acst-2 over 2500 patients randomised, what do we know? · cefalù fondazione istituto g. giglio 1...
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ACST-2 –over 2500 patients randomised, what do we know?
Alison Halliday, Professor of Vascular SurgeryUniversity of Oxford30th January 2018
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Disclosure
Speaker name: Alison Halliday
I do not have any potential conflict of interest
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Asymptomatic stenosis – what is important?
• Stroke, not just ipsilateral stroke
• Durability of any treatment – 5-10 years at least
• Affordability – drugs for ever, intervention once
• Appropriate patients - high-risk vs any patient
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ACST-2:A very European Trial in
Over 30 countries
Large Network: Neurologists,
Surgeons, Interventionalists
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ACST-2 Surgery vs Stenting
Asymptomatic patients with tight stenosis requiring intervention:
Which procedure is generally better (in addition to good medical treatment)? :
carotid surgery (CEA)or
carotid stenting (CAS)?
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ACST-2 – what makes it different from other trials?
Collaborators are free to use their usual techniques
Any CE marked stent. CPD not mandatedGA or LA; Primary or patch closure…
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Two stenting hazards – crossing the
lesion + navigating in the aortic arch
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Asymptomatic carotid disease –modern CAS therapy since ACT-1
Stable plaque - lower peri-procedural risk and..
• Newer stent designs
• Flow reversal (MOMA)
• Direct cervical access (TECAR)
• Greater experience
May
reduce
risk
further
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Carotid Stents – Avoid plaque protrusion
Closed Cell
Open Cell
Membrane covered
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And: the direct approach to stenting – avoiding
aortic arch atheroma, controlling flow reversal
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ACST-2: What do we know?Sex, Age, Co-morbidities:
Men 70%
Median age 69 years
Ischaemic heart disease 37%
Diabetic 29%
Renal impairment 9%
Stroke risk factors:
Atrial Fibrillation 6%
Age >75 yrs 26%
Previous stroke symptoms or infarct 35%
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ACST-2: What do we know?Ipsilateral Stenosis:Median 80%50-69% 3%70-89% 73%90-99% 23%
Contralateral Stenosis:50-99% 31%Occlusion 7%
Plaque Echolucency: 29%
Cholesterol:Total (Mean) 4.7mm/l (ACST-1 5.6)HDL 1.3mm/l
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Time from randomisation to procedure
Jan 2018
CEA: 24 days
CAS: 29 days
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Compliance with allocated
treatment
Allocated
procedure
1-month form
entered
Procedure
not yet doneCross-over
Procedure as
allocated
CAS 62
CEA 39
Total 100% 4% 4% 91%
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Mean follow-up January 2018
CEA: 3.6 person-years
CAS: 3.6 person-years
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Surgery: anaesthesia and techniques
(3% CAS under GA)
General714 (58%)
Local515 (42%)
Total1231
Patches Yes
377 (53%) 150 (29%) 527 (43%)
Shunts Yes
207 (29%) 39 (8%) 246 (20%)
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2017 ESVS and ESC Guidelines
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81% lipid-lowering drugs
85% anti-hypertensive therapy
96% anti-thrombotic(anti-platelet/anti-coagulant)
ACST-2 ‘modern’ medical therapy
- At Trial Entry
and long-term compliance is good
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1 month after treatment
Allocated procedures
(n=2391)
Anti-hypertensive 86%
Lipid-Lowering 88%
Anti-platelet or
anti-coagulant99%
On at least one of
aspirin or clopidogrel96%
On both
aspirin and clopidogrel41%
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2016 Annual follow-up
CAS
(n=793)
CEA
(n=818)
Total allocated
procedure done
(n=1650)
Anti-hypertensive 80%
Lipid-Lowering 80%
Anti-platelet or anti-
coagulant93%
On at least one of
aspirin or clopidogrel85%
On both
aspirin and clopidogrel12% 8% 10%
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Atorvastatin 42%
Simvastatin 23%
Rosuvastatin 13%
Other statins 4%
Fibrates 1%
Ezetimibe 5%
On 2 lipid-lowering drugs 5%
2016 Annual Follow up
Lipid Lowering Treatment
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2009 2010 2011 2012 2013 2014 2015 2016
Statin Use by YearF
