Abstract 2654: Major Bleeding in Patients with Acute Coronary Syndrome Undergoing Early Invasive Management Can Be Reduced by Fondaparinux, Even in the Context of Trans-Radial Coronary Intervention: Insights from OASIS-5 Trial
Background The use of combined antithrombotic therapies and routine invasive procedures in acute coronary syndromes (ACS) has decreased the risk of ischemic events substantially but is associated with a significant increase in bleeding risk. Recently, fondaparinux has been shown to be an alternative to enoxaparin in this setting because it preserves efficacy and by significantly reducing major bleeding provides for better long-term event-free survival.
Objectives The aim of this subanalysis was to examine the impact of the transradial approach (TRA), in comparison to the trans-femoral approach (TFA), on PCI-related bleeding and patients’ outcomes in a contemporary pharmacological environment in the 7678 patients with ACS who underwent PCI in the OASIS-5 trial.
Methods In OASIS-5, patients with ACS were randomly assigned to receive either fondaparinux (2.5 mg daily) or enoxaparin (1 mg per Kg twice daily) for a mean of 6 days. We compared patients according to the arterial access site. The primary outcome (death, myocardial infarction, refractory ischemia) and major bleeding and their combination were evaluated in the two groups at 9 days. Patients were followed up for up to six months.
Results Similar primary-outcome events were observed at 9 days whatever the arterial access site used in PCI (7.7% in 7,013 TFA and 7.1% in 872 TRA, NS). However, major bleeding was significantly decreased in patients who underwent PCI with TRA by comparison to TFA (1.6% vs 3.5%, p<0.003, respectively). No difference between patients treated by fondaparinux or enoxaparin was noted for ischemic events at 9 days according to the access site. The rate of major bleeding at 9 days was markedly reduced with fondaparinux when compared to enoxaparin for both access sites (from 4.8% to 2.3%, HR 0.48 [0.37– 0.62], p< 0.0001 for TFA and from 2.4 to 0.9%, HR 0.36 [0.11- 1.16], p<0.08 for TRA).
Conclusions TRA substantially reduces PCI-related bleeding in current contemporary pharmacological environment in comparison to TFA. However, even in the context of low access site complication rate provided by TRA, fondaparinux was markedly effective in reducing major bleeding while maintaining similar ischemic event rate as compared to enoxaparin.