Post on 30-Dec-2015
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 !