1. Simon Redwood Advanced Angioplasty Jan 2006
UK Trial Update
Simon Redwood
Advanced Angioplasty Jan 2006
No Conflict of Interest

2. BCIS-1 Study Balloon-pump assisted Coronary Intervention Study
A British Cardiovascular Intervention Society Project

3. IABP use during high-risk PCI
n=133, elective PCI
Non-randomised trial
Briguori et al, Am Heart J 2003
p=0.29
p=0.001

4. Study Design Prospective, open, randomised trial
Randomisation to Elective IABP or No Planned IABP
UK study 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

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

6. MACE at hospital discharge or 28 days
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

7. Principal Investigator
Institution
Principal Investigator
Study Co-ordinator
Birmingham Heartlands
Dr Mike Pitt
Juliet Hulse
Edinburgh Royal Infirmary
Dr Neal Uren
Susan Spiers
Glenfield Hospital
Dr Anthony Gershlick
Amanda Lloyd
Kings College London
Dr Martyn Thomas
Joanne Gregory
Liverpool CTC
Dr Rod Stables
Heather Rodgers
Northern General Hospital
Dr Julian Gunn
Clare Wales
Royal Victoria Hospital
Dr David Roberts
Lesley Radford
Royal Sussex County Hospital
Dr Adam de Belder
Nina Cooter
Royal Bournemouth General
Dr Rosie Swallow
Nicki Lakeman
St George's
Dr Stephen Brecker
Sue Brown
St Thomas Hospital
Dr James Coutts
Alison Child
Southwest Cardiothoracic Centre
Dr Chris Burrell
Chris Burrell
University Hospital of North Staffordshire
Dr Jim Nolan
Julie Machin
Wessex CTC
Dr Nick Curzen
Zoe Nicholas
Western Infirmary
Dr Keith Oldroyd
Joanne Kelly
Wolverhampton Heart & Lung Centre
Dr James Cotton
Andy Smallwood
Yorkshire Heart Centre
Dr Dan Blackman
Claire Priestley

8. Recruitment at 17th January 2006
1st patient randomised 20th Dec 06

9. Timelines Jan to Apr 06 Bring remaining centres on-line Apr 24th 06
Investigators Meeting BCS
Dec 05 to Mar 07
Recruitment
Jan 07 to Apr 07
Closeout of centres
Finalise dataset
May 07
Analyse data
June 07
Manuscript

10. 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

11. BBC ONE Inclusion criteria >18 yrs Stable or unstable angina
Bifurcation types I-IV suitable for stenting of both vessels
Vessel diameters >2.25mm side, >2.5mm main

12. (according to operator preference)
BBC ONE
Simple – provisional T-stenting
Following main vessel stenting, the side branch should not be treated further unless there is:
<TIMI 3 flow in the side branch
Severe ostial pinching (>90%) of the side branch
Threatened side vessel closure
Side-branch dissection >type A
Complex – crush or culotte
(according to operator preference)

13. Primary endpoints (9 months)
BBC ONE
Primary endpoints (9 months)
Death
Target vessel failure
main vessel or side branch TIMI<3 (after vasodilators) on further angiogram
main vessel or side branch undergoes attempted repeat PCI/CABG
Myocardial infarction

14. No. Patients recruited 88
Steering committee:
David Hildick-Smith
Rod Stables
Nick Curzen
Keith Oldroyd
BBC ONE
Jan 2006
ACTIVE CENTRES
CENTRE PI
Admin
Recruited
Brighton
H-Smith
Cooter 45
Coventry
Glennon
Gill 13
Bristol
Baumbach
Singh 12
Glasgow
Oldroyd
Kelly 6
Wolverhpton
Cotton
Smallwood
KingsCollege
Thomas
Grogory 4
Nottingham
Henderson
Burton 1
St George’s
Brecker
Brown
Southampton
Curzen
Liverpool
Stables
Manchester
F-Ordoubadi
Stoke
Butler
Blackpool
Roberts
Oxford
Banning
Papworth
Clarke
St Thomas
Redwood
Dublin
Mulvihill
Hull
Hoye
Lanarkshire
Gilbert
Newcastle
Zaman
Reading
Orr
UCH
Kennon
TRIAL DESIGN |
Patients with bifurcation coronary artery disease requiring PCI
(main vessel ≥2.5mm, side branch ≥2.25mm)
RANDOMIZED TO EITHER
SIMPLE COMPLEX
(Stepwise provisional T-stent) (Total lesion coverage)
Primary endpoint: composite at 9 months of death, MI, TVF.
500 patients to be recruited by mid New centres welcome.
Trial started Brighton January 2005
For more information, please see BBC ONE website: Or

15. BBC ONE recruitment to January 20th 2006

16. The CARDia Trial Coronary Artery Revascularisation in Diabetes

17. Study Design Primary endpoint:
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

18. Diabetic patients with multivessel disease
or complex single vessel disease
Suitable for PCI
or CABG
Inclusion and exclusion
criteria met
CONSENT
Randomisation
CABG
PCI +DES No
registry

19. CARDia Centres The 6 centres London are: Hammersmith St Mary’s
Hairmyers
Glasgow Western
James Cook University
Dublin
Brighton
Southampton
Papworth
LONDON
Bristol
Birmingham
Nottingham
Blackpool
Liverpool
Sheffield
The 6 centres London are:
Hammersmith
St Mary’s
St Thomas’
Kings College
London Chest
Harefield

20. If every centre recruited 1 per month we would finish in 10 months, if 2 then 5 months !
Recruitment So Far !

21. R-PCI mortality
5.4%

22. MANDATED RESCUE PCI (REACT)
Chest Pain
Paramedic Δ AMI
Prehospital
Thrombolysis
300 mg clopidogrel
(CLARITY)
600 mg clopidogrel
90 min ECG
< 50% ST resolution > 50% ST segment resolution
PPCI
MANDATED RESCUE PCI (REACT)
Pre-discharge angio
(GRACIA)