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Postconditioning with Lactate-enriched Blood for Cardioprotection in ST-segment Elevation Myocardial Infarction
Published on: May 28, 2019
Prasugrel plus bivalirudin vs. clopidogrel plus heparin in patients with ST-segment elevation myocardial infarction
Stefanie Schulz1, Gert Richardt2, Karl-Ludwig Laugwitz3
1Deutsches Herzzentrum München, Technische Universität, Munich, Germany DZHK, Partner Site Munich Heart Alliance, Munich, Germany schulzs@dhm.mhn.de.
Insights
In ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI), prasugrel plus bivalirudin did not show superiority over clopidogrel plus heparin. This randomized trial found no significant differences in net clinical outcomes or bleeding events.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- ST-segment elevation myocardial infarction (STEMI) is a critical condition requiring timely reperfusion.
- Primary percutaneous coronary intervention (PCI) is the preferred treatment strategy for STEMI.
- Optimal antithrombotic therapy during primary PCI remains an area of active research.
Purpose of the Study:
- To compare the efficacy and safety of prasugrel plus bivalirudin versus clopidogrel plus unfractionated heparin in STEMI patients undergoing primary PCI.
- To assess the net clinical outcome, including ischemic events and bleeding complications.
Main Methods:
- The Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 study was a randomized, open-label, multicenter trial.
- 548 STEMI patients undergoing primary PCI were enrolled.
- Patients received either prasugrel plus bivalirudin or clopidogrel plus unfractionated heparin.
Main Results:
- The primary composite endpoint (death, myocardial infarction, unplanned revascularization, stent thrombosis, stroke, or bleeding) occurred in 15.6% of the prasugrel group and 14.5% of the clopidogrel group (RR 1.09, P=0.680).
- Composite ischemic events were similar between groups (4.8% vs 5.5%, RR 0.89, P=0.894).
- Bleeding events were also comparable (14.1% vs 12.0%, RR 1.18, P=0.543).
Conclusions:
- Prasugrel plus bivalirudin was not superior to clopidogrel plus unfractionated heparin in STEMI patients undergoing primary PCI.
- No significant differences were observed in net clinical outcome, ischemic complications, or bleeding.
- Results should be interpreted cautiously due to premature trial termination due to slow recruitment.
Aims:
Whether prasugrel plus bivalirudin is a superior strategy to unfractionated heparin plus clopidogrel in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) has never been assessed in specifically designed randomized trials.
Methods And Results:
The Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 study is an investigator-initiated, randomized, open-label, multicentre trial, designed to test the hypothesis that in STEMI patients with planned primary PCI a strategy based on prasugrel plus bivalirudin is superior to a strategy based on clopidogrel plus heparin in terms of net clinical outcome. Owing to slow recruitment, the trial was stopped prematurely after enrolment of 548 of 1240 planned patients. At 30 days, the primary composite endpoint of death, myocardial infarction, unplanned revascularization of the infarct related artery, stent thrombosis, stroke, or bleeding was observed in 42 patients (15.6%) randomized to prasugrel plus bivalirudin and 40 patients (14.5%) randomized to clopidogrel plus heparin [relative risk, 1.09; one-sided 97.5% confidence interval (CI) 0-1.79, P = 0.680]. The composite ischaemic endpoint of death, myocardial infarction, unplanned revascularization of the infarct-related artery, stent thrombosis, or stroke occurred in 13 patients (4.8%) in the prasugrel plus bivalirudin group and 15 patients (5.5%) in the clopidogrel plus heparin group (relative risk, 0.89; 95% CI 0.40-1.96, P = 0.894). Bleeding according to the HORIZONS-AMI definition was observed in 38 patients (14.1%) in the prasugrel plus bivalirudin group and 33 patients (12.0%) in the clopidogrel plus heparin group (relative risk, 1.18; 95% CI 0.74-1.88, P = 0.543). Results were consistent across various subgroups of patients.
Conclusion:
In this randomized trial of STEMI patients, we were unable to demonstrate significant differences in net clinical outcome between prasugrel plus bivalirudin and clopidogrel plus heparin. Neither the composite of ischaemic complications nor bleeding were favourably affected by prasugrel plus bivalirudin compared with a regimen of clopidogrel plus unfractionated heparin. However, the results must be interpreted in view of the premature termination of the trial.
Clinical Trial Registration Information:
Unique identifier NCT00976092 (www.clinicaltrials.gov).
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