AA 2007 Bifurcation PCI and UK Trial Update Rosie Swallow Royal Bournemouth Hospital.
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Transcript of AA 2007 Bifurcation PCI and UK Trial Update Rosie Swallow Royal Bournemouth Hospital.
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-ordinatorBirmingham Heartlands Dr Mike Pitt Juliet HulseGlenfield Hospital Dr Anthony Gershlick Amanda LloydKings College London Dr Martyn Thomas Joanne Gregory
Manchester Heart Centre Dr Doug Fraser Heather Iles-SmithLiverpool CTC Dr Rod Stables Heather RodgersRoyal Victoria Hospital Dr David Roberts Lesley RadfordRoyal Sussex County Hospital Dr Adam de Belder Nina CooterRoyal Bournemouth General Dr Rosie Swallow Nicki LakemanSt George's Dr Stephen Brecker Sue BrownSt Thomas Hospital Dr James Coutts Alison ChildUniversity Hospital of North Staffordshire Dr Jim Nolan Julie MachinWessex CTC Dr Nick Curzen Zoe NicholasWestern Infirmary Dr Keith Oldroyd Joanne Kelly
Wythenshaw Hospital Dr Bernard Prendegast Teresa CoppengerWolverhampton Heart & Lung Centre Dr James Cotton Andy SmallwoodYorkshire Heart Centre Dr Dan Blackman Claire Priestley
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BCIS-1 Study Recruitment at 19th January 2006
02468
10121416
Liverpo
ol CTC
RSCH Brig
hton
Kings C
olleg
e Londo
n
Yorkshir
e HC
Wess
ex C
TC
Weste
rn Infirm
ary
St Georg
e's
St Thomas'
Birmingh
am Heartla
nds
Royal V
ictori
a Black
pool
Royal B
ourn
emouth
Wolve
rhampton
Heart&
Lung
Universi
ty of N
orth S
tafford
shire
Total 88 patients
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0
25
50
75
100
125
150
175
200
225
250
275
300
Dec-0
5
Feb-0
6
Apr-0
6
Jun-
06
Aug-0
6
Oct-
06
Dec-0
6
Feb-0
7
Apr-0
7
Jun-
07
Aug-0
7
Oct-
07
Dec-0
7
Feb-0
8
Apr-0
8
Jun-
08
Aug-0
8
Actual per month
Actual cummulative totalPredicted 10 pts per month
Predicted 15 pts per month
Average recruitment per site last 4 months is 0.7pts/month
BCIS-1 Projected Study Recruitment
End Sep 2008End 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-stentingFollowing 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 CurzenKeith Oldroyd
No. Patients recruited
310RECRUITING 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
Septe
mber
Octo
ber
Novem
ber
Decem
ber
Jan-0
6
Febru
ary
Marc
h
April
May
June
July
August
Septe
mber
Octo
ber
Novem
ber
Decem
ber
Jan-0
7
Febru
ary
Marc
h
April
May
June
July
Target recruitment
Current 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
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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
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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
LONDONBristol
Birmingham
Nottingham
BlackpoolLiverpool Sheffield
ManchesterStoke
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Recruitment
0
100
200
300
400
500
600
Jan-
05
Feb-0
5
Mar
ch-0
5
April-0
5
May
-05
Jun-
05
Jul-0
5
Aug-0
5
Sep-0
5
Oct-05
Nov-0
5
Dec-0
5
Jan-
06
Feb-0
6
Mar
-06
Apr-0
6
May
-06
Jun-
06
Jul-0
6
Aug-0
6
Sep-0
6
Oct-06
Nov-0
6
Dec-0
6
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.
