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TCT 2005. SPIDER S aphenous Vein Graft P rotection I n a D istal E mbolic Protection R andomized Trial. Simon R. Dixon MBChB, William W. O’Neill MD William Beaumont Hospital, on behalf on the SPIDER Investigators. 18 October 2005. Objective.

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spider s aphenous vein graft p rotection i n a d istal e mbolic protection r andomized trial
TCT 2005

SPIDERSaphenous 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

objective
Objective
  • To evaluate the safety and efficacy of the SPIDER™/SpideRX™ Embolic Protection Device during PCI of saphenous vein graft disease
spider device
5 sizes (3.0 – 7.0mm)

Heparin coated

6 or 7F guide catheter

Delivery

Guidewire of choice

3.2F Delivery catheter

Rapid exchange system (SpideRX)

Retrieval

4.2/4.9F catheter (SpideRX 4.2F)

SPIDER Device

Nitinol Mesh Filter

Retrieval

Caution: Investigational device. Limited by US Federal Law to investigational use.

study design
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

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

Major Inclusion Criteria
major exclusion criteria
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
study endpoints
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 30-days, and Device success)
    • Efficacy (Clinical & Procedural success)

*Defined as CKMB >3x ULN

study design and analysis
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
top ten enrollers
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
svg distribution
Control

N=379 vessels

SPIDER

N=396 vessels

RCA

RCA

Circumflex

Circumflex

LAD

LAD

Other

P=NS

92.4% lesions proximal-mid

90.1% lesions proximal-mid

SVG Distribution
secondary endpoints
Secondary Endpoints

*Device success=Successful delivery, operation and retrieval device

**Clinical success=Device success with no in-hospital MACE

primary endpoint 30 day mace
Primary Endpoint: 30-Day MACE

P = 0.79for Superiority,P = 0.012 for Non-Inferiority

P=NS for all comparisons

Intent-to-treat analysis

30 day mace in other studies
GW & FW

GuardWire

Emboshield

GuardWire

FilterWire

GuardWire

GW & FW

SPIDER

TriActiv

TRAP

Superiority

Non-Inferiority

30-Day MACE In Other Studies
conclusion
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
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