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- S1936879816313449-c7a635021cb40fb04b379204deb67e98Gian Battista Danzi, MD∗ ()
- ↵∗Ospedale Santa Corona, Division of Cardiology, Pietra Ligure (SV) 17027, Italy
In a recent paper, Mina et al. (1) presented an interesting meta-analysis of 8 randomized trials evaluating the safety and the efficacy of antithrombotic therapy according to the type of vascular access and vice versa. The investigators concluded that bivalirudin reduced the risk for major bleeding in patients who underwent femoral access but was ineffective in case of radial access. Analogously, radial access reduced the risk for bleeding among patients who received unfractionated heparin, but not bivalirudin.
However, the investigators did not formally assess the presence of treatment heterogeneity through interaction testing. As shown in Figure 1, although bivalirudin versus heparin significantly reduced the risk for major bleeding in patients with femoral access (odds ratio [OR]: 0.51; 95% confidence interval [CI]: 0.46 to 0.60) compared with radial access (OR: 0.75; 95% CI: 0.45 to 1.26), the test for interaction was not significant (p for interaction = 0.155). However, radial versus femoral access significantly reduced the risk for major bleeding in patients who received unfractionated heparin (OR: 0.57; 95% CI: 0.43 to 0.77), but not in those who received bivalirudin (OR: 0.96; 95% CI: 0.65 to 1.41), and, importantly, the test for interaction was significant (p interaction = 0.035). Therefore, a more nuanced interpretation would be that bivalirudin reduces the risk of major bleeding irrespective of the type of access, whilst radial access reduces the risk for major bleeding predominantly among patients receiving unfractionated heparin. Although apparently puzzling, this result is easily explained by the fact that bivalirudin decreases the risk for both access- and non-access-site bleeding, and therefore, its safety profile is not determined exclusively by the type of vascular access (2). Of course, radial access is only able to reduce access-site bleeding.
In addition, other considerations should guide the choice of vascular access and antithrombotic therapy. Radial compared with femoral access reduces the risk for mortality among patients with acute coronary syndrome (3), whereas the use of bivalirudin is associated with a higher risk for stent thrombosis, which is particularly increased among patients with acute myocardial infarctions and tends to be less pronounced among those pretreated with unfractionated heparin (4). Therefore, in clinical practice, it seems reasonable to prefer radial access over bivalirudin and to consider bivalirudin particularly in patients with failed or contraindicated radial access undergoing femoral procedures.
Please note: Dr. Danzi has reported that he has no relationships relevant to the contents of this paper to disclose.
- American College of Cardiology Foundation
- Mina G.S.,
- Gobrial G.F.,
- Modi K.,
- Dominic P.
- Piccolo R.,
- De Biase C.,
- D’Anna C.,
- Trimarco B.,
- Piscione F.,
- Galasso G.