348 Therapy and prevention Safety and efficacy of a prolonged bivalirudin infusion after urgent and complex percutaneous coronary interventions: a descriptive study Bernardo Cortese a , Andrea Micheli a , Andrea Picchi a , Loria Bandinelli a , Maria Gina Brizi a , Silva Severi b and Ugo Limbruno a Objective Bivalirudin, 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. Methods From 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. Results There 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. Conclusion A 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. Coron Artery Dis 20:348–353 c 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins. Coronary Artery Disease 2009, 20:348–353 Keywords: acute coronary syndromes, bleeding, glycoprotein IIb/IIIa inhibitors, percutaneous coronary intervention, procedural-related myocardial infarction a Interventional Cardiology Unit and b Cardiologic Department, Ospedale della Misericordia, Grosseto, Italy Correspondence to Dr Bernardo Cortese, MD, Interventional Cardiology Unit, Ospedale della Misericordia, via Senese, 48, Grosseto, Italy Tel: + 39 564 483465; fax: + 39 564 483464; e-mail: bcortese@gmail.com Received 29 October 2008 Revised 31 March 2009 Accepted 7 April 2009 Introduction The addition of glycoprotein IIb/IIIa inhibitors (GPI) to unfractionated heparin (UFH) during percutaneous coronary intervention (PCI) has been shown to improve both angiographic and clinical outcomes [1,2], and is recommended by the European Society of Cardiology and the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for the treatment of patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) [3,4]. The direct thrombin inhibitor bivalirudin has also received a class I recom- mendation in the ACC/AHA and the European Society of Cardiology guidelines for patients with NSTE-ACS undergoing an early invasive strategy [3,4] based on the findings of the ACUITY trial that showed similar protection from ischemic complications but with sig- nificantly fewer bleeding events compared with a heparin (UFH or enoxaparin) plus GPI strategy [5,6]. Although the European Medicines Agency and FDA approved labeling for bivalirudin allows for low-dose prolonged postprocedure administration, this practice is not routine. Therefore, clinical trial data of bivalirudin do not reflect the impact of a longer postprocedural infusion [7,8]. We theorized that a lack of postprocedure antithrombotic therapy, a timeframe of critical importance because of the thrombogenicity of the procedure, might contribute to increased rates of ischemic outcomes during the post-PCI 0954-6928 c 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins DOI: 10.1097/MCA.0b013e32832cff08 Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.