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Safety and efficacy of a prolonged bivalirudin infusion after urgent and complex percutaneous coronary interventions: a descriptive study

ObjectiveBivalirudin, a direct thrombin inhibitor, provides similar ischemic outcomes with significantly less major bleeding compared with unfractionated heparin (UFH) plus a glycoprotein IIb/IIIa inhibitor (GPI) in patients undergoing percutaneous coronary interventions (PCI). Although the approved labeling for bivalirudin allows for low-dose prolonged postprocedure administration, this practice is not routine. Therefore, we sought to evaluate the safety and efficacy of longer post-PCI infusion. MethodsFrom our database, we retrospectively compared two groups of patients with acute coronary syndrome undergoing complex PCI, one group treated with UFH+GPI (n = 59) and another with a periprocedural and post-PCI bivalirudin infusion for 4 h (n = 50). Endpoints included periprocedural myocardial infarction (MI), 30-day major adverse cardiac events, and in-hospital major and minor bleeding. ResultsThere were no significant differences in the baseline and procedural characteristics of the two groups; most patients (approximately 90%) had complex coronary lesions (the American College of Cardiology/American Heart Association type B2/C). There was no significant difference in the rates of periprocedural MI (11.9 vs. 8.0%, P = NS) or 30-day major adverse cardiac events (8.5 vs. 6.0%, P = NS) among patients treated with UFH+GPI or bivalirudin. However, patients who received bivalirudin had significantly lower rates of minor bleeding (20.3 vs. 4.0%, P<0.05), and a trend toward significantly less major bleeding (8.5 vs. 4.0%, P = 0.07). When we compared the group treated with a prolonged bivalirudin infusion with a historical group treated with peri-PCI-only bivalirudin infusion, we observed in the latter an increased incidence of periprocedural MI and a comparable incidence of bleeding. ConclusionA prolonged bivalirudin infusion after urgent PCI seems effective in protecting myocardium without increasing bleeding rates, and represents an attractive alternative to the standard pharmacological treatment of UFH+GPI in the catheterization laboratory.