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.