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SPIDER S aphenous Vein Graft P rotection I n a D istal E mbolic Protection R andomized Trial PowerPoint PPT Presentation


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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

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Spider s aphenous vein graft p rotection i n a d istal e mbolic protection r andomized trial l.jpg

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 l.jpg

Objective

  • To evaluate the safety and efficacy of the SPIDER™/SpideRX™ Embolic Protection Device during PCI of saphenous vein graft disease


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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.


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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


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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


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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


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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


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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


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Study Organization


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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


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Clinical Characteristics


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Baseline Angiographic Data


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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


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Procedural Results


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Secondary Endpoints

*Device success=Successful delivery, operation and retrieval device

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


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Primary Endpoint: 30-Day MACE

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

P=NS for all comparisons

Intent-to-treat analysis


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GW & FW

GuardWire

Emboshield

GuardWire

FilterWire

GuardWire

GW & FW

SPIDER

TriActiv

TRAP

Superiority

Non-Inferiority

30-Day MACE In Other Studies


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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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