Transcript Bifurcation PCI and UK Trial Update Rosie Swallow Royal Bournemouth Hospital AA 2007

Bifurcation PCI and UK Trial Update
Rosie Swallow
Royal Bournemouth Hospital
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No conflicts of interest
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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)
Clinical Follow up, 6 months
(n: 207)
Stenting main vessel and side
branch (MV+SB) (n: 206)
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
(n:151)
MV+SB
(n:156)
MLD SB (mm)
late lumen loss SB (mm)
1.52 ± 0.58 1.86 ± 0.60
-0.04 ± 0.52 0.2 ± 0.57
<0.001
<0.001
Restenosis MV (%)
Restenosis SB(%)
4.6
19.2
0.84
0.062
5.1
11.5
p
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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
Secondary Outcomes
• MACE at hospital discharge
or 28 days
• 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
Total 88 patients
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BCIS-1 Projected Study Recruitment
300
275
250
225
200
175
Actual per month
Actual cummulative total
Predicted 10 pts per month
Predicted 15 pts per month
Average recruitment per site last
4 months is 0.7pts/month
150
125
100
75
50
End Feb 2008
End Sep 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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No. Patients recruited
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Steering committee:
David Hildick-Smith
Rod Stables
Nick Curzen
Keith Oldroyd
310
January 1st 2007
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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BBC ONE
recruitment to January 1st 2007
(Ethics-approved centres)
0
10
20
30
40
50
60
70
80
90
Brighton
Wolverhampton
Coventry
Bristol
King's College
Liverpool
Dublin (St James)
Glasgow
Southampton
Nottingham
St. Georges
Bournemouth
St Thomas
Dublin (Beaumont)
Stoke
Manchester
Reading
Birmingham
Birmingham (West)
Edinburgh
Leeds
Blackpool
Papw orth
Leicester
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July
June
May
April
March
February
Jan-07
December
November
October
September
August
July
June
May
April
March
February
Jan-06
December
November
October
September
BBC ONE
current and target recruitment January 1st 2007
600
500
400
300
Target recruitment
Current recruitment
200
100
0
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Study Timelines
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Regulatory Approval (COREC/MHRA)
Pilot Study (Brighton Site Only)
First Wave of UK Sites recruiting
1st Interim analysis (220 pts)
2nd Interim analysis (350 pts)
Final patient recruited
Follow up complete
Presentation
Nov 2004
Jan 2005
Nov 2005
Sep 2006
July 2007
Mar 2008
May 2008
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BBC 1 Contacts
David Hildick Smith
[email protected]
Nina Cooter
[email protected]
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The CARDia Trial
Coronary Artery Revascularisation in Diabetes
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Study Design
• Multi-centre, randomised, prospective comparison of PCI vs
CABG for diabetics with MV or complex SVD
• ‘Up-to-date’ strategy – DES, GPIIbIIIa, Arterial conduits, offpump, optimum glucose control
• Non Inferiority design, target 600 patients, revised to 500
Dec 2006
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Diabetic patients with multivessel disease
or complex single vessel disease
No
Suitable for PCI
or CABG
registry
No
registry
Inclusion and exclusion
criteria met
No
registry
CONSENT
Randomisation
CABG
PCI +DES
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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
Glasgow Western
Hairmyers
James Cook University
Dublin
Blackpool
Liverpool
Sheffield
Manchester Nottingham
Stoke
Birmingham
Papworth
Bristol
LONDON
Southampton
Brighton
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Recruitment
600
500
400
300
200
100
0
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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.
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