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Dean Kereiakes M. Turco, B, McLaurin, R. Feldman, N. Farhat, J. Breall and M.Foster on behalf of the study investigators PowerPoint PPT Presentation


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The AMEthyst Trial A prospective randomized controlled study of the Medtronic Interceptor® PLUS Coronary Filter System for PCI of Degenerative SVG. Late Breaking Clinical Trial Presentation TCT 2007. Dean Kereiakes M. Turco, B, McLaurin, R. Feldman, N. Farhat, J. Breall and M.Foster

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Dean Kereiakes M. Turco, B, McLaurin, R. Feldman, N. Farhat, J. Breall and M.Foster on behalf of the study investigators

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The amethyst trial a prospective randomized controlled study

The AMEthyst TrialA prospective randomized controlled study of the Medtronic Interceptor® PLUS Coronary Filter System for PCI of Degenerative SVG

Late Breaking Clinical Trial Presentation

TCT 2007

Dean Kereiakes

M. Turco, B, McLaurin, R. Feldman, N. Farhat, J. Breall and M.Foster

on behalf of the study investigators


The amethyst trial a prospective randomized controlled study

Dean J. Kereiakes, M.D., FACC Disclosure:

  • SCIENTIFIC ADVISORY BOARD:

  • Cordis/Johnson & Johnson

  • Boston Scientific Corporation, Inc.

  • Abbott Vascular

  • Core Valve

  • RESEARCH GRANT SUPPORT:

  • Boston Scientific Corporation Inc.

  • Abbott Vascular

  • Medtronic

  • Daiichi Sankyo

  • CONSULTING:

  • Eli Lilly Co.

  • Daiichi Sankyo

  • Medtronic


Amethyst

AMEthyst

Study Device

Medtronic Interceptor PLUS Filter Catheter

100 µ distal pores

1400-1800 µ

proximal openings

Nitinol Filter Basket

71% Open pore area

Low profile 2.7 Fr

0.0014” wire

Actuator handle


Amethyst1

AMEthyst

Enrollment : 73 U.S. Centers - “Top 10”

* Principal Investigator


Amethyst study design

AMEthyst: Study Design

Randomized, Open Label, Multicenter Trial

De Novo or restenotic lesions of Saphenous Vein Grafts

Vessel Diameter: 2.5-5.25mm

Control DEP*

n = 200

Interceptor® PLUS

n= 600

2:1 randomization

*GuardWire® or FilterWireTM EZ at physician’s discretion

Clinical Procedure

30 days

Primary Endpoint:

MACE (death, MI, repeat revascularization) at 30 days

Secondary Endpoints:

Elevated CK, CK-MB during index hospitalization, in hospital MACE, device and clinical success


Amethyst2

AMEthyst

Subject Selection Criteria

Includes multivessel PCI with following restrictions:

  • Total of 2 lesions in up to 2 native vessels (non-target lesions [NTL])

  • NTLs successfully treated before enrollment to study

  • Unlimited target lesions (TL) in up to 2 SVG’s

    Key Inclusion Criteria:

  • Subjective or Objectiveevidence of ischemia

  • TL in a SVG >50 and <100% stenosed

  • Target Vessel has TIMI 1 flow or greater

    Key Exclusion Criteria:

  • Recent Myocardial Infarction (MI) >24 hrs, with + CK-MB, or Acute MI

  • Surgery within 30 days

  • LVEF <25%

  • TL has been previously stented

  • TL within 5mm of graft ostium or <35mm from graft-native anastomosis


Amethyst3

AMEthyst

Core Labs

  • QCA Core Lab

    • Brigham and Women’s Hospital, Boston, MA, USA

    • Jeffrey J. Popma, MD

  • Data Coordinating Center

    • Harvard Clinical Research Institute, Boston, MA, USA

    • Laura Mauri, MD

  • ECG Core Lab

    • Harvard Clinical Research Institute, Boston, MA, USA

    • Peter Zimetbaum, MD

  • Clinical Events Committee/DSMB

    • Harvard Clinical Research Institute, Boston, MA, USA

    • Donald Cutlip, MD


The amethyst trial a prospective randomized controlled study

AMEthyst

Sample Size Calculation

  • INITIAL ASSUMPTIONS:

  • D30 MACE rate for Interceptor and Control group <10%

  • Power 80%

  • 1-sided alpha error 5%

  • Delta for equivalence 5.5%

600 Patients

Control Device

200 Patients

2:1 Randomization Ratio

Interceptor PLUS

400 patients

SAFER Trial

Borrow additional patients using Bayesian methods


Revised sample size calculations

AMEthyst

Revised Sample Size Calculations

DSMB Safety Review 04/18/05

(first 300 patients)

  • No Safety Issues

  • However:

  • Observed control 30D MACE <<10%

  • ? Pooling with SAFER patients

  • ? Study Adequately Powered

  • Revised Assumptions

  • 30D MACE rate for control and Interceptor assumed < 6%

  • Power 80%

  • 1-sided alpha error 5%

  • Delta for equivalence 4.5%

Continue Study

Add 200 patients


Amethyst4

Clinical F/U30 days

522/533

97.9%

Clinical F/U

30 days

258/265

97.4%

FilterWire*

n=73

GuardWire

n= 194

AMEthyst

Final Patient Distribution and Follow-up

Patients Enrolled

n=800

Randomized

2:1

Control DEP

n = 267

Interceptor

n = 533

*Additional optional control device added per Amendment Feb 2006


Amethyst5

AMEthyst

Patient Demographics


Amethyst6

AMEthyst

Procedural and Lesion Characteristics


The amethyst trial a prospective randomized controlled study

SVG Degenerative Score (% lumen irregularities )

Am J Cardiol 2005; 95(2) 173-7

0 (0-25%) 1 (26-50%)

2 (51-75%) 3 (76-100%)


Amethyst7

AMEthyst

Extent of SVG Degeneration


Amethyst8

AMEthyst

Procedural Characteristics


Amethyst9

AMEthyst

Outcomes – in hospital


Amethyst10

AMEthyst

Device Effectiveness (ITT population)

Device successdefined as delivery, deployment and retrieval of the assigned device

Clinical successdefined as delivery, deployment and retrieval of the assigned device with no in hospital MACE


Amethyst11

AMEthyst

Outcomes to 30 days


Amethyst12

AMEthyst

Primary Endpoint

30 day MACE

P for Non-Inferiority 0.027 (for delta=4.5%)

P for difference 0.77

7.2%

8.0%

Control

(n=18/250)

Interceptor

(n=40/501)


Conclusions

Conclusions

AMEthyst

  • The Interceptor® PLUS filter is not inferior in safety and efficacy to 30 days when compared with currently approved DEP device standards (GuardWire, FilterWire EZ).

  • A trend toward less frequent TVR (non-TL) to 30 days observed following Interceptor (vs. Control DEP)

  • Overall MACE to 30 days in DEP device-treated patients appears to be less frequent in contemporary PCI practice and deserves further study.


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