The safety and effectiveness of bivalirudin in female patients with acute myocardial infarction undergoing primary angioplasty: A subgroup analysis of the BRIGHT trial
Randomized controlled trial published in Catheter Cardiovasc Interv (2016)
Abstract
BACKGROUND: Being female is an independent predictor of adverse events during percutaneous coronary interventions (PCI). OBJECTIVE: To evaluate the safety and efficiency of bivalirudin during emergency PCI in female patients with acute myocardial infarction (AMI). METHODS: The present study was a subgroup analysis of the randomized Bivalirudin in Acute Myocardial Infarction vs. Heparin and GPI plus Heparin (BRIGHT) trial. A total of 392 female patients enrolled in the BRIGHT trial were assigned to receive bivalirudin with post-procedure dose infusion (n = 127) or heparin with or without tirofiban (n = 265). The primary efficiency endpoint was 30-day net adverse clinical events (NACEs). The secondary efficiency endpoints were 30-day major cardiac and cerebral events (MACCEs) and bleeding events defined according to Bleeding Academic Research Consortium (BARC) definitions. RESULTS: For female patients, bivalirudin treatment was associated with significantly lower incidences of 30-day NACEs (6.3% vs. 21.5%, P < 0.001), any bleeding (2.4% vs. 12.8%, P = 0.001) and BARC 2-5 type bleeding (1.6% vs. 7.2%, P = 0.021) compared with the control regimen. The incidence of MACCEs (3.4% vs. 9.4%, P = 0.055) and stent thrombosis (0% vs. 1.1%, P = 0.229) were comparable between the two groups. Multivariate analysis showed that bivalirudin (OR: 0.245, 95% CI: 0.113-0.532, P < 0.001), transradial access (OR: 0.119, 95% CI: 0.067-0.211, P < 0.001), and statin (OR: 0.254, 95% CI: 0.08-0.807, P = 0.02) were independent protective factors for 30-day NACEs in female patients. CONCLUSIONS: The use of bivalirudin during emergency PCI for AMI in female patients significantly reduced the bleeding risk with anticoagulation effects compared with heparin with or without tirofiban.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
BRIGHT trial subgroup of 392 female patients showed bivalirudin reduced 30-day NACE 6.3% vs 21.5% with comparable MACCE rates.
Why This Matters for Hirudotherapy
This subgroup analysis of the randomized BRIGHT trial evaluated 392 female patients with acute myocardial infarction undergoing emergency percutaneous coronary intervention (PCI), comparing bivalirudin (n=127) with heparin with or without tirofiban (n=265). Bivalirudin, a direct thrombin inhibitor derived from the medicinal-leech anticoagulant hirudin, is of direct interest to hirudotherapy and ASH because it represents a pharmacological application of the leech secretome in modern anticoagulation. The study found bivalirudin was associated with significantly lower 30-day net adverse clinical events (6.3% vs. 21.5%) and bleeding rates, while major cardiac and cerebral events and stent thrombosis were comparable between groups. However, as a subgroup analysis of female patients from a single trial, the findings are hypothesis-generating rather than definitive and should be interpreted with caution.
Citation
The safety and effectiveness of bivalirudin in female patients with acute myocardial infarction undergoing primary angioplasty: A subgroup analysis of the BRIGHT trial.
Liang Z et al. · Catheter Cardiovasc Interv, 2016
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