UK Trial UpdateUK Trial Update

Simon RedwoodSimon Redwood

Advanced Angioplasty Jan 2006Advanced Angioplasty Jan 2006

No Conflict of Interest

BCIS-1 StudyBCIS-1 Study

BBalloon-pump assisted alloon-pump assisted

CCoronary oronary IIntervention ntervention SStudy tudy

A British Cardiovascular Intervention Society Project

n=133, elective PCINon-randomised trial

Briguori et al, Am Heart J 2003

IABP use during high-risk PCIIABP use during high-risk PCI

0

10

20

%

Conventional Rx Elective IABP

In-lab events

In-hospitalMACE

p=0.29

p=0.001

Study DesignStudy Design

Prospective, open, randomised trialProspective, open, randomised trial

Randomisation to Elective IABP or No Randomisation to Elective IABP or No Planned IABP Planned IABP

UK study 15-20 centresUK study 15-20 centres

Sample size 300 patientsSample size 300 patients

Follow-up to hospital discharge or 28 days Follow-up to hospital discharge or 28 days after randomisation which ever is soonerafter randomisation which ever is sooner

Six month follow-up ONS / GROSSix month follow-up ONS / GROSBCIS-1

Inclusion CriteriaInclusion Criteria– Impaired LV Function (EF < 30%)Impaired LV Function (EF < 30%)– Extensive Myocardium at RiskExtensive Myocardium at Risk

LMS StenosisLMS Stenosis

Jeopardy Score > 8Jeopardy Score > 8

Exclusion CriteriaExclusion Criteria– Cardiogenic ShockCardiogenic Shock– STEMI within 48 hoursSTEMI within 48 hours– VSD, MR, Intractable VT/VFVSD, MR, Intractable VT/VF– Contraindication to IABPContraindication to IABP

BCIS-1

Primary OutcomePrimary OutcomeMACE at hospital discharge or 28 MACE at hospital discharge or 28 daysdays

Secondary OutcomesSecondary OutcomesMortality at six monthsMortality at six monthsProcedural complications Procedural complications Procedural success Procedural success Bleeding complicationsBleeding complicationsAccess site complications Access site complications Transient ischaemic attackTransient ischaemic attackDuration of hospital stayDuration of hospital stay BCIS-1

InstitutionInstitution Principal Principal Investigator Investigator

Study Co-Study Co-ordinatorordinator

Birmingham HeartlandsBirmingham Heartlands Dr Mike PittDr Mike Pitt Juliet HulseJuliet Hulse

Edinburgh Royal InfirmaryEdinburgh Royal Infirmary Dr Neal UrenDr Neal Uren Susan SpiersSusan Spiers

Glenfield HospitalGlenfield Hospital Dr Anthony GershlickDr Anthony Gershlick Amanda LloydAmanda Lloyd

Kings College LondonKings College London Dr Martyn ThomasDr Martyn Thomas Joanne GregoryJoanne Gregory

Liverpool CTCLiverpool CTC Dr Rod StablesDr Rod Stables Heather RodgersHeather Rodgers

Northern General Hospital Northern General Hospital Dr Julian GunnDr Julian Gunn Clare WalesClare Wales

Royal Victoria HospitalRoyal Victoria Hospital Dr David Roberts Dr David Roberts Lesley RadfordLesley Radford

Royal Sussex County HospitalRoyal Sussex County Hospital Dr Adam de BelderDr Adam de Belder Nina CooterNina Cooter

Royal Bournemouth GeneralRoyal Bournemouth General Dr Rosie SwallowDr Rosie Swallow Nicki LakemanNicki Lakeman

St George's St George's Dr Stephen BreckerDr Stephen Brecker Sue BrownSue Brown

St Thomas HospitalSt Thomas Hospital Dr James CouttsDr James Coutts Alison ChildAlison Child

Southwest Cardiothoracic CentreSouthwest Cardiothoracic Centre Dr Chris BurrellDr Chris Burrell Chris BurrellChris Burrell

University Hospital of North University Hospital of North StaffordshireStaffordshire

Dr Jim NolanDr Jim Nolan Julie MachinJulie Machin

Wessex CTCWessex CTC Dr Nick CurzenDr Nick Curzen Zoe NicholasZoe Nicholas

Western InfirmaryWestern Infirmary Dr Keith OldroydDr Keith Oldroyd Joanne KellyJoanne Kelly

Wolverhampton Heart & Lung CentreWolverhampton Heart & Lung Centre Dr James CottonDr James Cotton Andy SmallwoodAndy Smallwood

Yorkshire Heart CentreYorkshire Heart Centre Dr Dan BlackmanDr Dan Blackman Claire PriestleyClaire Priestley

04/19/2304/19/23

Recruitment at 17Recruitment at 17thth January 2006 January 2006

0

1

2

3

4

5

1st patient randomised 20th Dec 06

TimelinesTimelines

Jan to Apr 06Jan to Apr 06 Bring remaining centres Bring remaining centres on-lineon-line

Apr 24Apr 24th th 06 06 Investigators Meeting Investigators Meeting BCSBCS

Dec 05 to Mar 07Dec 05 to Mar 07 RecruitmentRecruitment

Jan 07 to Apr 07Jan 07 to Apr 07 Closeout of centresCloseout of centres

Finalise datasetFinalise datasetMay 07May 07 Analyse dataAnalyse data

June 07June 07 ManuscriptManuscript

BBC ONEBBC ONE

The The BBritish ritish BBifurcation ifurcation CCoronary study: oronary study:

