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State of the Art Review: Carotid Stenting, Patient Selection, and Clinical Trial Results

State of the Art Review: Carotid Stenting, Patient Selection, and Clinical Trial Results. William A. Gray MD Director of Endovascular Services Associate Professor of Clinical Medicine. Disclosures. Consultant Abbott Vascular Cordis /J&J BSC Medtronic Contego Silk Road. Overview.

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State of the Art Review: Carotid Stenting, Patient Selection, and Clinical Trial Results

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  1. State of the Art Review:Carotid Stenting, Patient Selection, and Clinical Trial Results William A. Gray MD Director of Endovascular Services Associate Professor of Clinical Medicine

  2. Disclosures • Consultant • Abbott Vascular • Cordis/J&J • BSC • Medtronic • Contego • Silk Road

  3. Overview • Large scale CEA data • Landmark • Recent validation of high risk population and differential outcomes • What has the evolution in CAS data been? • What predicts stroke in CAS? • What are the data for outcomes as regards: • Experience • Devices

  4. Landmark CEA studiesACAS, ACST and NASCET: Comparative Results 110 ACST crossover 100 95 6% 91 90 89 17% Surgical-ACAS % without stroke 80 Medical-ACAS 74 Surgical-NASCET 70 Medical-NASCET Surgical-ACST 60 Medical-ACST 50 0 1 2 3 4 5 Year of study

  5. NY State Registry ResultsState of the state of CEA Stroke. 2009;40:221-229

  6. Validation of high-risk CEA subsets.

  7. Conclusions from these recent data • Although limited in terms of surveillance for events (retrospective, not neurologist evaluated): • Confirmatory data on the outcomes after CEA, though probably underestimates events • Clearly identifies subgroups at increased risk • Including patients >80 years

  8. Evolution in CAS Outcomes

  9. Incidence of stroke and death in high risk carotid stent IDE trials: 2002-2008

  10. ARMOUR results: 1° Endpoint 30d Results (ITT & Full Population) 30d Results by Symptoms and Age (ITT)

  11. Predictors of Outcomes

  12. CAPTURE 3500: Predictors of CAS Outcomes Odds Ratio Variable Symptomatic Pre-dilatation w/o EPD (n=143) Age ≥ 80 (n=788) Multiple stents per procedure (n=196) 2.46 2.44 2.17 3.09 2.93 3.15 4.97 2.21 2.19 2.42 1.84 2.00 2.53 All Patients (3307) Symptomatic (479) Asymptomatic (2517) >80 (809) <80 (2611)

  13. CAS Outcomes by age and symptoms CAPTURE 3500

  14. CAPTURE 3500: Stroke by Location 44% 22% • 18% of all strokes in CAPTURE are non-ipsilateral • More non-ipsilateral strokes were minor c/w ipsilateral

  15. Experience and Outcomes

  16. Experience • Preface (assumption: volume equals experience) • Trial-based outcome data supporting experience as a determinant of outcomes • Surgical • Pro-CAS • EVA-3S • SPACE • PMS registries

  17. Retrospective CEA Survey Demonstrates Inverse Relationship between Volume and Neurologic and Mortality Outcome Maryland state 1998 J Vasc Surg. 1998;27:25-33

  18. …More CEA Volume Data Mortality Length of stay Stroke J Vasc Surg. 1998;27:25-33

  19. Pro-CAS: Prospective registry of CAS • Prospective, multi-center German registry • 25 sites/6 year enrollment (July 1999-June 2005) • 5341 interventions (outcomes of first 3267 published 2004) • Median # of center CAS before enrollment: 38 (0-1200) • Median # of center CAS SPACE enrollment: 140 (10-806) • No learning curve data available • No defined inclusions or exclusions, or procedural methods • No angiographic core lab • Voluntary independent neurologic assessment (no stroke scales or CEC) • Primary endpoint: in-hospital death and stroke Stroke 2008;39;2325-2330;

  20. Pro-CAS: Overall outcomes • Median age: 70 years (32-96) • In-hospital stoke and death: 3.6%

  21. Pro-CAS: Effect of experience* *Univariate analysis

  22. Pro-CAS: effect of age and gender* *Univariate analysis

  23. Pro-CAS: effect of symptom status* *Univariate analysis

  24. Pro-CAS: Multivariate analysis of predictors

  25. The trouble with (European) randomized CAS data • Trial analysis in CAS using ICSS as a primer

  26. EVA-3S Randomized CEA vs CAS RR 2.5 (95% CI, 1.2-5.1) P=0.01 265 262 Mas JL, et al. New Engl J Med. 2006;355:1661-1671

