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AA 2007
Bifurcation PCI and UK Trial Update
Rosie Swallow
Royal Bournemouth Hospital
AA 2007
No conflicts of interest
AA 2007
Randomized Study on Simple Versus Complex Stenting of Coronary Artery
Bifurcation Lesions.
The Nordic Bifurcation Study
Circulation. 2006;114: 1955-1961
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Background
• Optimal stenting strategy in coronary artery bifurcation lesions is unknown
• Sirolimus coated stents reduce the rate of restenosis in
simple and complex coronary artery lesions
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Nordic Bifurcation Study
• Non blinded • Randomised • Multi-centre • 28 cardiology centres – Denmark, Sweden, Finland,
Norway and Latvia • September 2004 – May 2005
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Aim
Compare two stenting strategies in de novo bifurcation lesions using Sirolimus Eluting Stents (SES):
I. Stenting Main Vessel and optional stenting of side
branch (MV)
II. Stenting Main Vessel and Side Branch (MV+SB)
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Randomised patients (n:413)
Stenting main vessel only (MV) (n: 207)
Stenting main vessel and side branch (MV+SB) (n: 206)
Clinical Follow up, 6 months (n: 207)
Clinical Follow up, 6 months (n: 206)
Scheduled angiographic Follow up after 8 months
(n: 176)
Scheduled angiographic Follow up after 8 months
(n: 182)
Angiographic Follow up available (n: 151)
Angiographic Follow up available (n: 156)
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Inclusion criteria
• Stable or unstable AP or silent ischemia • Bifurcation lesion (including LMS in RCA dominant) • Diameter of main vessel by visual estimate ≥2.5 mm • Diameter of side branch by visual estimate ≥2.0 mm
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Exclusion criteria
• ST- elevation AMI within 24 hours
• Expected survival <1year
• Serum creatinine >200 µmol/l
• Allergy to aspirin, clopidogrel or ticlopidine
• Allergy to sirolimus
• Left main bifurcation in a non-right dominant system
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Primary end points
Combined end point at 6 months of : • Cardiac death • Myocardial infarction • Stent thrombosis • Target vessel revascularisation
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Secondary end points
• Combined end point of cardiac death, index lesion MI, target lesion revascularization (TLR), stent thrombosis
• Procedure related biomarker increase • Angiographic follow-up after 8 months
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QCA Analysis at 8/12
307 patients MV MV+SB p (n:151) (n:156)
MLD SB (mm) 1.52 ± 0.58 1.86 ± 0.60 <0.001 late lumen loss SB (mm) -0.04 ± 0.52 0.2 ± 0.57 <0.001
Restenosis MV (%) 4.6 5.1 0.84 Restenosis SB(%) 19.2 11.5 0.062
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Study Limitations
• Open design
• No ischaemia testing
• Underpowered given low MACE rate
• Variety of lesion types and locations
• Clinical follow up at 6/12
• Angiography at 8/12
• Long term results not known
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Conclusions
• Excellent 6/12 clinical and 8/12 angiographic results • Procedural success rates high, MACE low, angiographic
restenosis low, independent of stenting strategy • Reduced procedure and fluoroscopy times, reduced
contrast and reduced risk of biomarker elevation in simple strategy
• Simple strategy recommended as routine for bifurcations
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Balloon-pump assisted Coronary Intervention Study (BCIS-1)
Study Update
A British Cardiovascular Intervention Society Project
Funded by Datascope, Cordis and Lilly
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Study Design
• Prospective, open, multi centre, randomised trial
• Randomisation to Elective IABP or No Planned IABP
• Sample size 300
