STENTING in 2010
    Najam Wasty, MD, FACC
      Director, Cardiac Cath Lab
  Director, Interventional Cardiology
         Fellowship Program
  Newark Beth Israel Medical Center
Carotid atherosclerosis - the burden

                Stroke is the 3rd leading cause of
                 death in US (164,000 deaths/year),
                 following heart disease and cancer
                Stroke is the primary cause of
                 long-term disability in the US
                1 million stroke-related events
                 each year, including 500,000 new
                 strokes, 200,000 recurrent strokes,
                 and 240,000 TIAs.
                30-40% of these are related to
                 carotid artery disease
                Carotid Epidemiology – 2005 (US)
                                                                        2.46 million with >50%
                                                                           carotid stenosis

                                            10%                                                                        90%
                                         Symptomatic                                                               Asymptomatic

                             74,000                            172,000                                      266,000       1,510,000
                           Undiagnosed                      Diagnosed/yr                                  Diagnosed/yr   Undiagnosed

                  Need to get                                        438,000 diagnosed/yr                                   Need to get
                   patients                                                                                                  patients
                  diagnosed                                                                                                 diagnosed

1.   Numbers reflect Epidemiology of United States only.
2.   Primary Prevention of Ischemic Stroke, Circulation, 2001;103:163-182.
3.   Endarterectomy for Asymptomatic Carotid Artery Stenosis, JAMA, 1995. Vol 273, No. 18. P.1421-1428.
4.   New Insights on Stroke Prevention in Patients without Symptoms. London, Ontario. June 7, 2000.
       Carotid Artery Disease

Medical treatment      Carotid Endarterectomy

          Carotid Artery Stenting
Carotid Endarterectomy
Carotid Endarterectomy
Carotid Endarterectomy
               Benefit of revascularization (CEA) versus
                          best medical therapy
     Trial       N     Stenosis   Follo       End Point         Medical   CEA      p      RRR
                                  w-Up                           (%)      (%)             (%)

ECST           3,018   ≥80%       3 yrs   Major stroke or        26.5     14.9   <0.001   44
NASCET         659     ≥70%       2 yrs   Ipsilateral stroke      26       9     <0.001   65
VA 309         189     >50%       1 yr    Ipsilateral stroke     19.4     7.7    0.011    60
                                          or TIA or surgical
NASCET         858     50%–69%    5 yrs   Ipsilateral stroke     22.2     15.7   0.045    29
NASCET         1,368   ≤50%       5 yrs   Ipsilateral stroke     18.7     14.9    0.16    20
ACAS           1,662   >60%       5 yrs   Ipsilateral stroke,     11      5.1    0.004    54
                                          surgical death
ACST           3,120   ≥60%       5 yrs   Any stroke             11.8     6.4    0.0001   46
VA             444     ≥50%       4 yrs   Ipsilateral stroke      9.4     4.7    <0.06    50
   CAS: Historical Perspective
1979 - The first balloon angioplasty for carotid
       stenosis was performed.
1989 - The first balloon-expandable stent was
       deployed in the carotid artery.
1990 - A balloon occlusion system used to reduce
       embolic complications.
2001 - Pre-EPD self-expanding Wallstent system
       results published.
2004 - FDA approval of CAS for high surgical risk
           Carotid Artery Stenting
 Goal of carotid stenting is to reduce
  the risk of future stroke
 Stenting the lesion:
    Stabilizes and “traps” the plaque    Tapered
    Reduces the flow pressures on the
    Improves blood flow                  Straight
 Angiographic perfection is not the
  goal – “The enemy of good is better”
                  Overview of Stent Procedural
         Percutaneous   femoral arterial access
         Guide catheter/sheath placed
         Embolic protection device positioned beyond the
          carotid stenosis
         Pre-dilatation, typically using an appropriately
          sized balloon catheter
         Stent delivery and deployment
         Post-dilatation (optional)
         Removal of the embolic protection device
         Wound closure/compression
1. Carotid Artery Stenting – A Guide for Patients and Their Families. Guidant Corporation, August 2004. LT 2921888.
         Percutaneous Femoral Arterial Access
            and Guide Catheter Placed1

