Conclusions From Completed Trials in Conclusions From Completed Trials in High Risk Carotid Stenting High Risk Carotid Stenting Jay S. Yadav MD Jay S. Yadav MD Chairman, CCF Innovations Chairman, CCF Innovations Director, Vascular Intervention Director, Vascular Intervention The Cleveland Clinic Foundation The Cleveland Clinic Foundation YADAV YADAV YADAV YADAV
Randomized Data Randomized Data ◆ Carotid Endarterectomy – 1954* Carotid Endarterectomy – 1954* ◆ 40 years for proof of efficacy 40 years for proof of efficacy ◆ 1991 NASCET/ECST 1991 NASCET/ECST ◆ Carotid Artery Stenting – 1994 Carotid Artery Stenting – 1994 ◆ 2001 CAVATAS (angioplasty) 2001 CAVATAS (angioplasty) ◆ 2002 SAPPHIRE 2002 SAPPHIRE ◆ 2004 2004 FDA Approval FDA Approval *Eastcott HH et al. Lancet 1954;267:994-996 YADAV YADAV YADAV YADAV
CEA Mortality CEA Mortality 113,000 Medicare Patients (1992- 1993) 30 day follow- up 3.0% 2.5 % 2.0% 1.7 Mortality % 1.4 % 1.0% .6% .1% 0.0% ACAS NASCE Trial Non- Low Volume T Hospital trial Hospitals s Hospital WENNBERG, JAMA,1998:16:279:1278 s YADAV YADAV YADAV YADAV
High Risk Features High Risk Features Surgery Intervention • Restenosis • XRT • Tortuosity • Elderly • Radical Neck • Poor Access • String Signs • CN Palsies • Coag/Platelet • Thrombus • Cardiac/Pulm • Severe Ca ++ • Acute Stroke • Pre-OHS • Arch Anatomy • High/Low Lesions • Contralateral Occl YADAV YADAV YADAV YADAV
High-Risk Patient Trials: High-Risk Patient Trials: Carotid Stenting with Emboli Protection Carotid Stenting with Emboli Protection ◆ Randomized against Surgery Randomized against Surgery ◆ SAPPHIRE SAPPHIRE ◆ Non-Randomized Registries Non-Randomized Registries ◆ ARCHER ARCHER ◆ SHELTER / BEACH SHELTER / BEACH ◆ MAVERICK MAVERICK ◆ CABERNET CABERNET ◆ SECURITY SECURITY YADAV YADAV YADAV YADAV
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High-Risk Patient Trials: High-Risk Patient Trials: Data to be Presented at TCT Data to be Presented at TCT ◆ CAPTURE: CAPTURE: Guidant PMS Study Guidant PMS Study Largest, prospective study to date Largest, prospective study to date ◆ SAPPHIRE SAPPHIRE 3 Year Follow-up 3 Year Follow-up YADAV YADAV YADAV YADAV
SAPPHIRE STUDY: Stroke at 360 Days at 360 Days SAPPHIRE STUDY: Stroke Yadav, NEJM,2004 Yadav, NEJM,2004 CEA (n=167) 25 Stent (n=167) 20 15 % P=0.83 10 7.2 P=0.50 6.0 P=0.21 5 3.6 3.0 1.8 0.6 0 Stroke Major Ipsi Minor Ipsi Note: 2/3 of all minor strokes resolved within one year. Note: 2/3 of all minor strokes resolved within one year. YADAV YADAV YADAV YADAV
SAPPHIRE STUDY SAPPHIRE STUDY MAE at 360 Days at 360 Days MAE Non-Randomized Stent Arm vs. Randomized Stent & CEA Cumulative Percentage of MAE Rand CEA: 20.1% Rand CEA: 9.8% Non-Rand Stent: 16.0% Non-Rand Stent: 6.9% Rand Stent: 12.2% Rand Stent: 4.8% Time After Initial Procedure (days) Yadav, NEJM,2004 Yadav, NEJM,2004 YADAV YADAV YADAV YADAV
