
All-Cause Mortality: All RCTsAll-Cause Mortality: All RCTs
I-V Overall (I-squared = 0.0%, p = 0.918)
BASKET (SES only)
TAXUS II
HAAMU-STENTSeville
Ortolani et al
TAXUS IV
E-SIRIUS
Study ID
DIABETES
PRISON II
STRATEGY
RAVEL
SES-SMART
TAXUS V
Typhoon
MISSION!
SCORPIUSSESAMI
D+L Overall
Passion
C-SIRIUS
Pache et al
SIRIUS
0.97 (0.81, 1.15)
0.82 (0.37, 1.84)
1.61 (0.57, 4.53)
2.00 (0.63, 6.38)1.35 (0.23, 7.78)
2.00 (0.19, 21.38)
0.89 (0.63, 1.25)
1.08 (0.25, 2.24)
ES (95% CI)
1.44 (0.48, 4.33)
0.50 (0.09, 2.67)
0.84 (0.36, 1.96)
1.75 (0.73, 4.16)
0.21 (0.02, 1.71)
0.97 (0.57, 1.65)
1.01 (0.38, 2.65)
0.48 (0.09, 2.59)
1.28 (0.35, 4.61)0.43 (0.11, 1.63)
0.97 (0.81, 1.15)
0.70 (0.36, 1.36)
0.68 (0.11, 4.04)
1.40 (0.45, 4.35)
1.02 (0.67, 1.54)
100.00
4.80
2.87
2.301.00
0.55
26.29
2.57
(I-V)
2.55
1.07
4.30
4.08
0.62
10.92
3.27
1.09
Weight
1.861.70
6.99
0.95
2.40
17.82
%
0.97 (0.81, 1.15)
0.82 (0.37, 1.84)
1.61 (0.57, 4.53)
2.00 (0.63, 6.38)1.35 (0.23, 7.78)
2.00 (0.19, 21.38)
0.89 (0.63, 1.25)
1.08 (0.25, 2.24)
ES (95% CI)
1.44 (0.48, 4.33)
0.50 (0.09, 2.67)
0.84 (0.36, 1.96)
1.75 (0.73, 4.16)
0.21 (0.02, 1.71)
0.97 (0.57, 1.65)
1.01 (0.38, 2.65)
0.48 (0.09, 2.59)
1.28 (0.35, 4.61)0.43 (0.11, 1.63)
0.97 (0.81, 1.15)
0.70 (0.36, 1.36)
0.68 (0.11, 4.04)
1.40 (0.45, 4.35)
1.02 (0.67, 1.54)
100.00
4.80
2.87
2.301.00
0.55
26.29
2.57
(I-V)
2.55
1.07
4.30
4.08
0.62
10.92
3.27
1.09
Weight
1.861.70
6.99
0.95
2.40
17.82
%
1.1 1 10
8,867 patients, 21 trials8,867 patients, 21 trials
Favors BMS
Estimate (95% CI) Weight (%)
0.97 (0.81,1.15)0.97 (0.81,1.15), p=0.72
Random Effects*Fixed Effects (I2=0.0%)
Favors DES
Mean f/u 2.9 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008
All-Cause Mortality: RCTs (On-Label)All-Cause Mortality: RCTs (On-Label)
I-V Overall (I-squared = 0.0%, p = 0.927)
Ortolani et al
TAXUS V - Simple
D+L Overall
TAXUS IV
Pache et al
C-SIRIUS
E-SIRIUS
SIRIUS
TAXUS II
Study ID
RAVEL
SCORPIUS
1.05 (0.84, 1.30)
2.00 (0.19, 21.38)
1.09 (0.53, 2.22)
1.05 (0.84, 1.30)
0.89 (0.63, 1.25)
1.40 (0.45, 4.35)
0.68 (0.11, 4.04)
1.08 (0.25, 2.24)
1.02 (0.67, 1.54)
1.61 (0.57, 4.53)
ES (95% CI)
1.75 (0.73, 4.16)
1.28 (0.35, 4.61)
100.00
0.85
9.20
40.20
3.67
%
1.45
3.93
27.25
4.39
(I-V)
6.23
2.84
Weight
1.1 1 10
4,818 patients, 10 trials4,818 patients, 10 trials
Favors DES Favors BMS
Estimate (95% CI) Weight (%)
1.05 (0.84,1.30)
1.05 (0.84,1.30), p=0.69
Random Effects
*Fixed Effects (I2=0.0%)
Mean f/u 4.0 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008
All-Cause Mortality: RCT’s (Off-Label)All-Cause Mortality: RCT’s (Off-Label)
I-V Overall (I-squared = 0.0%, p = 0.798)
HAAMU-STENT
Passion
PRISON II
MISSION!