            The procedure is
            completed through the
            femoral artery. The groin
            area is washed with an
            antibiotic solution and then
            covered with a sterile
            sheet. A catheter is

1. Carotid Artery Stenting – A Guide for Patients and Their Families. Guidant Corporation, August 2004. LT 2921888.
               Canulation of the common
                     carotid artery

The Achille’s heel of this procedure is safely accessing the carotid
artery from the leg. Much has been published regarding arch types,
their calcifications and tortuosity, lending to the difficulty of the
procedure. We are proud to report that at NBIMC we have developed
a rather simple, straightforward and safe way of canulating these
vessels. Our results will be published soon in the Catheterization &
Coronary Interventions Journal.
           Embolic Protection Device Positioning1

        The EPD is positioned into the
        carotid artery. The EPD has a
        small filter on the end. After
        crossing the diseased area of
        the artery with the EPD, the
        small filter will be opened. The
        EPD will stay in place during
        the procedure to help capture
        any plaque or emboli.

1. Carotid Artery Stenting – A Guide for Patients and Their Families. Guidant Corporation, August 2004. LT 2921888.
            Pre-dilatation of Diseased                                                                                Area 1

        A balloon catheter may be
        inserted into the narrowed
        area. The balloon will be
        temporarily inflated in order
        to open up the artery. After
        the dilatation (s), the balloon
        catheter will be removed
        from the body.

1. Carotid Artery Stenting – A Guide for Patients and Their Families. Guidant Corporation, August 2004. LT 2921888.
            Stent Delivery and                                                            Deployment 1

              The self-expandable stent
              will be fed through the
              vessels to the area of the
              plaque. After careful
              positioning, the stent will
              be opened to cover the

1. Carotid Artery Stenting – A Guide for Patients and Their Families. Guidant Corporation, August 2004. LT 2921888.
                                             Post-Dilatation 1

     If necessary, a balloon
     catheter may be inserted into
     the stent to open it wider.

1. Carotid Artery Stenting – A Guide for Patients and Their Families. Guidant Corporation, August 2004. LT 2921888.
                                          System                          Removal 1

         The stent will remain in
         place permanently, but
         the balloon will be
         removed. The EPD and
         all other devices will be
         removed from the body.

1. Carotid Artery Stenting – A Guide for Patients and Their Families. Guidant Corporation, August 2004. LT 2921888.
       CEA and CAS pooled data of 32 studies,
               Yadav, Balzer, et al.
Treatment      Symptomatic   30d death/stroke   30d stroke, MI or
               Patients                         death

CEA                 63%          2.58%              2.81%
3369 pts
CAS with EPD        46%           2.7%              2.64%
1222 pts

CAS without         56%          5.37%              6.11%
EPD 1638 pts
CAS with EPD                 P > 0.82           P >0.78
vs CEA
                   CAS – studies
   Pre EPD
       Wallstent trial (1999)
   Post EPD
      Normal risk randomized
          CREST – symptomatic and asymptomatic
          ICSS - symptomatic
                                  Post Marketing Studies
       Normal risk registry      -CAPTURE 3500,
          CARESS(2003)
                                   CAPTURE 2
       High risk randomized      (Largest prospective data to date)
          SAPPHIRE (2002)        -EXACT 1500
       High risk registry        -CASES
            SAPPHIRE (2002)
            ARCHeR (2003)
            SECURITY (2003)
            BEACH(2004)
            CABERNET (2004)
            CREATE (2005)
            MAVERICK
       CAS – SAPPHIRE trial

                  Multidisciplinary team
           Surgeon, Interventionalist, Neurologist

Surgical                                         Interventional
                       Randomized                   Refusal
406                                                    7

   CEA                                           CAS

   159                                           151
SAPPHIRE selection
         SAPPHIRE – 30-Day                                                                  Outcomes 1

           Overall, subjects randomized to CAS had lower 30-day events,
             although not statistically significant unless combined.

