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!!