1. Bivalirudin during percutaneous coronary intervention plus high-dose infusion after demonstrated decreased all-cause mortality compared to heparin monotherapy.
2. Risk of major bleeding was marginally greater in the heparin monotherapy group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Percutaneous coronary intervention (PCI) is used as first-line treatment in patients with ST-segment elevation myocardial infarction (STEMI). Although studies show that bivalirudin, a direct-acting thrombin inhibitor, may be used to reduce bleeding, there has been conflicting evidence with differences in methodology. This randomized trial aimed to compare the safety and efficacy of bivalirudin versus heparin monotherapy in patients with ST-segment elevated myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). The primary outcome was a composite of all-cause mortality and major bleeding, as defined by Bleeding Academic Research Consortium (BARC) types 3-5. Patients were randomly assigned to either intervention group and received bivalirudin with a post-PCI high-dose infusion or unfractionated heparin monotherapy. According to study results, patients randomized to bivalirudin demonstrated significantly decreased all-cause mortality and major bleeding at 30 days. This study was strengthened by a large sample size, adding to its validity.
Relevant Reading: Bivalirudin versus Heparin Monotherapy in Myocardial Infarction
In-depth [randomized-controlled trial]: Between Feb 14, 2019, and Apr 7, 2022, 6016 patients were assigned from 87 clinical sites in China. Included were patients undergoing primary percutaneous coronary intervention (PCI) within 48 hours of STEMI who were not on any anticoagulants, fibrinolytic therapy, or glycoprotein IIb/IIIa inhibitors. Altogether, 6016 patients (3009 to bivalirudin plus high-dose infusion after PCI and 3007 to heparin monotherapy) were included in the final analysis. The primary outcome composite of all-cause mortality and major bleeding at 30 days was significantly decreased in the bivalirudin group compared to the heparin monotherapy group (3.06% vs. 4.39%, respectively, hazard ratio [HR] 0.69, 95% confidence interval [CI] 0.53-0.91, p=0.0070). Although stent thrombosis was more common in the heparin group (n=33, 1.10%) than bivalirudin (n=11, 0.37%), no significant differences occurred concerning reinfarction, stroke, or target vessel revascularization. Findings from this study suggest that treatment with bivalirudin plus high-dose infusion post-PCI may reduce mortality and major bleeding in patients with recent STEMI.
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