req
uen
cy (
%)
Year
0
20
40
60
80
100
Long-term statin use >80%
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2013 2014 2015 2016
Intensity of Statin Therapy by YearF
req
uen
cy (
%)
Year
0
20
40
60
80
100 (Unclear)
High Dose
Moderate Dose
Low Dose
>75% on good (or very good)
statin regimens
Simva 40 Atorva 20 Rosuva 10 Combined
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Wallstent (Closed) (44%) 306
Xact 188
Adapt 10
Precise (Open) (34%) 155
Protégé® RX 113
RX Acculink 111
ViVEXX 9
Zilver 7
Cristallo Ideale (Hybrid) (16%) 175
Sinus Carotid Conical RX 10
Mer 1
Roadsaver (Membrane) (6%)
CGuard
46
26
TOTAL 1160
Stents used
Filter (67%) Emboshield 252
Filterwire 231
Spider 170
Accunet 74
AngioGuard 47
FiberNet 1
Wirion System 1
Proximal
occlusion (17%)
Moma
Gore Flow Reversal
171
29
Distal balloon Twin One
Viatrac
6
2
None (15%) 177
1160
CPD use
ACST-2 and modern CAS therapy
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2008 2009 2010 2011 2012 2013 2014 2015 2016
Cerebral Protection by YearF
req
uen
cy (
%)
Year
0
20
40
60
80
100
None
(Distal Balloon)
Proximal Occlusion
Filter
Cerebral Protection in
~85% of cases
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2008 2009 2010 2011 2012 2013 2014 2015 2016
Stent Devices by Year
Fre
qu
en
cy (
%)
Year
0
20
40
60
80
100
Membrane
Hybrid
Closed Cell
Open Cell
Closed cell stents predominateMembrane stents emerging
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ACST-2 stenting
• Medical therapy in ACST-2 is good (>80%)Moderate and high statin regimens favoured
• Cerebral protection widely used (85%)
• Flow reversal quite common (17%)Mo.Ma often used
• Closed cell stents still predominate (43%)Membrane-mesh covered stents emerging
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ACST-2 Procedural hazards (CEA+CAS)much lower than symptomatic trials
Disabling and fatal Stroke ≤ 30 days :
1.0%
Suggests procedural competence in ACST-2,
confirms interventions are low-risk
And lower than in previous trial
of CEA :
1.7% (ACST-1)
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Recruitment - target 3600
0
600
1200
1800
2400
3000
3600
2010Jan
2011Jan
2012Jan
2013Jan
2014Jan
2015Jan
2016Jan
2017Jan
2018Jan
2019Jan
2020Jan
Projectedrecruitment
Currentrecruitment
2778
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Other countries
Slovenia
Spain
Switzerland
France
The Netherlands
Greece
Poland
Hungary
Czech Republic
Belgium
Russia
Germany
Sweden
Serbia
United Kingdom
Italy
Italy – Best recruiters in ACST-2 (>650)(UK >400)
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Recruitment – Website (acst-2.org)October 2016 September 2016
East Tallinn Central Hospital 2Novosibirsk Research Institute 3Klinikum rechts der Isar Muenchen 2Semmelweis Medical University 2Albert Szent-Györgyi Medical Centre 1Cheltenham General Hospital 1Circolo University Hospital 1Dedinje Cardiovascular Unit 1Foothills Medical Centre 1Guadalajara Hospital 1Kent and Canterbury Hospital 1Lasarettet Helsingborg 1Malmo Vascular Centre 1Mirano Hospital 1Nottingham University Hospital 1San Giovanni Di Dio 1Santa Maria Hospital 1Serbian Clinical Centre 1Sodersjukhuset 1St. Anna University Hospital Ferrara 1Teaching Hospital Maribor 1University of Basel 1TOTAL SEPTEMBER 27
Novosibirsk Research Institute of Circulation Pathology 4
Serbian Clinical Centre 3
University of Bologna 3
UniversitäTsklinikum Leipzig 3
Santa Maria Hospital 2
Sodersjukhuset 2
University of Dresden 'Carl-Gustav-Carus' 2
Cantonal Hospital Aarau 1
Cefalù Fondazione Istituto G. Giglio 1
Ceske Budejovice - Budweiss 1
Dedinje Cardiovascular Unit 1
Hospital de Santa Marta 1
Istituto Auxologico Italiano
1
Mirano Hospital 1
Semmelweis Medical University
1
Sendai Medical Centre 1
St Anne's University Hospital Brno
1
UniversitäTs Klinikum Hamburg-Eppendorf 1
Vascular Endovascular Unit of Perugia
1
Wythenshawe Hospital (University of South Manchester)
1
TOTAL OCTOBER
32Website Front Page:
Our new patient (s) were
randomised from:
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ACST-2 Time Line
Jan 2018 Nearly 2800 randomised
Dec 2019 Randomise 800 more patients
Median follow-up of 5 years
Mid 2021 ACST-2 report 5-year results
Procedural risks and early benefits
IPD: with CREST-1, ACT-1 + SPACE-2 (n=6000)
Mid 2025 ACST-2 10-year results
Reliably compare durability of CEA vs CAS
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ACST-2 –over 1500 patients randomised, what do we know?
Alison Halliday, Professor of Vascular SurgeryUniversity of Oxford30th January 2018