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 !!!