  27. EVA-3S: Trial design • Randomized, multicenter, non-inferiority trial of standard surgical risk patients with symptomatic carotid stenosis >60% • Primary endpoint: 30-day death and stroke • Secondary endpoint: 30-day MAE plus ipsilateral stroke to 4 years • 30 centers in France • 527 patients Lancet Neurol 2008; 7: 885–92

  28. EVA-3S critique • Slow enrollment resulted in limited investigator experience • 1.7 CAS patients/year/site • Early and/or non-standard technique resulted in unnecessary morbidity • Use of EPD not widespread or familiar • Lack of use in the early phase of the trial likely responsible for 4-5 excess strokes (~20% of all strokes in the CAS arm) • 5% stent procedure failure requiring emergency surgery in this trial resulting in 2 strokes in the CAS group • Major pivotal trials in this country (e.g., SAPPHIRE, ARCHeR) have not reported any emergent surgical conversions • No pre-dilation in >80% of procedures (standard in US) • Significant (beyond local) anesthesia was employed in ~30% of procedures (estimated <5% in US)

  29. EVA-3S critique • Limited investigator experience and number of trained sites/operators • Experienced operators defined by 12 lifetime CAS procedures or 5 CAS procedure if 35 supra-aortic procedure • These operators were deemed experienced and allowed to tutor the non-experienced • No centralized training qualification process (local proctors pronounced the operators qualified) • Approximately 2/3 of sites were under tutelage at the beginning of their randomized participation.

  30. EVA 3S • Prototypical low operator experience multi-center trial • Outcomes for CAS in EVA-3S for symptomatic standard risk patients are higher than the contemporary cohorts

  31. SPACE: an incomplete study • Randomized, multicenter non-inferiority study of CEA vs. CAS in standard surgical risk symptomatic patients with 70% carotid stenosis • Primary endpoint 30-day ipsilateral stroke and death • Only 27% EPD use • Stopped before non-inferiority was proven ($$$) • Pre-specified secondary analyses include: • Age • Sex • Type of event • Side of intervention • Degree of stenosis • High-grade contralateral stenosis

  32. SPACE Randomized CEA vs. CAS symptomatic patients Abs diff: 0.51, 90%CI 1.89-2.91, P=0.09 (non-inferiority) 595 605 SPACE collaborators. Lancet 2006;368:1239-47

  33. SPACE: Effect of volumes on outcome Neuroradiology, Sept 2008

  34. SPACE: sub-group analysis (PP)

  35. SPACE: Hazard ratio for 30-day MAE plus ipsilateral stroke to 2 years

  36. The evolution of CAS in symptomatic patients:EVA-3S, SPACE, ICSS vs. the world AHA guideline limit

  37. Long-term CAS efficacy for stroke prevention

  38. EVA-3S: 4-year outcomes Any ipsilateral stroke Any stroke Any stroke or death

  39. SPACE: K-M plots of 2-year outcomes Ipsilateral stroke and vascular death 30-day stroke/death plus ipsilateral stroke to 2 years

  40. SPACE and Pro-CAS: conclusions • Experience determines outcomes in CAS • Age related gradient for outcomes in CAS, favoring the younger patient (even over surgery) • Long-term efficacy of CAS similar to CEA

  41. Post-market US registries

  42. CAS after device approval: Increasingly safe in the “real world” All stroke/death* 2004 2007 ARCHeR 8.3% C: n=573; E#: n=204 C2#: n=197 C: n= 3574; E: n=1917; C2: n=1788 #Small symptomatic cohorts preclude any comparisons * Hierarchical Events – Includes only the most serious event for each patient and includes only each patient’s first occurrence of each event

  43. SAPPHIRE WW: 30 day major adverse events Asymptomatic vs. Symptomatic 6% AHA Sx 3% AHA Asx P=NS P=0.0010 P=0.0003 P=0.0005 P=0.0286 MAE defined as any death, MI or stroke

  44. CAPTURE: Asymptomatic Patients <80 Years 30 day stroke/death distribution by site N=2764 3% No stroke/death at 43% (61/143) of sites

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