DIABETES
BASKET (SES only)
Seville
D+L Overall
SES-SMART
STRATEGY
TAXUS V - complex
Study ID
SESAMI
Typhoon
0.84 (0.62, 1.13)
2.00 (0.63, 6.38)
0.70 (0.36, 1.36)
0.50 (0.09, 2.67)
0.48 (0.09, 2.59)
1.44 (0.48, 4.33)
0.82 (0.37, 1.84)
1.35 (0.23, 7.78)
0.84 (0.62, 1.13)
0.21 (0.02, 1.71)
0.84 (0.36, 1.96)
0.84 (0.38, 1.84)
ES (95% CI)
0.43 (0.11, 1.63)
1.01 (0.38, 2.65)
100.00
6.64
20.16
Weight
3.10
3.16
7.36
13.84
%
2.87
1.80
12.40
14.32
(I-V)
4.90
9.44
1.1 1 10
4,049 patients, 12 trials4,049 patients, 12 trials
Favors DES Favors BMS
Estimate (95% CI) Weight (%)
0.84 (0.62,1.13)
0.84 (0.62,1.13), p=0.24
Random Effects
*Fixed Effects (I2=0.0%)
Mean f/u 1.5 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008
All-Cause Mortality: All RegistriesAll-Cause Mortality: All Registries
NOTE: Weights are from random effects analysis
D+L Overall (I-squared = 70.1%, p = 0.000)
Ontario (matched)Germany Metabolic Syndrome
GHOST (adjusted)
RESTEMARTS II (from RCT)
ACUITY (from RCT)
Western Denmark (adjusted)
STENT (adjusted)Massachusetts (matched)
Cedars Acute MI
I-V Overall
NHLBI (on label, adjusted)
Wake Forest (adjusted)
DEScover (unadjusted)
Multicenter SVG (adjusted)
MIDAS (adjusted)
Liverpool (matched)
ERACI III (from RCT)
SCAAR (adjusted)Asan Korea (adjusted)
Study ID
Melbourne
McMaster STEMI (adjusted)
REAL (adjusted)
Mayo FFR SubstudyItalian Diabetic Multivessel (adjusted)
Washington Hosp Center (matched)Rotterdam Off-Label
NHLBI (off label, adjusted)
NY State (adjusted, unmatched)
0.80 (0.72, 0.88)
0.71 (0.59, 0.84) 1.47 (0.65, 3.35)
0.55 (0.36, 0.83)
0.73 (0.51, 1.05) 0.74 (0.41, 1.35)
0.63 (0.49, 0.82)
1.00 (0.86, 1.17)
0.69 (0.55, 0.87) 0.79 (0.71, 0.89)
0.82 (0.37, 1.83)
0.83 (0.79, 0.86)
1.47 (0.87, 2.48)
0.72 (0.55, 0.95)
0.53 (0.35, 0.80)
1.33 (0.47, 3.76)
0.66 (0.59, 0.74)
0.45 (0.24, 0.84)
1.18 (0.54, 2.58)
1.03 (0.94, 1.14) 0.60 (0.46, 0.79)
ES (95% CI)
0.67 (0.23, 1.94)
0.17 (0.03, 0.97)
0.83 (0.70, 0.98)
1.00 (0.21, 4.75) 1.22 (0.36, 4.10)
1.16 (0.78, 1.75) 0.98 (0.85, 1.13)
0.94 (0.64, 1.38)
0.84 (0.72, 0.97)
100.00
5.981.15
3.09
3.631.92
Weight
4.87
6.29
5.256.80
1.20
2.31
4.66
3.13
0.76
6.80
1.78
%
1.25
6.984.70
(D+L)
0.73
0.29
6.10
0.360.57
3.216.44
3.40
6.35
1.1 1 10
161,232 patients, 28 registries161,232 patients, 28 registries
Favors BMS
Estimate (95% CI) Weight (%)
0.80 (0.72,0.88), p<0.0010.83 (0.79,0.86)
Favors DES
*Random Effects (I2=70.1%)Fixed Effects
Mean f/u 2.5 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008
MI: All RCTsMI: All RCTs8,850 patients, 20 trials8,850 patients, 20 trials
D+L Overall (I-squared = 3.0%, p = 0.420)I-V Overall
SCORPIUS
TAXUS II
PRISON II
TAXUS V
Passion
STRATEGY
MISSION!
Typhoon
SIRIUS
TAXUS IV
BASKET (All)
RAVEL
Ortolani et alDIABETES
HAAMU-STENT
Study ID
E-SIRIUS
SES-SMART
SCANDSTENT
SESAMI
C-SIRIUS
1.1 1 10
I-V Overall (I-squared = 3.0%, p = 0.420)
SESAMI
Passion
C-SIRIUS
RAVEL
TAXUS IV
TAXUS V
SCORPIUS
SIRIUS
DIABETES
MISSION!
