Original title: Comparison of bivalirudin and radial access across a spectrum of preprocedural risk of bleeding in percutaneous coronary intervention: Analysis from the National Cardiovascular Data Registry. Reference: Baklanov DV et al. Circ Cardiovasc Interv. 2013, article in press.
Bleeding complications are clearly associated to mortality increase and two of the current best strategies to reduce bleeding are the transradial access and the use of bivalirudin. Despite the evidence that separately has proved them successful, the combination of these two strategies has not been thoroughly studied.
This study looked at the association between access site, bivalirudin and periprocedural bleeding in 501.017 patients included in the National Registry of Angioplasty between the years 2009 and 2012. Radially approached patients receiving heparin (n=63.037) were compared to patients receiving bivalirudin (n=55.188). Femoral access patients who received bivalirudin and a vascular closure device served as a reference group (n=382.792).
Global bleeding rate was 2.59%. Considering each of the groups separately, this complication presented in 2.71% of femoral accessed patients, 2.5% of transradial accessed patients with heparin and 1.82% of the radial-bivalirudin combination group (p>0.0001). There were no differences among the groups for death, periprocedural infarction or stroke.
Inverse probability weighting analysis incorporating propensity scores found the risk of bleeding was significantly lower for patients in the radial-bivalirudin group, but not in the radial-heparin group, compared with the femoral group. The radial-bivalirudin combination reduced all types of bleeding with a number needed to treat (NNT) of 561 in low risk patients, 253 in medium-risk, and 68 in high-risk patients.
Conclusion:
In this observational analysis, the combination of bivalirudin and transradial access was associated with a reduction of bleeding risk. This benefit was observed in all patients beyond basal bleeding risk.
Editorial Comment:
Transradial access can create a false sense of safety that could result in indiscriminate use of IIBIIIA glycoprotein inhibitors and heparin; we should remember that this access reduces puncture site bleeding alone, which is approximately 50% of cases. On the other hand, femoral access advocates may feel confident using bivalirudin combined with closure devices. However, not even this combination matches transradial access results, let alone costs. Probably, the most rational thing to do would be to adopt the transradial approach for all patients and reserve bivalirudin for those at highest risk of bleeding.
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