Bivalirudin Trial Shows Less Bleeding

Patients with acute coronary syndrome undergoing angioplasty who got the anticoagulant bivalirudin (Angiomax/Medicines Company) had significantly lower rates of bleeding complications and death than controls, according to a Dutch study.

Reporting March 16 at the American College of Cardiology, Marco Valgimigli MD, PhD, senior interventional cardiologist at the Erasmus University Medical Center in the Netherlands said his team saw “an impressive reduction in bleeding with bivalirudin,” compared to patients who got unfractionated heparin, the current standard drug.

Patients who got bivalirudin had a death rate of 1.7% compared to the 2.3% rate in the control group.

The difference in death rates was due to less bleeding in the bivalirudin group, particularly bleeding beyond that near the catheter insertion site—a dangerous complication of angioplasty.

The effects of bivalirudin were consistent whether the access site for insertion of the catheter was the arm or the groin. In another research report related to the study, known MATRIX, the team reported that radial (arm) access, while technically more difficult, is safer for the patient.

The patients, more than 7,200 people treated at 78 hospitals in 4 European countries, were undergoing angioplasty due to acute coronary syndrome.

The researchers said the group who got bivalirudin did not show significant improvements in their composite rate of death, heart attack, or stroke at 30 days, or a composite of those events plus major bleeding. But that was likely because a high rate of heart attacks (8.5%) in both groups likely diluted the benefits reflected in the rates of death and bleeding. The study design permitted the inclusion of high-risk patients, which undoubtedly contributed to the death rates, the team said.

Trials of bivalirudin have been inconsistent in the past and have not included high-risk patients.

In another departure from earlier studies, MATRIX allowed the interventional cardiologists to decide whether to give glycoprotein IIb/IIIa inhibitors in addition to unfractionated heparin in the control group, unlike the prior studies which either forbade or required those drugs.

In MATRIX glycoprotein IIb/IIIa inhibitors were allowed only as a backup for patients getting bivalirudin.

MATRIX was sponsored by the drug's manufacter and a device maker.