E-SIRIUS
SCANDSTENT
Study ID
Ortolani et al
SES-SMARTSTRATEGY
HAAMU-STENT
BASKET (All)
Typhoon
TAXUS II
PRISON II
D+L Overall
0.94 (0.79, 1.13)
1.00 (0.20, 4.88)
0.83 (0.26, 2.69)
0.59 (0.14, 2.47)
1.24 (0.49, 3.14)
0.99 (0.66, 1.48)
1.27 (0.79, 2.04)
0.82 (0.23, 2.95)
0.96 (0.59, 1.55)
0.60 (0.20, 1.50)
0.62 (0.28, 1.39)
1.94 (0.93, 4.02)
0.33 (0.09, 1.18)
ES (95% CI)
1.50 (0.26, 8.61)
0.16 (0.04, 0.67)0.82 (0.31, 2.40)
0.25 (0.03, 2.19)
1.15 (0.64, 2.08)
0.80 (0.22, 2.97)
0.63 (0.23, 1.72)
0.83 (0.26, 2.64)
0.94 (0.78, 1.13)
100.00
1.29
2.40
1.59
3.80
20.13
Weight
14.59
2.02
14.07
3.23
5.11
6.13
%
1.98
(I-V)
1.07
1.653.13
0.71
9.45
1.94
3.24
2.44
1.1 1 10
Estimate (95% CI) Weight (%)
0.94 (0.78,1.13)0.94 (0.79,1.13), p=0.54
Favors DES Favors BMS
Random Effects*Fixed Effects (I2=3.0%)
Ajay J. Kirtane and Gregg W. Stone, 2008
Mean f/u 2.9 yrs
MI: RCTs (On Label)MI: RCTs (On Label)
I-V Overall (I-squared = 0.0%, p = 0.761)
RAVEL
Study ID
D+L Overall
SIRIUS
E-SIRIUS
TAXUS II
TAXUS IV
C-SIRIUS
TAXUS V - Simple
SCORPIUS
Ortolani et al
1.03 (0.81, 1.30)
1.24 (0.49, 3.14)
ES (95% CI)
1.03 (0.81, 1.30)
0.96 (0.59, 1.55)
1.94 (0.93, 4.02)
0.63 (0.23, 1.72)
0.99 (0.66, 1.48)
0.59 (0.14, 2.47)
0.98 (0.52, 1.81)
0.82 (0.23, 2.95)
1.50 (0.26, 8.61)
100.00
6.29
(I-V)
23.26
%
10.13
5.36
33.28
2.63
13.95
Weight
3.33
1.77
1.1 1 10
4,318 patients, 9 trials4,318 patients, 9 trials
Favors DES Favors BMS
Estimate (95% CI) Weight (%)
1.03 (0.81,1.30)
1.03 (0.81,1.30), p=0.82
Random Effects
*Fixed Effects (I2=0.0%)
Ajay J. Kirtane and Gregg W. Stone, 2008
Mean f/u 4.4 yrs
MI: RCT’s (Off Label)MI: RCT’s (Off Label)4,532 patients, 12 trials4,532 patients, 12 trials
1.1 1 10
I-V Overall (I-squared = 25.5%, p = 0.194)
SCANDSTENT
HAAMU-STENT
Typhoon
D+L Overall
SES-SMART
PRISON II
TAXUS V - complex
Passion
Study ID
STRATEGY
MISSION!
SESAMI
BASKET (All)
DIABETES
0.83 (0.62, 1.10)
0.33 (0.09, 1.18)
0.25 (0.03, 2.19)
0.80 (0.22, 2.97)
0.77 (0.54, 1.10)
0.16 (0.04, 0.67)
0.83 (0.26, 2.64)
1.84 (0.86, 3.94)
0.83 (0.26, 2.69)
ES (95% CI)
0.82 (0.31, 2.40)
0.62 (0.28, 1.39)
1.00 (0.20, 4.88)
1.15 (0.64, 2.08)
0.60 (0.20, 1.50)
100.00
5.08
1.83
4.97
4.24
Weight
6.26
%
14.52
6.16
(I-V)
8.03
13.11
3.30
24.22
8.29
1.1 1 10
Estimate (95% CI) Weight (%)
I-V Overall (I-squared = 25.5%, p = 0.194)
SCANDSTENT
HAAMU-STENT
Typhoon
D+L Overall
SES-SMART
PRISON II
TAXUS V - complex
Passion
Study ID
STRATEGY
MISSION!
