Fundación Favaloro

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Fundación Favaloro
Revascularización en la enfermedad carotidea
sintomática ¿La resurrección de la angioplastia?
Gaspar Caponi
Editor para el sitio web de SOLACI
Staff Cardiología Intervencionista
Hospital Universitario – Fundación Favaloro
Buenos Aires - Argentina
Octubre 2015
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Symptomatic Carotid Stenosis
Event Risk by lesion severity
NASCET. NEJM 1991, 325:445-453
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Risk of Stroke after warning
TIA / Minor Stroke
Coull AJ et al, BMJ 2004;328:326
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Absolute Risk Reduction (ARR)
conferred by CEA in the 5-year risk of
Ipsilateral Ischemic Stroke / Death
NACSET & ECST Pooled data (2003)
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http://www.mdcalc.com/abcd2-score-for-tia
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ABCD2 score ≥4
ABCD2 score <4
NICE Guidelines
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The risk benefit ratio & NNT
Performing CEA or CAS with a 10% risk within
14 days will prevent approximately 150 strokes
at 5 years per 1000 CEAs or CAS.
By contrast, if one were to defer CEA/CAS until
4 weeks had elapsed and then undertake that
intervention with a 3% risk, only 100 strokes
would be prevented.
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A Systematic Review of Randomized
Controlled Trials for Symptomatic Carotid
Stenosis
Pooled analysis of 6,092 pts from NASCET, ECST, and VACSP trials
evaluating CEA vs. medical therapy alone.
• CEA was of the most benefit in pts with 70-99% stenosis (risk
reduction of 16% for ipsilateral ischemic stroke; P < 0.001).
• Male sex (P = 0.003), age older than 75 (P = 0.03), and time delay
less than 2 weeks from ischemic event to surgery (P = 0.009) were all
associated with reduced risk of ipsilateral stroke with CEA.
Conclusion: Benefit from CEA depends not only on the degree of
carotid stenosis but also on several other factors, including
delays to surgery.
Rerkasem K, et al. Stroke 2011
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Are There Patients at High Risk
for CEA?
Anatomic High Risk Criteria
Surgically Inaccessible
Contralateral Occlusion
Restenosis after CEA
Previous Radiation to Carotid Area
Ipsilateral Radical Neck Dissection
Obese/Short Neck
Spinal Immobility due to Arthritis
Tracheostoma
High Risk Co-morbidities
Advanced age (>75-80)
UA
Recent MI (4-6 weeks)
Abnormal stress test or 2-vessel
CAD
LVEF < 30-35% or NYHA Class IIIIV HF
Dialysis dependent renal failure
Severe COPD
Need for CABG or valve surgery
Need for vascular surgery
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A Clinical Rule to Select Patients for
Stenting vs. CEA
Data from 170 observational studies used to create clinical rule
known as
SCAR (sex, contralateral occlusion, age, and restenosis).
In validation study of over 3,000 patients, those who were
SCAR-positive had higher risk of procedural stroke/death
with CAS vs. CEA (RR 2.44; 1.71-3.48; P = 0.83).
Similar results were seen in sensitivity analysis
considering all 4 risk factors as equivalent.
Contralateral occlusion or restenosis, women (but not men)
aged < 75 years had lower risk with CAS vs. CEA.
Conclusion: A simple rule incorporating 4 clinical risk factors may help
clinicians choose between CAS and CEA.
Touzé E, et al. Stroke.2013
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Safety of Stenting and Endarterectomy by
Symptomatic Status in the CREST Trial
Subanalysis of 1,181 asymptomatic and 1,321 symptomatic
patients.
Conclusion: Carotid artery stenting or endarterectomy produce
similar overall outcomes within asymptomatic and symptomatic
subgroups.
Silver FL, et al. Stroke. 2011.
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CREST: Similar mortality to 4
years
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CREST: Similar freedom from ipsilateral
stroke day 31 to 4 years
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Why Didn’t CREST End the
Debate?
Surgeons feel that CEA reduced stroke risk
more than CAS and excess MI rate with CEA
less of an issue.
Interventionists feel that CAS performed as
safely as CEA, excess stroke risk was minor
stroke only and MI risk of CEA is important.
Neurologists feel that although outcomes were
low, medical therapy is more effective than any
revascularization.
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Long-term mortality: No association with
minor stroke Strong association with MI
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Long-term Outcomes After Stenting vs CEA for
Treatment of Symptomatic Carotid Stenosis
ICSS: 1,713 patients randomized to CAS (n = 855) or CEA (n = 858)
at 50 centers worldwide, 2001-2008.
Conclusion: Long-term data on symptomatic patients demonstrate
similar rates of fatal or disabling stroke between CAS and CEA.
Bonati LH, et al. Lancet.2014.
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Long-term Follow-up of Endarterectomy vs
Angioplasty in Patients with Symptomatic Severe
Carotid Stenosis (EVA-3S) Trial
527 randomized patients followed for a median of 7.1 years.
Conclusion: Despite higher early risk of stroke with CAS vs CEA, in
the long run, both treatments provide similar stroke protection.
Mas J-L, et al. Stroke. 2014.
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Real world outcomes for symptomatic high
risk patients: AHA guidelines met or
exceeded by >500 operators N=589
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Impact of Symptoms, Gender, Comorbidities,
and Operator Volume on Outcomes of CAS
Data from Nationwide Inpatient Sample on 13,564 patients who
underwent carotid stenting, 2006-2010.
Postprocedural mortality (0.5%),
complications (8%) low overall but higher in
symptomatic patients and women.
Higher annual operator volumes (threshold
of ≥ 5 cases) were predictive of lower
mortality and complications.
High operator volume also associated with
shorter hospital stay and lower cost.
Badheka AO, et al. Am J Cardiol.2014.
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Carotid Angioplasty – Fundación Favaloro Experience
October 1995 – October 2015
In-Hospital Results related to previous symptoms: n=877
Symptom
21
Asymptom
69
p
With Distal Protection %
80
88.5
0.003
Procedure Success %
Major Stroke %
Minor Stroke %
93
3.9
2.6
97.3
0.4
1.6
0.01
0.006
0.3
TIA %
3.5
0.6
0.005
Death (non-related to carotid stenting)
Related Death
Any Stroke or All Death %
Any Stroke or Related-Death %
0.5
6.9
6.5
0.8*
0.2
2.4*
2.1
1
1
0.007
0.005
Number of Procedures %
•non-related death. CV surgery the same day.
# 9 cases in feasibility studies of new stent or Angioguard
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Conclusions
Early intervention after index event (especially
cortical) may be risk-associated but will benefit
the individual & society in the longer term.
CAS performed within two weeks of event is
feasible – and may be safe - more work is
required.
These are the results from experienced CAS
units & might not be extrapolated to less
experienced units
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