CEA and Stroke Prevention in China

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CEA and Stroke Prevention in China

• Douglas J. Wirthlin, M.D.
• Division of Vascular Surgery
• Department of Cardiovascular Medicine
• Intermountain Health Care, Salt Lake City, Utah

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Causes of Stroke in China
1996-2000, 8258 strokes, 10 populations gt 75
CT scans
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Stroke 2003342091-6
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• Carotid Endarterectomy (CEA) in USA
• lt 2 mortality
• 0-5 stroke rate
• 1-2 day LOS
• 10 x reduction in stroke risk

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Asymptomatic Carotid Atherosclerosis Study (ACAS)
JAMA 2731421, 1995
North American Symptomatic Carotid Endarterectomy
Trial (NASCET)
NEJM 325445 1991
CEA only effective if 1. outcomes are good
2. expected
patient survival 2-5 years
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Carotid Endarterectomy in Mainland China
Douglas J Wirthlin MD, Qin Yi Zhang MD, Gen Xue
Qu MD, Jian Lin Liu MD, Xeng Meng MD, Raphael C
Sun BS, Nai Dong Wang MD, Donald B Doty
MD. Xian Jian Tong University No. 1
Xian, Peoples
Republic of China Intermountain Health Care, LDS
Hospital, Salt Lake City,
Utah
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• February 2002 present
• February 2002 July 2004
• 2 exchanges in USA
• 2 exchanges in China

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Results

• (4/02-7/04) 104 CEA performed in 4 hospitals
• US surgeon (3 cases)

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Demographics

• 65 CEA in 60 patients
• 48 male, 12 female
• Hypertension 47 (78)
• Hypercholesterolemia 57(95)
• Smoking 31 (52)
• Diabetes 14 (23)

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Neurologic Presentation

• Asymptomatic 0 (0)
• TIA 4 (7)
• Stroke 61 (93)
• Minor 36 (67)
• Major 22 (33)

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• 62 y/o man
• Smoking, HTN
• R MOB L Sided weakness
• Bilateral ICA occlusions

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Operative Technique

• General Anesthesia 64 (98)
• Shunt 64 (98)
• Longitudinal Endart. 65 (100)
• Primary closure 59 (91)
• Prosthetic patch 6 (9)

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30 day Outcomes

• Mortality 0 (0)
• MI 0 (0)
• Neurologic events 4 (6)
• Major 3 (5)
• Minor (TIA) 1 (2)
• CN injury 6 (10)
• Bleeding 1 (2)

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LOS/Hospital Charges

• Mean LOS
  2620 days (10-127d)
• Mean Operative Charges
  13,3894937 RMB (1,613595 US )
• Mean Total Charges 24,1512557
  RMB (2,909308 US )

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• With adequate training, Carotid Endarterectomy
  (CEA) in China is very safe and effective

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CEA in USA gt 200,000 cases/year CEA in China
lt 200 cases/year
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• Why so few CEA in China?
• No formal training
• Poor outcomes (in the past)
• Patients present with advanced disease
• CEA developed concurrent with CAS
• Financial incentives for CAS over CEA
• Limited Referrals from medical doctors
• Patient fear of surgery

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History of CEA in USA

• First CEA 1954
• 1960s 1980s improvement in surgical technique
  and understanding of cerebrovascular disease.

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History of CEA in USA

• 1970s - 80s Efficacy of CEA questioned
• 1990s Randomized trials establish CEA as the
  treatment of choice for high-grade carotid
  stenosis over best medical therapy.
  (NASCET ACAS)

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North American Symptomatic Carotid Endarterectomy
Trial (NASCET)
NEJM 325445 1991

• 50 centers US Canada (qualified based on lt 5
  morbidity mortality following CEA)
• Patient symptoms (Low surgical risk) TIA or
  minor stroke w/in 3 months
• Lesion classified 30-69 or 70-99
• 659 pts
• 331 ECASA
• 328 CEA ECASA
• Stopped after 18 mo. Mean f/u secondary to
  significant advantage of CEA ( stenosis gt 70 )

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NASCET (stenosis gt 70)
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Asymptomatic Carotid Atherosclerosis Study (ACAS)

• NIH sponsered
• Asymptomatic patients (low surgical risk) w/ gt
  60 stenosis
• Angiography not mandatory
• Angiographic related stroke 1.2

JAMA 2731421, 1995
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ACAS
JAMA 2731421, 1995
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History of CEA in USA

• CEA becomes the gold standard for treatment of
  extra-cranial carotid stenosis.
• Guidelines for CEA are established.
• Rate of CEA increases. (200,000 CEA/yr)

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Indications for CEA

• Asymptomatic
• gt 70 stenosis
• gt 50 stenosis w/ large ulcer
• TIA
• gt 70 stenosis
• gt 50 stenosis w/ large ulcer
• Previous Stroke
• Stable/Improving neurologic exam
• gt 70 stenosis
• gt 50 stenosis w/ large ulcer
• Evolving Stroke
• gt 70 stenosis
• Global Symptoms
• gt 70 stenosis and uncorrectable
  vertebrobasilar disease

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AHA Standards for CEA (1989)
CEA only effective if 1. outcomes are good
2. expected
patient survival 2-5 years
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History of CEA in USA

• 1990s Carotid Angioplasty and Stent (CAS)
  introduced.
• 2000 Cerebral protection devices introduced and
  outcomes of CAS appear comparable to CEA.
• Randomized prospective trial establishes CAS
  equivalent to CEA in high-risk symptomatic
  patients (SAPPHIRE).
• Currently the role of CEA is being redefined.

