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- 1. CAROTID ARTERY STENTING WITH EMBOLI PROTECTION PMA # P030047 Cordis Presentation Sidney A. Cohen, M.D., Ph.D. Group Director, Clinical Research
2. REQUESTED INDICATION
- The Cordis [Carotid Stent System is] indicated for use in the treatment of carotid artery disease in high-risk patients.High-risk is defined as patients with neurological symptoms (one or more TIAs or one or more completed strokes) and> 50% atherosclerotic stenosis of the common or internal carotid artery by ultrasound or angiogram;
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- Patients without neurological symptoms and> 80% atherosclerotic stenosis of the common or internal carotid artery by ultrasound or angiogram.
- Symptomatic and asymptomatic patients must also have one or more condition(s) that place them at high-risk for carotid endarterectomy.
3. AGENDA
- Project Overview & CAS Background
- Description of Devices
- Overview of PMA Clinical Data (Total of 1619 Pts)
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- 1. Non-Randomized CAS Clinical Trials Supportive data
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- CASCADE (European) Study
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- US FEASIBILITY Study
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- 2. SAPPHIRE Pivotal Trial Ken Ouriel, M.D.
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- Randomized Arm: CAS vs. CEA
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- Non-Randomized Arms: CAS and CEA
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- Overview of Training
- Post-Market Surveillance Study
4. PROJECT OVERVIEW
- US FEASIBILITY Study start date - September 1998
- SAPPHIRE Pivotal Study start date August 2000
- PMA filed on October 8, 2003
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- Achieved primary endpoint of non-inferiority of CAS to CEA for 1-year
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- CAS - improved outcomes for MI and re-interventions with a significant decrease in cranial nerve injuries
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- Sustained benefit of CAS treatment demonstrated through 3-years follow up
- PMA granted Expedited Review Status November 14, 2003
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- Significant therapeutic advance
5. BACKGROUND Stroke & Carotid Disease
- > 700,000 strokes occur annually in the U.S. 1
- Stroke is the third leading cause of death with an estimated 164,000 deaths per year1
- Up to 30% of strokes are caused by carotid artery disease 2
- Stroke is the number 1 cause of disability in the U.S.1
- Health care costs for stroke in excess of $53.6 billion/year 1
- Over 50% of people under age 65 who have a stroke die within 8 years 1
- Older population with co-morbid disease 1
1. Heart Disease and Stroke Statistics 2004 Update, American Heart Association2. ACAS Executive Committee JAMA 273:1421-1428, 1995 6. BACKGROUND Carotid Endarterectomy
- 50 year history of technique development and refinement
- CEA is the current interventional standard of care in treating carotid artery disease to reduce the risk of stroke
- Up to 200,000 CEAs performed per year in the U.S. 1
- Estimated that 20% of CEAs are performed on high surgical-risk patients annually in the U.S. 2
- High surgical risk defined:
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- Anatomic - increased procedure risk
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- Medical Co-morbidities - increased risk MI and death
1.Heart Disease and Stroke Statistics 2004 Update, American Heart Association2.Ouriel et al., J Vasc Surg 33:728-732, 2001 7.
- Randomized clinical studies
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- Superiority of CEA vs. best medical therapy
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- NASCET 1
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- Symptomatic> 50% diameter stenosis
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- ACAS 2
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- Asymptomatic> 60% diameter stenosis
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- ECST 3
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- Symptomatic> 50% diameter stenosis
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- VA Cooperative Study 4
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- Symptomatic> 50% diameter stenosis
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- Standard of Care for interventional treatment of symptomatic and asymtomatic carotid artery disease
BACKGROUND Carotid Endarterectomy - cont 1.NASCET Trial Collaborators NEJM 325:445-453, 19912. ACAS Executive Committee JAMA 273:1421-1428, 19953.Rothwell et al., Stroke 34: 514-523, 20034.Hobson et al., NEJM328:221-227, 1993 8. TYPE OF PATIENTS CURRENTLY TREATED WITH CEA
- CEA treatment of patients clearly extends beyond
- NASCET/ACAS inclusion criteria:
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- NASCET/ACAS studied a relatively healthy subset of patients:
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- ACAS screened 25 to enroll 1 patient 1
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- NASCET 1 out of every 3 treated patients enrolled 1
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- Patients considered high risk for CEA as defined by trial ineligibility comprise up to 50% of patients in published series:
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- Ochsner Clinic 46.2% 2
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- CCF Registry 19.4% 3
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- Wennberg et al., JAMA 279:1278-1281, 1998.2. Leporre et al., J Vasc Surg 34: 581-586, 2001.
