Decreased bleeding with radial access leaves little to bivalirudin for additional benefit

Original title: Bivalirudin or heparin in primary angioplasty performed through the transradial approach: results from a multicentre registry. Reference: Sciahbasi A et al. Eur Heart J: Acute Cardiovasc Care. Epub ahead of print.

Bivalirudin benefit has been demonstrated in terms of bleeding; however when primary angioplasty is performed by radial access this information is not clear. To get an idea of this, in the HORIZONS study only 5% of patients were performed by radial access. This study retrospectively evaluated 1009 patients undergoing primary angioplasty by radial access between January 2008 and June 2013. Patients were divided into two groups according to the use or bivalirudin. The primary end point of the study was major bleeding and major cardiovascular events at 30 days. 

At surgeon discretion provisionally, bivalirudin (n = 159) or heparin plus glycoprotein inhibitors IIb IIIa (n = 855) were used. Using glycoprotein inhibitors in bivalirudin group was 4 % versus 55 % in the heparin group (p <0.001). Procedure characteristics were similar between both groups (door ball, number of stents, total stent length, or use of thromboaspiration). At 30 days, no differences between those who received bivalirudin or heparin regarding mayor bleeding (0.65 % for bivalirudin versus 1.17 % for heparin; p = 0.88) minor bleeding (1.3% versus 1.5% respectively; p=0.83) or major cardiovascular events (7.1 % versus 10.4 % respectively, p = 0.27). Mortality at 30 days was 3.9 % in the bivalirudin group and 5.4 % in the heparin group (p = 0.56).

Conclusion

This register of primary angioplasty by radial access, bivalirudin did not demonstrate a significant reduction in major bleeding or major cardiovascular events compared with heparin plus glycoprotein provisionally.

Editorial comment

The lack of randomization and the relatively few patients receiving bivalirudin (only 159 of 1009) are significant limitations of the study. Overall, bleeding complications were uncommon, which can be explained by 100% of radial access. Only provisional use of glycoprotein in the heparin group (55 %) may also have contributed and is well below the use thereof in randomized studies. About half of the bleeding is not related to the access, so that bivalirudin still has a large population to benefit even using radial access. However, the use must be more selective given the risk of bleeding in each patient.

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