Bivalirudin versus Unfractionated Heparin during Percutaneous Coronary Intervention in XXXX at High Risk for Bleeding.

@entity1 @entity548 @entity3032 @entity951 @entity299 @entity583 @entity360
Low/medium- @entity548 -risk populations undergoing percutaneous coronary intervention (PCI) show significantly less @entity548 with bivalirudin ( @entity3032 ) than with unfractionated heparin (UFH), but this has not been established for high-risk @entity1 . We performed a randomized double-blind prospective trial comparing efficacy and safety of @entity3032 versus UFH combined with dual antiplatelet therapy during PCI among 100 high-risk @entity1 with non-ST elevation @entity583 (NSTEMI) or @entity951 . The baseline characteristics were similar in both treatment arms. A radial approach was used in 84% of @entity1 with a higher rate in the @entity3032 group (90 vs. 78%, p   <   0.05). Study end points were: major and @entity548 , port-of-entry complications, major adverse @entity299 (MACE) in-hospital, and at long-term follow-up. There was one case of major @entity360 in the @entity3032 group and 7% @entity548 complications in both categories. Rate of periprocedural @entity583 (PPMI) in the @entity3032 group was twice that in the UFH group (20 vs. 10%, p   <   0.16). In-hospital MACE rate was higher in @entity3032 @entity1 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 @entity3032 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 @entity1 at high risk for @entity548 undergoing PCI, @entity3032 was not superior to UFH for @entity548 complications, and early and late clinical outcomes.