                                                    Stenting                      CEA                        p
                           Death (any)                1.2%                        2.4%                      0.68
                           Stroke (any)               3.6%                        3.0%                      1.00
                                 MI (any)             2.4%                        6.0%                      0.17
                MAE (Death, any
               stroke, and/or MI)                     4.8%%                        9.6%                     0.14

1. Sidney A. Cohen, M.D., Ph.D., Group Director, Clinical Research, Cordis Corporation. CAROTID ARTERY STENTING WITH EMBOLI PROTECTION, PMA
PMA # P030047. Final Cordis Presentation. April 20, 2004.
SAPPHIRE 1 year data: Death/Stroke/MI
                                  CAS registries
30 days MI/stroke/D 8.3%
                    5.8%    N          Stent Comments        EPD          30 days results
ARCHeR                     581   Acculink               Accunet          MI/stroke/D 8.3%
BEACH                      480   Wallstent              FilterWire       MI/stroke/D 5.8%
CABERNET                   454   NexStent               FilterWire       MI/stroke/D 3.8%
CAPTURE                    2,500 RX Acculink            Accunet          MI/stroke/D 5.7%
CaRESS                     143   Wallstent              Guardwire Plus   stroke/D 2.1%
CREATE Pivotal             419   Protege                SPIDER OTW       MI/stroke/D 6.2%
CREATE SpideRx             125   Acculink               SpideRx          MI/stroke/D 5.6%
CREST                      749   RX Acculink            RX Accunet       stroke/D 4.4%
MAVErIC I                   99   Exponent               GuardWire        MI/stroke/D 5.1%
MAVErIC II                 399   Exponent               GuardWire        MI/stroke/D 5.3%
MO.MA                      157   Any                    MO.MA            stroke/D 5.7%
PRIAMUS                    416   Any                    MO.MA            stroke/D 4.6%
SECuRITY                   398   Xact Carotid Stent     Emboshield       MI/stroke/D 8.5%
Improving outcomes with improving experience
Evolution of Outcomes after Carotid Artery Stenting
in a Community Hospital
M. Abidi MD, N.Mejevoi MD, N.Wasty MD, M.Cohen MD
Newark Beth Israel Medical Center, Newark, New Jersey,
USA                                                           The results of NBIMC
Carotid artery stenting (CAS) as an alternative to carotid
endarterectomy (CEA) evolved, peaked and gradually
                                                              CAS experience were
decreased since FDA approval. However, little is known        presented at MEET
about the quality of CAS results that may be achieved in
a relatively low volume, community hospital setting,          Congress in Nice,
especially when used an alternative to CEA for high-risk
surgical candidates.
Objective: To analyze clinical outcomes of CAS
performed by interventional cardiologists and vascular        June 29, 2008
surgeons in real-world, high-surgical risk patients.
This was an observational, retrospective study of
outcomes in high-surgical-risk patients treated with the
self-expandable carotid stent system and embolic
protection device. From March 2004 to December 2007,
68 consecutive patients with carotid disease underwent
CAS at our institution. All patients were high-risk for
surgery by SAPPHIRE criteria. The end points were 30-
day and 1-year composite of morbidity and mortality. We
also compared outcomes in the group of the first 20
patients (10 by each operator) and the rest of the study
The overall adverse event rate was low, however slightly
higher than presented in published CAS trials and
registries. After a clear cut “learning curve”, the results
were dramatically improved and competitive.
                     SPACE trial
   Multicenter randomized
       33 centers (Neurology, surgery and interventional
   Surgery versus stenting in symptomatic patients
   Embolic protection not mandatory
   Sponsored by the government, scientific
    societies and industry
                      SPACE trial
   Primary endpoint
       Ipsilateral stroke or death within 30 days
   Secondary endpoints
     Ipsilateral stroke or vascular death < 2 yrs
     Ipsilateral major stroke or death < 30 days

     Minor or major stroke < 2 yrs

     Re-stenosis > 70%

     Technical failure
                  SPACE trial
      stopped after the second interim-
 Trial
 analysis (n=1200)
              power too low
   Statistical

