Transcript Future Direction & Development

PCI: Indications & Future Directions
S. Chiu Wong MD, FACC
Associate Professor of Medicine
Weill Medical College of Cornell University
Director, Cardiac Catheterization Laboratories
The New York Presbyterian Hospital-Cornell Campus
ACC Symposium: Cardiology Update 2004
Great Wall International Congress of Cardiology
October 17, 2004 Beijing China
PCI: Indications & Future Directions
Summary
• History and Current Status of PCI
• Indications of Percutaneous Coronary Intervention
• Future Development
Novel Drug Eluting Stents
Expanding Beyond Coronary Vasculature
Newer Imaging Technologies
Cellular Approach: Angiogenesis and Myogenesis
PCI: Indications & Future Directions
• History and Current Status of PCI
• Indications of Percutaneous Coronary Intervention
• Future Development
Novel Drug Eluting Stents
Expanding Beyond Coronary Vasculature
Newer Imaging Technologies
Cellular Approach: Angiogenesis and Myogenesis
PCI: Indications & Future Directions
Milestones of PTCA
1939-1985
Balloon Angioplasty
NHLBI Registry 1977-81 PTCA Results
•
•
•
•
Angiographic Success –88%
Procedural Mortality – 1%
Non-fatal MI – 4.3%
Emergency CABG – 3.4%
New Device Angioplasty
How Good is Balloon PTCA?
Balloon Angiographic Success
89
82
71
Percent
69
83
NHLBI
(N=458)
1985-86
NACI
(N=140)
1992-93
CAVEAT
STRESS
Angiopeptin
(N=500)
1991-92
(N=202)
1991-93
(N=1399)
1991-92
PCI: Indications & Future Directions
Restenosis Following PTCA
An Achilles' heel for interventional cardiology……
PCI: Indications & Future Directions
How Good is Balloon PTCA?
Balloon PTCA Restenosis Rate
57
60
51
50
45
Percent
40
32
30
20
10
0
STRESS
I+II
Benestent
CAVEAT I
CAVEAT II
SVG’s
New Device Angioplasty
Two Major Goals
1. Increase Procedure Success
Angiographic
Success
complications
2. Reduce Restenosis
New Device Angioplasty
How Good is New Device Angioplasty?
Angiographic Success
96.9
94.7
Percent
94.8
89
NACI
Overall
(N=2267)
RA
Registry
(N=215)
CAVEAT
STRESS
DCA
(N=512)
Stent
(N=259)
PCI: Indications & Future Directions
Restenosis Post Stent Vs. Balloon
42.1
*
PTCA
25%
Restenosis (%)
31.6
32 **
31%
22
STRESS
*P=0.046,**P=0.02
BENESTENT
NEJM 1994
Stent
Impact of New Device Interventions
NHLBI 1985-1986 Vs. Dynamic Registry 1997-1998
Percent
NHLBI (N=2431)
100
90
80
70
60
50
40
30
20
10
0
Dynamic (N=1559)
P<0.001
P<0.001
58 62
P<0.001
25.5 32.1
Age
P<0.001
P<0.001
Female
Williams et al, Circ 2000;102:2945-2951
9.9 22.9
AMI
70.5
29.5
10.8
Calcified
lesions
0
Stent
Impact of New Device Interventions
NHLBI 1985-1986 Vs. Dynamic Registry 1997-1998
NHLBI (N=2431)
Dynamic (N=1559)
100.0 P<0.001
Percent
80.0
60.0
81.8 92.0
40.0
P=0.001
20.0
7.9
0.0
Procedural
Success
4.9
In-Hospital
Death/MI/CABG
Williams et al, Circ 2000;102:2945-2951
P<0.001
12.6 6.9
1-Year CABG
Landmark in Interventional Cardiology
Circa 1808
Circa 2003/4
Circa 1886
PCI: Indications & Future Directions
SIRIUS: Key Clinical Findings
Dramatic Reduction in late loss
83%
Marked Reduction in TVF
69%
9-month Event Free Survival in the Cypher
Group
92.7%
PCI: Indications & Future Directions
Current Treatment Options In Coronary Artery Disease
Obstructive Coronary Artery Disease
Medicine
Angioplasty
Risk Reduction
CABG
PCI: Indications & Future Directions
Medical Vs. CABG in the Treatment of CAD
Mortality
In meta-analysis of 7 randomized trial, 1324 patients were assigned to CABG and 1325 to
medical therapy between 1972 and 1984
At 5, 7, and 10 years,
10.2%, 15.8%, and
26.4% of patients,
respectively, assigned
to CABG had died,
compared with 15.8%,
21.7%, and 30.5% of
their medically
assigned counterparts.
