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Dangas et al, SCAI-ACCi2 2008

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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Dangas et al, SCAI-ACCi2 2008

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  1. 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

  2. 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

  3. Baseline Characteristics Dangas et al, SCAI-ACCi2 2008

  4. Baseline Characteristics Dangas et al, SCAI-ACCi2 2008

  5. Drug Administration Dangas et al, SCAI-ACCi2 2008

  6. Procedural characteristics (PCI) Dangas et al, SCAI-ACCi2 2008

  7. Procedural characteristics (PCI) Dangas et al, SCAI-ACCi2 2008

  8. 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

  9. 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

  10. Overall: 30 Day MACE Components* *CEC adjudicated Dangas et al, SCAI-ACCi2 2008

  11. Bivalirudin group: 30 Day MACE Components* *CEC adjudicated Dangas et al, SCAI-ACCi2 2008

  12. Overall: 30 Day Stent Thrombosis *Protocol definition of stent thrombosis, CEC adjudicated Dangas et al, SCAI-ACCi2 2008

  13. BIV group: 30 Day Stent Thrombosis *Protocol definition of stent thrombosis, CEC adjudicated Dangas et al, SCAI-ACCi2 2008

  14. Overall: 30 Day Bleeding Endpoints *Life threatening Dangas et al, SCAI-ACCi2 2008

  15. Prediction of 30-day Outcomes • Multivariate predictors using logistic regression model Dangas et al, SCAI-ACCi2 2008

  16. Prediction of 30-day Outcomes • Multivariate Predictors Using Cox proportional hazards model Dangas et al, SCAI-ACCi2 2008

  17. 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

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