SAPPHIRE STUDY SAPPHIRE STUDY Cumulative % of MAE MAE to 720 Days to 720 Days Cumulative % of Randomized Patients – Kaplan Meier Analysis Randomized Patients – Kaplan Meier Analysis Yadav, NEJM,2004 Yadav, NEJM,2004 Cumulative Percentage of MAE CEA 26.7% CEA 26.7% 20.1% 20.1% Stent 19.2% Stent 19.2% 12.2% 9.8% 12.2% 9.8% 4.8% 4.8% Time After Initial Procedure (days) 30 Days: 30 360 720 N at Risk (CEA): 161 125 59 N at Risk (Stent): 163 147 88 YADAV YADAV YADAV YADAV
SAPPHIRE STUDY SAPPHIRE STUDY Cumulative % of Stroke Stroke* to 720 Days * to 720 Days Cumulative % of Randomized Patients - Kaplan Meier Analysis Yadav, NEJM,2004 Yadav, NEJM,2004 Randomized Patients - Kaplan Meier Analysis * All Stroke to 30 days and ipsilateral stroke from 31-720 Days Cumulative Percentage of Stroke Yadav, NEJM,2004 Yadav, NEJM,2004 4.9% Stent 5.9% Stent 3.6% Stent 3.1% CEA 5.8% CEA 5.8% CEA 30 Time After Initial Procedure (days) Days: 30 360 720 N at Risk (CEA): 159 130 59 N at Risk (Stent): 162 145 88 YADAV YADAV YADAV YADAV
US FEASIBILITY FEASIBILITY STUDY STUDY US Cumulative Percentage of All Stroke All Stroke to 30 Days and to 30 Days and Cumulative Percentage of Ipsilateral Stroke from 31-1080 Days Ipsilateral Stroke from 31-1080 Days Yadav, NEJM,2004 Yadav, NEJM,2004 Cumulative Percentage of Stroke 8.7% 8.7% 7.3% 6.1% 30 Time After Initial Procedure (days) Days: 30 360 720 1080 N at Risk: 247 218 176 113 YADAV YADAV YADAV YADAV
High-Risk Patient Trials: High-Risk Patient Trials: Carotid Stenting with Emboli Protection Carotid Stenting with Emboli Protection ◆ Difficult to Compare Even 30 Day Results Difficult to Compare Even 30 Day Results ◆ Varying Definitions / Methodologies Varying Definitions / Methodologies ◆ Inclusion of Device Failures Inclusion of Device Failures ◆ All Stroke Vs Ipsilateral Stroke Vs Procedure All Stroke Vs Ipsilateral Stroke Vs Procedure Related Stroke Related Stroke ◆ At 1 year, many do not count death or At 1 year, many do not count death or count only neurological death count only neurological death ◆ Not Published (except SAPPHIRE) Not Published (except SAPPHIRE) YADAV YADAV YADAV YADAV
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30 Day MAE-Composite Endpoint in 30 Day MAE-Composite Endpoint in High Risk Carotid Stenting Trials High Risk Carotid Stenting Trials 9.0% 8.0% 8.3% 4.8% 7.0% 7.2% 3.8% 5.3% 5.4% % of Patients 6.0% 4.8% 5.0% 4.0% 3.0% 2.0% 1.0% 0.0% SECURITY CREATE SIR SAPPHIRE ARCHER 2 BEACH TCT MAVERIC II CABERNET TCT 2003 TCT 2004 TCT 2004 NEJM IFU 2004 2005 YADAV YADAV YADAV YADAV
30-Day Risk of Stroke in High Risk Carotid Stenting Trials 8 6.2% 4.8% 5.8% Proced 6 contrala lat 4.9% Patients (%) Only 3.3% 4.2% Ipsil 3.2% 4 Device only 3.1% Only 2 0 ARCHeR Maveric Create SAPPHIRE BEACH Cabernet 2 2 SECuRITY Rand Non-Rand YADAV YADAV YADAV YADAV
