Cardiology Symposium

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Cardiology Symposium

• James T. DeVries, MD
• Assistant Professor of Medicine
• Dartmouth Medical School
• Dartmouth-Hitchcock Medical Center

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No disclosure or conflicts
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Outline

• What is new with revascularization?
• Bypass surgery (CABG) versus coronary stents
  (PCI)
• New technologies in the pipeline- ready for
  primetime?
• Aortic valve replacement without opening the
  chest
• Stroke therapy

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Coronary Artery Disease

• Heart disease is the 1 killer in the US
• We are diagnosing heart disease more frequently
  due to better testing, improved sensitivity and
  increased awareness
• As a nation, we have too much obesity and lack of
  physical activity, risk factors for the
  development of coronary artery disease

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How do we best treat heart disease?

• Medical therapy?
• Coronary stents (PCI)?
• Bypass surgery (CABG)?

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CABG PCI Historical Pro Cons

• Cost effective
• Fast recovery
• Reduced acute complications
• Increased restenosis
• Repeat revascularization

• Angina relief
• Reducedre-intervention
• Completerevascularization
• High costs
• Invasive

The pros and cons of CABG historically outweighed
those of PCI
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Evolution of Revascularization
?

• Off pump technique
• Less invasive approach
• Increased arterialrevascularization
• Optimal perioperative monitoring

• Improved technique
• Improved stent design
• DES

• Increased restenosis
• Repeat revascularization

• High costs
• Invasive
• Recovery time

Over the last decade, the standard of care for
both CABG and PCI has continuously improved,
leveling the playing field.
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CABG vs PCI TrialsResults Summary
No stents used
Superior Treatment Modality
CABG
PCI
No difference
Stents used

RepeatRevascularization
Significant decrease of revascularization
expected with DES
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Drug Eluting Stent Trials
Complex Lesions
QCA long lesion breakdown pending
Lesion Complexity C Type
Long Stented lengths
TAXUS VI
TAXUS V
TAXUS IV
E-SIRIUS
C-SIRIUS
TAXUS II
SIRIUS
RAVEL
TAXUS I
Mean stent length mm
expanding lesion procedural complexity with
randomized trials
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Arterial Revascularization Therapies Part II a
non-randomized comparison of contemporary PCI and
coronary artery bypass grafting (CABG) in
patients with multi-vessel coronary artery lesions
ARTS-II Trial
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ARTS-II Trial
Historical Controls from ARTS I 1202 patients
with multivessel coronary lesions 18.2
diabetic 28 3 vessel disease 7.5 type C lesions
607 patients with multivessel coronary
lesions 26.2 diabetic 54 3 vessel disease 13.9
type C lesions
Bare Metal Stent 2.8 stents per patient Avg total
length 48 mm n 600
Sirolimus-eluting stent 3.7 stents per
patient Avg total length 73 mm n 607
CABG n 602

• Endpoints
• Primary Major adverse cardiac and
  cerebrovascular events (MACCE), including
  death, cerebrovascular event, myocardial
  infarction, and revascularization, at 1 year
  for the comparison of CABG treated patients in
  the ARTS I trial with sirolimus-eluting stent
  patients in the ARTS II trial
• Secondary MACCE at 30 days, 6 months, 3 and 5
  years.
• Total cost at 30 days
• Cost, cost effectiveness, quality of life at
  six mo, and 1, 3, and 5 years

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ARTS II Event free survival
p p 0.003
p 0.46
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ARTS II MACCE at one year
Overall MACCE at 1 year

• At 1 year, there was no difference in the
  incidence of MACCE between the ARTS II SES group
  and the ARTS I CABG group.
• The ARTS I bare metal stent group was
  associated with a significantly higher rate of 1
  year MACCE compared to the other groups

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ARTS II components of MACCE
pNS
pNS
pNS
pNS

ACC 2005
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ARTS II Summary

• Among patients with multivessel coronary
  lesions, patients treated with sirolimus-eluting
  stents had significantly lower rates of MACCE
  compared with a historical registry of similar
  patients treated with bare metal stents and rates
  of MACCE statistically equivalent to patients
  from the same registry treated with CABG.
• The majority of the difference in MACCE between
  the ARTS II and ARTS I BMS groups was driven by
  the increased need for repeat revascularization
  in the bare metal stent group. The ARTS II group
  had equal rates of revascularization to the ARTS
  I CABG group, despite having increased length
  and complexity of lesions.

