Anticoagulation During Primary PCI in Acute MI | Journal Scan
What is the efficacy of bivalirudin compared with heparin alone and with heparin plus tirofiban during primary percutaneous coronary intervention (PCI)?
This was a multicenter, open-label trial involving 2,194 patients with acute myocardial infarction (AMI) undergoing primary PCI at 82 centers in China between August 2012 and June 2013. Patients were randomly assigned to receive bivalirudin with a post-PCI infusion (n = 735), heparin alone (n = 729), or heparin plus tirofiban with a post-PCI infusion (n = 730). Among patients treated with bivalirudin, a postprocedure 1.75 mg/kg/h infusion was administered for a median of 180 minutes (interquartile range [IQR], 148-240 minutes). The primary endpoint was 30-day net adverse clinical events, a composite of major adverse cardiac or cerebral events (all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke), or bleeding. Additional prespecified safety endpoints included the rates of acquired thrombocytopenia at 30 days, and stent thrombosis at 30 days and 1 year.
Net adverse clinical events at 30 days occurred in 65 (8.8%) of 735 patients who were treated with bivalirudin, compared with 96 (13.2%) of 729 patients treated with heparin (relative risk [RR], 0.67; 95% confidence interval [CI], 0.50-0.90; difference, −4.3%; 95% CI, −7.5% to −1.1%; p = 0.008); and 124 (17.0%) of 730 patients treated with heparin plus tirofiban (RR for bivalirudin vs. heparin plus tirofiban, 0.52; 95% CI, 0.39-0.69; difference, −8.1%; 95% CI, −11.6% to −4.7%; p < 0.001). The 30-day bleeding rate was 4.1% for bivalirudin, 7.5% for heparin, and 12.3% for heparin plus tirofiban (p < 0.001). There were no statistically significant differences between treatments in the 30-day rates of major adverse cardiac or cerebral events (5.0% for bivalirudin, 5.8% for heparin, and 4.9% for heparin plus tirofiban, p = 0.74), stent thrombosis (0.6% vs. 0.9% vs. 0.7%, respectively, p = 0.77), acquired thrombocytopenia (0.1% vs. 0.7% vs. 1.1%; p = 0.07), or in acute (<24-hour) stent thrombosis (0.3% in each group). At the 1-year follow-up, the results remained similar.
The authors concluded that among patients with AMI undergoing primary PCI, the use of bivalirudin with a median 3-hour postprocedure PCI-dose infusion resulted in a decrease in net adverse clinical events compared with both heparin alone and heparin plus tirofiban.
This study reports that the use of bivalirudin with a median 3-hour postprocedure PCI-dose infusion compared with both heparin alone and heparin plus tirofiban resulted in a decrease in net adverse clinical events at 30 days and 1 year. This was primarily due to a reduction in bleeding events with bivalirudin, without significant differences in the rates of major adverse cardiac or cerebral events or stent thrombosis. The overall body of evidence regarding anticoagulation for primary PCI suggests that as the degree of anticoagulation increases, the risk of thrombotic complications declines, but also increases the likelihood of bleeding complications. It seems reasonable that patients undergoing PCI have a tailored approach with regard to their antithrombotic regimen, taking into account both thrombotic and bleeding risk.
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