Why the study?
Does bivalirudin with provisional IIb/IIIa antagonists improve outcomes and reduce bleeding compared to heparin and IIb/IIIa antagonists in patients with acute coronary syndrome?
Does bivalirudin with provisional IIb/IIIa antagonists improve outcomes and reduce bleeding compared to heparin and IIb/IIIa antagonists in patients with acute coronary syndrome?
Bivalirudin is an effective and safer alternative to heparin plus IIb/IIIa inhibitors in ACS patients, offering similar ischemic protection with less bleeding and improved mortality in STEMI.
May support bivalirudin preference in STEMI to limit bleeding; leaves open confirmation versus contemporary standards.
BACKGROUND: Bivalirudin is a direct thrombin inhibitor with several pharmacological advantages over heparin. It has been studied extensively in non-ST elevation acute 60 coronary syndromes (NSTE-ACS) and in percutaneous coronary intervention. Bivalirudin has also recently been investigated in patients with ST-elevation myocardial infarction (STEMI) treated with primary angioplasty and stenting. More than 27,000 patients were randomized in these trials. OBJECTIVE: To provide an overview of the pharmacological properties of bivalirudin and its efficacy and safety profile in patients across the spectrum of acute coronary syndromes (ACS). METHODS: All published, peer-reviewed clinical trials were reviewed and as relevant were included. RESULTS AND CONCLUSIONS: Bivalirudin with provisional IIb/IIIa antagonists provides consistent results across the full spectrum of ACS, with similar or non-inferior protection from ischemic events and significantly reduces bleeding complications compared with heparin and IIb/IIIa antagonists. In STEMI, mortality at 30 days and 1 year is significantly reduced. The unique pharmacokinetic profile of bivalirudin allows for simultaneous reductions in both ischemic and hemorrhagic events and makes it an appropriate alternative to heparin.
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Harvey D. White (2009) studied this question.
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