Risk reductions (RR)
were significant at all
3 time points
(RR=0.61, 0.68, 0.83).
Yusuf S et al. Lancet. 1994; 344: 563–570
PCI: Indications & Future Directions
Medical Vs. CABG in the Treatment of CAD
Tertile * of
Risk
Patients
N
5-year Medical
Mortality Rate %
Odds Ratio
(95% CI)
P Value
Low
738
6.3
1.17 (0.66-2.07)
0.60
Medium
784
13.9
0.55 (0.34-0.88)
0.01
High
783
25.2
0.54 (0.37-0.77)
0.001
* Tertiles of risk determined by a stepwise risk score incorporating
both clinical (age, angina, MI, diabetes, hypertension) and
angiographic (ejection fraction, lesion location) variables.
Yusuf S et al. Lancet. 1994; 344: 563–570
PCI: Indications & Future Directions
PTCA Vs. Medical Therapy in the Treatment of Non-Acute CAD
Pooled risk ratios for various end points from 6 randomized trials comparing
PTCA with medical treatment in pts with stable non-acute CAD ( N=953 for
PTCA and N=951 for medical treatment) published between 1979-1998
Thus, PTCA results in greater angina relief but at the cost of more CABG
Bucher HC, et al. BMJ. 2000; 321: 73–77
PCI: Indications & Future Directions
Mortality up to 12 months for invasive versus conservative strategies
Meta-analysis on 5 studies on 6,766 UA/NSTEMI pts (3,371
invasive and 3,385 conservative) enrolled from 6/96 to 3/20 with
contemporary use of both IIbIIIa inhibitors and stents in most cases
Summary estimate:
RR = 0.80, 95% CI
0.63 to 1.03.
Bavry AA et al, Am J Cardiol. 2004; 93:830-5.
PCI: Indications & Future Directions
All-cause mortality for 1, 3, 5, and 8 years post-initial revascularization.
Meta-analysis of 13 Randomized trials comparing bypass surgery
with PCI on 7964 pts enrolled from 1987 to 2002.
All trials
1.5% absolute survival
advantage at 5 years
multivessel coronary artery disease
Hoffman SN et al, JACC 2003;41:1293-1304
PCI: Indications & Future Directions
CABG Vs. PTCA in the Treatment of CAD
Risk difference for all-cause mortality for years 4 and 6.5 postinitial revascularization comparing coronary artery bypass graft
surgery (CABG) to PTCA for diabetic and non-diabetic patients.
