Indications for CAS vs Surgical_Medical

1. Indications for CAS vs Surgical_Medical Marianne Brodmann Division of Angiology Graz

2. Therapeutic Options • Medical Management • Carotid Endarterectomy_CEA • Carotid Artery Stenting _CAS

3. What to prevent? Therapeutic Progress Lausanne Stroke Registry

4. Therapeutic Progress • Western Countries stroke 3rd most case of death and • number 1 condition associated with permanent disability • Carotid artery stenosis responsible for 10-20% of all • ischemic cerebral events • Based mostly on atherosclerotic disease, typically affection of • origin of carotid internal artery • Symptomatic stenosis means • Amaurosis fugax, TIA or stroke affecting the corresponding territory in the proceeding 6 mths • The greater the severity of stenosis, the greater the risk of recurrent ischemic event Roffi M. Herz 2008;33:490-7.

5. Therapeutic Progress Risk of recurrence in territory of symptomatic CA stenosis [NASCET1] >70% 26% over 2 years (13%/year) 50-69% 18.5% over 5 years (4.4%/year) Risk of recurrence in territory of asymptomatic CA stenosis [ACST2] >60% yearly risk is ~2% may increase in elderly patients to 3-4%/year contralateral CA stenosis/occlusion carotid plaque heterogenity poor collateral blood supply cardiac or medical illnesses 1 Inzitari D et al. NEJM 2000;342:1693-700. 2 Halliday A et al Lancet2004;363:1491-502.

6. Medical Management Aggressive riskfactor Management ! Kragsterman B et al. Stroke 2006;37:2886-91.

7. Medical Management/Best Medical Treatment SVS Guidelines EVIDENCE Symptomatic and asymptomatic patients with low grade stenoses <50% symptomatic <60% asymptomatic BEST MEDICAL TREATMENT [Grade I] 2 RCT´s with 5950 patients [NASCET/ECST] Patients with low-grade stenosis (NASCET <50%, ESCT <70%) CEA elevated the risk for disabling stroke and death at 20% Hobson RW J Vasc Surg 2008;48:480-6.

8. Best Medical Treatment Evidence Surgery Medical Barnett HJM NEJM. 1998;339:1415-25.

9. Best Medical Treatment Antiplatelet Therapy Recommended indefinitely in all patients with carotid stenosis, irrespective of symptoms Antithrombotic Trialists´Collaboration. BMJ 2002;324:71-86.

10. Best Medical Treatment Antiplatelet Therapy Recent symptomatic CA stenosis Aspirin+Clopidogrel>>Aspirin ??? [Markus HS Circulation 2005;111:2233-40]

11. Best Medical Treatment Lipids Heart Protection Study20000 patients (asymptomatic CA stenosis included) 40 mg Simvastatin/Placebo Decline of LDL Cholesterol per 29% associated with a 24% RR for composite endpoint major vascular events [25% RR for stroke] Independent of Baseline Cholesterol Indication for CEA /CAS reduced for 50% in existing CA stenosis

12. Best Medical Treatment Lipids 4731 patients with recent stroke or TIA, without CAD on high-dose atrovastatin 80 mg atrovastatin daily Influence of aggressive statin therapy Amarenco P et al. NEJM 2006;355:549-59.

13. Best Medical Treatment Arterial Hypertension 5-6 mmHG Reduction systolic blood pressure 2-3 mmHG Reduction diastolic blood pressure [Collins R. Lancet 1990;335:827-38] Effect independent of age, even above 80 yrs, and isolated arterial hypertension [Staessen JA. Lancet 2001;358:1305-15.] Symptomatic patients < 5 years/ PROGRESS [Lancet 2001:358:1033-41] 40% RR RR 28% 28% RR

14. Carotid Endarterectomy_CEA SVS Guidelines Symptomatic patients with stenosis > 50% Asymptomatic patients with stenosis > 60% [as long as perioperative risk is low] [Grade I] Hobson RW J Vasc Surg 2008;48:480-6.

15. Carotid Endarterectomy_CEA Evidence NASCETGrade of stenosis 50-69% 5-year FU any ipsilateral 15.7% vs 22.2% = 15 patients to prevent an ipsilateral stroke Grade of stenosis 70-99% 2-year FU any ipsilateral 9% vs 26% = 6 patients to prevent an ipsilateral stroke disabling or fatal 13.1% vs 2.5% ESCT Grade of stenosis 70-99% similiar results 3-year FU any ipsilateral 2.8 vs 16.8% = 7 patients to prevent an ipsilateral stroke Hobson RW J Vasc Surg 2008;48:480-6.

