ClinicalTrials.gov Identifier:
This presentation is the property of its rightful owner.
Sponsored Links
1 / 31

Principal Investigator: Michel Le May, MD PowerPoint PPT Presentation


  • 61 Views
  • Uploaded on
  • Presentation posted in: General

ClinicalTrials.gov Identifier: NCT00251823. A. s. s. I. s. T. A S afety and Efficacy S tudy of I ntegrilin Facilitated PCI versus Primary PCI in ST Elevation Myocardial Infarction. Principal Investigator: Michel Le May, MD. Disclosure Statement of Financial Interest.

Download Presentation

Principal Investigator: Michel Le May, MD

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Principal investigator michel le may md

ClinicalTrials.gov Identifier: NCT00251823

A

s

s

I

s

T

ASafetyand EfficacyStudyofIntegrilinFacilitated PCI versus Primary PCI inSTElevation Myocardial Infarction

Principal Investigator: Michel Le May, MD


Disclosure statement of financial interest

Disclosure Statementof Financial Interest

Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.

Affiliation/Financial RelationshipCompany

Grant/Research SupportInvestigator initiated trial

with financial support from

Schering- Plough of Canada Inc., &

Medtronic of Canada Ltd.

Consulting Fees/Honoraria

Major Stock Shareholder/Equity

Royalty Income

Ownership/Founder

Intellectual Property Rights

Other Financial Benefit


Principal investigator michel le may md

Investigators

Michel R. Le May MD, George A. Wells, PhD, Chris A. Glover, Derek Y. So, MD, MD, Michael P. Froeschl, MD, Jean-François Marquis, MD, Edward R. O'Brien, MD, Michele Turek, MD, Marino Labinaz, MD

Research Nurses/Staff

Allyson Thomas, Tanya. Abarbanel, Julie Finnigan

Adjudication Committee

Cathy McLellan (chair), Waytak. Kong , Paul Malik

Data Safety Monitoring

Jean-Claude Tardif (chair), Philippe L'Allier

Participating Hospitals

University of Ottawa Heart Institute (on-site cath lab)

Ottawa Hospital (Alta Vista campus)

Ottawa Hospital (Civic campus)


Background

Background

  • Randomized trials have shown that abciximab is a useful adjunct in pts referred for primary PCI.

  • Observational studies have shown that eptifibatide yields similar results to abciximab.

  • No study has examined clinical outcomes by directly comparing eptifibatide to a control group in primary PCI.

  • Studies with high clopidogrel loading dose are limited in primary PCI.


Trial design

Trial Design

Primary endpoint

Death, Reinfarction, Recurrent Severe Ischemia at 30 Days.


Reinfarction

Reinfarction

Recurrent ischemic symptoms at rest lasting

at least 30 min and accompanied by

  • New or recurrent ST-segment elevation of ≥1 mm (0.1 mV) in any contiguous leads or

  • New left bundle branch block or

  • Re-elevation in serum CK level > twice the upper limit of normal and at least 50% above the lowest level measured post-infarction.


Recurrent severe ischemia

Recurrent Severe Ischemia

Recurrent symptoms of ischemia at rest associated with any one of the following

  • New ST-segment deviation (elevation at least 0.1 mV or depression > 0.05 mV measured 80 ms after the J-point in at least 2 contiguous leads).

  • An episode of acute pulmonary edema, sustained ventricular arrhythmias or hemodynamic instability.

  • The need for urgent revascularization.

  • Recurrent myocardial infarction.


Exclusion criteria

Exclusion Criteria

  • Active bleeding

  • Stroke within 90 days or intracranial bleeding at any time

  • Major surgery or trauma within six weeks

  • Systolic blood pressure > 200 mm Hg

  • Diastolic blood pressure > 110 mm Hg

  • Prolonged CPR (>10 min)

  • PCI within 30 days

  • Fibrinolytic or GP 2b/3a within 7 days

  • Coagulation disorder / warfarin therapy


Exclusion criteria 2

Exclusion Criteria (2)

  • Known severe renal impairment (creatinine > 200 mol/L)

  • Contrast allergy

  • LMWH within 12 hrs

  • Cardiogenic shock

  • Intolerance to aspirin or clopidogrel

  • Medical condition likely to result in death within 12 months

  • Participation in another study

  • Pregnancy


Sample size

Sample Size

  • Estimated the incidence of the primary endpoint at 30 days in pts assigned to PCI with heparin alone at 15% and in pts assigned to PCI with heparin plus eptifibatide at 5%.

  • -level: 0.05 (two-sided); -error: 0.10

  • Anticipated a loss to follow-up rate of 5%.

  • The number of pts required was 200 per group.


Timeline

Timeline

  • Open label study design

    400 pts were randomly assigned:

    • 201 to PCI with heparin plus eptifibatide

    • 199 to PCI with heparin alone

  • Enrollment started August 2005

  • Enrollment completed March 2008

  • Final 6-month follow-up September 2008


  • Baseline characteristics

    Baseline Characteristics


    Baseline characteristics 2

    Baseline Characteristics (2)


    Initial medications

    Initial Medications

    * Duration of eptifibatide infusion > 16 hrs in 82% pts;

    94% received eptifibatide before cardiac catheterization.