• Follow-up to hospital discharge or 28 days after randomisation
• Six month follow-up ONS / GROS
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Main Eligibility Criteria - Inclusion
• Proposed single or multi-vessel PCI
• Presence of both the following 1. EF<30%
2. Large area of myocardium at risk (one of the following)
– Unprotected LMS target lesion
– Jeopardy score ≥8
– Target vessel provides collateral supply to an occluded 2nd vessel which supplies > 40% myocardium
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Main Eligibility Criteria - Exclusion
• Systolic BP<85mmHg despite correction of hypovolaemia
• Acute MI within previous 48 hours
• Planned staged PCI within 28 days of index PCI
• CI to IABP
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Outcomes
Primary Outcome • MACE at hospital discharge or
28 days
Secondary Outcomes • Mortality at 6/12
• Procedural complications
• Bleeding complications
• Access site complications
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Institution Principal Investigator Study Co-ordinator Birmingham Heartlands Dr Mike Pitt Juliet Hulse Glenfield Hospital Dr Anthony Gershlick Amanda Lloyd Kings College London Dr Martyn Thomas Joanne Gregory Manchester Heart Centre Dr Doug Fraser Heather Iles-Smith Liverpool CTC Dr Rod Stables Heather Rodgers 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 University Hospital of North Staffordshire Dr Jim Nolan Julie Machin Wessex CTC Dr Nick Curzen Zoe Nicholas Western Infirmary Dr Keith Oldroyd Joanne Kelly Wythenshaw Hospital Dr Bernard Prendegast Teresa Coppenger Wolverhampton Heart & Lung Centre Dr James Cotton Andy Smallwood Yorkshire Heart Centre Dr Dan Blackman Claire Priestley
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BCIS-1 Study Recruitment at 19th January 2006
0246810121416
Liverpo
ol CTC
RSCH Brighto
n
Kings C
ollege Lo
ndon
Yorkshir
e HC
Wessex C
TC
Western
Infirmary
St Georg
e's
St Thomas'
Birmingh
am Heartland
s
Royal V
ictoria
Blackpoo
l
Royal B
ournem
outh
Wolverhampton
Heart&Lung
Universi
ty of N
orth Staffo
rdshire
Total 88 patients
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0
25
50
75
100
125
150
175
200
225
250
275
300
Dec-05
Feb-06
Apr-06
Jun-0
6
Aug-06
Oct-06
Dec-06
Feb-07
Apr-07
Jun-0
7
Aug-07
Oct-07
Dec-07
Feb-08
Apr-08
Jun-0
8
Aug-08
Actual per monthActual cummulative totalPredicted 10 pts per monthPredicted 15 pts per month
Average recruitment per site last 4 months is 0.7pts/month
BCIS-1 Projected Study Recruitment
End Sep 2008 End Feb 2008
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Study Timelines
MREC submission 24th Mar 2005
MREC approval 28th Apr 2005
1st REC approval 13th May 2005
First patient 20th Dec 2005
New target of 25 – 30 centres
Invite more centres Jan/Feb 2007
Projected end recruitment Feb/Mar 2008
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Join BCIS-1Centres - Contacts
Rod Stables [email protected]
Simon Redwood [email protected]
Divaka Perera [email protected]
Jean Booth [email protected]
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BBC ONE
The British Bifurcation Coronary study: Old, New and Evolving strategies
A randomised comparison of simple versus complex drug-eluting
stenting for bifurcation lesions
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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
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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:
• <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
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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
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BBC ONE January 1st 2007
Steering committee: David Hildick-Smith Rod Stables Nick Curzen Keith Oldroyd
No. Patients recruited
310 RECRUITING CENTRES
CENTRE INVESTIGATOR ADMINISTRATOR RECRUITMENT
Brighton Hildick-Smith Cooter 82
