Update : Carotid Stenting and Current Trial Data

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1 Update : Carotid Stenting and Current Trial Data J. Michael Bacharach, MD, MPH, FACC, FSCAI Section Head, Vascular Medicine and Vascular Intervention North Central Heart Institute, Sioux Falls, South Dakota Clinical Professor of Medicine University of South Dakota Sanford School of Medicine Clinical Associate Professor of Surgery Mayo Graduate School of Medicine Faculty Disclosure J. Michael Bacharach, MD, MPH, FACC, FSCAI I have no relevant financial relationships to disclose with regard to this continuing medical education activity. Controversies in Treatment of Extracranial Carotid Disease Carotid Disease Treatment Moving targets 3 3 What is the Optimal Therapy for carotid artery stenosis? When to perform Carotid Revascularization: Carotid endarterectomy vs carotid stenting with embolic protection are they equivalent? What longer-term data is available? What about medical therapy? Medical Therapy Carotid stenting has evolved. Outcomes are improving and the procedure is maturing. Randomized trials (including CREST) now supported by large post-market surveillance outcomes Asymptomatic High-Risk patient Medical therapy has also evolved with evidence suggesting the risk of stroke in asymptomatic patients today may be much lower than even 10 years ago Carotid Revasularization Who should receive carotid revascularization? And of these who should get a stent? It depends on who you ask Neurologist? Outcomes of CAS Trials Over Time CAS results have vastly improved over time due to: (1) more experienced operators; (2) better patient selection and; (3) a wider spectrum of technology CAS outcomes have evolved over time similarly to CEA Vascular surgeon? Interventionalist Year 2000 Year (Enrollment: ) CREST 5.7% (Enrollment: ) CREST 1.1% 1

2 Death or Major Stroke Rates Decrease for CAS over the Period of CREST Enrollment 50% Trial Enrollment CAS = 0.4% CEA = 0.4% 7 N Engl J Med Death, Stroke and MI within 30 Days Per protocol All Death, Stroke, or MI CAS N = 1,131 CEA N = 1,176 Difference Unadjusted p-value* 5.8% (65) 5.1% (60) 0.7% Death 0.53% (6) 0.26% (3) 0.27% Any Stroke 4.1% (46) 1.9% (22) 2.2% Major Stroke 0.9% (10) 0.4% (5) 0.5% CREST Primary Endpoint* Isn t This The End of the Debate? *Periprocedural Death, Stroke, MI PLUS Ipsilateral Stroke at 4 Years Minor Stroke 3.2% (36) 1.5% (18) 1.7% MI 2.0% (22) 3.4% (40) -1.5% * Fisher s exact p-values were not adjusted for multiple comparisons; p-values for descriptive purposes only 9 10 N Engl J Med 2010;363:11-23 Why Didn t CREST Settle the Debate? Surgeons feel that carotid revascularization is performed for stroke prevention CEA reduced stroke risk more than CAS Excess MI rate with CEA less of an issue Interventionists feel that CAS performed as safely as CEA Excess stroke risk was minor stroke only MI risk of CEA is important Neurologists feel that although outcomes were low, medical therapy is more effective than any revascularization J Am Coll Cardiol 2011;

3 So, Can I Make Sense of the Data? Firstly, it still never ceases to amaze me how even after Level A Multicenter Randomized Trials that Meet the Primary Endpoint, Physicians Don t Agree on the Interpretation Released February 18, 2016 Options for Patients with Carotid Artery Disease CEA: Effective when performed by skilled surgeons with excellent track record CAS: Effective when performed by skilled interventionists Medical Therapy: Still must be tested head-to-head with revascularization, but impact likely improving 3

4 But Vascular Surgeons Heard the Hoofbeats.. ROADSTER J Vasc Surg 2015;62: Ongoing CAS/CEA Studies Released February 17, 2016 Trial Trial Start Enrolled/ Projected Duration Sx Protocol OMT RCT of CEA vs CAS ASCT / yrs N N Y SPACE / ~ yrs N Y/N N ECST / 2000 CREST / ~ yrs Y Y N 6 yrs N Y N Rubin MN, et al. JRSM Cardiovasc Dis. 2014;3. DOI: /

5 Finally.ACT 1 Reported February 17, 2016 Stroke-Free Survival N Engl J Med 2016;Feb 17 N Engl J Med 2016;Feb 17 The Controversy is Fueled By Advocates of Modern Medical Therapy as the Primary Treatment for CEA/CAS-Eligible Patients Stroke 2015;46: pts with 70-79% carotid stenosis randomized to CEA plus Maximal Medical Therapy (31) Maximal Medical Therapy (24) Stroke 2015;46:3288 J Vasc Surg 2015;62:914 5

6 J Vasc Surg 2015;62:914 J Vasc Surg 2015;62:914 CREST 2 Trial Scheme Primary EP: Stroke + Death in 30 Days PLUS Ipsilateral Stroke to 4 Years J Vasc Surg 2015;62: Management of Carotid Artery Disease All patients require comprehensive medical therapy Revascularization based on Symptom Status Health and (anticipated) longevity of the patient Skill of the Operator Right now, the largest patient population you will see are ASYMPTOMATIC STANDARD RISK Patients At least for US Medicare patients, your only options are medical therapy and CEA ACT 1 and 10-Year CREST Data may force a shift in payment So, Who Should Get a Carotid Stent? Symptomatic patient with 70-99% stenosis who is at high risk for surgical events Asymptomatic patient with truly anatomic high risk scenario All others: Optimal Medical Therapy All others: Enroll in FDA-IDE Approved Trial 6

7 Mount Rushmore South Dakota 7