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Bivalirudin or Heparin in ACS Patients
Study Questions:
What is the efficacy and safety of bivalirudin compared with unfractionated heparin (UFH) with or without glycoprotein IIb/IIIa inhibitors (GPIs) in patients with acute coronary syndrome (ACS) undergoing invasive management?
Methods:
The investigators used data from the MATRIX program, in which 7,213 patients were randomly assigned to receive either bivalirudin or UFH with or without GPI at the operator’s discretion to assess efficacy and safety of bivalirudin compared with UFH with or without GPI in patients with ACS undergoing invasive management. The 30-day coprimary outcomes were major adverse cardiovascular events (MACE; composite of death, myocardial infarction [MI], or stroke), and net adverse clinical events (NACE; composite of MACE or major bleeding).
Results:
Among 3,603 patients assigned to receive UFH, 781 (21.7%) underwent planned treatment with GPIs prior to coronary intervention. Bailout use of GPIs was similar between bivalirudin and UFH groups (4.5% and 5.4%, p = 0.11). At 30 days, the two coprimary endpoints of MACE and NACE, as well as individual endpoints of mortality, MI, stent thrombosis, or stroke, did not differ among the three groups after adjustment. Compared to UFH and UFH + GPI groups, bivalirudin reduced bleeding, mainly most severe ones, including fatal and non–access-site-related events, as well as transfusion rates and need for surgical access-site repair. These findings were not influenced by intraprocedural dose of UFH administered, and were confirmed at multiple sensitivity analyses, including the randomly allocated access site.
Conclusions:
The authors concluded that in patients with ACS, the rates of MACE and NACE were not significantly lower with bivalirudin than with UFH, irrespective of planned GPI use.
Perspective:
This prespecified analysis of the MATRIX trial reports that the rates of MACE and NACE were not significantly lower among those who received bivalirudin than among those who received UFH alone or with planned GPI at the time of PCI. However, compared to UFH and UFH + GPI groups, bivalirudin consistently reduced major bleeding, including fatal and non–access-site-related events, as well as transfusion rates and need for surgical access-site repair. Additional studies are indicated to compare bivalirudin against UFH on other endpoints, such as mortality, and to assess the cost-effectiveness of these two strategies.
Keywords: Acute Coronary Syndrome, Anticoagulants, Blood Transfusion, Cardiac Surgical Procedures, Hemorrhage, Heparin, Myocardial Infarction, Percutaneous Coronary Intervention, Platelet Glycoprotein GPIIb-IIIa Complex, Stents, Stroke, Thrombosis
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