Bivalirudin vs heparin anticoagulation in STEMI: confirmation of the BRIGHT-4 results
Individual patient data meta-analysis of randomized controlled trials published in Journal of the American College of Cardiology (2024)
Abstract
BACKGROUND: In the BRIGHT-4 (Bivalirudin With Prolonged Full-Dose Infusion During Primary PCI Versus Heparin Trial-4), anticoagulation with bivalirudin plus a 2- to 4-hour high-dose infusion after percutaneous coronary intervention (PCI) reduced all-cause mortality and bleeding without increasing reinfarction or stent thrombosis compared with heparin alone in patients with ST-segment elevation myocardial infarction (STEMI). These findings require external validation. OBJECTIVES: This study sought to determine outcomes of bivalirudin vs heparin anticoagulation during PCI in STEMI. METHODS: We performed an individual-patient-data meta-analysis of all large randomized trials of bivalirudin vs heparin in STEMI patients undergoing primary PCI performed before BRIGHT-4. The primary endpoint was all-cause mortality. RESULTS: Six trials randomizing 15,254 patients were included. Pooled across all regimens of bivalirudin and glycoprotein IIb/IIIa inhibitor (GPI) use, bivalirudin reduced 30-day all-cause mortality (2.5% vs 2.9%; adjusted OR: 0.78; 95% CI: 0.62-0.99), cardiac mortality (adjusted OR: 0.69; 95% CI: 0.54-0.88), and major bleeding (adjusted OR: 0.53; 95% CI: 0.44-0.64) but increased reinfarction (adjusted OR: 1.30; 95% CI: 1.02-1.65) and stent thrombosis (adjusted OR: 1.43; 95% CI: 1.05-1.93) compared with heparin. In 4 trials in which 6,244 patients were randomized to bivalirudin plus a high-dose post-PCI infusion vs heparin without planned GPI use (the BRIGHT-4 regimens), 30-day all-cause mortality occurred in 1.8% vs 2.9% of patients, respectively (adjusted OR: 0.74; 95% CI: 0.48-1.12), and bivalirudin reduced cardiac mortality (adjusted OR: 0.62; 95% CI: 0.39-0.97) and major bleeding (adjusted OR: 0.49; 95% CI: 0.35-0.70), with similar rates of reinfarction (adjusted OR: 0.89; 95% CI: 0.58-1.38) and stent thrombosis (adjusted OR: 0.80; 95% CI: 0.41-1.57). CONCLUSIONS: In STEMI patients undergoing primary PCI, bivalirudin with a 2- to 4-hour post-PCI high-dose infusion reduced cardiac mortality and major bleeding without an increase in ischemic events compared with heparin monotherapy with provisional GPI use, confirming the BRIGHT-4 results.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
An individual patient-data meta-analysis of six randomized STEMI trials (15,254 patients) found bivalirudin reduced mortality and major bleeding but increased reinfarction and stent thrombosis. In 4 trials with a post-PCI high-dose infusion (6,244 patients), bivalirudin also reduced cardiac mortality and bleeding without more ischemic events.
Why This Matters for Hirudotherapy
This individual-patient-data meta-analysis of six large randomized trials compares bivalirudin to heparin for anticoagulation during primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction, finding reduced cardiac mortality and major bleeding with bivalirudin plus a post-PCI high-dose infusion. While bivalirudin is listed under the MeSH heading 'Hirudins,' the abstract provides no supporting discussion of this classification. Bivalirudin (formerly Hirulog) is a synthetic peptide anticoagulant designed partly on the C-terminal sequence of hirudin, the anticoagulant of the medicinal leech (Maraganore et al., 1990); this paper studies the drug, not leech therapy.
Citation
Reference (Vancouver style)
Stone GW, Valgimigli M, Erlinge D, Han Y, Steg PG, Stables RH, et al. Bivalirudin vs heparin anticoagulation in STEMI: confirmation of the BRIGHT-4 results. J Am Coll Cardiol. 2024;84(16):1512-1524. doi:10.1016/j.jacc.2024.07.045. PMID: 39384262
Bibliographic details (authors, volume, pages, DOI) are taken from the PubMed record.
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