OOld, ld, NNew and ew and EEvolving strategies volving strategies

A randomized comparison of simple versus A randomized comparison of simple versus complex drug-eluting stenting for bifurcation complex drug-eluting stenting for bifurcation

lesionslesions

BBC ONEBBC ONE

Inclusion criteriaInclusion criteria– >18 yrs>18 yrs– Stable or unstable Stable or unstable

anginaangina– Bifurcation types I-IV Bifurcation types I-IV

suitable for stenting of suitable for stenting of both vesselsboth vessels

– Vessel diameters Vessel diameters >2.25mm side, >2.5mm >2.25mm side, >2.5mm mainmain

BBC ONEBBC ONE

Simple – provisional T-stentingSimple – provisional T-stenting– Following main vessel stenting, the side Following main vessel stenting, the side

branch should not be treated further unless branch should not be treated further unless there is:there is:

<TIMI 3 flow in the side branch<TIMI 3 flow in the side branch

Severe ostial pinching (>90%) of the side branchSevere ostial pinching (>90%) of the side branch

Threatened side vessel closureThreatened side vessel closure

Side-branch dissection >type ASide-branch dissection >type A

Complex – crush or culotteComplex – crush or culotte (according to operator preference)(according to operator preference)

BBC ONEBBC ONE

Primary endpoints (9 months)Primary endpoints (9 months)

DeathDeathTarget vessel failureTarget vessel failure– main vessel or side branch TIMI<3 (after main vessel or side branch TIMI<3 (after

vasodilators) on further angiogramvasodilators) on further angiogram– main vessel or side branch undergoes main vessel or side branch undergoes

attempted repeat PCI/CABGattempted repeat PCI/CABG

Myocardial infarctionMyocardial infarction

BBC ONEBBC ONE

Jan 2006Jan 2006

Steering committee:David Hildick-Smith Rod Stables Nick CurzenKeith Oldroyd

No. Patients recruited

88

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/FrontPages/bbcs.csp

Or david.hildick-smith@bsuh.nhs.uk

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.

ACTIVE CENTRESACTIVE CENTRES

CENTRECENTRE PIPI AdminAdmin RecruitedRecruited

BrightonBrighton H-SmithH-Smith CooterCooter 4545

CoventryCoventry GlennonGlennon GillGill 1313

BristolBristol BaumbachBaumbach SinghSingh 1212

GlasgowGlasgow OldroydOldroyd KellyKelly 66

WolverhptonWolverhpton CottonCotton SmallwoodSmallwood 66

KingsCollegeKingsCollege ThomasThomas GrogoryGrogory 44

NottinghamNottingham HendersonHenderson BurtonBurton 11

St George’sSt George’s BreckerBrecker BrownBrown 11

SouthamptonSouthampton CurzenCurzen

Liverpool Liverpool StablesStables

ManchesterManchester F-OrdoubadiF-Ordoubadi

StokeStoke ButlerButler

BlackpoolBlackpool RobertsRoberts

OxfordOxford BanningBanning

PapworthPapworth ClarkeClarke

St ThomasSt Thomas RedwoodRedwood

DublinDublin MulvihillMulvihill

HullHull HoyeHoye

LanarkshireLanarkshire GilbertGilbert

NewcastleNewcastle ZamanZaman

ReadingReading OrrOrr

UCHUCH KennonKennon

BBC ONE BBC ONE recruitment to January 20recruitment to January 20thth 2006 2006

0

10

20

30

40

50

60

70

80

90

Overall recruitment

Brighton

Bristol

Coventry

Kings College

Glasgow

Wolverhampton

Nottingham

St George's

The CARDia TrialThe CARDia Trial

CCoronary oronary AArtery rtery RRevascularisation in evascularisation in DiaDiabetesbetes

Multi-centre, randomised, prospective comparison of Multi-centre, randomised, prospective comparison of PCI vs CABG for diabetics with MV or complex SVDPCI vs CABG for diabetics with MV or complex SVD

‘‘Up-to-date’ strategy – DES, 2b3a, Arterial conduits, off-Up-to-date’ strategy – DES, 2b3a, Arterial conduits, off-pump, optimum glucose control, etcpump, optimum glucose control, etc

Non Inferiority design, target 600 patientsNon Inferiority design, target 600 patients

Primary endpoint:Primary endpoint:

Composite event rate at 1 year of death/non-Composite event rate at 1 year of death/non-fatal MI/non-fatal strokefatal MI/non-fatal stroke

MajorMajor secondary:secondary:

Further revascularisation proceduresFurther revascularisation procedures

Study Design

Diabetic patients with multivessel diseaseor complex single vessel disease

Suitable for PCI or CABG

Inclusion and exclusion criteria met

CONSENT

Randomisation

CABG PCI +DES

No

registry

No

registry

No

registry

CARDiaCARDia CentresCentres

The 6 centres London are:The 6 centres London are:

HammersmithHammersmith

St Mary’s St Mary’s

St Thomas’St Thomas’

Kings CollegeKings College

London Chest London Chest

HarefieldHarefield

Hairmyers

Glasgow Western

James Cook University

Dublin

Brighton Southampton

Papworth

LONDONBristol

Birmingham

Nottingham

BlackpoolLiverpool Sheffield

050

100150200250300350400450

Pa

tie

nts

Months

Cumulative Recruitment

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 resolution > 50% ST segment resolution

REACT 2Chest Pain

Paramedic Δ AMI

Prehospital

Thrombolysis

600 mg clopidogrel

300 mg clopidogrel

(CLARITY)

90 min ECG