   Patient recruitment too slow

   Funding too low
                SPACE trial
   Randomized 1200 cases
                         CAS      CEA
Intention to treat       599       584
Cross over               13         6
EPD                      29% !!
30 d Stroke/Death (p=NS) 6.84%    6.34%
           SPACE trial issues
   Many centers did not have enough volume to
    fulfill entrance criteria
   71% CAS done without EPD
   Did not include MI, CN palsy and other
    MAE as outcomes
   High surgical risk excluded but high stenting
    risk not excluded
   Statistically underpowered
   Despite all this, outcomes were the same!!
  Stenting versus Endarterectomy for Treatment of
               Carotid-Artery Stenosis
Thomas G. Brott, M.D., Robert W. Hobson, II, M.D., George Howard, Dr.P.H., Gary S.
   Roubin, M.D., Ph.D., Wayne M. Clark, M.D., William Brooks, M.D., Ariane Mackey,
M.D., Michael D. Hill, M.D., Pierre P. Leimgruber, M.D., Alice J. Sheffet, Ph.D., Virginia
J. Howard, Ph.D., Wesley S. Moore, M.D., Jenifer H. Voeks, Ph.D., L. Nelson Hopkins,
M.D., Donald E. Cutlip, M.D., David J. Cohen, M.D., Jeffrey J. Popma, M.D., Robert D.
Ferguson, M.D., Stanley N. Cohen, M.D., Joseph L. Blackshear, M.D., Frank L. Silver,
 M.D., J.P. Mohr, M.D., Brajesh K. Lal, M.D., James F. Meschia, M.D., for the CREST

                                     N Engl J Med
                                  Volume 363(1):11-23
                                      July 1, 2010
            CREST Trial – Patient inclusion criteria

   Patients with symptomatic stenosis:
       ≥ 50% stenosis by angiography
       ≥ 70% stenosis by ultrasonography
       ≥ 70% by computed tomography (CT) or magnetic resonance angiography (MRA)
   Asymptomatic patients:
       ≥ 60% by angiography
       ≥ 70% by ultrasonography
       ≥ 80% by CT/MRA
     CREST Trial
    and Follow-up
     of the Study

Brott TG et al. N Engl J Med 2010;363:11-23
    CREST: Primary, secondary and safety end points

End point                                      CAS      CEA Hazard ratio (95% CI) p
Primary end point <4 y                         7.2      6.8     1.11 (0.81–1.51)    0.51
Primary end point: Peri-procedural             5.2      4.5     1.18 (0.82–1.68)    0.38
Periprocedural stroke and MI
•Any periprocedural stroke                     4.1      2.3     1.79 (1.14–2.82)    0.01
•Periprocedural major stroke                   0.9      0.7     1.35 (0.54–3.36)    0.52
•Periprocedural MI                             1.1      2.3     0.50 (0.26–0.94)    0.03
•Cranial nerve palsies                         0.3      4.8     0.07 (0.02–0.18)    0.0001
•Ipsilateral stroke after periprocedural       2.0      2.4     0.94 (0.50–1.76)    0.85
period <4 y

CAS=carotid artery stenting
CEA=carotid endarterectomy

Brott TG et al. American Stroke Association International Stroke Conference 2010;
February 26, 2010; San Antonio, TX.
  CREST - Primary End Point, According to
             Treatment Group

Brott TG et al. N Engl J Med 2010;363:11-23
                        CREST - Conclusion

•   Among patients with symptomatic or asymptomatic carotid stenosis in
    this randomized comparison, the risk of the composite primary outcome
    of stroke, myocardial infarction, or death did not differ significantly in the
    group undergoing carotid-artery stenting and the group undergoing
    carotid endarterectomy (7.2% and 6.8%, respectively; P=0.51)
•   During the periprocedural period, there was a higher risk of stroke with
    stenting (driven largely by non-major stroke, while rates of major stroke
    were comparable) and a higher risk of myocardial infarction and cerebral
    palsies with endarterectomy

   CAS is a very effective and durable
    procedure, at least as safe as CEA, safer in
    high risk patients.
   Trial results reproduced in real world practice-
    CAPTURE registry
   EVA3S, SPACE flawed, unfair conclusions,
    does not reflect US standard of care.
   Results of CREST confirm long-term safety
    and durability of CAS

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