Tony Gershlick University Hospitals of Leicester UK PROTECT TRIAL
Tony Gershlick University Hospitals of Leicester UK
Dec 31, 2015
PROTECT TRIAL. Tony Gershlick University Hospitals of Leicester UK. Speaker Bureau, Advisory Board, Recipient Research Grants Medtronic Vascular. Bare metal stent (n=878). Bare metal stent (n=1,757). CYPHER stent (n=870). TAXUS stent (n=1,749). 0. 0. 1. 1. 2. 2. 3. 3. 4. 4. - PowerPoint PPT Presentation
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Tony Gershlick University Hospitals of Leicester UK Tony Gershlick University Hospitals of Leicester UK
PROTECT TRIAL
Speaker Bureau, Advisory Board, Recipient Research Grants
Medtronic Vascular
60
70
80
90
100
60
70
80
90
100
Time after Initial Procedure (years)Time after Initial Procedure (years)
00 11 22 33 44
Time after Initial Procedure (years)Time after Initial Procedure (years)
TAXUS I, II, IV, V, VITAXUS I, II, IV, V, VI(n=3,506)(n=3,506)
RAVEL, SIRIUS, E-SIRIUS, C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, C-SIRIUS(n=1,748)(n=1,748)
P=0.3989.7% (88)88.4% (100)
CYPHER stent (n=870) Bare metal stent (n=878)
00 11 22 33 44
P=0.7788.2% (182)87.6% (186)
TAXUS stent (n=1,749) Bare metal stent (n=1,757)
Independent CRF patient-level meta-analysisIndependent CRF patient-level meta-analysis Freedom From Death or Myocardial InfarctionFreedom From Death or Myocardial InfarctionIndependent CRF patient-level meta-analysisIndependent CRF patient-level meta-analysis Freedom From Death or Myocardial InfarctionFreedom From Death or Myocardial Infarction
Conclusion : No clinical difference in outcome out to 4 years Conclusion : No clinical difference in outcome out to 4 years
95
96
97
98
99
100
95
96
97
98
99
100
Time after Initial Procedure (years)Time after Initial Procedure (years)00 11 22 33 44
Time after Initial Procedure (years)Time after Initial Procedure (years)
TAXUS I, II, IV, V, VITAXUS I, II, IV, V, VI(n=3,506)(n=3,506)
RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS(n=1,748)(n=1,748)
CYPHER stent (n=870)
Bare metal stent (n=878)
Independent CRF patient-level meta-analysisIndependent CRF patient-level meta-analysis
00 11 22 33 44
95
96
97
98
99
100
95
96
97
98
99
100
TAXUS stent (n=1,749)
Bare metal stent (n=1,757)
Freedom From (Protocol) Stent ThrombosisFreedom From (Protocol) Stent Thrombosis
P=0.2099.4% (5)98.8% (10)
P=0.2999.1% (14)98.7% (20)
95
96
97
98
99
100
95
96
97
98
99
100
Time after Initial Procedure (years)Time after Initial Procedure (years)
00 11 22 33 44
Time after Initial Procedure (years)Time after Initial Procedure (years)
TAXUS I, II, IV, V, VITAXUS I, II, IV, V, VI(n=3,506)(n=3,506)
RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS(n=1,748)(n=1,748)
CYPHER stent (n=870) Bare metal stent (n=878)
00 11 22 33 44
95
96
97
98
99
100
95
96
97
98
99
100
TAXUS stent (n=1,749) Bare metal stent (n=1,757)
Freedom From (Protocol) Stent ThrombosisFreedom From (Protocol) Stent Thrombosis
P=0.2099.4% (5)98.8% (10)
P=0.2999.1% (14)98.7% (20)
5 vs. 0, P=0.025After 1 yearAfter 1 year
9 vs. 2, P=0.033After 1 yearAfter 1 year
Variation in DefinitionsVariation in Definitions
No clinical sequelaeNo clinical sequelae
Sirolimus-Eluting - - - - - Bx Velocity - - - - -
Definite or Probable : Cypher versus Velocity Definite or Probable : Cypher versus Velocity
1.5% versus 1.7% p= 0.70
Definite or Probable : Endeavor versus Driver Definite or Probable : Endeavor versus Driver
ENDEAVOR - - - - - Driver - - - - -
0.5% versus 1.4% p= 0.06New
(A
RC
) D
efin
ition
s N
ew (
AR
C)
Def
initi
ons
Need for
1. Long term adequately powered trial
2. Handle on whether any one stent presents less of a risk
Need for
1. Long term adequately powered trial
2. Handle on whether any one stent presents less of a risk
All patients who you currently now treat
CYPHER & ENDEAVOR on shelf
@ up to 100+50 patients / site
UK ~ 2000 - 3500 /8800 patients
Trial time-lines
Finalisation protocol Current
Ethics
Ist patient projected
Interim analysis
trial duration 3 years
Subgroup studies UK : APT compliance
CYPHER & ENDEAVOR on shelf
@ up to 100+50 patients / site
UK ~ 2000 - 3500 /8800 patients
Trial time-lines
Finalisation protocol Current
Ethics
Ist patient projected
Interim analysis
trial duration 3 years
Subgroup studies UK : APT compliance
PROTECT –AMI & the UKPROTECT –AMI & the UK
Expected Timelines
First patient enrolment: Spring 2007
Last patient enrolment: Autumn 2008
Completion of Follow-up: Autumn 2013
In Conclusion : PROTECT-AMI
- a large, important study with significant UK input
– READY TO GO !!!
In Conclusion : PROTECT-AMI
- a large, important study with significant UK input
– READY TO GO !!!
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