30 Day Risk of Major Stroke in High 30 Day Risk of Major Stroke in High Risk Carotid Stenting Trials Risk Carotid Stenting Trials 8.0% 7.0% 6.0% % of Patients 5.0% 4.0% 3.0% 2.3% 2.3% 2.0% 2.0% 1.4% 1.1% 1.0% 1.0% 0.0% 0.0% CREATE SIR SECURITY CABERNET SAPPHIRE MAVERIC II BEACH TCT ARCHER 2 TCT 2003 TCT 2004 TCT 2004 NEJM IFU 2004 2005 YADAV YADAV YADAV YADAV
1 year clinically driven TLR in 1 year clinically driven TLR in High Risk Carotid Stenting Trials High Risk Carotid Stenting Trials 8.0% 7.0% 6.0% % of Patients 5.0% 4.0% 5.3% 3.0% 2.2% 2.0% 0.7% 1.0% 0.6% 0.0% CABERNET CREATE SIR BEACH TCT SECURITY ARCHER 2 SAPPHIRE MAVERIC II TCT 2003 TCT 2004 TCT 2004 NEJM IFU 2004 2005 YADAV YADAV YADAV YADAV
Carotid stenting with cerebral protection: Carotid stenting with cerebral protection: Pooled analysis of perioperative outcomes Pooled analysis of perioperative outcomes Yadav, Balzer, Beyssen, Cleveland, Cremonesi, Daoud Yadav, Balzer, Beyssen, Cleveland, Cremonesi, Daoud ◆ 32 studies of CEA, Stenting 32 studies of CEA, Stenting ◆ 30 Day Stroke/Death and 30 Day Stroke/Death and Stroke/MI/Death Stroke/MI/Death ◆ Cea Cea 3369 pts 3369 pts ◆ PCAS PCAS 1222 pts 1222 pts ◆ UPCAS UPCAS 1638 pts 1638 pts YADAV YADAV YADAV YADAV
Carotid stenting with cerebral protection: Carotid stenting with cerebral protection: Pooled analysis of 30 Day perioperative outcomes Pooled analysis of 30 Day perioperative outcomes Yadav, Balzer, Beyssen, Cleveland, Cremonesi, Daoud Yadav, Balzer, Beyssen, Cleveland, Cremonesi, Daoud TX # Pts Sx Pts (%) S/D (%) S/D/MI(%) TX # Pts Sx Pts (%) S/D (%) S/D/MI(%) CEA 3,369 1,253 (62.8) 87 (2.6) 64 (2.8) CEA 3,369 1,253 (62.8) 87 (2.6) 64 (2.8) PCAS 1,222 656 (46.3) 33 (2.7) 25 (2.6) PCAS 1,222 656 (46.3) 33 (2.7) 25 (2.6) UPCAS 1,638 723 (55.9) 88 (5.4) 77 (6.1) UPCAS 1,638 723 (55.9) 88 (5.4) 77 (6.1) ALL 6,229 2,636 (57.7) 208 (3.3) 166 (3.7) ALL 6,229 2,636 (57.7) 208 (3.3) 166 (3.7) YADAV YADAV YADAV YADAV
Carotid stenting with cerebral protection: Carotid stenting with cerebral protection: Pooled analysis of 30 Day perioperative outcomes Pooled analysis of 30 Day perioperative outcomes Yadav, Balzer, Beyssen, Cleveland, Cremonesi, Daoud Yadav, Balzer, Beyssen, Cleveland, Cremonesi, Daoud Treatments Symptomatic patients 30-day stroke-death 30-day stroke-MI-death [95% CI] [95% CI] [95% CI] Endarterectomy 62.78% 2.58% 2.81% [61.15% ; 64.41%] [2.05% ; 3.12%] [2.25% ; 3.37%] Protected stenting 46.32% 2.70% 2.64% [43.52% ; 49.11%] [1.79% ; 3.61%] [1.74% ; 3.54%] Unprotected stenting 55.86% 5.37% 6.11% [53.46% ; 58.27%] [4.28% ; 6.46%] [4.95% ; 7.27%] Protected stenting versus p-value >.82 p-value >.78 Endarterectomy Protected stenting versus p-value <.00045 p-value <.00012 Unprotected stenting YADAV YADAV YADAV YADAV
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