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OPTIMAL UPSTREAM ANTITHROMBIN THERAPY IN NSTE ACS PATIENTS MANAGED IN THE CARDIAC CATH LAB: DOES IT MATTER WHICH AGENT IS STARTED IN THE ED?. Charles V. Pollack, Jr., M.A., M.D., FACEP, FAAEM Department of Emergency Medicine Pennsylvania Hospital, Philadelphia.

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OPTIMAL UPSTREAM ANTITHROMBIN THERAPY IN NSTE ACS PATIENTS MANAGED IN THE CARDIAC CATH LAB: DOES IT MATTER WHICH AGENT IS STARTED IN THE ED?

Charles V. Pollack, Jr., M.A., M.D., FACEP, FAAEMDepartment of Emergency MedicinePennsylvania Hospital, Philadelphia

Steven V. Manoukian, Gregg W. Stone, Judd E. Hollander, Chadwick Miller, Deborah B. Diercks, W. Frank Peacock, Gerard X. Brogan, Charles L. Emerman, Andra Blomkalns, W. Brian Gibler, Ivan Rokos, David Larson, and James W. Hoekstra

nste acs optimal therapy 2006
NSTE ACS: Optimal Therapy, 2006
  • Braunwald E, Antman EM, Beasley JW, et al: ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients with Unstable Angina). J Am Coll Cardiol 2000;36:970-1062 (2002 update at www.acc.org; summary in Circulation 2002;106:1893-1900)
  • Pollack CV, Roe MT, Peterson ED: 2002 Update to the ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction: Implications for emergency department practice. Ann Emerg Med 2003;41:355-69.
hospital care anti thrombotic therapy

I

IIa

IIb

III

Hospital Care: Anti-Thrombotic Therapy

Immediate aspirin

Clopidogrel, if aspirin contraindicated

Heparin (IV unfractionated, LMW) with antiplatelet agents listed above

Enoxaparin preferred over UFH unless CABG is planned within 24 hours

Braunwald et al, Circulation 2002;106:1893-1900

acute medication use in high risk nste patients crusade
Acute Medication Use in High-RiskNSTE Patients: CRUSADE

Within first 24 hours in patients without contraindications

CRUSADE DATA: Quarter 4, 2004 – Quarter 3, 2005 (n=35,897)

hospital care conservative vs invasive strategies

I

IIa

IIb

III

Hospital CareConservative vs. Invasive Strategies

Early invasive strategy in high-risk patients with any of the following:

- Recurrent ischemia, despite meds

- Elevated Troponin I or T

- New ST-segment depression

- New CHF symptoms

- High-risk stress test findings

- LV dysfunction (EF < 40%)

- Hemodynamic instability, sustained VT

- PCI within 6 months, prior CABG

Braunwald et al, Circulation 2002;106:1893-1900

hospital care conservative vs invasive strategies1

I

IIa

IIb

III

Hospital CareConservative vs. Invasive Strategies

Either strategy in low- to moderate-risk patients without contraindications to revascularization

Early invasive strategy for patients with repeated ACS presentations, without high-risk features or ongoing ischemia

Braunwald et al, Circulation 2002;106:1893-1900

invasive cardiac procedures crusade among patients without contraindications to cath
Invasive Cardiac Procedures: CRUSADE(among patients without contraindications to cath)
  • Median Times
  • Cath - 22 hrs
  • PCI - 21 hrs
  • CABG - 69 hrs

CRUSADE data, unpublished, March 2006

acuity study acc march 2006

Medical

management

UFH or

Enoxaparin

+ IIb/IIIa

PCI

Bivalirudin

+ IIb/IIIa

Angiography within 72h

R*

Bivalirudin

Alone

CABG

ACUITY Study (ACC, March 2006)

Moderate and high risk unstable angina or NSTEMI undergoing an invasive strategy (N = 13,819)

Moderate

and

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

primary endpoint measures itt
Primary Endpoint Measures (ITT)

