The argument against revascularization for asymptomatic carotid stenosis

Transcription

1 The argument against revascularization for asymptomatic carotid stenosis Seemant Chaturvedi, MD, FAHA, FAAN Professor of Clinical Neurology Vice-Chair for VA Programs Univ. of Miami Miller School of Medicine

2 Disclosures Research: Executive committee member for CREST 2 and ACT I studies Research: Boehringer-Ingelheim Speakers bureau: None

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4 Absolute Benefits of Carotid Endarterectomy (CEA) Absolute RR Ipsilateral Stroke/Yr CEA showed only marginal benefits on annual rates of ipsilateral stroke for patients with asymptomatic or moderate lesions. Dramatic benefit was seen for high-grade symptomatic stenoses.

5 Subgroup analysis Do women benefit? Do the elderly benefit?

6 Rothwell, PM and Goldstein, LB. Stroke 2004; 35:

7 Largest asymptomatic carotid stenosis study 650 patients 75 years enrolled No definite benefit seen (For patients age 75 and over) because their normal life expectancy is short, any net benefits would probably be of limited duration. Lancet 2004; 363:

8 ACST study

9 Statin use in previous carotid stenosis studies NASCET 14.5%* ACE 28% ACST 38% *any lipid lowering agent

10 So why are we relying on data from 1995? We are doing patients a disservice by relying on obsolete data Patient safety

11 Events in 1995 Bill Clinton was still in his first term Forrest Gump won the Oscar for best picture Derek Jeter had not even played his first full season in his major league baseball career

12 Medical therapy then and now 1995 Aspirin monotherapy Very little lipid lowering therapy use Suboptimal BP control No organized lifestyle modification approach 2017 Expanded AP therapy High potency statins PCSK9 inhibitors Targeted BP lowering Expanded options for smoking cessation Mediterranean diet Increased physical activity

13 Potential risk reduction with aggressive medical therapy Risk reduction High potency statins 33%* Dual antiplatelet therapy 10-32%** Blood pressure control 20-30% Lifestyle measures 10-30% * Sillesen et al. SPARCL trial; **Wang et al CHANCE trial

14 Aggressive Medical Management Identical in both arms: Aspirin 325 mg / day for entire follow-up Clopidogrel 75mg per day for 90 days Aggressive, protocol driven risk factor management primarily targeting systolic blood pressure < 140 mm Hg (130 mm Hg diabetics) and low density cholesterol < 70 mg / dl Intervent USA a lifestyle modification program

15 Effect of multi-modality therapy

16 Carotid stenosis 2017 Medical Management Newer antiplatelet agents Aggressive use of statins Targeted BP lowering ACE/ARB utilization Smoking cessation Control of other risk factors (DM) Increased physical activity Other lifestyle interventions (Med Diet) PCSK 9 inhibitors

17 Asymptomatic carotid stenosis and current medical therapy Study N Follow up duration Annual stroke rate Oxford Vascular years 0.34% SMART years 0.3% ACES 77 2 years 3.6% with microemboli ACES years 0.7% w/o microemboli Stroke 2010; 41: e11-17; Stroke 2013; 44: ; Lancet Neurol 2010; 9:

18 Decline in stroke rate Naylor, R. Stroke 2011; 42:

19 An important new clinical trial

20 Primary Aim To assess in patients with 70% asymptomatic stenosis: If contemporary MEDICAL alone is not inferior to contemporary revascularization plus contemporary medical management using CEA, and If contemporary MEDICAL alone is not inferior to contemporary revascularization plus contemporary medical management using CAS

21 Primary Outcome Composite of stroke and death within 30 days of enrollment or ipsilateral stroke up to 4 years.

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23 CREST 2 website For further information Your help is urgently needed! Many centers in New England and NY are participating Please refer your patients

24 Ethics of informed consent You cannot honestly consent a patient in 2017 without some knowledge of how CEA/CAS compares to optimal, multi-modal medical therapy Patients deserve to know this Do what is right for the patient To not participate in new asymptomatic carotid stenosis trials would be.

25 SAD!

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