Bivalirudin Monotherapy Improves 30-day Clinical Outcomes in Diabetics with
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Bivalirudin Monotherapy Improves 30-day Clinical Outcomes in Diabetics with Acute Coronary Syndrome: Report from the ACUITY Trial. Frederick Feit, Steven Manoukian, Ramin Ebrahimi, Charles Pollack, Magnus Ohman, Michael Attubato, Roxana Mehran and Gregg Stone.

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Bivalirudin Monotherapy Improves 30-day Clinical Outcomes in Diabetics with

Acute Coronary Syndrome:

Report from the ACUITY Trial

Frederick Feit, Steven Manoukian, Ramin Ebrahimi, Charles Pollack,

Magnus Ohman, Michael Attubato, Roxana Mehran and Gregg Stone


Slide2 l.jpg

Bivalirudin Monotherapy Improves 30-day Clinical Outcomes in Diabetics

with Acute Coronary Syndrome:

Report from the ACUITY Trial

Conflicts:

Shareholder: Johnson and Johnson, Medicines Co.,

Millenium Pharmaceuticals; Consultant: Medicines Co.


Acs in diabetics metabolic abnormalities l.jpg
ACS in Diabetics: DiabeticsMetabolic Abnormalities

  • Increased blood glucose causes coronary artery inflammation and is prothrombotic

  • Increased generation of thrombin, CRP, fibrinogen, von Willebrand factor, factors VII and VIII, and platelet factor 4

  • Increased expression of platelet activation markers including p-selectin, which mediates platelet-leukocyte interactions

  • Higher proportion of platelets expressing GPIIb/IIIa receptors


Acs in diabetics background l.jpg
ACS in Diabetics: DiabeticsBackground

  • Based on prior data including a meta-analysis of ACS trials current clinical guidelines recommend the use of GPIIb/IIIa inhibitors (GPI) in diabetic patients with ACS, especially those in whom PCI is planned1

  • In the ACUITY Trial 13,819 pts, including 3852 diabetics, with moderate or high risk ACS, undergoing an early invasive strategy were randomly assigned to either the standard of care: Heparin (UFH or enoxaparin) + GPI; or, Bivalirudin + GPI; or Bivalirudin with provisional GPI

1. Roffi et al. Circulation.2001;104:2767-71


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ACS in Diabetics: Methods Diabetics

  • We compared adverse events: composite ischemia (death, nonfatal MI, unplanned ischemia driven revascularization), major bleeding and net clinical outcome (composite ischemia or bleeding) within the first 30 days in diabetic vs. nondiabetic pts

  • We compared the same 30-day end points in diabetic pts by treatment group


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ACUITY Design Diabetics

ACS: Unstable angina or NSTEMI, N=13,819

Chest pain >10’ within 24 hours, plus

Biomarker +, or

Dynamic ECG changes, or

Documented CAD or all other TIMI risk criteria

ASA

Clopidogrel

per local practice

Prior UFH, LMWH (1 dose), eptifibatide and tirofiban allowed

Bivalirudin

+ IIb/IIIa inhibitor

Bivalirudin +

provisional

IIb/IIIa

Enoxaparin or UFH

+ IIb/IIIa inhibitor

Cath within 72 hours

PCI, CABG or medical management

30 day endpoints

Death, MI, IUR, ACUITY major bleeding

(net clinical outcome)

Stone et al. Presented 2006; ACC


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Study Medications Diabetics

  • 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 IIb/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


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ACS in Diabetics: Diabetics Angiographic Triage

* - p<0.001


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ACS in Diabetics: DiabeticsBaseline Characteristics

* CrCL <60 mL/min


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ACS in Diabetics: Diabetics30-Day Outcomes

Diabetes vs. No Diabetes

P = 0.0002

P = 0.0037

P = 0.0002

†Heparin=unfractionated or enoxaparin


Diabetic acs patients baseline characteristics by treatment l.jpg
Diabetic ACS Patients DiabeticsBaseline Characteristics by Treatment

* creatinine clearance <60 mL/min

†Heparin = unfractionated or enoxaparin


Diabetic acs patients 30 day endpoints by treatment group l.jpg

P = 0.94 Diabetics

P = 0.64

P = 0.43

Diabetic ACS Patients: 30-Day Endpoints by Treatment Group

Heparin* + GP IIb/IIIa vs. Bivalirudin + GP IIb/IIIa

*Heparin = unfractionated or enoxaparin


Diabetic acs patients 30 day endpoints l.jpg

P = 0.02 Diabetics

P = 0.39

P=0.0002

Diabetic ACS Patients: 30-Day Endpoints

Heparin* + GP IIb/IIIa vs. Bivalirudin alone

*Heparin = unfractionated or enoxaparin


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P = 0.39 Diabetics

P = 0.32

P= 0.27

P = 0.37

Diabetic ACS Patients: Components of Ischemic Endpoint

Heparin* + IIb/IIIa vs. Bivalirudin Alone

*Heparin=unfractionated or enoxaparin


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Diabetic ACS Patients: DiabeticsMyocardial Infarction Classification*

Heparin† + IIb/IIIa vs. Bivalirudin Alone

p = 0.27

5.6%

4.7%

30 day events (%)

Q-wave 1.6%

p = 0.05

Q-wave 0.8%

Non Q-wave

Non Q-wave

p = 0.87

3.9%

4.0%

Heparin + IIb/IIIa

Bivalirudin alone

(N=1298)

(N=1287)

*CEC-adjudicated

†Heparin=unfractionated or enoxaparin


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Diabetic ACS Patients: Diabetics Bleeding Endpoints 30-days

*P value for bivalirudin alone vs. heparin + IIb/IIIa inhibitor

†Heparin=unfractionated or enoxaparin


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Insulin-dependent Diabetic ACS Patients: Diabetics30-Day Endpoints by Treatment Group

Heparin† + GP IIb/IIIa vs. Bivalirudin alone

P = 0.23

P = 0.74

P = 0.04

†Heparin=unfractionated or enoxaparin


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Diabetic Patients with ACS : Conclusions Diabetics

  • Compared with non-diabetics, diabetic patients have worse net clinical outcomes at 30 days (12.8% vs. 10.5%; p=0.0002), resulting from significantly higher rates of the composite ischemic end point (8.6% vs. 7.2%; p=0.0037) and non-CABG major bleeding (5.7% vs. 4.2%; p=0.0002)

  • In diabetic patients, compared with the standard of care, heparin (UFH or enoxaparin) + GPIIb/IIIa, bivalirudin + GPIIb/IIIa was not better for protection from ischemic events or bleeding and resulted in similar net clinical outcome


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Diabetic Patients with ACS: Conclusions Diabetics

  • Compared to those receiving the reference standard, diabetics receiving bivalirudin monotherapy, with provisional GPIIb/IIIa in 7.9%, had similar protection from ischemic events (7.8% vs. 8.8%; p=0.39) and a marked reduction in major bleeding (3.7% vs. 7.1%; p=0.0002) with improved net clinical outcome (10.8% vs. 13.7%; p=0.02)

  • These 30-day outcomes suggest that bivalirudin monotherapy is safe and effective for diabetic patients with ACS, including those requiring insulin

  • One-year clinical and economic data will determine whether this regimen will become the standard of care for these patients.


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