SESAMI
BASKET (All)
DIABETES
0.83 (0.62, 1.10)
0.33 (0.09, 1.18)
0.25 (0.03, 2.19)
0.80 (0.22, 2.97)
0.77 (0.54, 1.10)
0.16 (0.04, 0.67)
0.83 (0.26, 2.64)
1.84 (0.86, 3.94)
0.83 (0.26, 2.69)
ES (95% CI)
0.82 (0.31, 2.40)
0.62 (0.28, 1.39)
1.00 (0.20, 4.88)
1.15 (0.64, 2.08)
0.60 (0.20, 1.50)
100.00
5.08
1.83
4.97
4.24
Weight
6.26
%
14.52
6.16
(I-V)
8.03
13.11
3.30
24.22
8.29
1.1 1 10
Favors DES Favors BMS
0.77 (0.54,1.10)
0.83 (0.62,1.10), p=0.19
Random Effects
*Fixed Effects (I2=25.5%)
Ajay J. Kirtane and Gregg W. Stone, 2008
Mean f/u 1.5 yrs
MI: All RegistriesMI: All Registries
NOTE: Weights are from random effects analysis
D+L Overall (I-squared = 57.9%, p = 0.000)
ACUITY (from RCT)
Melbourne
ARTS II (from RCT)
Asan Korea (adjusted)
Ontario (matched)
Study ID
NHLBI (on label, adjusted)
Washington Hosp Center (matched)
STENT (adjusted)
ERACI III (from RCT)
Wake Forest (adjusted)
Germany Metabolic Syndrome
NHLBI (off label, adjusted)
Western Denmark (adjusted)
GHOST (adjusted)
SCAAR (adjusted)
REAL (adjusted)
RESTEM
DEScover (unadjusted)
Brazil Large Vessels
Cedars Acute MI
Massachusetts (matched)
Italian Diabetic Multivessel (adjusted)
I-V Overall
Mayo FFR Substudy
McMaster STEMI (adjusted)
0.89 (0.80, 0.98)
1.07 (0.91, 1.25)
1.00 (0.39, 2.58)
0.53 (0.32, 0.88)
0.66 (0.42, 1.05)
1.10 (0.91, 1.32)
ES (95% CI)
0.71 (0.47, 1.05)
0.51 (0.29, 0.88)
0.69 (0.52, 0.92)
2.30 (0.91, 5.96)
0.84 (0.60, 1.18)
0.23 (0.07, 0.78)
0.71 (0.50, 1.00)
1.29 (1.06, 1.57)
1.12 (0.74, 1.70)
1.01 (0.91, 1.11)
0.92 (0.76, 1.11)
0.80 (0.52, 1.23)
0.69 (0.40, 1.18)
1.50 (0.25, 8.90)
0.25 (0.06, 1.16)
0.92 (0.83, 1.02)
1.02 (0.46, 2.25)
0.96 (0.91, 1.01)
0.67 (0.12, 3.84)
0.28 (0.04, 1.71)
100.00
8.90
1.10
3.09
3.55
8.26
(D+L)
4.21
2.69
6.10
1.11
5.15
0.70
5.01
Weight
%
8.02
4.03
10.17
8.18
3.86
2.80
0.33
0.48
10.10
1.50
0.35
0.30
0.89 (0.80, 0.98)
1.07 (0.91, 1.25)
1.00 (0.39, 2.58)
0.53 (0.32, 0.88)
0.66 (0.42, 1.05)
1.10 (0.91, 1.32)
ES (95% CI)
0.71 (0.47, 1.05)
0.51 (0.29, 0.88)
0.69 (0.52, 0.92)
2.30 (0.91, 5.96)
0.84 (0.60, 1.18)
0.23 (0.07, 0.78)
0.71 (0.50, 1.00)
1.29 (1.06, 1.57)
1.12 (0.74, 1.70)
1.01 (0.91, 1.11)
0.92 (0.76, 1.11)
0.80 (0.52, 1.23)
0.69 (0.40, 1.18)
1.50 (0.25, 8.90)
0.25 (0.06, 1.16)
0.92 (0.83, 1.02)
1.02 (0.46, 2.25)
0.96 (0.91, 1.01)
0.67 (0.12, 3.84)
0.28 (0.04, 1.71)
100.00
8.90
1.10
3.09
3.55
8.26
(D+L)
4.21
2.69
6.10
1.11
5.15
0.70
5.01
Weight
%
8.02
4.03
10.17
8.18
3.86
2.80
0.33
0.48
10.10
1.50
0.35
0.30
1.1 1 10
129,955 patients, 24 registries129,955 patients, 24 registries
Favors DES Favors BMS
Estimate (95% CI) Weight (%)
0.89 (0.80,0.98), p=0.023 0.96 (0.91,1.01)
*Random Effects (I2=57.9%)Fixed Effects
*MI is QWMI in Washington Hospital Center, RESTEM
Ajay J. Kirtane and Gregg W. Stone, 2008Mean f/u 2.5 yrs
TVR: All RCTsTVR: All RCTs
NOTE: Weights are from random effects analysis
D+L Overall (I-squared = 53.2%, p = 0.006)
Pache et al
Study ID
HAAMU-STENT
C-SIRIUS
Typhoon
STRATEGY
SIRIUS
SCANDSTENT
TAXUS II
PRISON II
TAXUS IV
E-SIRIUS
MISSION!
