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Carotid_Stenting

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					  FIFTH ANNUAL
                 Sarah Johnson, MD
  PERPHERIAL       Alexian Brothers
CARDIOVASCULAR     Medical Center
  CONFERENCE
 CAROTID STENTING


WHERE ARE WE TODAY



    DR. SARAH JOHNSON
   CARDIOVASCULAR ASSOCIATES
CAROTID ARTERY STENTING
          STROKE

   #1 CAUSE OF MORBIDITY

      #3 CAUSE OF DEATH

   800,000 STROKES PER YEAR

 60% DUE TO CAROTID DISEASE

 ONLY 200,000 CEA’s ANNUALLY
 CAROTID ARTERY STENTING
          1999




Before                After
CAROTID ARTERY STENTING
          2003
CAROTID TRIALS
               CAPTURE
CAPTURE IS PART OF GUIDANT’S POST APPROVAL
STUDY PLAN THAT WILL INCLUDE AT LEAST 1,500
PATIENTS RECEIVING GUIDANT’S FDA-APPROVED
ACCULINK™ CAROTID STENT SYSTEM AND
ACCUNET™ EMBOLIC PROTECTION SYSTEM AT
APPROXIMATELY 150 SITES IN THE UNITED
STATES

THE PRIMARY ENDPOINT OF THE STUDY WILL BE
A COMPOSITE OF STROKE, DEATH AND HEART
ATTACK AT 30 DAYS FOLLOWING THE CAROTID
STENTING PROCEDURE
         CAPTURE

 1603 PATIENTS          30 DAYS

STROKE           4.1%
MI               0.9%
DEATH            1.6%

INCREASED MAE IN PTS > 80YRS

DEATH            > 80      10%
                 < 80      2%
                               ACT I

ACT I WHICH STANDS FOR “CAROTID ANIGOPLASTY AND STENTING vs.
ENDARTERECTOMY IN ASYMPTOMATIC PATIENTS WITH SIGNIFICANT EXTRACRANIAL
CAROTID OCCLUSIVE DISEASE TRIAL, WILL COMPARE CAS TO CEA IN ASYMPTOMATIC
PATIENTS WHO ARE AT STANDARD RISK FOR SURGERY. THIS RANDOMIZED TRIAL IS
DESIGNED TO ESTABLISH THE NON-INFERIORITY OF CAS TO CEA IN THIS PATIENT
POPULATION. THE CAS ARM OF THE TRIAL WILL USE ABBOTT’S Xact CAROTID STENT
SYSTEM AND EMBOSHIELD PROTECTION SYSTEM, WHICH WERE DESIGNED TOGETHER
SPECIFICALLY FOR CAROTID STENTING PROCEDURES. ALL PATIENTS ENROLLED IN
THE TRIAL WILL RECEIVE APPROPRIATE MEDICATIONS AND LIFESTYLE
MODIFICATION COUNSELING DURING THE STUDY.

THE TRIAL WILL INVOLVE UP TO 50 HOSPITALS IN THE UNITED STATES AND
APPROXIMATELY 1,500 PATIENTS, WITH PRIMARY ENDPOINT DATA SUBMITTED AFTER
ONE YEAR OF PATIENT FOLLOW-UP. THE TRIAL’S PRIMARY ENDPOINTS ARE AS
FOLLOWS; (1) 30-DAY MAJOR ADVERSE EVENTS (MAE) RATES COMBINNG STROKE,
DEATH AND MYOCARDIAL INFARCTION (HEART ATTACK); AND (2) IPSILATERAL
STROKES (THOSE OCCURRING O THE SAME SIDE AS THE THERAPY BETWEEN 31 AD 365
DAYS. THE TRIAL’S SECONDARY ENDPOINTS INCLUDE TARGET LESION
REVASCULARIZATION RATE (THE RATE AT WHICH THE VESSEL MUST BE RE-OPENED),
DEVICE/PROCEDURAL SUCCESS RATES, CUMULATIVE COMPOSITE MORBIDITY (NERVE
DAMAGE, WOUND COMPLICATIONS, GENERAL ANESTHETIC COMPLICATIONS, ETC.),
AND LONG-TERM IPSILATERAL STROKE RATES THROUGH FIVE YEARS OF FOLLOW-UP.
     RANDOMIZED TRIALS
• TACIT           ASYMPTOMATIC
•                  medical management
•                  carotid endarterectomy
•                  carotid stenting
• 2400 patients    3 year followup
•                   all strokes and death
    RANDOMIZED TRIALS
• ACST-2           ASYMPTOMATIC
•                   carotid endarterectomy
•                   carotid stenting
• 5 year follow up
• MAE               stroke
•                   death
•                   myocardial infarction
CAROTID ARTERY STENTING
      STRING SIGN
CAROTID ARTERY STENTING
  TYPE III AORTIC ARCH
CAROTID ARTERY STENTING
   SEVERE TORTUOSITY
CAROTID ARTERY STENTING
   SEVERE TORTUOSITY
  CAROTID ARTERY STENTING




BEFORE              AFTER
CAROTID ARTERY STENTING




BEFORE          AFTER
 CAROTID ARTERY STENTING
       RESTENOSIS




BEFORE          AFTER
    CAROTID ARTERY STENTING




BEFORE     SPASM       AFTER
   CAROTID ARTERY STENTING




BEFORE    AIR EMBOLISM   AFTER
CAROTID ARTERY STENTING
      DISSECTION
 CAROTID ARTERY STENTING




BEFORE          AFTER
CAROTID ARTERY STENTING
 TORTUOSITY WITH SPASM
CAROTID ARTERY STENTING
      AFTER NITRO
CAROTID STENT: CURRENT STATUS CMS
               SYMPTOMATIC

SYMPTOMATIC > 70%       FDA APPROVED
HIGH RISK               DEVICE



SYMPTOMATIC 50-70%      CLINICAL TRIAL
LOW RISK

SYMPTOMATIC 50-70%      FDA APPROVED
HIGH OR LOW RISK        DEVICE-PRIVATE
                        INSURANCE
CAROTID STENT: CURRENT STATUS CMS
              ASYMPTOMATIC

ASYMPTOMATIC > 80%      CLINICAL TRIAL
LOW RISK

ASYMPTOMATIC > 80%      CLINICAL TRIAL
HIGH RISK

ASYMPTOMATIC > 80%      FDA APPROVED
HIGH OR LOW RISK        DEVICE-PRIVATE
                        INSURANCE

				
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