- 3.Ouriel et al.,J Vasc Surg 33: 728-732, 2001.
9. NASCET/ACAS EXCLUSION CRITERIA
- Anatomic Risks
- Tandem lesions
- Previous CEA
- Radiation therapy to neck (ACAS)
- Status post radical neck dissection
- Medical Co-morbidities
- Age >79
- Previous CVA with profound deficit
- MI within 6 months (NASCET)
- Unstable angina
- Atrial fibrillation
- Symptomatic CHF
- Valvular heart disease
- Cancer with 70% stenosis if symptomatic by U/S or angiography
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- >85% stenosis if asymptomatic by U/S or angiography
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- Stenosis between origin of CCA and extracranial segmentof the ICA
29. CASCADE STUDY30-Day Data % n=121 30. CASCADE STUDY30-Day Outcomes With/Without ANGIOGUARD % P=0.45 P>0.99 P=0.68 31. CASCADE STUDY
- Conclusion:
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- Carotid artery stentingwas found to be feasible for the treatment of carotid stenosis
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- The ANGIOGUARD distal protection device functioned well and reduced the risk of distal embolization, resulting in fewer strokes.
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- 30-day stroke rate of 3.2%, with no major strokes
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32. US FEASIBILITY STUDY The Cordis Nitinol Carotid Stent and Delivery System (SDS) in Patients with de novo or Restenotic Native Carotid Artery Lesions Trial 33. US FEASIBILITY STUDY
- Objective:
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- Primary: Assess the feasibility of carotid artery stenting in the treatment of obstructive carotid artery disease
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- Secondary: Assess and standardize optimal operator techniques for pivotal trial
34. US FEASIBILITY STUDY Overview
- Design:
- Non-randomized, prospective, 33 center trial
- 6/7F SMART and 5.5F PRECISE SDS
- 261 patients enrolled
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- 176 stent
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- 85 stent plus ANGIOGUARD
- Sept 1998 through July 2001
- Follow up to 3 years
- Key Inclusion Criteria:
- Symptomatic> 60% stenosis by U/S or angiography
- Asymptomatic> 80% stenosis by U/S or angiography
- Native Common or Internal Carotid Artery
35. US FEASIBILITY STUDY Overview - cont
- Key Inclusion Criteria: (cont)
- High Risk for Surgical Endarterectomy
- Anatomic risk factors (not ACAS eligible):
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- Restenosis after CEA
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- Radical neck dissection
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- Contralateral carotid artery occlusion
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- Ostial lesion of the common carotid
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- High take-off carotid bifurcation disease
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36. US FEASIBILITY STUDY
- Primary Endpoint:
- 30-day MAE (death, any stroke, &/or MI)
- Key Secondary Endpoints:
- Major clinical events
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- 6 months, 1, 2, 3 years
- Patency (< 50% restenosis) by carotid U/S
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- 48 hours, 30 days, 6 months, 1, 2, & 3 years
- Neurological assessments
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- 28 hours, 30 days, 6 months, 1, 2, & 3 years
37. US FEASIBILITY STUDY 30-Day Events % n=261 38. US FEASIBILITY STUDY 30-Day Events With/Without ANGIOGUARD P = 1.00 P = 0.31 P= 0.51 P = 0.19 % P = 0.10 39. US FEASIBILITY STUDY Cumulative Percentage of MAE to 1080 Days 6.9% 30 10.9% 16.8% 21.8% Error bars are 1.5 X S.E. Time After Initial Procedure (days) Cumulative Percentage of MAE Days: 30 360 720 1080 N at Risk: 247 218 177 113 40. US FEASIBILITY STUDYCumulative Percentage of All Stroke to 30 Days andIpsilateral Stroke from 31-1080 Days 6.1% 7.3% 8.7% 8.7% 30 Time After Initial Procedure (days) Cumulative Percentage of Stroke Days: 30 360 720 1080 N at Risk: 247 218 176 113 41. US FEASIBILITY STUDY Cumulative Percentage of Death to 1080 Days 9.0% 13.9% 4.0% 0.8% 30 Time After Initial Procedure (days) Cumulative Percentage of Death Days: 30 360 720 1080 N at Risk: 258 234 192 127 42. US FEASIBILITY STUDY
