George Trellopoulos MDPapanikolaou Hospital

Thessaloniki

Course: Carotid Artery Stenting. A detailed approach

CAS or CEA? What is the evidence from the clinical trials?

Registries & Clinical Trials

• CAVATAS • SAPHIRE• WALLSTENT• SPACE• EVA- 3S• CREST• ACST II, ACST I• ICSS• TACIT

CAVATASLong-term outcome after angioplasty and stenting for symptomatic vertebral artery stenosis

compared with medical treatment in the Carotid And Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomized trial

Stroke. 2007 May;38(5):1526-30.

CAVATASLong-term outcome after angioplasty and stenting for symptomatic vertebral artery stenosis compared

with medical treatment in the Carotid And Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomized trial

Stroke. 2007 May;38(5):1526-30.

SAPPHIREProtected carotid-artery stenting versus endarterectomy in high-risk patients.

N Engl J Med. 2004 Oct 7;351(15):1493-501.

SAPPHIREProtected carotid-artery stenting versus endarterectomy in high-risk patients.

N Engl J Med. 2004 Oct 7;351(15):1493-501.

SAPPHIREProtected carotid-artery stenting versus endarterectomy in high-risk patients.

N Engl J Med. 2004 Oct 7;351(15):1493-501.

SAPPHIREProtected carotid-artery stenting versus endarterectomy in high-risk patients.

N Engl J Med. 2004 Oct 7;351(15):1493-501. •CAS not inferior to CEA in high surgical risk

SPACE 30 day results from the SPACE trial of stent-protected

angioplasty versus carotid endarterectomy in symptomaticpatients: a randomised non-inferiority trial,

Lancet 2006; 368: 1239–47

SPACE 30 day results from the SPACE trial of stent-protected

angioplasty versus carotid endarterectomy in symptomaticpatients: a randomised non-inferiority trial,

Lancet 2006; 368: 1239–47

SPACE 30 day results from the SPACE trial of stent-protected

angioplasty versus carotid endarterectomy in symptomaticpatients: a randomised non-inferiority trial,

Lancet 2006; 368: 1239–47

SPACE 30 day results from the SPACE trial of stent-protected

angioplasty versus carotid endarterectomy in symptomaticpatients: a randomised non-inferiority trial,

Lancet 2006; 368: 1239–47

SPACE 30 day results from the SPACE trial of stent-protected

angioplasty versus carotid endarterectomy in symptomaticpatients: a randomised non-inferiority trial,

Lancet 2006; 368: 1239–47

SPACE 30 day results from the SPACE trial of stent-protected

angioplasty versus carotid endarterectomy in symptomaticpatients: a randomised non-inferiority trial,

Lancet 2006; 368: 1239–47

SPACE 30 day results from the SPACE trial of stent-protected

angioplasty versus carotid endarterectomy in symptomaticpatients: a randomised non-inferiority trial,

Lancet 2006; 368: 1239–47

EVA -3SEndarterectomy versus Stenting in Patients with

Symptomatic Severe Carotid Stenosis N. Engl. J. Med 355:16

• multicenter• non-inferiority randomized trial • national research organisation funding

EVA - 3SEndarterectomy versus Stenting in Patients with Symptomatic Severe

Carotid StenosisN. Engl. J. Med 355:16

EVA - 3SEndarterectomy versus Stenting in Patients with

Symptomatic Severe Carotid StenosisN. Engl. J. Med 355:16

EVA - 3SEndarterectomy versus Stenting in Patients with

Symptomatic Severe Carotid StenosisN. Engl. J. Med 355:16

EVA - 3SEndarterectomy versus Stenting in Patients with Symptomatic Severe

Carotid StenosisN. Engl. J. Med 355:16

EVA -3S Support 1

EVA -3S Support 2

Eva 3S - Support 3

Meta-analysis of Randomised Trials Comparing Carotid Endarterectomy and Endovascular Treatment

Eur. J. Vasc. Endovasc. Surg, 34 470 -479(2007) CEA vs. CAS

CREST Carotid Revascularization Endarterectomy versus Stenting Trial:

Curr Control Trials Cardiovascular Med. 2001; 2(4): 160–164.

CREST Carotid Revascularization Endarterectomy versus Stenting Trial:

Curr Control Trials Cardiovascular Med. 2001; 2(4): 160–164.

CREST Carotid Revascularization Endarterectomy versus Stenting Trial

LEAD IN PHASE

CREST

• Summary

ACST-2Asymptomatic Carotid Surgery Trial

A large, simple randomized trial to comparecarotid endarterectomy versus carotid artery stenting to prevent stroke

ACST-2Asymptomatic Carotid

Surgery Trial A large, simple randomised trial to comparecarotid endarterectomy versus carotid artery stenting to prevent stroke

TACIT Transatlantic Asymptomatic Carotid Intervention Trial

TACIT Transatlantic Asymptomatic Carotid Intervention Trial

TACIT Transatlantic Asymptomatic Carotid Intervention Trial

TACIT Transatlantic Asymptomatic Carotid Intervention Trial

Critical Issue 1Operator’s Experience

Critical Issue 1Operator’s Experience

Critical Issue 2:Octogenarians

Critical Issue 3:Cognitive Changes

Cognitive Changes after Carotid Stenting

Cognitive Changes should be included as End Points in all Clinical Trials

Critical Issue 4:Protected VS. Unprotected CAS

Critical Issue 4:Protected VS. Unprotected CAS

Critical Issue 5:Heterogeneity of Clinical Trials

Critical Issue 6: High Risk Patients

30-Day MAE Results: CAS High Risk Registries

3.9%4.8%

5.4% 5.4% 5.6% 5.9% 6.2%7.2%

8.3% 8.6%

0%1%2%3%4%5%6%7%8%9%

10%

CABERNET (BSX)

SAPPHIRE (C

ordis

)

MAVErIC I&

II (MDT)

BEACH (BSX)

CREATE Arm

2 (e

v3/G

DT)

MAVErIC In

t'l (M

DT)

CREATE Arm

1 (ev

3)

SECuRITY

(ABT)

ARCHeR III

(GDT)

ARCHeR II

(GDT)

Critical issue 6: Impacts after Space & Eva 3S

Critical issue 6: Impacts after Space & Eva 3S

Critical issue 7: Medical Therapy

CAS or CEA ?

Conclusion

Conclusions