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Carotid Artery StenosisCarotid Artery Stenosis:: Stenting vs. Endarterectomy Stenting vs. Endarterectomy
Városmajor Study.Városmajor Study.
L. Entz,, E.Dósa, K. Hüttl. L. Entz,, E.Dósa, K. Hüttl.
Department of Cardiovascular Surgery,
Semmelweis University,
Budapest, Hungary
Oxford,ACST-2 2014
Conflict of InterestConflict of Interest
NoneNone
IntroductionIntroductionClinical TrialsClinical Trials:C:CEA vs. CASEA vs. CAS
CAVATAS CAVATAS • Very Very high high perioperative perioperative
strokestroke//morbidity/mortalitymorbidity/mortality for for both both CEACEA (9,9%)(9,9%) and CASand CAS (26%) (26%)
• Protection deviceProtection device: 0: 0• Recurrent stenosis rateRecurrent stenosis rate: 22%: 22%
SAPPHIRE: SAPPHIRE: • high risk patients onlyhigh risk patients only• funded by industry (protection devices, funded by industry (protection devices,
stentsstents))
Clinical Trials Clinical Trials CEA vs. CASCEA vs. CAS
SPACE:SPACE:• PProtection device was obligatoryrotection device was obligatory• 30-day death/stroke rate: CEA/CAS: 6.3%/6.8% 30-day death/stroke rate: CEA/CAS: 6.3%/6.8%
p=p=NSNS• Non-inferiority was not prooveNon-inferiority was not proovenn p=0.9 NS p=0.9 NS• StoppedStopped
EVA-3S:EVA-3S:• 527 patients, death/stroke rate:527 patients, death/stroke rate:• CEA/CAS: 3,9%/9,6% CEA/CAS: 3,9%/9,6% (p<.05)(p<.05)• StoppedStopped
Clinical Trials Clinical Trials CEA vs. CASCEA vs. CAS
ICSS:ICSS: 1713 symptomatic patients 1713 symptomatic patients CEA CASCEA CAS
• Stroke, MI, death rate: Stroke, MI, death rate: 4,0%.vs. 7.4%4,0%.vs. 7.4%((p<.p<.006) 006)
• stroke alone: 3.3%vs.7.0%stroke alone: 3.3%vs.7.0%• MRI Substudy: new ischMRI Substudy: new ischemicemic lesions lesions • CEA/CAS: 13/50 p=0.001CEA/CAS: 13/50 p=0.001• 4-6 weeks 4-6 weeks laterlater : : 8%/30%8%/30%
• CREST:CREST: • 2502 asympt. And sympt.patients 2502 asympt. And sympt.patients CEA CASCEA CAS• Stroke, MI, death rate: Stroke, MI, death rate: 4.5% vs.5.2% 4.5% vs.5.2%
NSNS• stroke alone: 2.3%vs.4.1% stroke alone: 2.3%vs.4.1%
Results of the study on postoperative intracranial Results of the study on postoperative intracranial hemorrhage (ICH) in cases of CEA/CAS in USAhemorrhage (ICH) in cases of CEA/CAS in USA
Timaran et al. J Vasc Surg 2009:49.(3):623-8Timaran et al. J Vasc Surg 2009:49.(3):623-8
The Nationwide Inpatient Sample was used for the year The Nationwide Inpatient Sample was used for the year 20052005
135,093 patients 135,093 patients were revascularized, were revascularized, 90,4% CEA90,4% CEA, , 9,6%CA9,6%CASS
Postop.stroke rate: CEA 1,1% CAS: 2.1% Postop.stroke rate: CEA 1,1% CAS: 2.1% p<0.001 p<0.001 In-hosp. Mortality: CEA 0.6% CAS: 1.1% In-hosp. Mortality: CEA 0.6% CAS: 1.1% p<0.001p<0.001 ICH CEA 0.016% CAS: 0.15% ICH CEA 0.016% CAS: 0.15% p<0.001 p<0.001
Conclusion: CAS was an independent predictor for:Conclusion: CAS was an independent predictor for: postop. stroke (OR:1.77)postop. stroke (OR:1.77) in-hosp. mortality (OR:1.49) in-hosp. mortality (OR:1.49) ICH (OR: 5.9 ) ICH (OR: 5.9 )
CEA/CAS CEA/CAS Experience at Varosmajor ClinicExperience at Varosmajor Clinic
01.01.2003-12.31.200801.01.2003-12.31.2008
