Bivalirudin versus unfractionated heparin during percutaneous coronary intervention in high-bleeding-risk patients with acute coronary syndrome in contemporary practice

Background: Bivalirudin, as compared with unfractionated heparin (UFH), has been shown to reduce bleeding complications and supply a better safety profile among low/medium-bleeding-risk patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) in some previous studies. Whether this advantage persists in patients at high risk of bleeding according to contemporary practice characterized by frequent use of radial-artery access and novel P2Y(12) inhibitors, and low use of glycoprotein IIb/IIIa inhibitors (GPIs) is unclear. Aim of the study: This study aimed to assess the efficacy and safety of bivalirudin compared with UFH in high bleeding risk patients with ACS undergoing PCI in current practice. Materials and methods: All consecutive high-bleeding-risk patients who underwent PCI for ACS at the First Affiliated Hospital of Zhengzhou University from January to September 2019 were retrospectively analyzed. The 30-day primary outcome was a composite of major bleeding, myocardial infarction, all-cause death, or stroke (net adverse clinical events [NACEs]), and the secondary outcomes at 30 days included a composite of myocardial infarction, stoke, or all-cause death (major adverse cardiovascular events [MACEs]), each component of the primary outcome, target vessel revascularization (TVR) and stent thrombosis (ST). Besides, we assessed angina-related health status at 30 days, the length of hospital stay, and hospitalization costs. A logistic regression model was used to adjust for baseline differences. Consistency of the treatment effect of bivalirudin for NACEs and MACEs compared with UFH was evaluated in 15 prespecified subgroups. Results: From January to September 2019, 823 patients (361 treated with bivalirudin and 462 treated with UFH) were enrolled in the study. GPIs, novel P2Y(12) inhibitors, and radial approach was used in 5.6 %, 66.1 %, and 89.7 % of the patients, respectively. After adjusting for baseline differences, bivalirudin was associated with significant reduction in NACEs, MACEs, major bleeding, and myocardial infarction at 30 days compared with UFH. The individual endpoints of death, stroke, ST and TVR did not differ significantly between the 2 groups after adjusting for covariates. Furthermore, bivalirudin consistently reduced the rates of NACEs and MACEs in the 15 prespecified subgroups compared with UFH. These benefits of bivalirudin can translate into improved angina-related health status, shorter hospital stays, and lower hospitalization costs. Conclusions: The treatment of bivalirudin showed better efficacy and safety as compared to UFH among patients with ACS undergoing PCI at high risk of bleeding in contemporary practice.