- Conclusion:
- Demonstrated feasibility of carotid stenting with the Cordis PRECISE Nitinol Stent System
- ANGIOGUARD emboli protection device reduced the incidence of stroke
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- 30-day stroke rate 2.4%, with no major strokes
- Provided run-in to pivotal study
43. CAROTID STENT 30-Day Stroke Rates by Study and ANGIOGUARD P=0.10 P=0.45 P=0.02 % 44. CONCLUSIONS FROM SUPPORTIVESTUDIES
- Refinement of CAS System
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- Reduction in profile (7F to 5.5F)
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- Improvement in design
- Data supports benefit of ANGIOGUARD emboli protection device in reducing stroke
- Demonstrated the feasibility of CAS
45. AGENDA
- Project Overview & CAS Background
- Description of Devices
- Overview of PMA Clinical Data(Total of 1619 Pts)
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- 1. Non-Randomized CAS Clinical Trials Supportive data
-
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- CASCADE (European) Study
-
-
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- US FEASIBILITY Study
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- 2. SAPPHIRE Pivotal Trial Ken Ouriel, M.D.
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- Randomized Arm: CAS vs. CEA
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- Non-Randomized Arms: CAS and CEA
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- Overview of Training
- Post-Market Surveillance Study
46. SAPPHIRE PIVOTAL STUDY Ken Ouriel, M.D., F.A.C.S, F.A.C.C. Chairman, Division of Surgery Chairman, Department of Vascular Surgery Cleveland Clinic Foundation 47. SAPPHIRE STUDY Objective: To compare the safety and effectiveness of carotid stenting with emboli protection to endarterectomy in the treatment of carotid artery disease in high-risk patients. 48. SAPPHIRE STUDY Trial Design and Patient Flow Patients Referred for Evaluation of Carotid Disease Screened for SAPPHIRE Inclusion/Exclusion Criteria2294 patients Evaluated by panel of physicians (interventionalist, surgeon, neurologist) whoconcur on qualification of patient n = 747 49. SAPPHIRE STUDY Trial Design and Patient Flow RCT334 Randomized(310 Treated) Stent Treatment n=167 CEA Treatment n=167 Surgeon & Interventionalistwilltreat patient Evaluated by panel of physicians (interventionalist, surgeon, neurologist) whoconcur on qualification of patient n = 747 50. SAPPHIRE STUDY Trial Design and Patient Flow Non-Randomized Stent Armn=406 RCT334 Randomized(310 Treated) Surgeon:unacceptablerisk for CEA Stent Treatment n=167 CEA Treatment n=167 Surgeon & Interventionalistwilltreat patient Evaluated by panel of physicians (interventionalist, surgeon, neurologist) whoconcur on qualification of patient n = 747 51. SAPPHIRE STUDY Trial Design and Patient Flow Non-Randomized Stent Armn=406 Non-Randomized CEA Armn=7 RCT334 Randomized(310 Treated) Interventionalist: unacceptable risk for stenting Surgeon:unacceptable risk for CEA Stent Treatment n=167 CEA Treatment n=167 Surgeon & Interventionalistwilltreat patient Evaluated by panel of physicians (interventionalist, surgeon, neurologist) whoconcur on qualification of patient n = 747 52. SAPPHIRE STUDY
- Primary Endpoint:
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- Death (all-cause), any stroke, and MI to 30 days post-procedure plus death (all-cause) and ipsilateral stroke between days 31 and 360 post-procedure.
