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

BCIS-1 Study B alloon-pump assisted C oronary I ntervention S tudy A British Cardiovascular Intervention Society Project

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

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

Inclusion 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

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

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

Recruitment at 17 th January st patient randomised 20 th Dec 06

Timelines Jan to Apr 06 Bring remaining centres on-line Apr 24 th 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

BBC ONE The B ritish B ifurcation C oronary study: O ld, N ew and E volving strategies A randomized comparison of simple versus complex drug-eluting stenting for bifurcation lesions A randomized comparison of simple versus complex drug-eluting stenting for bifurcation lesions

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

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)

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

BBC ONE Jan 2006 Steering committee: David Hildick-Smith Rod Stables Nick Curzen Keith Oldroyd No. Patients recruited patients to be recruited by mid New centres welcome. Trial started Brighton January 2005 For more information, please see BBC ONE website: dendrite.com/csp/bbcs/FrontPages/bbcs.csp Or TRIAL DESIGN | Patients with bifurcation coronary artery disease requiring PCI (main vessel ≥2.5mm, side branch ≥2.25mm) | RANDOMIZED TO EITHER SIMPLECOMPLEX (Stepwise provisional T-stent) (Total lesion coverage) Primary endpoint: composite at 9 months of death, MI, TVF. ACTIVE CENTRES CENTREPIAdminRecruited BrightonH-SmithCooter45 CoventryGlennonGill13 BristolBaumbachSingh12 GlasgowOldroydKelly6 WolverhptonCottonSmallwood6 KingsCollegeThomasGrogory4 NottinghamHendersonBurton1 St George’s BreckerBrown1 SouthamptonCurzen LiverpoolStables ManchesterF-Ordoubadi StokeButler BlackpoolRoberts OxfordBanning PapworthClarke St Thomas Redwood DublinMulvihill HullHoye LanarkshireGilbert NewcastleZaman ReadingOrr UCHKennon

BBC ONE recruitment to January 20 th 2006

The CARDia Trial C oronary A rtery R evascularisation in Dia betes

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 Study Design

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

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

If every centre recruited 1 per month we would finish in 10 months, if 2 then 5 months !

R-PCI mortality 5.4%

MANDATED RESCUE PCI (REACT) Pre-discharge angio (GRACIA) PPCI 50% ST segment resolution REACT 2 Chest Pain Paramedic Δ AMI Prehospital Thrombolysis 600 mg clopidogrel 300 mg clopidogrel (CLARITY) 90 min ECG