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Bivalirudin vs. unfractionated heparin during percutaneous coronary interventions in patients with stable and
Stefanie Schulz1, Julinda Mehilli, Gjin Ndrepepa
1Deutsches Herzzentrum, Technische Universität, Munich, Germany. schulzs@dhm.mhn.de
European Heart Journal
|February 13, 2010
Summary
Bivalirudin and unfractionated heparin showed similar 1-year outcomes for patients undergoing percutaneous coronary intervention (PCI) after clopidogrel pre-treatment. This study found no significant differences in major adverse events between the two anticoagulants.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- The ISAR-REACT 3 trial initially assessed 30-day outcomes in biomarker-negative patients undergoing percutaneous coronary intervention (PCI) after clopidogrel pre-treatment.
- Previous findings indicated less bleeding with bivalirudin compared to unfractionated heparin, but no difference in 30-day net clinical benefit.
- ClinicalTrials.gov identifier: NCT00262054.
Purpose of the Study:
- To evaluate the long-term (1-year) impact of bivalirudin versus unfractionated heparin on clinical outcomes in patients undergoing PCI.
- To compare the efficacy and safety of bivalirudin and unfractionated heparin in a specific patient population pre-treated with clopidogrel.
Main Methods:
- Analysis of 1-year outcomes from the ISAR-REACT 3 trial.
- Primary outcome: composite of death, myocardial infarction, or target vessel revascularization.
- Secondary outcome: composite of death or myocardial infarction.
Main Results:
- At 1 year, the primary outcome occurred in 17.1% of patients on bivalirudin versus 17.5% on heparin (HR 0.98, P=0.816).
- No significant differences were observed in the combined incidence of death or myocardial infarction (7.7% vs. 6.7%, P=0.200).
- Mortality rates were comparable: 1.9% for bivalirudin and 1.7% for heparin (P=0.667). No significant differences were found in subgroups.
Conclusions:
- Bivalirudin and unfractionated heparin demonstrate comparable 1-year clinical outcomes in biomarker-negative patients undergoing PCI.
- These findings suggest that both anticoagulants are suitable options for this patient cohort when used with clopidogrel pre-treatment.
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