53. SAPPHIRE STUDY Differences Between SAPPHIRE and Previous Surgical Trials
- Primary endpoint included all-cause mortalityfor 1 year
- MAE includes MI in addition to death/stroke
- 24-hour post procedure stroke evaluation performed by neurologist
- Use of Stroke scales in addition to PEx
- Objective vessel patency data obtained byduplex U/S
- Different specialties providing input on treatment strategy (multi-disciplinary team)
54. SAPPHIRE STUDY Relevance of MI as Part ofthe Primary Endpoint
- MI leads to disability, death, prolonged hospitalization, and increased health care costs key safety endpoint
- In patients undergoing peripheral vascular surgery who sustain a non-Q wave MI:
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- 6-fold increase in mortality over 6 mo 1
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- Perioperative MI predicts mortality at one-year 2
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- 27-fold increased risk of another MI over the next 6 mo 1
- Thus, perioperative MI is a strong surrogate for long-term mortality after vascular surgical procedures
- Perioperative MI is part of the primary endpoint for other CAS trials (e.g. CREST)
1 Kim et al. Circulation 2002;106:2366-2371 2 McFalls et al. Chest 1998;113:681-686 55. DEFINITIONS
- Myocardial Infarction :
- Q wave MI
- Chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in two or more contiguous ECG leads as determined by an ECG Core Laboratory or independent review by the CEC, in the absence of timely cardiac enzyme data.
- Non-Q wave MI
- CK ratio >2, CK-MB >1 in the absence of new, pathologicalQ waves.
56. DEFINITIONS (cont)
- Stroke :
- Any non-convulsive, focal neurological deficit of abrupt onset persisting more than 24 hours was a stroke.The deficit must correspond to a vascular territory.Strokes were classified as major or minor using the NIH Stroke, Rankin and Barthel scales. For a stroke to be minor, it must be minor on all three scales.A stroke rated as major on any scale was considered major if the deficit persisted more than 3 months.Disabilities or impairments attributed to medical conditions that were non-neurological in origin were not considered strokes.
57. SAPPHIRE STUDY Statistical Analysis Plan (Randomized)
- Primary hypothesis: Non-inferiority of CAS to CEA
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- Primary Endpoint: Composite 360-day MAE
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- 3% non-inferiority delta assumed(i.e., Stent no more than 3% higher than CEA)
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- If non-inferiority demonstrated, then test for superiority (2 hypothesis)
- Study was designed to stop enrollment based on interim analysis of 30-day MAE (2 endpoint) with final analysis on 360 day data (1 endpoint)
- Enrollment stopped for administrative reasons
- First planned interim analysis at 300 patients was not done as it was already evident that enrollment would stop
- Final analysis on the 1 endpoint utilized the interval censored survival analysis method designated in protocol
- No adjustments were required since no interim analysis performed
58. SAPPHIRE STUDY Diminishing Enrollment (Randomized) Competing CAS registriesStop Enrollment 59. SAPPHIRE STUDYKey Inclusion Criteria
- Patients referred for treatment of Carotid Artery Disease
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- Symptomatic> 50% stenosis by U/S or angiography
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- Asymptomatic> 80% stenosis by U/S or angiography
- Disease of Native Common or Internal Carotid Artery
- Consensus agreement by multidisciplinary team
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- Interventionalist, Consulting Neurologist, Surgeon
- Must also have at least 1 co-morbid condition which increases the risk of endarterectomy:
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- Anatomic
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- Medical
60.
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- Anatomic factors:
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- Contralateral carotid occlusion
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- Contralateral laryngeal nerve palsy
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- Radiation therapy to neck
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- Previous CEA with recurrent stenosis
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- Difficult surgical access
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- Severe tandem lesions
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SAPPHIRE STUDY Key Inclusion Criteria - cont 61.
