Key result
Bivalirudin shows no mortality benefit over heparin plus GPIs during primary PCI for STEMI.
Why the study?
Does bivalirudin reduce mortality compared to heparin plus glycoprotein inhibitors in patients undergoing primary PCI for STEMI?
Observational (n=61,136)
Yes
Does bivalirudin reduce mortality compared to heparin plus glycoprotein inhibitors in patients undergoing primary PCI for STEMI?
Odds Ratio: 1
In a large national registry of primary PCI for STEMI, bivalirudin was not associated with a mortality benefit compared to heparin plus glycoprotein inhibitors.
Bivalirudin shows no mortality benefit versus heparin plus glycoprotein inhibitors in observational STEMI PCI data; leaves open the need for randomized confirmation.
AIMS: The HORIZONS trial reported a survival advantage for bivalirudin over heparin-with-glycoprotein inhibitors (GPIs) in primary PCI for ST elevation myocardial infarction. This drove an international shift in clinical practice. Subsequent studies have produced divergent findings on mortality benefits with bivalirudin. We investigated this issue in a larger population than studied in any of these trials, using the United Kingdom national PCI registry. METHODS AND RESULTS: 61 136 primary PCI procedures were performed between January 2008 and January 2012. Demographic and procedural data were obtained from the registry. Mortality information was obtained through the UK Office of National Statistics. Multivariable logistic regression and propensity analysis modelling were utilized to study the association of different anti-thrombotic strategies with outcomes. Unadjusted data demonstrated near-identical survival curves for bivalirudin and heparin-plus-GPI groups. Significantly higher early and late mortality was found in patients treated with heparin alone ( ITALIC! P < 0.0001) but this group had a markedly higher baseline risk. After propensity matching, the bivalirudin vs. heparin-plus-GPI groups still demonstrated very similar adjusted mortality (odds ratio 1.00 at 30 days, and 0.96 at 1 year). Patients treated with heparin alone continued to show higher mortality after adjustment, although effect size was considerably diminished (odds ratio vs. other groups 1.17-1.24 at 30 days). CONCLUSIONS: Analysis of recent UK data showed no significant difference in short- or medium-term mortality between ST elevation myocardial infarction patients treated with bivalirudin vs. heparin-plus-GPI at primary PCI.
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Sirker et al. (2015) conducted an observational in ST elevation myocardial infarction (n=61,136). Bivalirudin vs. Heparin plus glycoprotein inhibitors (GPIs) was evaluated on 30-day mortality (OR 1.00). Bivalirudin use during primary PCI for STEMI was associated with similar adjusted 30-day (OR 1.00) and 1-year (OR 0.96) mortality compared to heparin plus glycoprotein inhibitors.
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