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Angiographic Findings in Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) Trial. Alexandra J. Lansky 1 , Ken Mori 1 , Ricardo A. Costa 1 , Michel Bertrand 2 , Frederick Feit 3 , Cordy Pietras 1 , Ecatarina Cristea 1 , Stuart Pocock 4 , Magnus Ohman 5 , Gregg W. Stone 1.

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angiographic findings in acute catheterization and urgent intervention triage strategy acuity trial

Angiographic Findings in Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) Trial

Alexandra J. Lansky1, Ken Mori1, Ricardo A. Costa1, Michel Bertrand2, Frederick Feit3, Cordy Pietras1, Ecatarina Cristea1, Stuart Pocock4, Magnus Ohman5, Gregg W. Stone1

1. Cardiovascular Research Foundation, New York, NY;

2. Hospital Cardiologique, Lambersart, France

3. New York University Medical Center, NY

4. London School of Hygiene and Tropical Medicine, London, United Kingdom

5. University of North Carolina, Chapel Hill, NC

background
Background
  • A number of angiographic morphologic parameters of prognostic importance have been identified in ACS pts undergoing PCI including the extent of disease, the presence of thrombus and coronary flow characteristics.
  • ACUITY Angiographic substudy was designed to investigate the angiographic findings in a cohort of patients enrolled in US.
acuity trial design

Medical

management

UFH or

Enoxaparin

+ GP IIb/IIIa

PCI

Bivalirudin

+ GP IIb/IIIa

Angiography within 72h

R*

Bivalirudin

Alone

CABG

ACUITY Trial Design
  • Moderate-high risk unstable angina or NSTEMI undergoing an invasive strategy (N = 13,800)

Moderate-

high risk

ACS

Aspirin in all

Clopidogrel

dosing and timing

per local practice

*Stratified by pre-angiography thienopyridine use or administration

ACUITY Design. Stone GW et al. AHJ 2004;148:764–75

major entry criteria
Major entry criteria
  • Moderate-high risk unstable angina or NSTEMI
acuity primary results itt

PNI <0.001

PSup = 0.015

PNI = 0.011

PSup = 0.32

PNI <0.001

PSup <0.001

ACUITY Primary Results (ITT)
  • Heparin* + IIb/IIIa vs. Bivalirudin + IIb/IIIa vs. Bivalirudin Alone

*Heparin=unfractionated or enoxaparin

acuity angiographic substudy
ACUITY: Angiographic Substudy
  • Objectives:

Investigate the angiographic basis of observed differences in efficacy of angiographic parameters in acute coronary syndrome patients.

  • Methods:

Angiographic films were analyzed in a blinded manner by the independent Core Laboratory:

    • Baseline Angiography on all patients to assess the extent of disease
    • Serial analysis of diseased vessels for patients undergoing PCI to determine procedural complications and final QCA results.
baseline clinical characteristics
Baseline clinical characteristics

*CrCL < 60ml/min as determined by the Cockcroft-Gault equation

baseline angiographic characteristics
Baseline angiographic characteristics

Diseased vessel is defied as %DS>30%

lad angiographic characteristics
LAD angiographic characteristics

Diseased vessel is defied as %DS>30%

rca angiographic characteristics
RCA angiographic characteristics

Diseased vessel is defied as %DS>30%

lcx angiographic characteristics
LCX angiographic characteristics

Diseased vessel is defied as %DS>30%

conclusions
Conclusions
  • The ACUITY trial demonstrated that a bivalirudin alone strategy results in a significantly improved net clinical outcome at 30 days when compared with heparin (unfractionated or enoxaparin) plus a GP IIb/IIIa inhibitor
  • A further analysis of the baseline angiographic characteristics demonstrated that angiographic parameters were well-balanced between the treatment groups
  • There were no clinically significant differences in the angiographic outcome of patients who underwent further PCI