- Medical Co-morbidities:
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- CHF (class III/IV) &/or severe LV dysfunction(LVEF 50%
Diameter Stenosis* P-value CEA (n=167) Stent (n=167) In-Vessel
Restenosis by U/S 80. SAPPHIRE STUDY Analysis of the Evaluable
(Treated) Patients 81. SAPPHIRE STUDY Randomized Patients Who Were
Not Treated 16 CEA Stent 8 TOTAL: 2 0 Other : 2 3 Patient Condition
Deteriorated/Too High a Risk: 8 3 Patient Withdrew Consent: 4 2
Subsequent to randomization found to not meet Inclusion Criteria:
82. SAPPHIRE STUDY Primary Endpoint 360 Days
RandomizedTREATEDPatients 83. SAPPHIRE STUDY Cumulative % of MAE to
360 DaysRandomizedTREATEDPatients Kaplan Meier Analysis Time After
Initial Procedure (days) LR p = 0.048 CAS: 12.0% CEA: 20.1%
Cumulative Percentage of MAE 84. SAPPHIRE STUDY Trial Design and
Patient Flow Non-Randomized Stent Arm n=406 Non-Randomized CEA
Armn=7 RCT334 Randomized(310 Treated) Stent Treatment n=167 CEA
Treatment n=167 Surgeon & Interventionalistwilltreat
patientSurgeon:unacceptable risk for CEA Evaluated by panel of
physicians (interventionalist, surgeon, neurologist) whoconcur on
qualification of patient n = 747 85. SAPPHIRE STUDY Non-Randomized
Stent Arm vs. CEA RandomizedDemographic Characteristics 86.
SAPPHIRE STUDY MAE at 360 Days Rand CEA: 20.1% Non-Rand Stent:
16.0% Rand Stent: 12.2% Non-Randomized Stent Arm vs. Randomized
Stent & CEA Time After Initial Procedure (days) Cumulative
Percentage of MAE Rand CEA: 9.8% Non-Rand Stent: 6.9% Rand Stent:
4.8% 87.
- Original non-inferiority analysis based on OPC ~12-14% plus 4% delta
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- Weighted OPC calculated at 12.94 was not met
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- OPC estimated (1999) without benefit of multi-center randomized data from high-surgical risk studies
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- SAPPHIRE CEA arm
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- 1 year MAE rate of 19.2%
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- Hasfrequency of high surgical-risk characteristics
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- Agency consulted in March 2003
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- FDA suggested supplemental non-inferiority analysis
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- Non-Randomized Stent Arm to the Randomized CEA Arm
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- Adjustment for differences in baseline demographics
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SAPPHIRE STUDY Non-Randomized Stent Arm 88. SAPPHIRE STUDY Primary Endpoint 360-day MAE Adjusted for Baseline Characteristics Margin of Non-inferiority % Difference (Non-randomized Stent Randomized CEA) Stent Non-inferior to CEA 3% Non-Inferiority Statistics 5.3%[13.4%, 3.0%] %Difference [95% C.I.] 89. SAPPHIRE STUDY Complications 50% DS)
- CHF (class III/IV) &/or severe LV dysfunction(LVEF 50%
Diameter Stenosis* P-value CEA (n=167) Stent (n=167) In-Vessel
Restenosis by U/S 80. SAPPHIRE STUDY Analysis of the Evaluable
(Treated) Patients 81. SAPPHIRE STUDY Randomized Patients Who Were
Not Treated 16 CEA Stent 8 TOTAL: 2 0 Other : 2 3 Patient Condition
Deteriorated/Too High a Risk: 8 3 Patient Withdrew Consent: 4 2
Subsequent to randomization found to not meet Inclusion Criteria:
82. SAPPHIRE STUDY Primary Endpoint 360 Days
RandomizedTREATEDPatients 83. SAPPHIRE STUDY Cumulative % of MAE to
360 DaysRandomizedTREATEDPatients Kaplan Meier Analysis Time After
Initial Procedure (days) LR p = 0.048 CAS: 12.0% CEA: 20.1%
Cumulative Percentage of MAE 84. SAPPHIRE STUDY Trial Design and
Patient Flow Non-Randomized Stent Arm n=406 Non-Randomized CEA
Armn=7 RCT334 Randomized(310 Treated) Stent Treatment n=167 CEA
Treatment n=167 Surgeon & Interventionalistwilltreat
patientSurgeon:unacceptable risk for CEA Evaluated by panel of
physicians (interventionalist, surgeon, neurologist) whoconcur on
qualification of patient n = 747 85. SAPPHIRE STUDY Non-Randomized
Stent Arm vs. CEA RandomizedDemographic Characteristics 86.
