For patients undergoing elective
percutaneous coronary intervention (PCI), procedural anticoagulation with
bivalirudin was previously shown to significantly reduce
bleeding complications at the cost of a modest increase in ischemic events compared with
unfractionated heparin (UFH) and
glycoprotein IIb/IIIa inhibitors (GPIs). However, the excess
bleeding in patients treated with UFH and GPIs may have been caused by excessively high UFH doses and increased activated clotting times. This study sought to determine the
bleeding risk of targeted low-dose UFH with GPIs compared with
bivalirudin in patients undergoing elective PCI. Of 1,205 patients undergoing elective PCI, 602 underwent PCI with adjunctive UFH and GPIs with the UFH dose targeted to an activated clotting time of approximately 250 seconds, and 603 patients matched for baseline characteristics underwent PCI with
bivalirudin. Outcomes were analyzed for major
bleeding (hematocrit decrease >15%, gastrointestinal bleed, or major
hematoma) and 6-month
major adverse cardiac events (death,
myocardial infarction, and target-lesion revascularization). The maximum activated clotting time achieved was 261.7 +/- 61.6 seconds in the UFH/GPI group and 355.4 +/- 66.6 in the
bivalirudin group (p <0.001). In-hospital major
bleeding rates were similar between groups (1.8% UFH/GPI vs 1.7%
bivalirudin; p = 0.83), as were transfusion requirements (1.2% UFH/GPI vs 0.5%
bivalirudin; p = 0.61). The 6-month major
adverse cardiac event rate was also similar between groups (9.5% UFH/GPI vs 9.0%
bivalirudin; p = 0.81). In conclusion, there were no significant differences in major
bleeding and 6-month
major adverse cardiac events for patients undergoing elective PCI treated with targeted low-dose UFH and GPIs compared with those treated with
bivalirudin.