Hoffman SN et al, JACC 2003;41:1293-1304
PCI: Indications & Future Directions
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History of Percutaneous Coronary Intervention
Indications of Percutaneous Coronary Intervention
Current Status of Percutaneous Coronary Intervention
Future Development
Novel Drug Eluting Stents
Expanding Beyond Coronary Vasculature
Newer Imaging Technologies
Cellular Approach: Angiogenesis and Myogenesis
PCI: Indications & Future Directions
Recommendation in Asymptomatic or Class I Angina
Class I Recommendation:
• Patients who do not have treated diabetes with
asymptomatic ischemia or mild angina with 1 or
more significant lesions in 1 or 2 coronary arteries
suitable for PCI with a high likelihood of success
and a low risk of morbidity and mortality. The
vessels to be dilated must subtend a large area of
viable myocardium (Level of Evidence B)
Smith et al. ACC/AHA PCI guidelines JACC 2001;37:2239i
PCI: Indications & Future Directions
Recommendation in Asymptomatic or Class I Angina
Class IIa Recommendation:
• The same clinical and anatomic
requirements for Class I, except the
myocardial area at risk is of moderate size
or the patient has treated diabetes. (Level of
Evidence B)
Smith et al. ACC/AHA PCI guidelines JACC 2001;37:2239i
PCI: Indications & Future Directions
Recommendation in Asymptomatic or Class I Angina
Class IIb Recommendation:
• Patients with asymptomatic ischemia or mild angina
with ≥2 coronary arteries suitable for PCI with a high
likelihood of success and a low risk of morbidity and
mortality. The target vessels must subtend at least a
moderate area of viable myocardium.
(Level of Evidence: B)
Smith et al. ACC/AHA PCI guidelines JACC 2001;37:2239i
PCI: Indications & Future Directions
Recommendation in Asymptomatic or Class I Angina
Class III Recommendation:
• Patients with asymptomatic ischemia or mild angina who do not
meet the criteria as listed under Class I or Class II and who have:
a. Only a small area of viable myocardium at risk.
b. No objective evidence of ischemia.
c. Lesions that have a low likelihood of successful dilation.
d. Factors associated with increased risk of morbidity or
mortality.
e. Left main disease.
f. Insignificant disease <50%.
(Level of Evidence: C)
Smith et al. ACC/AHA PCI guidelines JACC 2001;37:2239i
PCI: Indications & Future Directions
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History of Percutaneous Coronary Intervention
Indications of Percutaneous Coronary Intervention
Current Status of Percutaneous Coronary Intervention
Future Development
Novel Drug Eluting Stents
Expanding Beyond Coronary Vasculature
Newer Imaging Technologies
Cellular Approach: Angiogenesis and Myogenesis
PCI: Indications & Future Directions
Current Newer Stent Designs
PCI: Indications & Future Directions
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History of Percutaneous Coronary Intervention
Indications of Percutaneous Coronary Intervention
Current Status of Percutaneous Coronary Intervention
Future Development
Novel Drug Eluting Stents
Expanding Beyond Coronary Vasculature
Newer Imaging Technologies
Cellular Approach: Angiogenesis and Myogenesis
PCI: Indications & Future Directions
Magnitude of Stroke Problem
• The World Health Organization estimates
that in 2001 there were over 20.5 million
strokes worldwide, 5.5 million of these were
fatal 1
• Stroke ranks as the 3rd leading cause of
death behind diseases of the heart and
cancer²
1. World Health Report 2002 2. CDC, NCHS
PCI: Indications & Future Directions
Percutaneous Closure of PFO
Amplatzer , AGA
STARFlex, NMT
PCI: Indications & Future Directions
Percutaneous Closure of Left Atrial Appendage: PLAATO, EV3
Cosgrove-Edwards Annuloplasty System
The Cosgrove-Edwards Annuloplasty System may be
used in either mitral or tricuspid repairs. The
implantable reinforcement band is made of silicone
covered by a polyester velour cloth.
PCI: Indications & Future Directions
Percutaneous Alfieri Edge to Edge Repair for MR
PCI: Indications & Future Directions
EVEREST Phase I
• Primary Endpoint: Acute safety
at 30 days
Freedom from death, MI, Cardiac
tamponade, cardiac surgery for
failed clip, Clip detachment,
stroke and septicemia
• Principle Secondary Efficacy
Endpoint
30-day and 6-month assessment
of mitral regurgitation severity
determined by echocardiography
PCI: Indications & Future Directions
Percutaneous Replacement of Aortic Valve: PVT
PCI: Indications & Future Directions
Percutaneous Replacement of Aortic Valve: CoreValve
PCI: Indications & Future Directions
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History of Percutaneous Coronary Intervention
Indications of Percutaneous Coronary Intervention
Current Status of Percutaneous Coronary Intervention
Future Development
Novel Drug Eluting Stents
Expanding Beyond Coronary Vasculature
Newer Imaging Technologies
Cellular Approach: Angiogenesis and Myogenesis
PCI: Indications & Future Directions
What do we mean by “vulnerable ?”