SAPPHIRE STUDY MAE at 360 Days Rand CEA: 20.1% Non-Rand Stent:
16.0% Rand Stent: 12.2% Non-Randomized Stent Arm vs. Randomized
Stent & CEA Time After Initial Procedure (days) Cumulative
Percentage of MAE Rand CEA: 9.8% Non-Rand Stent: 6.9% Rand Stent:
4.8% 87.
- Significant decrease in cranial nerve injuries
112. SAPPHIRE STUDYConclusions: Randomized Arm
- Symptomatic and asymptomatic subgroups
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- ITT Asymptomatic: Significant improvement at 360 days in favor of CAS compared to CEA with 50% reduction in MAE rate
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- ITT Symptomatic: MAE rates at 360 days were similar between CAS and CEA
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- Outcomes for ipsilateral stroke overlap those from NASCET and ACAS
113.
- Risk factors contributing to too high risk for CEA:
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- Anatomic
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- Prior CEA
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- Prior radiation therapy
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- High cervical ICA lesion
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- Medical
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- Angina Class CCS III or IV
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- Previous stroke
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- Non-inferior to randomized CEA
- Surgeons in SAPPHIRE were experienced in CEA and had outcomes similar to referenced literature
- Too high risk for surgery Too high risk for stenting
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- True for symptomatic and asymptomatic patients
SAPPHIRE STUDY Conclusions: Non-Randomized Stent Arm 114. AGENDA
- Project Overview & CAS Background
- Description of Devices
- Overview of PMA Clinical Data(Total of 1619 Pts)
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- 1. Non-Randomized CAS Clinical Trials Supportive data
-
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- CASCADE (European) Study
-
-
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- US FEASIBILITY Study
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- 2. SAPPHIRE Pivotal Trial Ken Ouriel, M.D.
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- Randomized Arm: CAS vs. CEA
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- Non-Randomized Arms: CAS and CEA
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- Overview of Training
- Post-Market Surveillance Study
115. Carotid Artery Stent Education System PROFESSIONAL EDUCATION 116. CAROTID ARTERY STENT TRAINING SYSTEM
- Training system is intended to build upon already existing endovascular expertise to develop a physicians knowledge and technical expertise in performing CAS
- System was developed using a variety of consultants:
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- SAPPHIRE Investigators
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- Internet based training
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- Simulator modeling
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- Proficiency measurements
117. On-lineDidactic Observation Simulation StaffIn-Service ProctorNetwork Step 1 Step 2 Step 3 Step 4 Step 5 Internet Delivery Regional EducationCenter On-site Training atPhysicians Facility Patient Outcomes StaffTraining DELIVERY PROCESS Proficiency Measurement 118.
- On-line didactic training:
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- Transferring Expert Knowledge
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- Through doing and decision making
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- Goal
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- Assure Procedural Success
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- Detailed understanding of anatomy
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- Appropriate case selection
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- High performance technical execution
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- Training at Regional Education Center:
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- Small group setting review 4 Modules Over 2 Days
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- Didactic Review, Case Observation, Simulation Lab, Product Lab
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- Physicians
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- interact with realistic graphical simulations
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- assess task performance
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- demonstrate understanding of the learning objectives
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CAROTID ARTERY STENT TRAINING SYSTEM 119.
