A study has found that bivalirudin use during percutaneous coronary intervention (PCI) is associated with less composite bleeding when compared with unfractionated heparin monotherapy, in patients with non-ST segment-elevation acute coronary syndromes or stable ischaemic heart disease.
The study authors, led by Sripal Bangalore (Cardiovascular Clinical Research Center, New York University School of Medicine, New York, USA) say that what is known about the benefits of bivalirudin in reducing bleeding is based on research among patients with ST-segment-elevation myocardial infarction (STEMI) or from studies in which bivalirudin was compared with unfractionated heparin plus glycoprotein IIb/IIIa.
Writing in Circulation Cardiovascular Interventions, Bangalore et al comment that their own study has now shown that these benefits may extend to more patients: “Use of bivalirudin during PCI was associated with a significant reduction in the risk of bleeding without a significant increase in ischaemic outcomes, including stent thrombosis, when compared with unfractionated heparin monotherapy, in either patients with stable ischaemic heart disease or patients with non-ST segment-elevation acute coronary syndromes. These associations should be tested in future randomised controlled trials.”
The researchers collected data prospectively from a population of patients enrolled in the EVENT (Evaluation of drug-eluting stents and ischemic events) registry, and focused on the outcomes of in-hospital composite bleeding (defined as clinically important access site bleeding, thrombolysis in myocardial infarction major or minor bleeding, or transfusion), primary ischaemic outcomes (in-hospital death, myocardial infarction), and secondary ischaemic outcomes (death, myocardial infarction, unplanned repeat revascularisation at 12 months). After propensity score matching, 1,036 patients with non-ST segment-elevation acute coronary syndromes and 2,062 patients with stable stable ischaemic heart disease were studied.
The researchers found that for the non-ST segment-elevation acute coronary syndromes cohort, bivalirudin use was associated with a 55% reduction in composite bleeding when compared with unfractionated heparin monotherapy, without increase in primary or secondary ischaemic outcomes. In the stable ischaemic heart disease cohort, bivalirudin use was associated with a 50% reduction in composite bleeding when compared with unfractionated heparin monotherapy, without increase in primary or secondary ischaemic outcomes.
They conclude: “These results suggest that treatment of 30 patients with non-ST segment-elevation acute coronary syndromes or 53 patients with stable ischaemic heart disease with bivalirudin will prevent one bleeding event, with no statistically significant increase in the risk of ischaemic complications including stent thrombosis, when compared with unfractionated heparin monotherapy.”
They comment that because the study used data derived from a registry with prospective follow-up of patients, it should be regarded as “hypothesis generating”, but point out that it involved a “real-world cohort of patients undergoing PCI using contemporary devices, procedures and pharmacotherapy”.
