UK Trial Update

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UK Trial Update

• Simon Redwood
• Advanced Angioplasty Jan 2006

No Conflict of Interest
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BCIS-1 StudyBalloon-pump assisted Coronary
Intervention Study
A British Cardiovascular Intervention Society
Project
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IABP use during high-risk PCI
n133, elective PCI Non-randomised trial
Briguori et al, Am Heart J 2003
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Study Design

• Prospective, open, randomised trial
• Randomisation to Elective IABP or No Planned IABP
  
• UK study 15-20 centres
• Sample size 300 patients
• Follow-up to hospital discharge or 28 days after
  randomisation which ever is sooner
• Six month follow-up ONS / GROS

BCIS-1
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• Inclusion Criteria
• Impaired LV Function (EF lt 30)
• Extensive Myocardium at Risk
• LMS Stenosis
• Jeopardy Score gt 8
• Exclusion Criteria
• Cardiogenic Shock
• STEMI within 48 hours
• VSD, MR, Intractable VT/VF
• Contraindication to IABP

BCIS-1
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• Primary Outcome
• MACE at hospital discharge or 28 days
• Secondary Outcomes
• Mortality at six months
• Procedural complications
• Procedural success
• Bleeding complications
• Access site complications
• Transient ischaemic attack
• Duration of hospital stay

BCIS-1
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Recruitment at 17th January 2006
1st patient randomised 20th Dec 06
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Timelines
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BBC ONE

• The British Bifurcation Coronary study Old, New
  and Evolving strategies
• A randomized comparison of simple versus complex
  drug-eluting stenting for bifurcation lesions

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BBC ONE

• Inclusion criteria
• gt18 yrs
• Stable or unstable angina
• Bifurcation types I-IV suitable for stenting of
  both vessels
• Vessel diameters gt2.25mm side, gt2.5mm main

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BBC ONE

• Simple provisional T-stenting
• Following main vessel stenting, the side branch
  should not be treated further unless there is
• ltTIMI 3 flow in the side branch
• Severe ostial pinching (gt90) of the side branch
• Threatened side vessel closure
• Side-branch dissection gttype A
• Complex crush or culotte
• (according to operator preference)

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BBC ONE

• Primary endpoints (9 months)
• Death
• Target vessel failure
• main vessel or side branch TIMIlt3 (after
  vasodilators) on further angiogram
• main vessel or side branch undergoes attempted
  repeat PCI/CABG
• Myocardial infarction

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No. Patients recruited 88
BBC ONE Jan 2006
Steering committee David Hildick-Smith Rod
Stables Nick Curzen Keith Oldroyd
500 patients to be recruited by mid 2007. New
centres welcome. Trial started Brighton January
2005 For more information, please see BBC ONE
website http//host.e-dendrite.com/csp/bbcs/Front
Pages/bbcs.csp Or david.hildick-smith_at_bsuh.nhs.uk
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BBC ONE recruitment to January 20th 2006
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The CARDia TrialCoronary Artery
Revascularisation in Diabetes
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Study Design

• Multi-centre, randomised, prospective comparison
  of PCI vs CABG for diabetics with MV or complex
  SVD
• Up-to-date strategy DES, 2b3a, Arterial
  conduits, off-pump, optimum glucose control, etc
• Non Inferiority design, target 600 patients
• Primary endpoint
• Composite event rate at 1 year of death/non-fatal
  MI/non-fatal stroke
• Major secondary
• Further revascularisation procedures

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CARDia Centres

• The 6 centres London are
• Hammersmith
• St Marys
• St Thomas
• Kings College
• London Chest
• Harefield

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If every centre recruited 1 per month we would
finish in 10 months, if 2 then 5 months !
Recruitment So Far !
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R-PCI mortality 5.4
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Chest Pain Paramedic ? AMI
REACT 2
Prehospital Thrombolysis
300 mg clopidogrel (CLARITY)
600 mg clopidogrel
90 min ECG
lt 50 ST resolution gt 50 ST segment
resolution
PPCI
MANDATED RESCUE PCI (REACT)
Pre-discharge angio (GRACIA)