Impact of sex on comparative outcomes of bivalirudin versus unfractionated heparin in patients with acute coronary syndromes undergoing invasive management: a pre-specified analysis of the MATRIX trial
Randomized controlled trial published in EuroIntervention (2019)
Abstract
AIMS: Our aim was to assess whether bivalirudin compared with unfractionated heparin (UFH) is associated with consistent outcomes in males and females with acute coronary syndrome (ACS) undergoing invasive management. METHODS AND RESULTS: In the MATRIX programme, 7,213 patients were randomised to bivalirudin or UFH. Patients in the bivalirudin group were subsequently randomly assigned to receive or not a post-PCI bivalirudin infusion. The 30-day co-primary outcomes were major adverse cardiovascular events (MACE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACE or major bleeding. The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target vessel revascularisation (TVR), definite stent thrombosis (ST), or NACE. The rate of MACE was not significantly lower with bivalirudin than with heparin in male (rate ratio [RR] 0.90, 95% confidence interval [CI]: 0.75-1.07; p=0.22) and female patients (RR 1.06, 95% CI: 0.80-1.40; p=0.67) without significant interaction (pint=0.31), nor was the rate of NACE (males: RR 0.85, 95% CI: 0.72-1.01; p=0.07; females: RR 0.98, 95% CI: 0.76-1.28; p=0.91; pint=0.38). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent TVR, definite ST, or NACE (males: RR 0.84, 95% CI: 0.66-1.07; p=0.15; females: RR 1.06, 95% CI: 0.74-1.53; p=0.74; pint=0.28). CONCLUSIONS: In ACS patients, the rates of MACE and NACE were not significantly lower with bivalirudin than with UFH in both sexes. The rate of the composite of urgent TVR, definite ST, or NACE was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion in both sexes.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
Our aim was to assess whether bivalirudin compared with unfractionated heparin (UFH) is associated with consistent outcomes in males and females with acute coronary syndrome (ACS) undergoing invasive management.
Why This Matters for Hirudotherapy
This analysis from the MATRIX trial evaluated whether outcomes with bivalirudin versus unfractionated heparin were consistent across sexes in 7,213 acute coronary syndrome patients undergoing invasive management. No significant sex-based differences were found: bivalirudin did not significantly reduce major adverse cardiovascular events or net adverse clinical events compared to heparin in either males or females, nor did post-PCI bivalirudin infusion significantly improve the composite of urgent target vessel revascularization, definite stent thrombosis, or net adverse clinical events in either sex. The abstract contains no reference to leeches, hirudin, or leech-derived products, and provides no basis for any connection to hirudotherapy or the leech secretome. This clinical cardiology study has no demonstrable relevance to ASH's domain.
Citation
Impact of sex on comparative outcomes of bivalirudin versus unfractionated heparin in patients with acute coronary syndromes undergoing invasive management: a pre-specified analysis of the MATRIX trial.
Gargiulo G et al. · EuroIntervention, 2019
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