Ortolani et al
SESAMI
I-V Overall
TAXUS V
RAVEL
0.45 (0.37, 0.54)
0.38 (0.23, 0.64)
ES (95% CI)
0.33 (0.09, 1.19)
0.30 (0.10, 0.93)
0.42 (0.25, 0.69)
0.34 (0.16, 0.77)
0.48 (0.37, 0.62)
0.17 (0.09, 0.33)
0.61 (0.35, 1.08)
0.37 (0.19, 0.69)
0.57 (0.45, 0.72)
0.35 (0.21, 0.56)
0.38 (0.17, 0.85)
0.58 (0.25, 1.36)
0.36 (0.17, 0.79)
0.51 (0.45, 0.57)
0.77 (0.60, 0.98)
0.51 (0.25, 1.04)
100.00
7.14
(D+L)
1.91
2.45
7.20
4.22
11.51
5.44
%
6.44
5.49
11.94
Weight
7.45
4.08
3.78
4.36
11.75
4.83
1.1 1 10
7,291 patients, 16 trials7,291 patients, 16 trials
Favors DES Favors BMS
Estimate (95% CI)Weight (%)
0.45 (0.37,0.54), p<0.0010.51 (0.45,0.57)
*Random Effects (I2=53.2%)Fixed Effects
Mean f/u 3.2 yrsAjay J. Kirtane and Gregg W. Stone, 2008
TVR: RCTs (On Label)TVR: RCTs (On Label)
NOTE: Weights are from random effects analysis
D+L Overall (I-squared = 48.8%, p = 0.048)
E-SIRIUS
TAXUS IV
SIRIUS
RAVEL
I-V Overall
TAXUS II
Study ID
C-SIRIUS
TAXUS V - Simple
Ortolani et al
Pache et al
0.53 (0.43, 0.65)
0.35 (0.21, 0.56)
0.57 (0.45, 0.72)
0.48 (0.37, 0.62)
0.51 (0.25, 1.04)
0.54 (0.47, 0.62)
0.61 (0.35, 1.08)
ES (95% CI)
0.30 (0.10, 0.93)
0.91 (0.64, 1.29)
0.58 (0.25, 1.36)
0.38 (0.23, 0.64)
100.00
10.98
19.99
19.03
6.65
9.25
(D+L)
3.19
15.38
5.08
Weight
10.44
%
1.1 1 10
4,618 patients, 9 trials4,618 patients, 9 trials
Favors DES Favors BMS
Estimate (95% CI) Weight (%)
0.53 (0.43,0.65), p<0.001
0.54 (0.47,0.62)
*Random Effects (I2=48.8%)
Fixed Effects
Mean f/u 4.2 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008
TVR: RCTs (Off Label)TVR: RCTs (Off Label)
NOTE: Weights are from random effects analysis
D+L Overall (I-squared = 47.8%, p = 0.063)
Typhoon
Study ID
STRATEGY
SCANDSTENT
TAXUS V - complex
I-V Overall
HAAMU-STENT
SESAMI
MISSION!
PRISON II
0.38 (0.27, 0.52)
0.42 (0.25, 0.69)
ES (95% CI)
0.34 (0.16, 0.77)
0.17 (0.09, 0.33)
0.62 (0.44, 0.86)
0.42 (0.34, 0.52)
0.33 (0.09, 1.19)
0.36 (0.17, 0.79)
0.38 (0.17, 0.85)
0.37 (0.19, 0.69)
100.00
16.43
(D+L)
10.35
12.95
21.55
%
4.98
10.65
10.04
Weight
13.06
1.1 1 10
2,673 patients, 8 trials2,673 patients, 8 trials
Favors DES Favors BMS
Estimate (95% CI) Weight (%)
0.38 (0.27,0.52), p<0.001
0.42 (0.34,0.52)
*Random Effects (I2=47.8%)
Fixed Effects
Mean f/u 1.6 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008
TVR: All RegistriesTVR: All Registries
NOTE: Weights are from random effects analysis
D+L Overall (I-squared = 71.2%, p = 0.000)
DEScover (adjusted)
McMaster STEMI (adjusted)
Wake Forest (adjusted)
GHOST (adjusted)
Montevergine
STENT (adjusted)
Washington Hosp Center (matched)
I-V Overall
Asan Korea (adjusted)
NY State (adjusted, unmatched)
RESTEM
Ontario (matched)
Cedars Acute MI
Brazil Large Vessels
REAL (adjusted)
Multicenter SVG (adjusted)
Study ID
Mayo FFR Substudy
ERACI III (from RCT)
0.53 (0.47, 0.61)
0.58 (0.40, 0.83)
0.32 (0.05, 1.92)
0.63 (0.48, 0.83)
0.28 (0.20, 0.39)
0.51 (0.39, 0.68)
0.58 (0.47, 0.71)
0.65 (0.49, 0.85)
0.57 (0.54, 0.60)
0.32 (0.24, 0.43)
0.54 (0.50, 0.60)
0.62 (0.47, 0.80)
0.69 (0.60, 0.80)
0.22 (0.08, 0.62)
0.43 (0.17, 1.10)
0.67 (0.59, 0.76)
0.58 (0.28, 1.18)
ES (95% CI)
0.18 (0.04, 0.78)
0.58 (0.39, 0.86)
100.00
5.81
0.46
7.38
6.31
7.30
8.70
7.35
Weight
7.05
10.70
7.53
9.88
1.34
1.57
10.17
