Carotid Artery Stenting Today: A Few Updating Remarks

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1 Carotid Artery Stenting Today: A Few Updating Remarks Camilo R. Gomez, MD, MBA Director, Alabama Neurological Institute Birmingham, Alabama Disclaimer & Warning Company Pharmaceutical BMS-Sanofi-Aventis Abbott Laboratories Parke-Davis Devices Alsius Corporation Boston Scientific Guidant Corporation CoAxia Relationship Consultant. Speaker. Investigator. Speaker. Investigator. Investigator Consultant. Speaker. Investigator. Consultant. Speaker. Investigator. Consultant. Speaker. Investigator. Consultant. Speaker. Investigator. Many Statements Not FDA-Approved Why Should We Even Consider This?

2 When We Can Do This? Avg = 15 minutes In Expert Hands It Could Not Be Simpler Local Anesthesia No Sedation Same Day Discharge (!) NASCET: Ipsilateral Stroke (18 mo.)

3 NASCET: The Best Patients Essentially Less than 80 years of age No Cardiac Arrhythmias No Organ Failure Less than 25% Had: Diabetes Hypercholesterolemia Angina NASCET. Stroke 1991; 22:711. NASCET: Other Surgical Complications Cranial Nerve Injury = 7.6% Wound Hematoma 5.5% Wound Infection = 3.4% Myocardial Infarction = 0.9% CHF = 0.6% Arrhythmia = 1.2% Other Cardiovascular = 1.2% NASCET. NEJM. 1991; 325: NASCET: Predictors of Stroke and Death 659 Patients with Contralateral Pathology Risk of Stroke & Death: Contralateral Mild --> 4.0% Contralateral Moderate --> 5.1% Contralateral Occluded --> 14.3% Contralateral Occlusion Hazards Ratio - -> Gasecki et al J NSG. 1995; 83: 778

4 Predictors of Stroke & Death from CEA Decreased Odds: Ocular Symptoms Only (0.49) Increased Odds: Women (1.44) SBP >180 (1.82) PVD (2.19) Contral. Occl. (1.91) Siphon Sten. (1.56) ECA Sten (1.61) Rothwell et al. BMJ 1997; 315:1571 Carotid Endarterectomy: ECST Surgical Group (n = 1807) Major Stroke 30d = 6.6% Major Stroke+Death 30d = 7.0% Medical Group (n=1211) Major Stroke 30d = 4.8% Major Stroke+Death 30d = 4.8% ECST. Lancet 1998; 351: Medicare Data on CEA 113,300 Medicare Patients Undergoing CEA Institutions: Trial Hospitals Non-Trial Hospitals (By Volume of CEA) Perioperative Mortality: Trial --> 1.4% Non-Trial --> 1.7% - 1.9% - 2.5% Wennberg et al. JAMA 1998; 279:1278

5 Medicare Coverage: The Process SAPPHIRE (30 Days) Yadav J et al. N Engl J Med 2004;351: SAPPHIRE (365 Days) Yadav J et al. N Engl J Med 2004;351:

6 International CAS Registry 30 Day Complication rates: Mortality = 41 (0.86%) Minor Stroke = 129 (2.72%) Major Stroke = 71 (1.49%) All Stroke = 192 (3.94%) All Stroke + Death = 241 (5.07%) Stroke = 1.42% over 6-12 months Restenosis rate = 1.99 % & 3.46% (6 & 12 months) Wholey M et al. Cathet Cardiovasc Interv 50: ARCHeR Trials Current Studies: Phase III CREST: Randomized vs. CEA 2500 Symptomatic or Asymptomatic ACT I Randomized vs. CEA 1858 Asymptomatic VIVA Single Group Symptomatic & Asymptomatic

7 CREST: Lead-In Phase 691 Cases (December 2003) Up to 20 cases per operator Peri-procedural Stroke & Death: 3.1% for Asymptomatic Patients (n=395) 4.3% for Symptomatic (n= 191) 3.5% Overall Current Studies: Phase IV SONOMA Single Group Registry 1650 Patients CREATE PAS Single Group Registry CAPTURE 2 Single Group Registry Patients Recent Reports: Preliminary CAPTURE Data Sponsor: Guidant Corporation Design: Phase IV Study (Post-Market) 315 Operators in 137 Hospitals Enrollment to Date: >4000 High-Risk Patients Preliminary Results (March 2006) Patients: 2500 Primary Outcomes: 30-day Death, Stroke and MI = 5.7% 30-day Major Stroke & Death = 2.5%

