slide1
Download
Skip this Video
Download Presentation
Accumetrics, Inc. Amgen, Inc. AstraZeneca Pharmaceuticals LP Baxter Bayer Healthcare LLC

Loading in 2 Seconds...

play fullscreen
1 / 11

Accumetrics, Inc. Amgen, Inc. AstraZeneca Pharmaceuticals LP Baxter Bayer Healthcare LLC - PowerPoint PPT Presentation


  • 163 Views
  • Uploaded on

Outcomes and Optimal Antithrombotic Therapy in Women Undergoing Fibrinolysis for ST-Elevation Myocardial Infarction Jessica L. Mega, MD; David A. Morrow, MD, MPH; Erika Ostor, MD; Maria Dorobantu, MD, PhD; Jie Qin, MS; Elliott M. Antman, MD; Eugene Braunwald, MD. Disclosures.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about ' Accumetrics, Inc. Amgen, Inc. AstraZeneca Pharmaceuticals LP Baxter Bayer Healthcare LLC' - arsenio-holt


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
slide1

Outcomes and Optimal Antithrombotic Therapy in WomenUndergoing Fibrinolysis forST-Elevation Myocardial InfarctionJessica L. Mega, MD; David A. Morrow, MD, MPH;Erika Ostor, MD; Maria Dorobantu, MD, PhD; Jie Qin, MS;Elliott M. Antman, MD; Eugene Braunwald, MD

slide2

Disclosures

The TIMI Study Group has received research / grant support in the past 2 years through the Brigham & Women’s Hospital with funding from (in alphabetical order):

The National Institutes of Health

Integrated Therapeutics Corporation

KAI Pharmaceuticals

Merck & Co., Inc.

Millennium Pharmaceuticals, Inc.

Novartis Pharmaceuticals

Nuvelo, Inc.

Ortho-Clinical Diagnostics, Inc.

Pfizer, Inc.

Roche Diagnostics Corporation

Roche Diagnostics GmbH

Sanofi-Aventis

Sanofi-Synthelabo Recherche

Schering-Plough Research Institute

St Jude Medical

Accumetrics, Inc.

Amgen, Inc.

AstraZeneca Pharmaceuticals LP

Baxter

Bayer Healthcare LLC

Beckman Coulter, Inc.

Biosite Incorporated

Bristol-Myers Squibb

CardioKinetix

CV Therapeutics, Inc.

Eli Lilly and Company

FoldRx

GlaxoSmithKline

INO Therapeutics LLC

Inotek Pharmaceuticals Corporation

background
Background
  • Since the 1980s, the number of deaths attributed to CVD has been greater for women than men.
  • Following STEMI, women experience higher rates of reinfarction and death.
  • Women continue to be under-represented in RCTs, and questions have been raised about treatment-specific outcomes in women post ACS.
  • ExTRACT – TIMI 25 allowed for the evaluation of the outcomes and optimal antithrombotic treatment strategy in 4,783 women undergoing fibrinolysis for STEMI.
slide4

Design

STEMI < 6 hLytic eligible

Lytic choice by MD(TNK, tPA, rPA, SK)

ASA

Double-blind, double-dummy

ENOX

< 75 y: 30 mg IV bolus SC 1.0 mg / kg q 12 h (Hosp DC)

≥ 75 y: No bolusSC 0.75 mg / kg q 12 h (Hosp DC)

CrCl < 30: 1.0 mg / kg q 24h

UFH60 U / kg bolus (4000 U) Inf 12 U / kg / h (1000 U / h)Duration: at least 48 hCont’d at MD discretion

Day 301° Efficacy Endpoint: Death or Nonfatal MI1° Safety Endpoint: TIMI Major Hemorrhage

N Engl J Med 2006;354:1477-88.

slide6

Clinical Outcomes - Mortality

Mortality at 30 Days (%)

OR 2.66

95% CI 2.40 – 2.99

slide7

Mortality by Age Group

Men

Women

Mortality

at 30 Days (%)

Age (Yrs)

Women (N) 433 305 545 577 822 887 741 317 146

Men (N) 4,502 2,065 2,443 1,909 1,952 1,497 956 296 76

slide8

Cumulative Incidence ofPrimary Endpoint

WOMEN

Relative Risk, 0.84

(95% CI 0.74 – 0.95)

P=0.007

Unfractionated Heparin

Enoxaparin

18.3%

15.4%

10.1%

Death or MI (%)

8.2%

MEN

Relative Risk, 0.82

(95% CI 0.74 – 0.90)

P<0.0001

Days After Randomization

slide9

Efficacy and Safety

UFH

(%)

ENOX

(%)

RRR

(%)

ARD

(%)

NNT

Day 30

Women 20.8 17.2 17 3.6 28

Death, MI, or

Urg Revasc

Men 12.6 10.0 21 2.6 38

Women 19.0 16.4 14 2.6 38

Death, MI, or

Major Bleed

Men 10.9 9.3 14 1.6 63

0.5 1 2

Enoxaparin Better

UFH Better

slide10

Events per 1,000 Subjects Treated with Enoxaparin

Nonfatal

Urgent Revascularization

Nonfatal TIMI

Major Bleeding

Death

Nonfatal

MI

+

+

Number of Events

Women

Men

conclusion
Conclusion
  • Women presented with a profile of higher baseline risk and had increased short-term mortality.
  • The RRR in Death and nonfatal MI for enoxaparin vs UFH was similar in women and men, with a larger ARD in women.
  • Although the excess risk of bleeding with enoxaparin was seen for both women and men, net clinical benefit strongly favored enoxaparin in both sexes.
ad