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Syntax Overall Study Goal

• To provide real-world answers to these questions
  in order to develop new guidelines for the
  beginning of the 21st century. This goal requires
  a novel study approach

consensus physician decision (surgeon
cardiologist) instead of inclusion exclusion
criteria
nested registry for CABG only and PCI only
patients to capture patient characteristics and
outcomes
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Eligible Study Population
Question of optimal treatment approach? new
disease
left main 1-vessel disease
3-vessel disease
Isolated left main
Revascularization in all 3 vascular territories
left main 2-vessel disease
left main 3-vessel disease

• Previous interventions (PCI or CABG) excluded
• Acute MI with CK2x
• Concomitant valve surgery

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Patient Flow
Patients with de novo 3-vessel-disease and/or
left main disease
screening
amenable for 1 interventional treatment
amenable for both treatments options
Multi-center randomized controlled trial
Registries

• define CABG only population (2750 pts)
• define PCI only population
• (50 pts)
• Establish profiles of non randomizable patients
  and their outcomes

Randomize 1500 pts
TAXUS
CABG
vs

• TAXUS DES non inferior to CABG for 12 months
  binary MACCE rate

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Follow Up and Data Collection
Multi-center randomized controlled trial
Registries
CABG only 750 pts Randomly selected out of
approx.2750 pts
PCI only PCI 750 pts
CABG 750 pts
Baseline data
QOL Costs Baseline to 5 years
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SYNTAX Results- 1 Year
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The Bottom Line

• Choice between CABG and PCI is complex, and
  depends on patient factors as well as technical
  considerations
• CABG tends to have less revascularization
• There is no one size fits all approach
• Discussion regarding the pros and cons of each
  approach is important

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Communication is Important!
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Future Tech-Coming to a cath lab near you!
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Aortic Valve Replacement-Without Surgery!
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Aortic Stenosis

• Common cause of cardiovascular morbidity and
  mortality, particularly in the elderly
• Narrowing of aortic valve results in increased
  work load on the heart
• Symptoms include shortness of breath, chest pain,
  and passing out (syncope)
• Currently, only open heart surgery with valve
  replacement can correct this problem

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Aortic Valve Replacement
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Percutaneous Aortic Valve
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Percutaneous Aortic Valve
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Technique for Insertion
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Aortic Valvuloplasty
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Stroke Therapy
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Stroke Statistics

• There are over 700,000 strokes per year in the US
• Stroke is the leading cause of adult disability
  and the third most common cause of death
• The vast majority of strokes result from blockage
  in the arteries of the brain
• The risk factors for stroke are the same as the
  risk factors for coronary heart disease
• Treatment of strokes is limited, consisting
  mostly of supportive care

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Stroke Therapy

• Intravenous thrombolytic (clot buster) is the
  only currently approved therapy for stroke
• Must be given within 3 hours of onset of symptoms
• Less effective in large strokes, risk of bleeding
  into the brain
• Nationwide, it is used in less than 3 of strokes

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Stroke Therapy

• Increasing interest in catheter-based therapies
  for acute stroke
• Mechanically open the artery with devices, pull
  out the clot
• Stroke teams are integral part of this therapy,
  available 24/7 for rapid activation
• Many similarities to treating heart attack

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Case Example

• 49 yo mother of three presents with ride sided
  paralysis, inability to speak, onset 1 hour prior
• Given thrombolytic drugs and transferred
• Remained with dense paralysis, inability to speak
  2 hours later
• Brought to angiography

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Case

• Immediately recovered partial use of right hand
  and foot
• Talking the following day
• Was discharged to home 3 days later with mild
  right sided weakness, but speech intact

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Technology is not always easy..
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Summary

• What we can do through catheters is increasing
  every day
• Many trials ongoing to determine the best therapy
  for stroke and heart disease
• Stay tuned!