BRIGHT-4: Is Bivalirudin Poised for a Comeback in STEMI PCI

The study was published online in The Lancet on November. BRIGHT-4 was an investigator-initiated, open-label, randomised controlled trial in China. 6016 patients with STEMI undergoing primary PCI were randomly assigned to receive either bivalirudin plus a high-dose infusion after PCI or unfractionated heparin monotherapy. Patients with STEMI undergoing primary PCI with radial artery access within 48 h of symptom onset who had not received previous fibrinolytic therapy, anticoagulants, or glycoprotein IIb/IIIa inhibitors were randomly assigned (1:1) to receive bivalirudin with a post-PCI high-dose infusion for 2–4 h or unfractionated heparin monotherapy.

Results show that a bivalirudin reduced all-cause mortality or major bleeding at 30 days to 31% (hazard ratio [HR], 0.69; 95% CI 0.53–0.91; P = 0.007). All-cause mortality within 30 days occurred in 118 (3·92%) heparin-assigned patients and in 89 (2.96%) bivalirudin-assigned patients (HR 0.75; 95% CI 0.57–0.99; p=0.0420), and BARC types 3–5 bleeding occurred in 24 (0.80%) heparin-assigned patients and five (0.17%) bivalirudin-assigned patients (HR 0.21; 95% CI 0.08–0.54; p=0.0014). There were no significant differences in the 30-day rates of reinfarction, stroke, or ischaemia-driven target vessel revascularisation between the groups. Within 30 days, stent thrombosis occurred in 11 (0.37%) of bivalirudin-assigned patients and 33 (1.10%) of heparin-assigned patients (p=0.0015).

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