- On-site training at physicians facility by physician proctors:
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- Network of CAS experienced physician proctors
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- Proctor Sign Off or Additional Training Recommendations Based on Proficiency Standards
- Training Program:
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- 34 Hours of Training with exposure to a minimum of 15 Cases
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- Serves as the foundation for hospital credentialing
CAROTID ARTERY STENT TRAINING SYSTEM 120. INITIAL ASSESSMENT OF TRAINING InstitutionalIDEs
- 36 centers ( 30 non-Sapphire Investigators)
- All investigators were trained and proctored on use of the stent and the emboli protection system
- Patient selection criteria similar to the US FEASIBILITY Study
- Neurologist evaluation 24 hours and 30 days post-procedure
- Data are site reported and unadjudicated
121. INSTITUTIONALIDEs30-Day Events - Site Reported % 122. COMPARISON OF 30-DAY EVENT RATES Treated Patients with ANGIOGUARD Only % 123.
- Carotid Stenting With Emboli Protection For The Treatment of Obstructive Carotid ArteryDisease
POST-MARKETING SURVEILLANCE 124. POST-MARKETING SURVEILLANCE
- Objective :
- To compare clinical outcomes with historical control data from SAPPHIRE in the early time period following approval and assess the effectiveness of the training program
- Design:
- Multicenter, prospective, non-randomized, open label
- Primary Endpoint:
- 30-day composite of major adverse clinical events
- (MAE = all death and all stroke)
125.
- Study Population:
- High Risk patients withde novoor restenotic lesions
- >1000 patients
- Inclusion Criteria: Per Label Indications
- Follow-up:
- Neurologic examinations at discharge and 30 days (Neurologist)
- Clinical events tracking through discharge
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- 30-day office visit
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- 9-month telephone contact
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- Monitoring with built in stopping rule:
- Electronic data capture to expedite review of outcomes
POST-MARKETING SURVEILLANCE 126. CAROTID ARTERY STENTING WITH EMBOLI PROTECTION Summary and Conclusions 127. SUMMARY AND CONCLUSIONS
- Stroke
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- Significant morbidity and mortality
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- Due to carotid disease in up to 30% of patients
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- Goal of Tx: to prevent stroke and improve quality of life
- CEA is the standard of care in:
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- NASCET/ACAS eligible and ineligible patients
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- Symptomatic and asymptomatic patients
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- Low, intermediate, and high risk
- There are no multi-center randomized studies that define outcomes in high medical- or surgical-risk patients
- SAPPHIRE is an objective comparison of CEA, the current interventional standard of care, with CAS, a less invasive approach to therapy
128.
- Cordis is seeking the following indication:
- The Cordis [Carotid Stent System is] indicated for use in the treatment of carotid artery disease in high-risk patients.High-risk is defined as patients with neurological symptoms (one or more TIAs or one or more completed strokes) and> 50% atherosclerotic stenosis of the common or internal carotid artery by ultrasound or angiogram;
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- Patients without neurological symptoms and> 80% atherosclerotic stenosis of the common or internal carotid artery by ultrasound or angiogram.
- Symptomatic and asymptomatic patients must also have one or more condition(s) that place them at high-risk for carotid endarterectomy.
SUMMARY AND CONCLUSIONS 129.
- This indication is supported by:
- SAPPHIRE
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- Achieved primary endpoint of non-inferiority of CAS to CEA for MAE at 1-year
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- CAS - improved outcomes for MI and re-interventions with a significant decrease in cranial nerve injuries
- SUPPORTIVE STUDIES
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- CAS treatment demonstrated sustained benefit through 3-year follow up
CONCLUSION 130.
- Cordis will institute a training program to ensure outcomes of carotid stenting in non-trial setting replicates safety and effectiveness demonstrated in SAPPHIRE
- Cordis will conduct a post-marketing surveillance study with the goal of
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- quantifying patient outcomes
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- confirming the adequacy of physician training
SUMMARY AND CONCLUSIONS 131. THANK YOU