    Median time intervals min

    Median Time Intervals (min)


    Angiographic results

    Angiographic Results


    Infarct related artery

    Infarct-Related Artery


    Pci procedure

    PCI Procedure


    Principal investigator michel le may md

    Prior to PCI

    After PCI

    %

    %

    Heparinplus

    eptifibatide

    Heparin plus

    eptifibatide

    Heparin

    alone

    Heparin

    alone

    TIMI 3

    TIMI 2

    TIMI 0-1

    Infarct-Related Artery

    TIMI Flow Rates

    p = 0.16

    p = 0.43


    Events within 30 days

    p = 0.54

    p = 0.62

    p = 0.76

    p = 0.69

    Events Within 30 Days

    % pts


    Kaplan meier estimates 30 days

    6.5%

    5.5%

    Kaplan-Meier Estimates30 days

    Log-Rankp = 0.70


    Clinical events at 30 days

    Clinical Events at 30 Days


    Events within six months

    p = 0.54

    p = 0.62

    p = 0.97

    p = 0.75

    Events Within Six Months

    % pts


    Kaplan meier estimates 180 days

    Kaplan-Meier Estimates180 days

    8.0%

    Log-Rank p = 0.76

    7.1%


    Clinical events at six months

    Clinical Events at Six Months


    Principal investigator michel le may md

    Subgroup

    Heparin plus

    Heparin

    Relative Risk

    Risk ratio and 95% CI

    Eptifibatide

    Alone

    (95%CI)

    All patients

    13 / 201

    11 / 199

    1.18 (0.52 - 2.70)

    Female sex

    2 / 39

    6 / 56

    0.48 (0.10 - 2.25)

    Male Sex

    11 / 162

    5 / 143

    1.94 (0.69 - 5.46)

    Age < 75 yrs

    9 / 170

    8 / 174

    1.15 (0.45 - 2.91)

    Age ≥ 75 yrs

    4 / 31

    3 / 25

    1.08 (0.26 - 4.37)

    No Diabetes

    8 / 172

    7 / 163

    1.08 (0.40 - 2.92)

    Diabetes

    5 / 29

    4 / 36

    1.55 (0.46 - 5.26)

    Location of infarct anterior

    6 / 73

    5 / 75

    1.23 (0.39 - 3.86)

    Location of infarct non-anterior

    7 / 128

    6 / 124

    1.13 (0.39 - 3.27)

    Killip class I

    11 / 182

    8 / 172

    1.30 (0.54 - 3.15)

    Killip class > I

    2 / 19

    3 / 27

    0.95 (0.17 - 5.14)

    Initial TIMI flow grade < 3

    13 / 150

    8 / 152

    1.65 (0.70 - 3.86)

    Initial TIMI flow grade 3

    0 / 51

    3 / 47

    0.13 (0.01 - 2.49)

    Symptom to randomization < 180 min

    9 / 164

    6 / 151

    1.38 (0.50 - 3.79)

    Symptom to randomization ≥ 180 min

    4 / 37

    5 / 48

    1.04 (0.30 - 3.60)

    Symptom onset to balloon < 180 min

    4 / 94

    4 / 97

    1.03 (0.27 - 4.01)

    Symptom onset to balloon ≥ 180 min

    9 / 107

    7 / 102

    1.23 (0.47 - 3.17)

    Hospital arrival to balloon < 90 min

    5 / 96

    6 / 94

    0.82 (0.26 - 2.58)

    Hospital arrival to balloon ≥ 90 min

    8 / 105

    5 / 105

    1.60 (0.54 - 4.73)

    Clopidogrel to balloon < 75 min

    5 / 105

    8 / 105

    0.63 (0.21 - 1.85)

    Clopidogrel to balloon ≥ 75 min

    8 / 96

    3 / 94

    2.61 (0.71 - 9.54)

    TIMI not high risk

    4 / 87

    2 / 70

    1.61 (0.30 - 8.53)

    TIMI high risk

    9 / 114

    9 / 129

    1.13 (0.47 - 2.75)

    0.1

    0.2

    0.5

    1

    2

    5

    10

    Heparin plus Eptifibatide

    Better

    Heparin Alone

    Better

    Primary OutcomeSubgroup Analysis


    Timi bleeding events during initial hospitalization

    TIMI Bleeding Events During Initial Hospitalization

    % pts

    p = 0.14

    p = 0. 21

    p = 0.04


    Revascularization initial hospitalization

    RevascularizationInitial Hospitalization


    Revascularization 30 days and six months

    Revascularization30 Days and Six Months


    Limitations

    Limitations

    • Relatively small sample size.

    • Study was performed after the establishment of an integrated city-wide rapid response STEMI system that resulted in relatively short ischemic time intervals.

    • Relatively high percentage of PCI to a non–infarct-related artery performed later during the initial hospitalization may have contributed to the low event rates.


    Conclusions

    Conclusions

    In pts with acute STEMI pre-treated with high dose clopidogrel, as compared with PCI with heparin alone,

    PCI with eptifibatide initiated before catheterization

    1) does not improve clinical outcomes and

    2) is associated with more bleeding.


  • Login