16. Carotid Endarterectomy_CEA Evidence … is not supported by high quality evidence but rather by very low quality evidence.. NASCET_ Exclusion criteria Life expectancy <5 years and significant co-morbidity Age >79 years proceeding ipsilateral endarterctomy Angiography of both carotid arteries and intercerebral arteries not possible Experience of surgeon and surgical center Hobson RW J Vasc Surg 2008;48:480-6.

17. Carotid Endarterectomy_CEA Evidence Ulcerated plaques with no flow limitation ????? Hobson RW J Vasc Surg 2008;48:480-6.

18. Carotid Endarterectomy_CEA SVS Guidelines Symptomatic patients with stenosis > 50% Asymptomatic patients with stenosis > 60% [as long as perioperative risk is low] [Grade I] Hobson RW J Vasc Surg 2008;48:480-6.

19. Carotid Endarterectomy_CEA Evidence 3 RCT´s with 5223 patients 2 > 50% Veteran affairs Cooperative Study (1986) > 60% ACAS/ACST (1995/2004) ACST3 5-year stroke risk 3.8% vs 11% [gain 7.2%] (-perioperative events) disabling/fatal 1.6% vs 5.3% [gain 3.7%] 5-year stroke risk 6.4% vs 11.8% [gain 5.4%] (+perioperative events) disabling/fatal 3.5% vs 6.1% [gain 2.5%] only fatal 2.1% vs 4.2% [gain 2.1%] ACST3 Benefits remained significantly separately men/women with stenosis graded >70%,80%,90% (duplex) younger < 65 years and between 65-74 years 1 Hobson RW J Vasc Surg 2008;48:480-6. 2 Chambers BR Cochrane Rev 2005 3 Halliday A Lancet 2004,363:1491-1502

20. Carotid Endarterectomy_CEA Limitations Benefits of CEA in RCT´s conveyed by low perioperative complication rates [high volume surgeons and low risk patients] Patients at risk to die [>80 yrs, co-morbidities….]not included Results of CEA observed in trials may not be reproduced in clinical practice [overall mortality rate in hospitals taking part in NASCET/ACAS was 1.4% vs 0.6 or 0.1in the trials] Low-volume hospitals perioperative mortality rate 2.5% [USA 136000 CEA, mean volume 15 procedures/yr/; 1/3 by mean volume 5/yr2] 1Roffi M. Herz 2008;33:490-7. 2Birkmeyer JD et al. NEJM 2003;349:2117-27.

21. Carotid Artery Stenting (CAS) SVS Guidelines Symptomatic patients with stenosis > 50% [+high perioperative risk] [Grad II, low quality evidence] Good defined by authors: high anatomic risk proceeding CEA with recurrent stenosis proceeding ipsilateral radiation therapy with persistent skin lesions proceeding local surgery (neckdissection….) stenosis of common carotid artery below clavicle contralateral lesion of vocal cord tracheostoma Authors have not well defined„ high medical risk“ renal failure extremly low ejection fraction COPD with necessity of constant oxygen therapy… Hobson RW J Vasc Surg 2008;48:480-6.

22. Carotid Artery Stenting (CAS) Evidence 10 RCT´s with 3182 patients2 Majority symptomatic, 1 Trial high surgical risk • Learning curve ?? • 617 patients /5 trials with low patient numbers • Early Trials • Multi Center with low patient number/center Hobson RW J Vasc Surg 2008;48:480-6. 2 Murad HM J Vasc Surg 2008;48:487-93

23. Carotid Artery Stenting (CAS) Evidence 10 RCT´s with 3182 patients2 Majority symptomatic, 1 trial high surgical risk Hobson RW J Vasc Surg 2008;48:480-6. 2 Murad HM J Vasc Surg 2008;48:487-93

24. Carotid Artery Stenting (CAS) SVS Guidelines asymptomatic patients Recommendation against stenting for asymptomatic disease [Grad I, low quality evidence] Hobson RW J Vasc Surg 2008;48:480-6.

25. Carotid Artery Stenting (CAS) Evidence No RCT´s comparing CAS with medical management 2 RCT´s compare CAS mit CEA small number of patients (323) and events (18) (all events in SAPHIRE) Hobson RW J Vasc Surg 2008;48:480-6.

26. Carotid Artery Stenting (CAS) Evidence Majority of data originate from Registries Periprocedural stroke and death rates > 3% (bar at large CEA trials) Deredyn CP. Stroke 2007;38:715-20.

27. Carotid Artery Stenting (CAS) Strengths/Limitations Strength Endovascular approach is less invasive May treat lesions that are not accessible to surgery Limitations Poor outcomes are related to challenging anatomies [steep aortic arch, severe tortuosity…. ] Inability to place an EPD Severe circumferential calicification Severe renal failure

28. Thank you for your attention!