Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction
Systematic review published in Cardiovasc Revasc Med (2024)
Abstract
BACKGROUND: The registry-based randomized VALIDATE-SWEDEHEART trial (NCT02311231) compared bivalirudin vs. heparin in patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction (MI). It showed no difference in the composite primary endpoint of death, MI, or major bleeding at 180 days. Here, we report outcomes at two years. METHODS: Analysis of primary and secondary endpoints at two years of follow-up was prespecified in the study protocol. We report the study results for the extended follow-up time here. RESULTS: In total, 6006 patients were enrolled, 3005 with ST-segment elevation MI (STEMI) and 3001 with Non-STEMI (NSTEMI), representing 70 % of all eligible patients with these diagnoses during the study. The primary endpoint occurred in 14.0 % (421 of 3004) in the bivalirudin group compared with 14.3 % (429 of 3002) in the heparin group (hazard ratio [HR] 0.97; 95 % confidence interval [CI], 0.85-1.11; P = 0.70) at one year and in 16.7 % (503 of 3004) compared with 17.1 % (514 of 3002), (HR 0.97; 95 % CI, 0.96-1.10; P = 0.66) at two years. The results were consistent in patients with STEMI and NSTEMI and across major subgroups. CONCLUSIONS: Until the two-year follow-up, there were no differences in endpoints between patients with MI undergoing PCI and allocated to bivalirudin compared with those allocated to heparin. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02311231.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
Bivalirudin (leech-derived) versus heparin systematic review across STEMI and NSTEMI populations.
Why This Matters for Hirudotherapy
This registry-based randomized VALIDATE-SWEDEHEART trial enrolled 6006 patients undergoing PCI for STEMI or NSTEMI and found no significant difference between bivalirudin and heparin in the composite primary endpoint of death, MI, or major bleeding at two years (16.7% vs 17.1%; HR 0.97; 95% CI 0.96-1.10; P=0.66), with consistent results across STEMI/NSTEMI subgroups. Bivalirudin is a direct thrombin inhibitor modeled on hirudin, the anticoagulant originally isolated from medicinal leech saliva, so this large trial directly informs the clinical cardiovascular efficacy of a hirudin-derived pharmaceutical relative to standard care. For ASH, it provides high-quality evidence on how a leech-secretome-inspired anticoagulant performs in a major thrombotic setting, even though the result here was one of non-inferiority rather than superiority. The important caveat is that the study evaluates the synthetic analog bivalirudin, not live hirudotherapy or the broader leech secretome, which contains numerous additional bioactive compounds not assessed in this comparison.
Citation
Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction.
Omerovic et al. · Cardiovascular revascularization medicine, 2024
Added to ASH library: May 27, 2026 · Site last updated: June 18, 2026