Study shows drug is safe and effective in cardiac patients

The direct thrombin inhibitor bivalirudin (Angiomax) reduces major bleeding and increases short-term survival in certain cardiac patients, according to a study published in the New England Journal of Medicine.

Bivalirudin was associated with a lower rate of major bleeding and death from cardiac and other causes at 30 days from treatment initiation. This was in comparison to treatment with heparin plus glycoprotein IIb/IIIa inhibitors.

Both therapies were tested in patients with ST-segment elevation myocardial infarction who were undergoing primary percutaneous coronary intervention (PCI).

Gregg Stone, MD, of Columbia University Medical Center, and colleagues randomized 3602 patients to receive either bivalirudin (n=1800) or heparin plus glycoprotein IIb/IIIa inhibitors (n=1802).

The 2 primary endpoints of the study were major bleeding and combined clinical events. Combined events included death, reinfarction, target-vessel revascularization for ischemia, and stroke.

Bivalirudin reduced the overall rate of combined events, as compared to heparin plus glycoprotein IIb/IIIa inhibitors (9.2% vs 12.1%, respectively). However, when evaluated separately, there were no significant differences in the incidence of these events between the 2 treatment groups.

The rate of reinfarction was the same in both groups (1.8%). The rate of stroke was insignificantly higher in the bivalirudin group (0.7% vs 0.6%). The same was true of target-vessel revascularization; the rate was 2.6% in bivalirudin patients and 1.9% in the other patient group.

Patients on bivalirudin experienced a lower rate of major bleeding than patients on heparin plus glycoprotein IIb/IIIa inhibitors (4.9% vs 8.3%, respectively). When large hematomas were excluded, the rates of major bleeding were reduced to 4.7% and 7.8%, respectively.

Bivalirudin also reduced the incidence of hemorrhagic complications, the development of thrombocytopenia, and the need for blood transfusions.

The rate of cardiac-related death at 30 days was significantly lower for bivalirudin patients than for patients who received heparin plus glycoprotein IIb/IIIa inhibitors (1.8% vs 2.9%, respectively). The rate of death from any cause was also lower in bivalirudin patients (2.1% vs 3.1%).

Bivalirudin increased the rate of acute stent thrombosis within 24 hours of treatment initiation (1.3% vs 0.3%). However, between 24 hours and 30 days, the incidence of acute stent thrombosis was lower in the bivalirudin patients than in those on heparin plus glycoprotein IIb/IIIa inhibitors (1.2% vs. 1.7%, respectively).

This study, known as HORIZONS-AMI, was sponsored, in part, by The Medicines Company, makers of bivalirudin (Angiomax).

The direct thrombin inhibitor bivalirudin (Angiomax) reduces major bleeding and increases short-term survival in certain cardiac patients, according to a study published in the New England Journal of Medicine.

Bivalirudin was associated with a lower rate of major bleeding and death from cardiac and other causes at 30 days from treatment initiation. This was in comparison to treatment with heparin plus glycoprotein IIb/IIIa inhibitors.

Both therapies were tested in patients with ST-segment elevation myocardial infarction who were undergoing primary percutaneous coronary intervention (PCI).

Gregg Stone, MD, of Columbia University Medical Center, and colleagues randomized 3602 patients to receive either bivalirudin (n=1800) or heparin plus glycoprotein IIb/IIIa inhibitors (n=1802).

The 2 primary endpoints of the study were major bleeding and combined clinical events. Combined events included death, reinfarction, target-vessel revascularization for ischemia, and stroke.

Bivalirudin reduced the overall rate of combined events, as compared to heparin plus glycoprotein IIb/IIIa inhibitors (9.2% vs 12.1%, respectively). However, when evaluated separately, there were no significant differences in the incidence of these events between the 2 treatment groups.

