Transcript Document 7419958

TCT 2005
SPIDER
Saphenous Vein Graft Protection
In a Distal Embolic Protection
Randomized Trial
Simon R. Dixon MBChB, William W. O’Neill MD
William Beaumont Hospital,
on behalf on the SPIDER Investigators
18 October 2005
SPIDER
Objective
• To evaluate the safety and efficacy of the
SPIDER™/SpideRX™ Embolic Protection
Device during PCI of saphenous vein
graft disease
SPIDER
SPIDER Device
Nitinol Mesh Filter
•
•
•
•
5 sizes (3.0 – 7.0mm)
Heparin coated
6 or 7F guide catheter
Delivery
– Guidewire of choice
– 3.2F Delivery catheter
Retrieval
– Rapid exchange
system (SpideRX)
• Retrieval
– 4.2/4.9F catheter
(SpideRX 4.2F)
Caution: Investigational device. Limited by US Federal Law to investigational use.
SPIDER
Study Design
732 pts with SVG lesions
80 clinical sites from Feb 2003-July 2005
ASA & Plavix
Randomization stratified by
planned IIbIIIa use
SPIDER/SpideRX*
N=375
GuardWire or
FilterWire (EX/EZ*)
N=357
(30% SpideRX)
(76% FilterWire)
Non-Inferiority Analysis
SpideRX & FilterWire EZ introduced Nov 2004
SPIDER
Major Inclusion Criteria
Evidence of myocardial ischemia
Diameter 3.0mm and 6.0mm
De novo lesion, 50% stenosis
TIMI flow 1
40mm proximal to distal
anastomosis
SPIDER
Major Exclusion Criteria
•
•
•
•
•
•
•
•
Recent AMI with elevated baseline CK/CKMB
LVEF <25%
SVG <6-months old
TIMI 0 Flow
Arterial conduit
Planned atherectomy
Creatinine >2.5mg/dL
TIA or stroke within 60-days
SPIDER
Study Endpoints
• Primary Endpoint
– MACE at 30-days = Death, MI* (Q-wave and
non-Q wave), TVR, urgent CABG
• Secondary Endpoints
– Safety (In-hospital MACE, CK/CKMB
elevation, major bleeding & vascular
complications or stroke in-hospital or 30days, and Device success)
– Efficacy (Clinical & Procedural success)
*Defined as CKMB >3x ULN
SPIDER
Study Design and Analysis
• Non-Inferiority Design
• Sample Size:
–
–
–
–
Expected event rate in each study arm 10.0%
Delta for equivalence = 5.5%
One sided  error = 0.05, Power 80%
732 evaluable patients to demonstrate non-inferiority
• Primary Endpoint Analysis: Intent-to-treat
SPIDER
Study Organization
Principal Investigator
William W. O’Neill MD,
William Beaumont Hospital
Data Management
Harvard Clinical Research
Institute, Boston, MA.