2.41
(D+L)
0.68
5.35
%
1.1 1 10
73,819 patients, 17 registries73,819 patients, 17 registries
Favors DES Favors BMS
Estimate (95% CI)Weight (%)
0.53 (0.47,0.61), p<0.001 0.57 (0.54,0.60)
*Random Effects (I2=71.2%)Fixed Effects
Mean f/u 2.2 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008
Conclusions (1)Conclusions (1)In 22 RCTs in which 9,470 pts were randomized to DES or BMS and followed for ≥1 yr, DES resulted in:
• Non significant 3% and 6% reductions in mortality and MI respectively
• A highly significant 55% reduction in TVR
In 30 registries in which 174,302 pts were treated with either DES or BMS and followed for ≥1 yr, DES resulted in:
• A highly significant 20% reduction in mortality
• A significant 11% reduction in MI
• A highly significant 47% reduction in TVR
Final NoteFinal Note
Majority of trial at short term Majority of trial at short term followup.followup.
No randomized studies so far to look No randomized studies so far to look at mortality benefit/harm between at mortality benefit/harm between BMS and DESBMS and DES
All powered to look at TLR and re-All powered to look at TLR and re-stenosis preventions.stenosis preventions.
Final NoteFinal Note
Of course there is sign benefit for TLR (5-8% vs Of course there is sign benefit for TLR (5-8% vs 30%)30%)
This is off set with slight (p= NS) increase in This is off set with slight (p= NS) increase in late ST.late ST. This has not translated into increase mortality in This has not translated into increase mortality in
meta-analysis and registeries.meta-analysis and registeries. We still do not know optimal time for anti We still do not know optimal time for anti
platelet therapy, but at least 1 yr recommended.platelet therapy, but at least 1 yr recommended. Increase risk of ST with increasing length of Increase risk of ST with increasing length of
stentstent SES better than PESSES better than PES
Endeavor StentEndeavor Stent
Endeavor-PharmocologyEndeavor-Pharmocology
MechanismMechanism
MechanismMechanism
MechanismMechanism
Drug Elution
• Zotarolimus elutes completely from the PC polymer coating to the injury site by the fourteenth day post-implant
0
20
40
60
80
100
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Days
Pe
rce
nt D
rug
Elu
ted
(%
)
0
20
40
60
80
100
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Days
Pe
rce
nt D
rug
Elu
ted
(%
)
Preclinical studies on file at Medtronic, Inc.
Strut ComparisonStrut Comparison
Low-Profile Stent and Polymer
PC basecoat (~1 μm thick)
Drug layer90% zotarolimus (10 μg/mm)10% PC (~2–3 μm thick)
PC overspray (~0.1 μm thick)
148 μm 153 μm95 μmTotal thickness
132 μm 140 μm91 μmStrut thickness16 μm 13 μm4 μm (2.7 d/1.4 p)Drug/polymerTaxus® Cypher®Endeavor
3.0-mm stents500x magnification
Illustrationsnot to scale
The Endeavor stent has thin struts and a thin polymer coating compared with other DES
Stent strut
Stent strutStent strut
Post-elution~1-μm coating of PC polymer
Taxus is a registered trademark of Boston Scientific Corporation. Cypher is a registered trademark of Cordis Corporation
PolymerPolymer
Inert polymer-does not induce Inert polymer-does not induce inflammationinflammation
Physiological polymerPhysiological polymer
Stent SummaryStent Summary