The rate of reinfarction was the same in both groups (1.8%). The rate of stroke was insignificantly higher in the bivalirudin group (0.7% vs 0.6%). The same was true of target-vessel revascularization; the rate was 2.6% in bivalirudin patients and 1.9% in the other patient group.

Patients on bivalirudin experienced a lower rate of major bleeding than patients on heparin plus glycoprotein IIb/IIIa inhibitors (4.9% vs 8.3%, respectively). When large hematomas were excluded, the rates of major bleeding were reduced to 4.7% and 7.8%, respectively.

Bivalirudin also reduced the incidence of hemorrhagic complications, the development of thrombocytopenia, and the need for blood transfusions.

The rate of cardiac-related death at 30 days was significantly lower for bivalirudin patients than for patients who received heparin plus glycoprotein IIb/IIIa inhibitors (1.8% vs 2.9%, respectively). The rate of death from any cause was also lower in bivalirudin patients (2.1% vs 3.1%).

Bivalirudin increased the rate of acute stent thrombosis within 24 hours of treatment initiation (1.3% vs 0.3%). However, between 24 hours and 30 days, the incidence of acute stent thrombosis was lower in the bivalirudin patients than in those on heparin plus glycoprotein IIb/IIIa inhibitors (1.2% vs. 1.7%, respectively).

This study, known as HORIZONS-AMI, was sponsored, in part, by The Medicines Company, makers of bivalirudin (Angiomax).

The direct thrombin inhibitor bivalirudin (Angiomax) reduces major bleeding and increases short-term survival in certain cardiac patients, according to a study published in the New England Journal of Medicine.

Bivalirudin was associated with a lower rate of major bleeding and death from cardiac and other causes at 30 days from treatment initiation. This was in comparison to treatment with heparin plus glycoprotein IIb/IIIa inhibitors.

Both therapies were tested in patients with ST-segment elevation myocardial infarction who were undergoing primary percutaneous coronary intervention (PCI).

Gregg Stone, MD, of Columbia University Medical Center, and colleagues randomized 3602 patients to receive either bivalirudin (n=1800) or heparin plus glycoprotein IIb/IIIa inhibitors (n=1802).

The 2 primary endpoints of the study were major bleeding and combined clinical events. Combined events included death, reinfarction, target-vessel revascularization for ischemia, and stroke.

Bivalirudin reduced the overall rate of combined events, as compared to heparin plus glycoprotein IIb/IIIa inhibitors (9.2% vs 12.1%, respectively). However, when evaluated separately, there were no significant differences in the incidence of these events between the 2 treatment groups.

The rate of reinfarction was the same in both groups (1.8%). The rate of stroke was insignificantly higher in the bivalirudin group (0.7% vs 0.6%). The same was true of target-vessel revascularization; the rate was 2.6% in bivalirudin patients and 1.9% in the other patient group.

Patients on bivalirudin experienced a lower rate of major bleeding than patients on heparin plus glycoprotein IIb/IIIa inhibitors (4.9% vs 8.3%, respectively). When large hematomas were excluded, the rates of major bleeding were reduced to 4.7% and 7.8%, respectively.

Bivalirudin also reduced the incidence of hemorrhagic complications, the development of thrombocytopenia, and the need for blood transfusions.

The rate of cardiac-related death at 30 days was significantly lower for bivalirudin patients than for patients who received heparin plus glycoprotein IIb/IIIa inhibitors (1.8% vs 2.9%, respectively). The rate of death from any cause was also lower in bivalirudin patients (2.1% vs 3.1%).

Bivalirudin increased the rate of acute stent thrombosis within 24 hours of treatment initiation (1.3% vs 0.3%). However, between 24 hours and 30 days, the incidence of acute stent thrombosis was lower in the bivalirudin patients than in those on heparin plus glycoprotein IIb/IIIa inhibitors (1.2% vs. 1.7%, respectively).

This study, known as HORIZONS-AMI, was sponsored, in part, by The Medicines Company, makers of bivalirudin (Angiomax).