Bivalirudin versus heparin in patients with or without bail-out GPI use: a pre-specified subgroup analysis
Pre-specified subgroup analysis published in BMC Med (2024)
Abstract
BACKGROUND: Conflicting results comparing bivalirudin versus heparin anticoagulation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), in part due to the confounding effect of glycoprotein IIb/IIIa inhibitors (GPI). The aim of the study was to compare the safety and effectiveness of bivalirudin plus a post-PCI high-dose infusion vs heparin with or without bail-out GPI use. METHODS: We conducted a pre-specified subgroup analysis from the BRIGHT-4 trial that randomized 6016 STEMI patients who underwent primary PCI to receive either bivalirudin plus a post-PCI high-dose infusion for 2-4 h or heparin monotherapy. GPI use was only reserved as bail-out therapy for procedural thrombotic complications. The primary outcome was a composite of all-cause death or Bleeding Academic Research Consortium (BARC) types 3-5 bleeding at 30 days. RESULTS: A total of 5250 (87.4%) patients received treatment without GPI while 758 (12.6%) received bail-out GPI. Bail-out GPI use was associated with an increased risk of the primary outcome compared to non-GPI use (5.28% vs. 3.41%; adjusted hazard ratio (aHR), 1.62; 95% confidence interval (CI), 1.13-2.33; P = 0.009) and all-cause death (5.01% vs. 3.12%; aHR, 1.74; 95% CI, 1.20-2.52; P = 0.004) but not in the risk of BARC types 3-5 bleeding (0.53% vs. 0.48%; aHR, 0.90; 95% CI, 0.31-2.66; P = 0.85). Among patients without GPI use, bivalirudin was associated with lower rates of the primary outcome (2.63% vs. 4.21%; aHR, 0.55; 95% CI, 0.39-0.77; P = 0.0005), all-cause death (2.52% vs. 3.74%; aHR, 0.58; 95% CI, 0.41-0.83; P = 0.003), and BARC types 3-5 bleeding (0.15% vs. 0.81%; aHR, 0.19; 95% CI, 0.06-0.57; P = 0.003) compared with heparin. However, among patients requiring bail-out GPI, there were no significant differences observed in the rates of the primary outcome (5.76% vs. 4.87%; aHR, 0.77; 95% CI, 0.36-1.66; P = 0.50; Pinteraction = 0.07) or its individual components between bivalirudin and heparin groups. CONCLUSIONS: Bivalirudin plus a post-PCI high-dose infusion was associated with significantly reduced 30-day composite rate of all-cause death or BARC types 3-5 bleeding compared with heparin monotherapy in STEMI patients undergoing primary PCI without GPI use. However, these benefits might be less pronounced in patients requiring bail-out GPI due to thrombotic complications during primary PCI. TRIAL REGISTRATION: ClinicalTrials.gov NCT03822975.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
Pre-specified subgroup analysis of bivalirudin versus heparin in patients with or without bail-out GPI use.
Why This Matters for Hirudotherapy
This pre-specified subgroup analysis from the BRIGHT-4 trial randomized 6,016 STEMI patients undergoing primary PCI to bivalirudin with post-PCI high-dose infusion versus heparin monotherapy, with glycoprotein IIb/IIIa inhibitors reserved only as bail-out therapy. Among patients not receiving bail-out GPI, bivalirudin was associated with significantly lower 30-day rates of the primary composite outcome (all-cause death or BARC types 3–5 bleeding), all-cause death, and major bleeding compared with heparin; benefits were less pronounced when bail-out GPI was required. Although MeSH terms include 'Hirudins,' the abstract itself does not discuss leeches, leech therapy, hirudin, or the leech secretome. No defensible hirudotherapy connection exists based on the abstract; the study evaluates a pharmaceutical anticoagulant in cardiovascular practice without reference to leeches or leech-derived substances.
Citation
Bivalirudin versus heparin in patients with or without bail-out GPI use: a pre-specified subgroup analysis.
Liao et al. · BMC medicine, 2024
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