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Studies have shown a reduction in major bleeding with trans-radial intervention (TRI) compared with trans-femoral intervention (TFI), and with use of bivalirudin compared with heparin + glycoprotein IIb/IIIa inhibitors (GPI). We compared major bleeding and mortality in Veterans stratified by arterial access site and anticoagulation strategy.
A retrospective cohort of 1192 consecutive patients who underwent PCI at a VA hospital between 2006 and 2012 was divided into TFI-heparin (n=192), TFI-bivalirudin (n=272), TRI-heparin (n=274) and TRI-bivalirudin (n=454) groups. Primary outcomes were in-hospital major bleeding and in-hospital and 1 year all-cause mortality. Secondary outcomes included in-hospital and 1 year MI, MACE and NACE (net adverse cardiovascular events; composite of major bleeding and MACE).
Predictors of major bleeding were femoral access site (OR 8.33, p< 0.007), age > 70 (OR 4.08, p< 0.009), Cr> 1.3 (OR 4.81, p< 0.004) and STEMI (OR 6.84, p< 0.009). Radial access (OR 0.12, p< 0.007) and bivalirudin (OR 0.30, p< 0.05) were associated with a significant reduction in major bleeding. There was no significant difference in the effect of bivalirudin on major bleeding between the radial and femoral groups, whereas heparin showed significantly greater major bleeding in the femoral group compared with the radial group. Severe anemia at baseline strongly predicted in-hospital all-cause mortality (OR 27.62, p < 0.008). All categories of anemia were associated with 1 year all-cause mortality. The combination of radial access and heparin was associated with a lower incidence of 1-year NACE (HR 0.38, p < 0.05).
There is a differential effect of heparin and bivalirudin on major bleeding depending on PCI access site. Bivalirudin lowers major bleeding compared with heparin only with femoral but not with radial access. There is no incremental reduction in major bleeding with a combination of radial access and bivalirudin. TRI lowers major bleeding compared with TFI, but does not impact in-patient or 1 year MACE and mortality. The combination of radial access and heparin had a synergistic effect in lowering 1 year NACE in this study. Severe anemia at baseline is strongly associated with increased in-patient and 1 year all-cause mortality post PCI.