Percutaneous Coronary Intervention

Bivalirudin has been studied for several cardiology indications, including most prominently PCI, but also other non-intervention cardiac situations (Table 5). Bivalirudin has been approved by the FDA for use in patients with unstable angina undergoing PCI. To date, over 1,000,000 patients have been treated with bivalirudin (personal communication with The Medicines Company). Bivalirudin is a safe and effective alternative to heparin in this patient population.

The first clinical study using bivalirudin for coronary angioplasty was reported by Topol and coworkers (1993) in a multicenter, open-label, dose finding trial of 258 patients. The encouraging results led to larger studies of patients requiring urgent angioplasty because of unstable or postinfarction angina, the Hirulog (bivalirudin) Angioplasty Study (for review, see Nawarskas and Anderson, 2001). The primary endpoint was in-hospital death, myocardial infarction (MI), or abrupt vessel closure within 24 h of initiating PCI, or rapid clinical deterioration of cardiac origin. In the original publication, no statistically significant difference in the primary endpoint was noted between bivalirudin and heparin (Bittl et al., 1995), causing the sponsor (Biogen) to abandon further drug development.

Subsequently, The Medicines Company reanalyzed the trial data (including an additional 214 patients analyzed by intention-to-treat principle who were not included in the per-protocol analysis initially reported). In this study, renamed as BAT, the frequency of endpoints (including death, revascularization or MI, and major hemorrhage) were found to be significantly reduced with bivalirudin. Bivalirudin was at least as effective as heparin in preventing ischemic complications

TABLE 5 Major Clinical Studies Using Bivalirudin in Cardiac Patients (PCI and Non-PCI Indications)

Study acronym or description

PCI indications

Dose-finding study

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