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Impact of clopidogrel loading dose on the safety and effectiveness of bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction: The HORIZONS AMI trial.

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Presentation Transcript
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Impact of clopidogrel loading dose on the safety and effectiveness of bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction: The HORIZONS AMI trial

George Dangas, Giulio Guagliumi, Bernhard Witzenbichler, Deepak Bhatt, Frederick Feit, Magnus Ohman, S. Chiu Wong, Helen Parise, Roxana Mehran, Gregg W. Stone

Dangas et al, SCAI-ACCi2 2008

background
Background

In the HORIZONS AMI trial, in pts undergoing primary PCI. bivalirudin monotherapy (Biv) compared to UFH plus GP IIb/IIIa inhibitors resulted in:

– Reduced 30 day rates of major bleeding,

– Comparable composite major adverse cardiovascular events (MACE)

– Enhanced freedom from net adverse clinical events (NACE).

All pts were to receive a clopidogrel loading dose in the ER, either 300 mg or 600 mg, and randomization was stratified by this decision.

Whether the beneficial effects of bivalirudin are independent of the clopidogrel loading dose has not been reported.

Dangas et al, SCAI-ACCi2 2008

baseline characteristics
Baseline Characteristics

Dangas et al, SCAI-ACCi2 2008

baseline characteristics1
Baseline Characteristics

Dangas et al, SCAI-ACCi2 2008

drug administration
Drug Administration

Dangas et al, SCAI-ACCi2 2008

procedural characteristics pci
Procedural characteristics (PCI)

Dangas et al, SCAI-ACCi2 2008

procedural characteristics pci1
Procedural characteristics (PCI)

Dangas et al, SCAI-ACCi2 2008

overall primary outcomes itt
Overall: Primary Outcomes (ITT)

P<.0001

P=0.002

P=0.001

  • *NACE = MACE or major bleeding
  • **Not related to CABG
  • ***MACE = All cause death, reinfarction, ischemic TVR or stroke

Dangas et al, SCAI-ACCi2 2008

primary outcomes itt
Primary Outcomes (ITT)
  • The impact of Biv was independent of the dose of clopidogrel loading. Interaction P values for the above 3 endpoints = 0.48 (NACE) 0.41 (Major bleeding), and 0.75 (MACE).

300 mg LD

600 mg LD

P=0.15

P=0.01

P=0.56

P=0.01

P=0.002

P=0.71

Dangas et al, SCAI-ACCi2 2008

overall 30 day mace components
Overall: 30 Day MACE Components*

*CEC adjudicated

Dangas et al, SCAI-ACCi2 2008

bivalirudin group 30 day mace components
Bivalirudin group: 30 Day MACE Components*

*CEC adjudicated

Dangas et al, SCAI-ACCi2 2008

overall 30 day stent thrombosis
Overall: 30 Day Stent Thrombosis

*Protocol definition of stent thrombosis, CEC adjudicated

Dangas et al, SCAI-ACCi2 2008

biv group 30 day stent thrombosis
BIV group: 30 Day Stent Thrombosis

*Protocol definition of stent thrombosis, CEC adjudicated

Dangas et al, SCAI-ACCi2 2008

overall 30 day bleeding endpoints
Overall: 30 Day Bleeding Endpoints

*Life threatening

Dangas et al, SCAI-ACCi2 2008

prediction of 30 day outcomes
Prediction of 30-day Outcomes
  • Multivariate predictors using logistic regression model

Dangas et al, SCAI-ACCi2 2008

prediction of 30 day outcomes1
Prediction of 30-day Outcomes
  • Multivariate Predictors Using Cox proportional hazards model

Dangas et al, SCAI-ACCi2 2008

conclusions
Conclusions

In patients with STEMI undergoing primary PCI:

  • 600 mg loading dose of clopidogrel was associated with significantly lower 30- day mortality, reinfarction and stent thrombosis rates compared with 300 mg loading dose.
  • 600 mg loading dose of clopidogrel did not increase the risk of bleeding compared with 300 mg loading dose.
  • Biv monotherapy significantly reduces major bleeding and NACE, independently of the clopidogrel loading dose.
  • By multivariate analysis, 600 mg loading dose of clopidogrel was an independent predictor of lower 30-day MACE (compared with 300 mg LD, Odds Ratio=0.72), but was not independently associated with death, reinfarction or major bleeding.

Dangas et al, SCAI-ACCi2 2008