1006-43 Hirulog™ vs. Heparin During Percutaneous Transluminal Coronary Angioplasty in Patients with Post-Infarction Angina: Results of the Myocardial Infarction Arm of the Hirulog Angioplasty Trial

Abstract

Acute intervention for recurrent angina following an acute myocardial infarction continues to present as a therapeutic challenge to the physician. Standard anticoagulation using heparin during PTCA in patients with post infarction angina is associated with a 16% incidence of abrupt vessel closure and an 11% incidence of death, CABG, and recurrent MI. The ability of Hirulog™ (BG8967), a direct thrombin inhibitor, to improve PTCA outcome was compared in a double blind fashion to heparin in the PhasE: III Hirulog Angioplasty Trial. Clinical and angiographic results from the post infarction subgroup (n = 635) will be reported. Patients were randomized to either Hirulog ™ (2.2 mg/kg bolus and 1.0 mg/kg/hr infusion) or heparin (175 U/kg bolus and 15 U/kg/hr infusion). Additional boluses were administered in order to maintain a minimum activated clotting time of 350 seconds. The primary endpoint was procedural failure (impending or established abrupt vessel closure, bypass surgery, recurrent MI, or death) with a secondary endpoint of major hemorrhage. The event rates in this 635 patient subgroup were: Death 0.8% (n = 5). Emergency Bypass 2.2% (n = 14), Recurrent Myocardial Infarction 2.5% (n = 16). Abrupt vessel closure 5.8% (n = 37). and Major Hemorrhage 6.8% (n = 43). In summary, this study will determine: (1) whether Hirulog™, a direct thrombin inhibitor, is superior to heparin when used during PTCA in patients with post-infarct angina and (2) the overall safety profile of Hirulog™ in this subgroup.