UFH/Enoxaparin + GPI vs. Bivalirudin Alone

PNI <0.0001

PSup = 0.015

PNI = 0.011

PSup = 0.32

PNI <0.0001

PSup <0.0001

acuity
ACUITY
  • More than 99% of patients in ACUITY were taken to the cath lab, at a median time of 19.6 hours after arrival.
  • One-third of these patients were randomized to receive bivalirudin monotherapy. The median time from randomization to angiography/intervention was approximately 5 hours.
  • Because of their assessed ischemic risk, 64.1% of patients enrolled in ACUITY were treated with either UFH or enoxaparin prior to randomization. Consistently, 63.9% of patients randomized to bivalirudin monotherapy were pretreated . . .
    • 40.5 % with UFH
    • 25.4 % with enoxaparin
rationale and hypothesis
Rationale and Hypothesis
  • In contemporary practice, bivalirudin is not ordinarily used outside the cardiac cath lab.
  • Patients with NSTE ACS and high risk features are typically administered an anticoagulant in the ED as empiric therapy. Whether UFH or enox is used in this setting is an issue of local preference and policy.
  • Hypothesis: The nature of upstream anticoagulant therapy—UFH or enox—will not affect outcomes of NSTE ACS patients who subsequently receive bivalirudin in the cath lab.
acuity methodology
ACUITY: Methodology
  • Patients were excluded from the study if they had received more than one dose of enox prior to potential randomization.
  • Patients who had received one dose of enox were eligible for inclusion.
    • Randomized therapy initiated 12h after enox dose
  • Patients who had received UFH were eligible for inclusion.
    • 30-minute wash-out period
acuity results
ACUITY: Results
  • Of 13,819 patients enrolled, 4,612* were randomized to receive bivalirudin monotherapy.
  • Of these:
    • 1,658 received no prior anticoagulant
    • 1,773 received UFH prior to randomization
    • 1,073 received enox prior to randomization
    • 97 received both UFH and enox and were excluded from this analysis.

* 11 pts did not have complete data available

patient characteristics
Patient Characteristics

*P value < 0.001

ischemic outcomes
Ischemic Outcomes

All comparisons NS - before and after adjustment for baseline characteristics

bleeding outcomes
Bleeding Outcomes

All comparisons NS - before and after adjustment for baseline characteristics

net clinical outcome
Net Clinical Outcome

BIV - no AT vs. UFH →BIVvs. Enox →BIV

All comparisons NS

primary outcomes summary by pre randomization at
Primary Outcomes: Summary by Pre-Randomization AT

BIV - no AT vs. UFH →BIVvs. Enox →BIV

All comparisons NS

outcomes in high risk patients elevated biomarker and or st segment changes
Outcomes in High-Risk PatientsElevated Biomarker and/or ST-segment changes

All comparisons NS

primary outcomes high risk patients
Primary Outcomes – High Risk Patients

BIV - no AT vs. UFH →BIVvs. Enox →BIV

All comparisons NS

caveats
Caveats
  • Further analysis of the ACUITY data will ascertain the impact of duration of therapy with bivalirudin on outcomes, as well as the relationship between upstream GPI use and risk as perceived in the ED. There will also be a comprehensive economic analysis.
  • The dose of bivalirudin used in ACUITY for pre-cath management is not a labeled dose.
  • The washout periods for prior AT therapy mandated in the study may not be scrupulously followed in contemporary practice.
conclusions
Conclusions
  • The efficacy and safety of bivalirudin in patients with moderate and high risk NSTE ACS from the ACUITY trial is not significantly influenced by prior AT with UFH or enox.
  • Prior UFH or enox does not significantly compromise the net clinical outcomes achieved in patients subsequently converted to bivalirudin for interventional management.
study medications
Study Medications
  • Anti-thrombin agents (started pre angiography)

1 Target aPTT 50-75 seconds

2 If last enoxaparin dose ≥8h - <16h before PCI; 3 If maintenance dose discontinued or ≥16h from last dose

4 Discontinued at end of PCI with option to continue at 0.25mg/kg for 4-12h if GPIIb/IIIa inhibitor not used

5 Bivalirudin option for off-pump same as PCI dose. For on-pump bivalirudin discontinued 2 hours before

6 Option to continue with pre-PCI anti-thrombotic regimen at physician discretion