Thin Cap
Inflammation
Lipid pool
PCI: Indications & Future Directions
Proposed Diagnostic Technologies for Vulnerable Plaque Detection
No shortage of contenders!!!
Angiosonics
Surgi-vision
Topspin
BSX
Magna Labs
Volcano/Jomed
Cordis
Includes IVUS
Histology
characterization,
Backscatter and
Elastography
Volcano
Thermacore
Optical Coherence
Tomography
LightLab
(Goodman)
Imetrx
MediSpies
Infraredx
PCI: Indications & Future Directions
5-Beat Cardiac™ Exclusive Benefits of VCT
LightSpeed Pro16 (16-Slice CT)
20-sec Coronary CTA
100cc contrast (4 cc/s for 25s)
LightSpeed VCT (64-Slice CT)
5-sec Coronary CTA
<<100 cc contrast
1cm / rotation
4cm / rotation
Entire heart:
12-15cm @ 0.625mm
Non-Invasive 5-second Coronary Angiogram
4x Speed
Robust/repeatable procedures – less heart rate drift
Better contrast enhancement
Shorter breath-hold for very sick patients
Contrast media reduction
Lower cost/procedure
Can proceed to cath same day, if needed
Better tolerated by patients with renal disease
PCI: Indications & Future Directions
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History of Percutaneous Coronary Intervention
Indications of Percutaneous Coronary Intervention
Current Status of Percutaneous Coronary Intervention
Future Development
Novel Drug Eluting Stents
Expanding Beyond Coronary Vasculature
Newer Imaging Technologies
Cellular Approach: Angiogenesis and Myogenesis
Angiographic Findings
100% RCA
No Collaterals
Extensive
Collaterals
Clinical Trials of Intracoronary Gene Therapy (Ad5FGF-4)
Study
Phase
Patients
Objective
Status
AGENT
Phase II
United States
n=79
(A=60, P=19)
Safety, selection of
doses, exercise
duration
Study complete; 12month follow-up
complete; telephone
contacts every 6 months
initiated
AGENT 2
Phase II
United States
n=52
Safety, effect on
Study complete; 12myocardial perfusion month follow-up
complete; telephone
contacts every 6 months
initiated
Safety and exercise
Study complete; 12duration
month follow-up
complete; telephone
contacts every 6 months
initiated
AGENT 3
AGENT 4
Phase II/III
United States
(A=35, P=17)
n=450
(A=300, P=150)
Phase II/III
n=450
Europe, N. and (A=300, P=150)
S. America
Safety and exercise
duration
A, active therapy; P, placebo; n, total number of patients recruited
Ongoing – enrolling
Myocardial Regeneration
• AMI mortality  infarct size/LV function
• Cardiac myocytes unable to divide
Necrotic tissue & scar
• Potential Cells for Cardiac Repair
• Stem cells
• Human fetal cells
• Bone marrow-derived stem cells
Intracoronary Stem Cell Administration
Figure by Strauer BE, et al. Circ 2002;106:1913
PCI: Indications & Future Directions
The Dawn of a New Era
• In the past decade, interventional cardiology
has certainly matured. We are still constantly
evolving new techniques and expanding our
capability to treat previously unexplored
disease entities.
• Restenosis, though not eliminated, is
markedly reduced with drug eluting stents.
Current RCTs will clarify the future role of
CABG vs PCI in these pts.
• Down the road, newer imaging and biologic
technologies will further enhance our ability
to treat and manage ever-more complex
disease states.
• Through careful evaluation of these
treatment options based on medical evidence,
we shall undoubtedly further improve our
patient’s quality of life in the foreseeable
future.