How to Choose Between Carotid Stenting and Carotid Endarterectomy for Stroke Prevention

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1 How to Choose Between Carotid Stenting and Carotid Endarterectomy for Stroke Prevention Christopher J. White MD, MSCAI Chief of Medical Services, Professor and Chairman of Medicine Ochsner Medical Center New Orleans, LA

2 Disclosure Slide Christopher J. White MD I have no financial relationships.

3 Stroke Prevention CAS MED CEA Stabilize plaque (Statin therapy). BP control (ACE-Inhibitor). Antiplatelet therapy. Tobacco cessation. Exercise program.

4 CAROTID REVASCULARIZATION High Surgical Risk SAPPHIRE BEACH ARCHER EXACT CAPTURE CABERNET CREATE MAVeRIC SECURITY Symptomatic Asymptomatic Avg Surgical Risk CREST ICSS SPACE EVA-3S CAVATAS ACT-1

5 Treatment Options 67-year-old man with a carotid bruit and 80% RICA. nonsmoker hypertension hyperlipidemia Klein, A, et al. New England Journal of Medicine (2008):

6 Asymptomatic Carotid Stenosis Risk of progression to occlusion is low. ACST 1 : 1,469 MED Group: 94 progressed to occlusion. 12 with symptoms. 1 with stroke. Yang et al 2 : 3,681 MED for 20 yrs. 80% occlusions before Only 1 stroke with occlusion. Occlusion by Year (Yang et al. 2 ) Intensity of MED Rx 1. Halliday A, et al. Lancet 2010;376: Yang, et al. JAMA Neurol. doi: /jamaneurol

7 Does Stenosis Affect Event Rate? 60 79% Stenosis 80 99% Stenosis Event Rate: 9.5% Event Rate: 9.6% Lancet 2004;363:

8 ACT-1: ASX CAS vs. CEA Freedom from death, stroke, and myocardial infarction within 30 days and from ipsilateral stroke within 365 days after the procedure in the intention-to-treat population. Rosenfield K, Matsumura JS, Chaturvedi S, et.al. N Engl J Med. 2016;374:

9 CAS vs CEA: Asymptomatic Meta-Analysis Death, Stroke, or MI during peri-procedural period and Ipsilateral Stroke during 4 year follow up ACT-1 CREST SAPPHIRE Sardar P, et al. J Am Coll Cardiol. 2017;69:

10 NIH Funded CREST - 2 Endpoint = all 30 day stroke & death plus 4 yr ipsilateral stroke. Inclusion Criteria Asymptomatic for 6 mos. Stenosis 70% Eligible for CEA/CAS S S R R CAS + MEDICAL n = 620 MEDICAL n = 620 CEA + MEDICAL n = 620 MEDICAL n = 620

11 Stroke Prevention ASYMPTOMATIC 70% Randomize to CREST-2. Best medical therapy. Equipoise for CAS vs. CEA. Patient suitable for either procedure.

12 CREST: CAS = CEA 30 Day Stroke, Death, MI and 4 Yrs Ipsilateral Stroke RCT with 2500 pts. Sx and Asx pts. Avg Surgical Risk Level 1 Evidence. Brott TG, et. al. N Engl J Med. 2010;363:11-23.

CREST 10 YEAR FOLLOW-UP Composite of stroke, myocardial infarction, or death from any cause during the periprocedural period or ipsilateral stroke within 10 years

13 CREST 10 YEAR FOLLOW-UP Composite of stroke, myocardial infarction, or death from any cause during the periprocedural period or ipsilateral stroke within 10 years after randomization. Brott TG, et al. Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis. N Engl J Med. 2016, DOI: /NEJMoa

14 International Carotid Stenting Study: CAS = CEA 1º Endpoint: Fatal or Disabling Stroke Level I Evidence RCT: N = 1,713 pts Symptomatic only Avg Surg Risk Bonati LH, et al. Lancet 2015; 385:

15 CAS vs CEA: Meta-Analysis Death, stroke, or MI during periprocedural period and ipsilateral stroke during long-term follow-up Sardar, P. et al. J Am Coll Cardiol. 2017;69(18):

16 Advocates for CEA Argue that stroke prevention is the purpose of CEA and that including MI s is not relevant to the decision. Do not limit their analysis to disabling (major) stroke, but include minor stroke, but not cranial nerve injury.

17 Heart Attacks Kill CEA Patients Blackshear et al. Circulation. 2011;123: Most of the MIs were small or moderate. One fourth of the patients had biomarker ratios <10 times the upper limit of normal, One half were detected only by troponin and did not meet diagnostic criteria by CK-MB. CREST patients with MI or biomarker only were 3 times more likely to die than those without MI.

18 Odds ratio of periprocedural (30 day) cranial nerve injuries for carotid endarterectomy versus carotid artery stenting. Pascal Meier et al. BMJ 2010;340:bmj.c467

19 CEA Dirty Little Secret Stroke Increased Incidence of Neurological Deficits with Carotid Endarterectomy Versus Protected Carotid Stenting in Randomized Controlled Trials Favors CAS Benjo AM, etal. JACC. VOL. 66, NO. 15, SUPPL B, 2015

EQUIPOISE FOR CAS & CEA WE STILL NEED TO UNDERSTAND: IN WHICH SUBGROUPS IS REVASCULARIZATION APPROPRIATE? IN WHICH SUBGROUPS ARE CEA OR CAS FAVORED?

20 EQUIPOISE FOR CAS & CEA WE STILL NEED TO UNDERSTAND: IN WHICH SUBGROUPS IS REVASCULARIZATION APPROPRIATE? IN WHICH SUBGROUPS ARE CEA OR CAS FAVORED? CAROTID STENT High risk for CEA. Younger age. Experienced operator. Experienced team. EQUIPOISE CAROTID SURGERY High CAS risk. Older age. Experienced operator. Experienced team. CAS CEA

21 High Risk for CEA CAS White; J. Am. Coll. Cardiol. Intv. 2010;3;

22 CAS Preferred in High Surgical Risk Patients Patients at increased risk for CEA, should be offered CAS as an alternative. Assumes operator and institutional experience and a track record for safety and quality.

23 Strategy Do not argue stent is superior to surgery. The main argument is equipoise for carotid stenting. In experienced stenter s hands. In patients with anatomically suitable lesions. Stent is preferred because it is less morbid. Fewer cranial nerve injuries that can be disabling. Fewer infections. Same day discharge.

25 THE END

Carotid Artery Disease How the Data Will Influence Management The Symptomatic vs. the Asymptomatic Patient

Carotid Artery Disease How the 2014-2015 Data Will Influence Management The Symptomatic vs. the Asymptomatic Patient Christopher J. White, MD, MSCAI, FACC, FAHA, FESC Professor and Chair of Medicine Ochsner