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Is Bivalirudin Monotherapy Sufficient for Diabetic Patients with Acute Coronary Syndrome Undergoing PCI? PowerPoint Presentation
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Is Bivalirudin Monotherapy Sufficient for Diabetic Patients with Acute Coronary Syndrome Undergoing PCI?. Frederick Feit, Steven Manoukian, Ramin Ebrahimi, Charles Pollack, Magnus Ohman, Michael Attubato and Gregg Stone. Is Bivalirudin Monotherapy Sufficient for Diabetic Patients

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Is Bivalirudin Monotherapy Sufficient for Diabetic Patients with Acute Coronary Syndrome Undergoing PCI?


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slide1

Is Bivalirudin Monotherapy Sufficient

for Diabetic Patients

with Acute Coronary Syndrome Undergoing PCI?

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

Magnus Ohman, Michael Attubato and Gregg Stone

slide2

Is Bivalirudin Monotherapy Sufficient

for Diabetic Patients

with Acute Coronary Syndrome Undergoing PCI?

Conflicts:

Shareholder: Johnson and Johnson, Medicines Co.,

Millenium Pharmaceuticals; Consultant: Medicines Co.

pci for acs in diabetics metabolic abnormalities
PCI for ACS in Diabetics: Metabolic 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
pci for acs in diabetics background
PCI for ACS in Diabetics: Background
  • 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

pci for acs in diabetics methods
PCI for ACS in Diabetics: Methods
  • 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
acuity design

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

Bivalirudin

+ IIb/IIIa inhibitor

Enoxaparin or UFH

+ IIb/IIIa inhibitor

Bivalirudin + IIb/IIIai

Cath within 72 hours

PCI, CABG or medical management

30 day endpoints

Death, MI, IUR, ACUITY major bleeding

(net clinical outcome)

ACUITY Design

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

Stone et al. Presented 2006; ACC

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 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

pci for acs in diabetics 30 day outcomes
PCI for ACS in Diabetics: 30-Day Outcomes

Diabetes vs. No Diabetes

P = 0.008

P = 0.15

P < 0.001

†Heparin=unfractionated or enoxaparin

diabetic acs patients undergoing pci baseline characteristics by treatment group
Diabetic ACS Patients Undergoing PCIBaseline Characteristics by Treatment Group

* creatinine clearance <60 mL/min

†Heparin = unfractionated or enoxaparin

diabetic acs patients undergoing pci baseline high risk features by treatment group
Diabetic ACS Patients Undergoing PCI: Baseline High Risk Features by Treatment Group

†Heparin = unfractionated or enoxaparin

diabetic acs patients undergoing pci intervention type
Diabetic ACS Patients Undergoing PCI: Intervention Type

†Heparin = unfractionated or enoxaparin

All comparisons p= NS

diabetic acs patients undergoing pci 30 day endpoints by treatment group

P = 0.27

P = 0.48

P = 0.51

Diabetic ACS Patients Undergoing PCI: 30-Day Endpoints by Treatment Group

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

*Heparin = unfractionated or enoxaparin

diabetic acs patients undergoing pci 30 day endpoints

P = 0.08

P = 0.42

P = 0.003

Diabetic ACS Patients Undergoing PCI: 30-Day Endpoints

Heparin* + GP IIb/IIIa vs. Bivalirudin alone

*Heparin = unfractionated or enoxaparin

diabetic acs patients undergoing pci components of ischemic endpoint

PSup = 0.42

PSup = 0.26

PSup = 0.57

PSup = 0.74

Diabetic ACS Patients Undergoing PCI: Components of Ischemic Endpoint

Heparin* + IIb/IIIa vs. Bivalirudin Alone

*Heparin=unfractionated or enoxaparin

diabetic acs patients undergoing pci myocardial infarction classification
Diabetic ACS Patients Undergoing PCI: Myocardial Infarction Classification*

Heparin† + IIb/IIIa vs. Bivalirudin Alone

p = 0.57

6.3%

5.6%

30 day events (%)

Q-wave 1.7%

p = 0.08

Q-wave 0.7%

Non Q-wave

Non Q-wave

p = 0.79

4.9%

4.6%

Heparin + IIb/IIIa

Bivalirudin alone

(N=703)

(N=721)

*CEC-adjudicated

†Heparin=unfractionated or enoxaparin

diabetic acs patients undergoing pci bleeding endpoints 30 days
Diabetic ACS Patients Undergoing PCI: Bleeding Endpoints 30-days

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

†Heparin=unfractionated or enoxaparin

insulin dependent diabetic acs patients undergoing pci 30 day endpoints by treatment group
Insulin-dependent Diabetic ACS Patients Undergoing PCI: 30-Day Endpoints by Treatment Group

Heparin† + GP IIb/IIIa vs. Bivalirudin alone

P = 0.08

P = 0.42

P = 0.04

†Heparin=unfractionated or enoxaparin

diabetic patients with acs undergoing pci conclusions
Diabetic Patients with ACS Undergoing PCI: Conclusions
  • Compared with non-diabetics, diabetic patients have worse net clinical outcomes at 30 days (14.9% vs. 12.6%; p=0.008), resulting from similar rates of the composite ischemic end point (9.5% vs. 8.5%; p=0.15) and a significantly higher rate of major bleeding (7.5% vs. 5.3%; p=0.008)
  • 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
diabetic patients with acs undergoing pci conclusions1
Diabetic Patients with ACS Undergoing PCI: Conclusions
  • Compared to those receiving the reference standard, diabetics receiving bivalirudin monotherapy, with provisional GPIIb/IIIa in 7.9%, had similar protection from ischemic events (8.3% vs. 9.5%; p=0.42) and a marked reduction in major bleeding (4.6% vs. 8.5%; p=0.003) with a trend towards improved net clinical outcome (12.1% vs. 15.2%; p=0.08)
  • These 30-day outcomes suggest that bivalirudin monotherapy is safe and effective for diabetic patients with ACS undergoing PCI, including those requiring insulin
  • One-year clinical and economic data will determine whether this regimen will become the standard of care for these patients.