Wolverhampton Cotton Smallwood 27
Coventry Glennon Gill 26
Bristol Baumbach Singh 25
Kings College Thomas Gregory 23
Liverpool Stables Matata 22
Dublin (St. James) Mulvihill Walsh 17
Glasgow Oldroyd Kelly 15
Southampton Curzen Kitt 15
Nottingham Henderson Burton 11
St George’s Brecker Brown 11
Bournemouth Talwar Lakeman 11
London (St. Thomas) Redwood Evans 8
Dublin (Beaumont) Foley McGrath 6
Stoke Butler Machin 3
Manchester Faz-Ordoubadi Gray 2
Birmingham Ludman Blount 1
Reading Orr Turner 1
Edinburgh Starkey Osborne 1
Birmingham (West) Varma Varma 1
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0 10 20 30 40 50 60 70 80 90
BrightonWolverhampton
CoventryBristol
King's CollegeLiverpool
Dublin (St James)Glasgow
SouthamptonNottingham
St. GeorgesBournemouth
St ThomasDublin (Beaumont)
StokeManchester
ReadingBirmingham
Birmingham (West)Edinburgh
LeedsBlackpoolPapw orthLeicester
BBC ONE recruitment to January 1st 2007
(Ethics-approved centres)
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BBC ONE current and target recruitment January 1st 2007
0
100
200
300
400
500
600
Sept
embe
r
Oct
ober
Nove
mbe
r
Dece
mbe
r
Jan-
06
Febr
uary
Mar
ch
April
May
June
July
Augu
st
Sept
embe
r
Oct
ober
Nove
mbe
r
Dece
mbe
r
Jan-
07
Febr
uary
Mar
ch
April
May
June
July
Target recruitmentCurrent recruitment
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Study Timelines
• Regulatory Approval (COREC/MHRA) Nov 2004 • Pilot Study (Brighton Site Only) Jan 2005 • First Wave of UK Sites recruiting Nov 2005 • 1st Interim analysis (220 pts) Sep 2006 • 2nd Interim analysis (350 pts) • Final patient recruited July 2007 • Follow up complete Mar 2008 • Presentation May 2008
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The CARDia Trial
Coronary Artery Revascularisation in Diabetes
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• Multi-centre, randomised, prospective comparison of PCI vs CABG for diabetics with MV or complex SVD
• ‘Up-to-date’ strategy – DES, GPIIbIIIa, Arterial conduits, off-
pump, optimum glucose control • Non Inferiority design, target 600 patients, revised to 500
Dec 2006
Study Design
AA 2007
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
No registry
No registry
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Primary endpoint: • Composite event rate at 1 year of death/non-fatal MI/
non-fatal stroke Major secondary endpoint: • Further revascularisation procedures
• Follow up is at 30 days, 6 months, 1 year, 2 years
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CARDia Centres
The 8 centres London are:
Hammersmith St Mary’s St Thomas’ Kings College London Chest Harefield St Bart’s Royal Brompton
Hairmyers Glasgow Western
James Cook University
Dublin
Brighton Southampton
Papworth
LONDON Bristol
Birmingham
Nottingham
Blackpool Liverpool Sheffield
Manchester Stoke
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Recruitment
0
100
200
300
400
500
600
Jan-05
Feb-05
March-05
April-05
May-05
Jun-05Jul-05
Aug-05
Sep-05
Oct-05
Nov-05
Dec-05
Jan-06
Feb-06
Mar-06
Apr-06
May-06
Jun-06Jul-06
Aug-06
Sep-06
Oct-06
Nov-06
Dec-06
Jan-07
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Study Timelines
• MREC approval was granted August 2001
• First sites activated January 2002
• Plan to finish recruitment April 2007
• Application for additional funding to support follow up at 5 years.
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CARDia Contacts • Co-chief Investigator and Chairman of Steering Committee - Prof Roger
Hall (Norfolk and Norwich and Hammersmith Hospitals) • Co-chief investigator and Project Manager - Dr Akhil Kapur (London
Chest Hospital) • Director CTEU - Dr Marcus Flather (Royal Brompton Hospital) • Study co-ordinator - Nicola Delahunty (CTEU, Royal Brompton Hospital) • Study has been managed by CTEU at the Royal Brompton Hospital
since April 2006. Prior to this time it was managed at the Hammersmith Hospital.