Abstract
Low/medium-bleeding-risk populations undergoing percutaneous coronary intervention
(PCI) show significantly less bleeding with bivalirudin (BIV) than with unfractionated
heparin (UFH), but this has not been established for high-risk patients. We performed
a randomized double-blind prospective trial comparing efficacy and safety of BIV versus
UFH combined with dual antiplatelet therapy during PCI among 100 high-risk patients
with non-ST elevation myocardial infarction (NSTEMI) or angina pectoris. The baseline
characteristics were similar in both treatment arms. A radial approach was used in
84% of patients with a higher rate in the BIV group (90 vs. 78%, p < 0.05). Study end points were: major and minor bleeding, port-of-entry complications,
major adverse cardiac events (MACE) in-hospital, and at long-term follow-up. There
was one case of major gastrointestinal bleeding in the BIV group and 7% minor bleeding
complications in both categories. Rate of periprocedural myocardial infarction (PPMI)
in the BIV group was twice that in the UFH group (20 vs. 10%, p < 0.16). In-hospital MACE rate was higher in BIV patients as well (12 vs. 2%, p = 0.1). By univariate analysis, the femoral approach was the predictor of PPMI and
in-hospital MACE. In a multivariate model, the independent predictor of PPMI was previous
MI (odds ratio, 7.7; p < 0.0158). PPMI was 49.7 times more likely with the femoral approach plus BIV than
the nonfemoral approach plus UFH (p < 0.0021). At 41.5 ± 14 months' follow-up, end points did not significantly differ
between the groups. In patients at high risk for bleeding undergoing PCI, BIV was
not superior to UFH for bleeding complications, and early and late clinical outcomes.
Keywords
bivalirudin - unfractionated heparin - PCI - bleeding - high-risk patient
