THE MEDICINES COMPANY COMPLETES ANGIOMAX PHASE III SAFETY TRIALS IN CARDIAC SURGERY

The Medicines Company has announced successful completion of the EVOLUTION-On Phase III clinical trial of Angiomax, the second of two safety trials of the Angiomax Phase III cardiac surgery program.

EVOLUTION-On evaluated the use of Angiomax (bivalirudin) as an anticoagulant during cardiac surgeries conducted with the use of a cardiac pulmonary bypass machine ("on-pump").

The primary objective of EVOLUTION-On was to demonstrate that Angiomax is a safe alternative anticoagulant to heparin with protamine reversal in on-pump cardiac surgery. The primary endpoint results, a comparison of rates of acute procedural success, met the prespecified objectives. Patients treated with Angiomax demonstrated a 95 percent success rate, compared to a 91.8 percent success rate in patients treated with heparin and protamine reversal. Acute procedural success was defined at seven days postsurgery as absence of death, Q-wave MI (heart attack), repeat operation or catheterization for coronary revascularization, or stroke.