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Bivalirudin Efficacy and Radial Access
Study Questions:
What is the relative impact of bivalirudin on bleeding outcomes associated with transradial interventions in real-world practice?
Methods:
Data for patients undergoing percutaneous coronary intervention (PCI) between January 2010 and March 2014 at the 47 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) were utilized. Propensity matching was used within cohorts defined by access site. The impact of bivalirudin use on in-hospital outcomes was evaluated with Fisher’s exact tests.
Results:
Among patients undergoing transfemoral interventions, use of bivalirudin was associated with a reduction in bleeding compared with both glycoprotein IIb/IIIa inhibitors (1.67 vs. 3.46%; absolute risk reduction (ARR), 1.79%; odds ratio [OR], 0.47; confidence interval, CI 0.41-0.54; number needed to treat [NNT], 56; p < 0.001) and heparin (1.26 vs. 1.76%; ARR, 0.5%; OR, 0.71; CI, 0.61-0.82; NNT, 197; p < 0.001). Among patients undergoing transradial intervention, there was a more modest absolute reduction in bleeding with bivalirudin compared with glycoprotein IIb/IIIa inhibitors (0.79 vs. 1.41%; ARR, 0.62%; OR, 0.56; CI, 0.34-0.90; NNT, 161; p = 0.016) and no difference in bleeding compared with heparin (0.46 vs. 0.46%; OR, 1; CI, 0.54-1.84; p = 1).
Conclusions:
The authors concluded that reduction in bleeding associated with bivalirudin use is minimal to absent in patients undergoing transradial interventions.
Perspective:
This registry study reports that the bleeding avoidance benefit previously seen with use of bivalirudin during femoral PCI is markedly attenuated during radial PCI. Furthermore, it appears that there is no difference in bleeding outcomes when heparin monotherapy is used in place of bivalirudin during radial PCI. The results are discordant with the large randomized, multicenter, MATRIX trial, which reported that the use of radial or femoral access, which was randomly assigned, did not prove to be an effect modifier in the bivalirudin group for any of the major outcomes. Based on totality of evidence, it appears reasonable that given its lower cost, heparin should be the preferred anticoagulation strategy in those undergoing radial PCI.
Keywords: Anticoagulants, Antithrombins, Femoral Artery, Heparin, Hirudins, Numbers Needed To Treat, Peptide Fragments, Percutaneous Coronary Intervention, Platelet Glycoprotein GPIIb-IIIa Complex, Radial Artery
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