Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med...

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Satish K Surabhi, MD,FACC,FSCAI Medical Director, Cardiac Cath Labs AnMed Health Heart and Vascular Care

Transcript of Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med...

Page 1: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Satish K Surabhi, MD,FACC,FSCAIMedical Director, Cardiac Cath Labs

AnMed Health Heart and Vascular Care

Page 2: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 3: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

NT

Page 4: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 5: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Objectives

• Review the era of CEA trials• Reiterate the limitations of CEA trials• Review landmark carotid stent trials• Compare and contrast outcomes• Address ongoing advances in CAS

Page 6: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Conflict of Interest• No financial conflict of interest relating to the

talk• Anticipate discussion on novel embolic

protection strategies• No conflict of interest, except…

- Interventional cardiologist with a passion for Carotid Artery Stenting

- Investigator in ongoing CAS trials.. EV3 ( CREATE-PAS and CREATE 2) Abbott Vascular ( CHOICE and CANOPY) Cordis ( SAPPHIRE)

Page 7: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Carotid Artery Disease Natural History

• Symptomatic disease:- > 70% stenosis: 26% stroke risk at 2 years- 50%-70% stenosis: 22% stroke risk at 5 years

• Asymptomatic disease:- > 60% stenosis: 11% stroke risk at 5 years- > 80% stenosis: 35% stroke or TIA at 2 years- Ulcerated lesions: 5%-12% stroke per year

NASCET Trial. N Engl J Med 1991;325:445-453. ACAS Trial. JAMA 1995;273:1421-1428. ACST Trial. Lancet 2004;363:1491-1502.

Page 8: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Carotid Endarterectomy

• Practiced for over 4 decades

• Safety well evaluated

• Superiority over medical therapy well established

Page 9: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 10: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 11: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Risk of Stroke or Death in Symptomatic patientsRothwell et al, Stroke 1996

• 51 centers• Stroke and Death 5.6%• Death 1.6%

• Neurologist Assessor 7.7%• Neurologist Author 6.4%• Multiple Surgeons Author 5.5%• Single Surgeon Author 2.3%

Page 12: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 13: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

5.87.1

11.4

0

5

10

15

20

%

NASCET ECST Medicare

Risk of Stroke and DeathSymptomatic Carotid disease treated with CEA

Wholey MH, TCT 2002

Page 14: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Carotid Stent Trials Carotid Stenting with Embolic Protection Devices

• ARCHeR• BEACH• CABERNERT• CARESS• CREST (RCT)

• MAVErICK• MedNova• SAPPHIRE (RCT)

• SHELTER• CREATE

Page 15: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

SAPPHIRE TrialStenting and Angioplasty in

Patients at High Risk for Endarterectomy

Yadav JS, et al. N Engl J Med 2004;351:1493-1501.

Page 16: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

High-Risk Criteria• Patients must have one or more of the following

conditions that place them at increased surgical risk:

- congestive heart failure (class III/IV) and/or known severe left ventricular dysfunction LVEF < 30%

- open heart surgery needed within six weeks

- recent MI (> 24 hours and < 4 weeks)

- unstable angina (CCS class III/IV)

Page 17: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

High-Risk Criteria (Continued)

- severe pulmonary disease- contralateral carotid occlusion- contralateral laryngeal nerve palsy- radiation therapy to neck- previous CEA with recurrent stenosis- high cervical ICA lesions or CCA lesions below

the clavicle- severe tandem lesions- age greater than 80 years

Page 18: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

SAPPHIRE≥ 50% Stenosis - Symptomatic≥ 80% Stenosis - Asymptomatic

One or More Comorbidity CriteriaPhysician Team: Neurologist, Surgeon, Interventionalist

CONSENSUS

RANDOMIZED334

SURGICALREFUSAL

STENTREGISTRY

409

INTERVENTIONALREFUSAL

SURIGICALREGISTRY

7Stenting = 167 CEA = 167

Page 19: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

5.8

12.6

0

5

10

15

20

%

CAS CEA

SAPPHIRE TrialDeath, Stroke, MI @ One Month

P = 0.047

Page 20: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

SAPPHIRE: One-Year OutcomeDeath/Stroke/MI

Yadav JS. N Engl J Med 2004;351:1493-1501.

Page 21: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 22: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

SAPPHIRE: One-Year Outcome

CAS CEA P• Death/Stroke 5.5% 8.4% 0.36• Cranial nerve 0% 4.9% 0.004

palsy• Repeat 0.6% 4.3% 0.04

revascularization

Page 23: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

SAPPHIRE TrialCAS clearly and significantly

superior to CEA in patients with high risk criteria

Yadav JS, et al. N Engl J Med 2004;351:1493-1501.

