uk clinical trials · 2016-12-15 · ebc two total (913) true bifurcations (657)...
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UK Clinical Trials UK TAVI: EBC TWO: RIPCORD
David Hildick-Smith Sussex Cardiac Centre
ACI 2013
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UK TAVI
• TAVI vs surgical AVR in intermediate-to-high risk patients
• HTA funded study
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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
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UK TAVI
• Exclusion criteria
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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
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UK TAVI
• SURTAVI • PARTNER 2-B
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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
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EBC TWO
• A European Bifurcation Coronary study: A randomised comparison of provisional T-stenting versus a systematic two-stent strategy in large calibre bifurcations
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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
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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
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EBC TWO
• 200 patients • 26 European centres • 8 UK centres • Nobori DES • CERC
• Primary endpoint – death/MI/TVR at 1 year
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RIPCORD
• Does routine pressure wire assessment influence management strategy at coronary angiography for diagnosis of chest pain?
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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
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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
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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….
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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
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RIPCORD
• Study results to be submitted for presentation in Spring 2013