8 Recent Results: CAPTURE 2 and EXACT 4,111 Patients in 150 Sites CAPTURE 2: 1,987 Patients (On-Going) EXACT: 2,124 Patients (Completed) Composite 30-day Stroke and Death Stroke & Death (SX) Stroke & Death (ASX) Stroke & Death (ALL) CAPTURE 2 6.0% 3.1% 3.8% EXACT 7.3% 3.0% 4.0% Courtesy of Gray, WA. TCT October 23, 2007 Recent Reports: SPACE Design: Phase III, Open label, Randomized CAS vs. CEA Enrollment: 1200 Symptomatic Patients in 35 Centers Primary Outcomes: 30-day Ipsilateral Stroke or Death Recent Reports: SPACE End Point, n (%) Carotid Endarterectomy, n (%) Odds Ratio (CAS vs CEA) (95% CI) Primary end point 41 (6.84) 37 (6.34) 1.09 ( ) Ipsilateral ischemic stroke 39 (6.51) 30 (5.14) 1.26 ( ) Ipsilateral intracerebral bleeding 1 (0.17) 5 (0.86) 0.19 ( ) Death 4 (0.67) 5 (0.86) 0.78 ( )

9 Cochrane Review of Evidence Cochrane Review of Evidence Cochrane Review of Evidence

10 Growth in : A Problem? Source: Roubin, G.S. Market Estimates (Millions) HRI, Dec 2003 $41.2 $92.3 $119.3 $145.2 $162.8 Morgan Stanley $23 $62 $74 $292 $398 Bernstein Research $5 $31 $53 $110 n/a Medicare Coverage: The Process

11 Medicare Coverage: Facilities Market Performance Acceptance by Surgical Community

12 Acceptance by Surgical Community Paradoxical Created Behavior The friend of my adversity I shall always cherish most. I can better trust those who helped to relieve the gloom of my dark hours than those who are so ready to enjoy with me the sunshine of my prosperity. Ulysses. S. Grant CAS Stenting Filters for Embolic Protection

13 CAS Stenting Global Impact of Protection Our Long-Term Experience Roubin et al Circulation Jan 30;103(4):532-7 Single Center Long-Term Experience

14 CAS Stenting Operator Skill s: Sine Qua Non No Equipment is a Substitute for Good Technique! Perspective on Operator s Skills Protection Devices Updated on 04/13/04 Wallstent Trial: Results N Age * Male 66% 62% Caucasian 90% 98% HTN 69% 81%* Diabetes 34% 28% MI 19% 28% CHF 7% 4% Baseline % stenosis 76% 75% * p < 0.05

15 Wallstent Trial: Major End-Points * p=0.036 ** p=0.049 Recent Reports: EVA3S Sponsor: Assistance Publique Hospitaux de Paris Design: Phase III, Open label, Randomized CAS vs. CEA Expected Enrollment: 872 Symptomatic Patients Enrollment: 527 (September 2005) in 30 Centers Primary Outcomes: 30-day Stroke or Death 2-4 year stroke, death or ipsilateral stroke Secondary Outcomes: Numerous Recent Reports: EVA3S Mas J et al. N Engl J Med 2006;355:

16 EVA3S Commentary Operator s Experience Surgeons -> At Least 25 CEA Previous Year Interventionists -> 12 CAS or 5/35 Supra-aortic -> No Difference (10% vs 12.3%) Technique: Antiplatelet Therapy Recommended (83-85% on Dual) Single device vs. Multiple devices (5/7) Credentialing, Experience and Learning Curve Beware of Guidelines!! The Growth of Intellectual Communism

17 Surgically Inaccessible Lesions Non-Atherosclerotic Pathology: FMD Non-Atherosclerotic Pathology: Radiation

18 Reconstructive Stenting Reconstructive Stenting CASE 1: Transient Ischemic Attacks History: 75 y.o. woman Recurrent Left Side Weakness One Episode of Right Side Weakness Physical Examination: No Deficits Loud Bruits

19 Final Thought The Warrior Creed Wherever I go, everyone is a little bit safer because I am there. Wherever I am, anyone in need has a friend. Whenever I return home, everyone is happy I am there......it's a better life! Robert L. Humphrey, J.D.