Page 24: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

CREST• Carotid Revascularization Endarterectomy Versus Stenting Trial, 2004

and 2010• 117 centers in US and Canada • Randomized clinical trial comparing the safety and efficacy of CAS

versus CEA• Symptomatic patients had >50% by angiography, >70% by duplex, or

>70% by CT angiography and stroke or TIA within 180 days• Asymptomatic patients had >60% stenosis by angiography, >70% by

ultrasound, or >80% by CT angiography• Unlike other studies, interventionalist used only one stenting system and

the distal protection device was used in 96% of the stented patients

Page 25: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

CREST Summary• 2502 patients over a median 2.5 y FU

• 4y rates of the primary end point (CAS & CEA)

- 7.2% and 6.8%

- hazard ratio with stenting, 1.11 (95% confidence interval, 0.81 to 1.51; P = 0.51)

- no significant difference

• 4y rate of stroke or death 6.4% with CAS & 4.7% with CEA (hazard ratio, 1.50; P = 0.03)

- symptomatic patients 8.0% and 6.4% (hazard ratio, 1.37; P = 0.14)

- asymptomatic patients 4.5% and 2.7% (hazard ratio, 1.86; P = 0.07)

(Periprocedural event )

- death (0.7% vs. 0.3%, P = 0.18)

- stroke (4.1% vs. 2.3%, P = 0.01)

- myocardial infarction (1.1% vs. 2.3%, P = 0.03)

(After this period)

- Ipsilateral stroke with CAS and with CEA were similarly low

- (2.0% and 2.4%, respectively; P = 0.85)

Page 26: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Kaplan-Meier analysis of the primary outcome (stroke, myocardial infarction, or death during the periprocedural period or any ipsilateral stroke within 4 years after randomization) for

patients undergoing carotid artery stenting or carotid endarterectomy.

©2010 by Cleveland Clinic

Page 27: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

CREST• “CREST demonstrated that with

experienced surgeons and interventionalists, both CEA and CAS are viable options for carotid revascularization because overall complication rates for both procedures are within current treatment guidelines”

Page 28: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 29: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 30: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

CEA has evolved and improved..

Page 31: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 32: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 33: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 34: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Death/ MI/Stroke by EPS Usage

Page 35: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

High Risk CAS Data

Page 36: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

NIHSS at 6 months: equal

Page 37: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

CREST after 50% enrollmentAug 2006

Death or Major Stroke

Page 38: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

CREST after 50% enrollmentAug 2006

Death or Any Stroke

Page 39: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

CREST after 50% enrollmentMarch 2006

Symptomatic patients

Page 40: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

CREST after 50% enrollmentMarch 2006

Symptomatic patients

Page 41: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

CREST after 50% enrollmentAug 2006

Death or Major Stroke

Page 42: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 43: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Operator Experience

Page 44: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Operator Experience

Page 45: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

CAS Data Over Time

Page 46: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Gore Flow reversal System

Page 47: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Microembolic signals with Filter Vs MoMA

Page 48: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

PCath Lab

Page 49: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

High risk for CAS• Difficult arch• Extreme angulation• Extreme calcification• Possibly elderly at reasonable clinical risk

Page 50: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Conclusions• CEA and CAS appear to be reasonably

similar means of carotid revascularization• Each has its strengths and weakness• Operator experience and improved

technology continues to improve both

Page 51: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 52: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

CAROTID ARTERY STENTING

Before After

1999

Page 53: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

CAROTID ARTERY STENTING2003

Page 54: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 55: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 56: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

RX ACCUNET™ Embolic Protection System

Carotid stent & Embolic protection devices

RX ACCULINK™

SpiderFX

PercuSurge

FilterWire EZ™

Acculink & Accunet systems Abbott Vascular Solutions

Page 57: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

Peri-procedural Death & Stroke

AHA Guideline 6.0%

Standard Surgical Risk High Surgical Risk Standard Surgical Risk

CAS CEA

High Surgical

Risk

Brott TG., et al. NEJM 2010

Page 58: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,
Page 59: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

4.2

15.4

0

5

10

15

20

%

CAS CEA

SAPPHIRE – Symptomatic PatientsDeath, Stroke, MI @ One Month

P = 0.13

Page 60: Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med 2004;351:1493- 1501. CREST • Carotid Revascularization Endarterectomy Versus Stenting Trial,

6.7

11.2

0

5

10

15

20

%

CAS CEA

SAPPHIRE – Asymptomatic PatientsDeath, Stroke, MI @ One Month

P = 0.33