Angiographic Core Lab
Brigham & Women’s Hospital,
Boston, MA (Jeffrey Popma, MD)
ECG Core Lab
HCRI, Boston, MA
Peter Zimetbaum MD
Bailer Research Group,
Lake Hopatcong, NJ
Study Monitor
Sponsor
ev3, Plymouth, MN
SPIDER
Top Ten Enrollers
• Munroe Regional Medical Center, Robert Feldman MD
• William Beaumont Hospital, William O’Neill MD
• Moses Cone Hospital, Thomas Stuckey MD
• Peninsula Cardiology Associates, Frank Arena MD
• St. Vincent Health Center, Jack Smith MD
• Our Lady of Lourdes Medical Center, Randy Mintz MD
• Wellmont Holston Valley Medical Center, Christopher
Metzger MD
• Washington Adventist Hospital, Mark Turco MD
• Wake Heart Associates, J. Tift Mann, MD
• Tallahassee Memorial Hospital, John Katopodis, MD
SPIDER
Clinical Characteristics
Age (yrs)
Male
Diabetes
Hypertension
Dyslipidemia
Current smoker
Previous MI
CCS III/IV angina
LVEF (%)
SPIDER
68.8  10.2
82.5%
39.3%
88.2%
91.4%
12.1%
59.4%
55.0%
48.7  12.2
Control
69.6  9.4
81.0%
45.1%
88.5%
92.9%
11.2%
53.0%
53.7%
48.8  12.1
P-value
0.27
0.64
0.12
1.00
0.50
0.73
0.09
1.00
0.93
SPIDER
Baseline Angiographic Data
No. vessels treated
SVG age (yrs)
Degeneration score
RVD (mm)
MLD (mm)
Diameter stenosis (%)
Lesion length
TIMI 3 flow
Thrombus grade 3
SPIDER
396
11.2  5.7
40.5  21.6
3.26  0.67
0.99  0.50
70  12
14.6  10.1
90.6%
15.5%
Control
379
11.7  5.8
40.6  20.7
3.34  0.63
1.04  0.48
69  12
14.4  9.6
89.0%
14.4%
P-value
0.29
0.96
0.08
0.12
0.26
0.77
0.48
0.76
SPIDER
SVG Distribution
SPIDER
Control
N=396 vessels
N=379 vessels
43.9%
40.1%
RCA
42.5%
39.0%
RCA
Circumflex
LAD
Circumflex
LAD
18.2%
16.0%
0.3% Other
P=NS
92.4% lesions proximal-mid
90.1% lesions proximal-mid
SPIDER
Procedural Results
No. vessels treated
Stent implantation
Stent length per lesion
IIbIIIa Inhibitor
MLD In-stent (mm)
DS In-stent (%)
TIMI 3 flow
Visible debris
No-reflow
Distal embolization
SPIDER
396
99.2%
25.1  13.4
30.3%
3.09  0.58
4.9  10.9
98.0%
63.5%
1.8%
1.0%
Control
379
99.5%
26.9  14.5
29.4%
3.11  0.58
6.7  12.3
98.1%
61.9%
3.8%
0.5%
P-value
1.00
0.08
0.81
0.76
0.03
1.00
0.72
0.12
0.69
SPIDER
Secondary Endpoints
Safety
Device success*
In-hospital MACE
Transfusion
Stroke
Efficacy
Clinical success**
Procedural success
SPIDER
Control
P-value
94.0%
7.9%
2.1%
0.5%
95.9%
7.1%
1.6%
0.5%
0.25
0.78
0.79
1.00
86.7%
91.6%
89.0%
93.1%
0.37
0.49
*Device success=Successful delivery, operation and retrieval device
**Clinical success=Device success with no in-hospital MACE
SPIDER
Primary Endpoint: 30-Day MACE
P = 0.79 for Superiority, P = 0.012 for Non-Inferiority
12
SPIDER N=375
Control N=357
P=NS for all comparisons
9.1
Incidence (%)
8.5
8.4
7.7
7.6
8
7.0
4
0.3
1.1
0.6
1.1
0.6
1.1
0
Death
Intent-to-treat analysis
MI
Q-wave MI
Non-Q MI
TVR
MACE
SPIDER
30-Day MACE In Other Studies
25
Control
Study Protection Device
17.3
SAFER
TRAP
Superiority
FIRE
10.1
9.1
11.2
CAPTIVE
PRIDE
Non-Inferiority
GW & FW
TriActiv
GW & FW
8.4
9.1
SPIDER
11.4
Emboshield
0
9.6
GuardWire
5
11.6
9.9
TRAP
10
12.7
GuardWire
15
FilterWire
16.5
GuardWire
Incidence (%)
20
SPIDER
SPIDER
Conclusion
• SPIDER trial demonstrated that distal
protection with the SPIDER/SpideRX
Embolic Protection Device during SVG
intervention results in a similar rate of
MACE at 30-days and secondary safety
endpoints, compared to distal protection
with the GuardWire and FilterWire devices