Written by Katrina Mountford, Medical Editor.
19th March 2018
The Bivalirudin vs. Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy (VALIDATE-SWEDEHEART) is a multicentre, randomised, registry-based, open-label clinical trial that compared the efficacy of anticoagulation strategies in patients with acute myocardial infarction who were undergoing percutaneous coronary intervention (PCI) according to current practice. This included the mandatory use of potent P2Y12 inhibitors prior to PCI, recommended low dose of heparin prior to randomisation, no planned use of glycoprotein IIb/IIIa inhibitors (GPI) and preferred radial access. The patients were randomly assigned to receive bivalirudin (n=3,005) or heparin (n=3,001) during PCI. The primary endpoint was a composite of death from any cause, myocardial infarction, or major bleeding during 180-days of follow-up. At 180-days, the primary endpoint had occurred in 12.3 % of the patients in the bivalirudin group and in 12.8 % of the heparin group (hazard ratio [HR] 0.96, p=0.54).1 Of the patients treated, radial access was used in 5,424, while femoral access was used in 524.
Dr Omerovic presented data from a pre-specified subgroup analysis, which aimed to assess whether the choice of access site (radial or femoral) had an impact on the primary and secondary endpoints. At 180-days, the primary endpoint occurred in fewer patients in whom radial access was used compared with femoral access (adjusted HR 0.66, p<0.001). There were significant differences in mortality (adjusted HR 0.42, p<0.001) and bleeding events (HR 0.57, p<0.001) although the latter was driven mostly by incidence of access site bleeding. Bivalirudin was not associated with less bleeding irrespective of access site. Dr Omerovic concluded that the totality of evidence supports the use of transradial PCI as the default access strategy in acute coronary syndrome.
The presentation prompted a lively debate among the audience about the benefits and limitations of the transradial approach, with some people considering that further study was needed.
1. Erlinge D, Omerovic E, Frobert O, et al., Bivalirudin versus Heparin Monotherapy in Myocardial Infarction, N Engl J Med, 2017;377:1132-42.