UK Clinical Trials UK TAVI: EBC TWO: RIPCORD

David Hildick-Smith Sussex Cardiac Centre

ACI 2013

UK TAVI

•  TAVI vs surgical AVR in intermediate-to-high risk patients

•  HTA funded study

UK TAVI

•  Inclusion •  Symptomatic native aortic stenosis •  Age ≥80 yrs •  Or age >70 yrs with intermediate/high operative

risk •  Governed by MDT •  Expected STS score 4-12

UK TAVI

•  Exclusion criteria

UK TAVI

•  800 patients across all UK TAVI sites •  Primary endpoint

•  All cause mortality at one year

•  Secondary endpoints •  Quality of life •  Safety •  Efficacy ……3months to 5 yrs

UK TAVI

•  SURTAVI •  PARTNER 2-B

How does UK-TAVI differ?

•  Industry-free •  Any appropriate CE-marked valve •  MDT has complete primacy •  No exclusion criteria •  Likely lowest risk cohort so far studied

EBC TWO

•  A European Bifurcation Coronary study: A randomised comparison of provisional T-stenting versus a systematic two-stent strategy in large calibre bifurcations

EBC TWO

•  Inclusion •  True bifurcation (x,x,1) •  Side branch ≥2.5mm diameter •  Side branch ostial >5mm disease

•  Hypothesis •  Culotte may prove superior in this group

EBC TWO

Total(913)

Truebifurcations(657)

Angle>60-70° (217)

SBdiameter≥2.75mm(281)

SBlesion>5mm(464)

SBdiameter≥2.75mm/lesion>5mm(137)

Equivalence(111)

FavoursSimple FavoursComplex

1.84(1.27-2.65)

1.91(1.23-2.96)

1.69(0.78-3.65)

2.34(1.15- 4.77)

1.66(1.02-2.68)

2.55(1.03-6.40)

1.62(0.50-4.76)

Oddsratioand95% CI

Total(913)

Truebifurcations(657)

Angle>60-70° (217)

SBdiameter≥2.75mm(281)

SBlesion>5mm(464)

SBdiameter≥2.75mm/lesion>5mm(137)

Equivalence(111)

FavoursSimple FavoursComplex

1.84(1.27-2.65)

1.91(1.23-2.96)

1.69(0.78-3.65)

2.34(1.15- 4.77)

1.66(1.02-2.68)

2.55(1.03-6.40)

1.62(0.50-4.76)

1.84(1.27-2.65)

1.91(1.23-2.96)

1.69(0.78-3.65)

2.34(1.15- 4.77)

1.66(1.02-2.68)

2.55(1.03-6.40)

1.62(0.50-4.76)

Oddsratioand95% CI

Behan et al, Meta-analysis of Nordic and BBC ONE, Circ Cardiovasc Intvn 2011

EBC TWO

•  200 patients •  26 European centres •  8 UK centres •  Nobori DES •  CERC

•  Primary endpoint – death/MI/TVR at 1 year

RIPCORD

•  Does routine pressure wire assessment influence management strategy at coronary angiography for diagnosis of chest pain?

RIPCORD

•  Premise •  Many patients have wrong treatment allocation

based on angiographic findings alone •  Adding FFR at the time of diagnostic angiography

will modify the treatment decision in a proportion of patients

RIPCORD

•  200 patients undergoing coronary angiography •  8 centres •  FFR undertaken in native epicardial coronaries

with >30% visual stenosis •  Consultant asked to indicate treatment plan

•  i) blinded to FFR data •  ii) privy to FFR data

RIPCORD

•  Primary outcome measure: •  No. of cases in which management strategy

changed •  CABG to PCI •  PCI to CABG •  No. of PCI vessels •  PCI to medical etc….

15/12/16

0

10

20

30

40

50

60

Numbers recruited per centre

RIPCORD recruitment Belfast

Brighton

Glasgow

Leeds

Newcastle

Oxford

Southampton

Derby

Portsmouth

Taunton

TheRIPCORDStudy

RecruitmentfinishedNov2012

RIPCORD

•  Study results to be submitted for presentation in Spring 2013