DrugDrug ZotarolimusZotarolimus
Pharmocokenetic (similar to sirolimus)Pharmocokenetic (similar to sirolimus) Mechanism (similar to sirolimus)Mechanism (similar to sirolimus)
PolymerPolymer PCPC
Dilevery systemDilevery system Driver Stent Driver Stent Significantly smaller profileSignificantly smaller profile
Endeavor Clinical Program Endeavor Clinical Program OverviewOverview
9m 2yr 3yr 9m 2yr 3yr 4yr 4yrENDEAVOR I
ENDEAVOR II
ENDEAVOR II CA
ENDEAVOR III
ENDEAVOR IVENDEAVOR IV
ENDEAVOR PK
Single Arm First-in-Man (n=100) 4yrSingle Arm First-in-Man (n=100) 4yr
1:1 RCT vs. BMS (E=598,D=599) PK (n=106) 3yr1:1 RCT vs. BMS (E=598,D=599) PK (n=106) 3yr
Continued Access Single Arm (n=296) 2yrContinued Access Single Arm (n=296) 2yr
3:1 RCT vs. Cypher® (E=323,C=113) 2yr3:1 RCT vs. Cypher® (E=323,C=113) 2yr
1:1 RCT vs.Taxus® (E=773,T=775)1:1 RCT vs.Taxus® (E=773,T=775) 12mo12mo1:1 RCT vs.Taxus® (E=773,T=775)1:1 RCT vs.Taxus® (E=773,T=775) 12mo12mo
Pharmacokinetic Study (n=43) 9moPharmacokinetic Study (n=43) 9mo
Single Arm (n=99) 9moSingle Arm (n=99) 9moENDEAVOR Japan
E-FIVE Open Label Single Arm (n=8000)Open Label Single Arm (n=8000)
US Post Approval
PROTECT 1:1 RCT vs. Cypher (E=4400,C=4400)1:1 RCT vs. Cypher (E=4400,C=4400)
Open Label Single Arm Study (n=5000)Open Label Single Arm Study (n=5000)
Proposed
Ongoing
Premarket Safety and Efficacy Package
STST
Endeavor IVEndeavor IVPatient FlowchartPatient Flowchart
Angio F/U (8 mo)Angio F/U (8 mo)135/164135/16482.3%82.3%
Patients EnrolledPatients EnrolledN = 1548N = 1548
RandomizedRandomizedEndeavorn = 773
TaxusTaxusn = 775n = 775
Angio F/U (8 mo)144/164 87.8%
Clinical F/U(9 mo)
758/77398.1%
Clinical F/UClinical F/U
(9 mo)(9 mo)749/775 749/775 96.6%96.6%
(12 mo)749/77396.9%
(12 mo)(12 mo)741/775 741/775 95.6%95.6%
Endeavor IV Endeavor IV Primary Endpoint Result Primary Endpoint Result
at 9 monthsat 9 monthsTarget Vessel Failure
TV
F
Ra
te
P for Non-Inferiority < 0.001Δ=3.8%
TaxusTaxus(n=54/749)(n=54/749)
EndeavorEndeavor(n=50/758)(n=50/758)
7.2%7.2%6.6%6.6%
Endeavor IVEndeavor IV 8 Month QCA8 Month QCA
EndeavorEndeavor(144 pts)(144 pts)
TaxusTaxus(135 pts)(135 pts) P valueP value
RVD (mm)RVD (mm) 2.65 2.65 0.470.47 2.68 2.68 0.45 0.45 0.6350.635
MLD (mm)MLD (mm)
In-stentIn-stent 1.95 1.95 0.610.61 2.25 2.25 0.61 0.61 <0.001<0.001
In-segment% DSIn-segment% DS 1.80 1.80 0.550.55 1.98 1.98 0.56 0.56 0.0080.008
% DS% DS
In-stentIn-stent 26.41 26.41 19.7419.74
16.09 16.09 17.9917.99 <0.001<0.001
In-segmentIn-segment 32.28 32.28 17.0217.02
26.61 26.61 15.5215.52 0.0040.004
Late loss (mm)Late loss (mm)
In-stentIn-stent 0.67 0.67 0.490.49 0.42 0.42 0.50 0.50 <0.001<0.001
In-segmentIn-segment 0.36 0.36 0.470.47 0.23 0.23 0.45 0.45 0.0230.023
Endeavor IVEndeavor IVClinical Events at 12 monthsClinical Events at 12 months
EndeavorEndeavorn=749n=749
TaxusTaxusn=741n=741 P-ValueP-Value
Death (all) – % (#)Death (all) – % (#) 1.1(8)1.1(8) 1.1(8)1.1(8) 1.0001.000
CardiacCardiac 0.5 (4)0.5 (4) 0.5 (4)0.5 (4) 1.0001.000
MI (all) – % (#)MI (all) – % (#) 1.6 (12)1.6 (12) 2.6 (19)2.6 (19) 0.2080.208
Q WaveQ Wave 0.3 (2)0.3 (2) 0.1 (1)0.1 (1) 1.0001.000
Non Q waveNon Q wave 1.3 (10)1.3 (10) 2.4 (18)2.4 (18) 0.1310.131