Limitations:Limitations:Retrospective studyRetrospective studyOnly iOnly in-hospital stroke/morbidity/mortalityn-hospital stroke/morbidity/mortalityThere is a significant difference between the There is a significant difference between the two groups in the number of symptomatic two groups in the number of symptomatic patientspatients
However:However:
the results are satisfactorythe results are satisfactory
large number of cases on both sideslarge number of cases on both sides
Clinical DatClinical DataaN=3974N=3974
CEA=2509 PCEA=2509 P M:M: 1455(58%)1455(58%) F :F : 1054(42%)1054(42%)
Mean ageMean age: 66: 66.9 .9 years years (20-90)(20-90)
CAS=1465 PCAS=1465 P M:M: 921(62,8%)921(62,8%) F :F : 544(37,2%)544(37,2%)
Mean age: 66.9 Mean age: 66.9 years years (39-91)(39-91)
CAROTID CEA + CASCAROTID CEA + CAS
Clinical PresentationClinical Presentation
CEACEA AsymptomaticAsymptomatic St. I+ IIb St. I+ IIb
15811581 P Ptsts.(63%).(63%)
SymptomaticSymptomaticIIa-IV.b. IIa-IV.b. 928928 P Pts.ts..(37%).(37%)
CASCAS AsymptomaticAsymptomatic St. I+ IIbSt. I+ IIb
11061106 P Ptsts. (75,5%). (75,5%)
SymptomaticSymptomatic359359 P Ptsts. (24,5%). (24,5%)
P<0,00001
P<0,00001
Surgical TechniqueSurgical Technique
Eversion Eversion EndarterectomyEndarterectomy• > 95%> 95%
Without shunt> 95%Without shunt> 95%
CASCAS
Protection device(100%)Protection device(100%) Type of stentType of stent
• WallstentWallstent• PrecisePrecise• NextstentNextstent
Indication for surgery/stentingIndication for surgery/stenting
Based on the results of : NASCETBased on the results of : NASCET ECSTECST ACSTACST
High risk patients and high High risk patients and high anatomic risk anatomic risk
indications for CASindications for CAS
restenosisrestenosis high localization of high localization of
stenosis.stenosis. after iafter irrrradiationadiation previous surgery previous surgery
on the neckon the neck high risk patientshigh risk patients
Contraindications Contraindications toto CAS CAS
Severe calcificationSevere calcification
CoilingCoiling
High risk High risk ofof embolization based embolization based on US/CTon US/CT
CEACEA CASCASTIATIA 3030
(1,2%)(1,2%)123123
(8,4%)(8,4%)
p<0.00001!p<0.00001!
MortalityMortality 12 12
(0.48%)(0.48%)55
(0.34%)(0.34%)
p=0,523p=0,523
Minor StrokeMinor Stroke 2626
(1,04%)(1,04%)1717
(1.16%)(1.16%)
p=0,715p=0,715
Major StrokeMajor Stroke 3939
(1.55%)(1.55%)1212
(0,82%)(0,82%)
p=0,047!p=0,047!
PSMMPSMM (3,3%)(3,3%) (2,25%)(2,25%)
p=0,057!p=0,057!
Postoperative complicationsPostoperative complications
Major stroke rate of symptomatic patientsMajor stroke rate of symptomatic patients
PreopPreop. stages. stages Postop.Postop.
strokestroke
CEACEA
Postop. Postop.
strokestroke
CASCAS
I.I. 4242
2.09%2.09%2525
2.25%2.25%
IIa-IVIIa-IV 2323
2,47%2,47%44
1.4%1.4%
p=0,136p=0,136
There is a sThere is a significant ignificant diffdifference erence in favor of CEA in favor of CEA vs. CAS vs. CAS in postopin postoperative erative TIA-rateTIA-ratess
Both procedures have Both procedures have Low PSMM rateLow PSMM ratess
CAS can be performed CAS can be performed by by experienced operatorexperienced operatorss in in high volume centerhigh volume center
ConclusionsConclusions
PERSPECKTIVES?PERSPECKTIVES?
CEACEA
++
CASCAS
Thank you…
..for your attention!!