Efficacy and safety of bivalirudin in percutaneous coronary intervention for coronary bifurcation lesions

Abstract

Objective To investigate the efficacy and safety of bivalirudin in percutaneous coronary intervention (PCI) for coronary bifurcation lesions. Methods This retrospective cohort study was conducted among 329 consecutive patients with coronary artery bifurcation lesions confirmed by coronary angiography and underwent PCI in our institute between January, 2016 and December, 2016. All the patients received anticoagulation treatment with bivalirudin (151 cases) or heparin (178 cases). The demographic and clinical data of the patients (including gender, age, and risk factors) and the conditions of the coronary artery lesions were compared between the 2 groups. In 24 h, 7 d and 12 months after the procedure, the incidences of main adverse cardiovascular events (MACE, including death, myocardial infarction, revascularization of the target vessel, and stroke) and bleeding were recorded after PCI. The bleeding endpoint was assessed in line with the BARC criteria for grading bleeding. Results No significant differences were found between the 2 groups in the baseline data (including the demographic data, medical history, proportion of acute coronary syndrome, important laboratory indicators, and drug treatment), nor in the characteristics of bifurcation lesions (including the lesion position, lesion type, true bifurcation ratio, length and diameter of the main branches and the branch vessels). In 24 h and 1 week after PCI, no MACE occurred in both groups. Bleeding and observed in 3 cases of the heparin group, but no major bleeding event was seen. In the bivalirudin group, there were 5 cases experiencing bleeding and 1 having major bleeding event. But no significant differonce was seen between the 2 groups (P=0.447, P=0.459). Within 12 months after PCI, MACE occurred in 20 patients in the heparin group and in 15 patients in the bivalirudin group. Multivariate analysis showed that bivalirudin did not significantly affect the incidence of MACE after PCI compared with heparin (HR=0.839, 95%CI: 0.420-1.676, P=0.619). During the 12-month follow-up, 49 patients in the heparin group had bleeding events (including major bleeding events in 6 patients), as compared with 27 patients in the bivalirudin group (including 3 major bleeding events). Multivariate analysis further showed that compared with heparin, bivalirudin significantly reduced the risk of bleeding events in patients with bifurcation lesions after PCI (HR=0.557, 95%CI: 0.355-0.937, P=0.026), but did not significantly affect the risk of major bleeding events (HR=0.535, 95%CI: 0.130-2.206, P=0.387). Conclusion In patients undergoing PCI for coronary bifurcation lesions, anticoagulation therapy with bivalirudin significantly reduces the risk of bleeding as compared with unfractionated heparin without increasing the incidences of MACE at 12 months after PCI.

Keywords

• bivalirudin
• coronary artery disease
• percutaneous coronary intervention
• heparin