Key result
Bivalirudin resulted in similar early inflammation and thrombin generation compared to unfractionated heparin plus eptifibatide after PCI, but lower hs-CRP at 30 days (by 3.5 mg/l, P=0.002).
Why the study?
Does bivalirudin compared with unfractionated heparin plus eptifibatide improve inflammation and thrombin generation in patients undergoing elective percutaneous coronary intervention?
RCT (n=63)
Does bivalirudin compared with unfractionated heparin plus eptifibatide improve inflammation and thrombin generation in patients undergoing elective percutaneous coronary intervention?
p-value: p=0.002
Bivalirudin may attenuate inflammation more effectively than unfractionated heparin plus eptifibatide at 30 days post-PCI, as evidenced by lower hs-CRP levels.
Similar early markers post-PCI; extends 30-day hs-CRP reduction but leaves clinical benefit unproven.
In Brief Objective To characterize effects of bivalirudin compared with unfractionated heparin plus eptifibatide on inflammation, and thrombin generation and activity after percutaneous coronary intervention. Methods We measured the concentration in blood of fibrinopeptide A, prothrombin fragment 1+2, soluble CD40 ligand, interleukin 1 receptor antagonist, interleukin 6, and high sensitivity C-reactive protein in 63 patients treated with aspirin and clopidogrel and undergoing elective percutaneous coronary intervention, who were randomized to treatment with either bivalirudin (n=34) or unfractionated heparin plus eptifibatide (n=29). Results Neither generation nor activity of thrombin increased 10 min after percutaneous coronary intervention in patients randomized to bivalirudin or unfractionated heparin plus eptifibatide. However, prothrombin fragment 1+2 increased modestly and comparably in both groups after 1 day. Inflammation, reflected by concentrations of interleukin 6 and high sensitivity C-reactive protein in blood, increased similarly 1 day after percutaneous coronary intervention in patients treated with either regimen. In a subset of patients (n=12 in each group) from whom blood was obtained 30 days after percutaneous coronary intervention, the concentration of high sensitivity C-reactive protein was lower in those who had been treated with bivalirudin (by 3.5 mg/l, P=0.002). Conclusion The early effects on inflammation and thrombin generation and activity are similar after treatment with bivalirudin alone compared with unfractionated heparin plus eptifibatide in patients treated with aspirin and clopidogrel who are undergoing percutaneous coronary intervention for symptoms of stable angina. The decreased concentration of high sensitivity C-reactive protein seen 30 days after percutaneous coronary intervention in those treated with bivalirudin is consistent with greater attenuation of inflammation that may have contributed to the trend toward reduced mortality 1 year later in those treated with bivalirudin in REPLACE-2. To characterize the effects of bivalirudin compared with unfractionated heparin plus eptifibatide on inflammation and thrombin after percutaneous coronary intervention, we measured the concentration of fibrinopeptide A, prothrombin fragment 1+2, and markers of inflammation including interleukin 6, and high sensitivity C-reactive protein in 63 patients treated with aspirin and clopidogrel and undergoing elective percutaneous coronary intervention, who were randomized to treatment with either bivalirudin (n=34) or unfractionated heparin plus eptifibatide (n=29). Neither generation nor activity of thrombin increased 10 min after percutaneous coronary intervention in patients randomized to bivalirudin or unfractionated heparin plus eptifibatide. Concentrations of interleukin 6 and CRP in blood increased similarly 1 day after percutaneous coronary intervention in patients treated with either regimen. The concentration of high sensitivity C-reactive protein was lower in patients treated with bivalirudin 30 days after percutaneous coronary intervention. The decreased concentration of high sensitivity C-reactive protein seen after 30 days may have contributed to the trend toward reduced mortality 1 year later in those treated with bivalirudin in REPLACE-2.
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Keating et al. (2005) conducted an RCT in stable angina undergoing elective percutaneous coronary intervention (n=63). bivalirudin vs. unfractionated heparin plus eptifibatide was evaluated on inflammation and thrombin generation and activity (p=0.002). Bivalirudin resulted in similar early inflammation and thrombin generation compared to unfractionated heparin plus eptifibatide after PCI, but lower hs-CRP at 30 days (by 3.5 mg/l, P=0.002).
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