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History of CEA in China

• Stroke awareness, prevention, and treatment
  recently became a priority for China
• No formal training for CEA.
• Few reports of CEA in China
• 22 CEA, Zhongshan Hospital, Fudan University,
  Shanghai (Chin Med J 2002115(3)405-8
• 62 CEA, Queen Mary Hospital, University of Hong
  Kong Medical Center, Hong Kong (Chin Med J
  2002115(4)536-9
• 105 CEA, Sino-American Stroke Group
• CAS is rapidly becoming an accepted treatment
  option for carotid stenosis.

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Carotid Revascularization which is better?
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Clinical Effectiveness

• Case Series (w/cerebral protection)
• All patients
• Perioperative outcomes of CEA and CAS comparable
• 0-5 stroke and death rate
• Cranial Nerve Deficit
• CEA 0 10
• CAS 0
• Restenosis
• CEA 0 20 , 4 clinically significant
• CAS 5 10 _at_ 12-24 months, most retreated with
  PTA/stent

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Protected Carotid-Artery Stenting versus
Endarterectomy in High-Risk Patients (SAPPHIRE)

• Randomized, prospective trial in highly qualified
  centers for both CEA and CAS
• 334 High-risk patients (asymptomatic and
  symptomatic) randomized.
• Designed to determine if CAS is inferior to CEA
• Endpoints stroke, MI, death, and cranial nerve
  injury (30 day and 12 month)

NEJM 2004 351(15) 1493-1501
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SAPPHIRE High-risk Criteria
Age gt 80 Cardiac CABG lt 6wks MI lt 4
wks Angina CCS class III/IV CHF
III/IV EF lt 30 Abnl Stress
test Pulmonary Chronic Oxygen use PO2 lt 60 mm
Hg Hct gt 50 FEV1 lt 50 predicted Renal Cr
eatinine gt 3.0 Anatomic Previous CEA Severe
tandem lesion Cervical Radiation Contralater
al carotid occlusion High cervical lesion
C2 Lesion below clavicle Contralateral
laryngeal palsy
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SAPPHIRE
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Endarterectomy versus Stenting in Patients with
Severe Carotid Stenosis
NEJM 3551660-1 2006

• Multicenter, randomized european trial,
  symptomatic patients (stenosis gt 60)
• Stroke or death at 30 days and 6 months
• 30 day stroke/death CEA 3.9 , CAS 9.6
• 2.5 relative risk increase for stroke/death CAS
  vs. CEA
• 6 month stroke/death CEA 6.1 , CAS 11.2
  (p0.02)
• Stopped after 527 patientd secondary to
  significant advantage of CEA

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Current Guidelines CEA or CAS?

• Good Surgical Risk
• Asymptomatic patients ?
• Symptomatic patients ? CREST trial
• High Surgical Risk
• Asymptomatic CAS vs. ? medical mgt.
• Symptomatic CAS ?

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History of Carotid Disease Treatment USA and
China
CAS protection devices 2000
CAS regulated by Government 2005
CAS outcomes inferior to CEA in Europe NEJM 2006
Efficacy of CEA validated ACAS, NASCET 1990s
CAS developed 1990s
SAPHIRE 2004
First CEA 1954
CEA Reports 22 cases Shanghai 2002, 62 cases
Hong Kong 2002
SinoAmerican Stroke Group 105 CEA, 2004
First CEA/CAS? 1990 - 2000
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Resource Utilization Cost
CEA
CAS

• Equipment
• Operating Room
• Surgical Instruments
• Personnel
• Trained Surgeon
• Anesthesiologist
• Cost
• Operative 13,3894,937 RMB
• Total 24,1512,557 RMB

• Equipment
• Angiography suite
• Wires, catheters, balloons, stents, protection
  device
• Personnel
• Trained Interventionalist
• Cost
• 70,000 RMB

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Cost of Treating Carotid Artery Disease
Stroke gt CAS gt CEA
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CVD Stroke Prevention Plan
CAS
CEA
Medicine
Screening Programs
Risk Factor Modification
Patient Education / Physician Education
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CVD Stroke Prevention Plan
CAS
CEA
Medicine
Screening Programs
Risk Factor Modification
Patient Education / Physician Education
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Recommendations

• Promote Patient and Physician Education
• Initiate Carotid Screening programs
• Establish training center and standards for CEA
• Monitor outcomes

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