Death (cardiac) + MI (all) – Death (cardiac) + MI (all) – % (#)% (#) 2.1 (16)2.1 (16) 3.1 (23)3.1 (23) 0.2600.260
Stent Thrombosis (all) – % Stent Thrombosis (all) – % (#)(#) 0.8 (6)0.8 (6) 0.1 (1)0.1 (1) 0.1240.124
0-30 days 0-30 days 0.4 (3)0.4 (3) 0.1 (1)0.1 (1) 0.6250.625
31-360days 31-360days 0.4* (3) 0.4* (3) 0 0 0.2500.250
TLR – % (#)TLR – % (#) 4.5 (34) 4.5 (34) 3.2 (24)3.2 (24) 0.2280.228
TVR (non-TL) – % (#)TVR (non-TL) – % (#) 2.5 (19)2.5 (19) 4.2 (31)4.2 (31) 0.0850.085
TVR – % (#)TVR – % (#) 6.3 (47)6.3 (47) 6.7 (50)6.7 (50) 0.7530.753
MACE – % (#)MACE – % (#) 6.5 (49)6.5 (49) 6.6 (49)6.6 (49) 1.0001.000
TVF – % (#)TVF – % (#) 7.7 (58)7.7 (58) 9.4 (70)9.4 (70) 0.2670.267
*Day 83, 145, 171
TaxusEndeavorFre
edo
m f
rom
TV
F
100%
85%0 30 60 90 120 150 180 210 240 270 300 330 360
Time after Initial Procedure (days)
TVFTVF 00 3030 181800
272700
363600
EndeavEndeavoror
773773 760760 737737 712712 670670
TaxusTaxus 775775 748748 721721 692692 655655
90%
95%
TVF-free 92.3% 90.6% 0.243
Endeavor Taxus P (log rank)
Endeavor IVEndeavor IVTVF Free Survival to 360 TVF Free Survival to 360
daysdays
Endeavor IVEndeavor IV Target Vessel Target Vessel
RevascularizationRevascularization
EndeavorEndeavor(41/758)(41/758)
TaxusTaxus(37/749)(37/749)
EndeavorEndeavor(47/749)(47/749)
TaxusTaxus(50/741)(50/741)
P P = 0.728= 0.728
9 months9 months 12 months12 months
Rat
eR
ate
P P = 0.753= 0.753
5.4% 4.9%6.3% 6.7%
Endeavor IVEndeavor IV Target Lesion Target Lesion
RevascularizationRevascularization
EndeavorEndeavor(31/758)(31/758)
TaxusTaxus(20/749)(20/749)
EndeavorEndeavor(34/749)(34/749)
TaxusTaxus(24/741)(24/741)
P P = 0.154= 0.154
9 months9 months 12 months12 months
Rat
eR
ate
P P = 0.228= 0.228
4.1%
2.7%
4.5%3.2%
8.5%
3.6%3.0% 3.3%
Endeavor IV Endeavor IV TLR by Angiographic Follow-up TLR by Angiographic Follow-up
at 12 monthsat 12 monthsT
LR
R
ate
12/14112/141 4/1334/133 22/60822/608 20/60820/608
EndeavorEndeavor TaxusTaxus EndeavorEndeavor TaxusTaxus
Angiographic Follow-upAngiographic Follow-up Clinical Follow-upClinical Follow-up
P P =0.070=0.070
P P =0.875=0.875
Endeavor IV Endeavor IV TVF – Post Hoc Subgroup AnalysisTVF – Post Hoc Subgroup Analysis
Risk Ratio Risk Ratio [95% CI][95% CI] Risk RatioRisk Ratio EndeavorEndeavor TaxusTaxus P-Value P-Value
InteractionInteraction
0.760.76
1.101.10
7.9%7.9%
6.2%6.2%
8.5%8.5%
6.9%6.9%0.9600.960
Diabetes
Non-diabetes
0.820.82
1.131.13
0.810.81
7.3%7.3%
7.2%7.2%
5.5%5.5%
9.0%9.0%
6.4%6.4%
6.7%6.7%
0.4790.479
RVD
2.5mm
>2.5 <3.0mm
3.0mm
0.650.65
1.191.19
0.530.53
4.4%4.4%
8.0%8.0%
5.8%5.8%
6.8%6.8%
6.7%6.7%
11.0%11.0%
0.7350.735
Lesion Length
10mm10mm
>10 <20mm>10 <20mm
20mm20mm
1.011.01
0.950.95
6.2%6.2%
14.3%14.3%
6.2%6.2%
15.1%15.1%0.9010.901
Single Stent
Multiple Stents
0.10.1 11 1010FavorsEndeavor
FavorsTaxus
Endeavor ConclusionEndeavor Conclusion
More flexible, smaller struts (driver More flexible, smaller struts (driver stent)stent)
Similar pharmo-kenetics to CypherSimilar pharmo-kenetics to Cypher Non inferior to Cypher and Taxus for Non inferior to Cypher and Taxus for
MACEMACE But higher late loss/re-stenosisBut higher late loss/re-stenosis Possibly no last stent thrombosis????Possibly no last stent thrombosis????
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