Primary Coronary Artery Bypass Graft Patients

Four placebo-controlled, double-blind studies of Trasylol® were conducted in the United States; of 1745 randomized patients undergoing primary CABG surgery, 1599 were valid for efficacy analysis. The dosage regimens used in these studies were identical to those used in the repeat CABG studies described above (Regimens A, B, pump prime, and placebo). All patients valid for efficacy were pooled by treatment regimen.

In this pooled analysis, fewer patients receiving Trasylol® Regimens A, B, and pump prime required any donor blood in comparison to the placebo regimen. The number of units of donor blood required by patients, the volume of donor blood transfused, the number of units of donor blood products transfused, the thoracic drainage rate, and total thoracic drainage volumes were also reduced in patients receiving Trasylol® as compared to placebo.

Efficacy Variables: Primary CABG Patients Mean (S.D.) or % of Patients

Additional subgroup analyses showed no diminution in benefit with increasing age. Male and female patients benefited from Trasylol® with a reduction in the average number of units of donor blood transfused. Although male patients did better than female patients in terms of the percentage of patients who required any donor blood transfusions, the number of female patients studied was small.

A double-blind, randomized, Canadian study compared Trasylol® Regimen A (n=28) and placebo (n=23) in primary cardiac surgery patients (mainly CABG) requiring cardiopulmonary bypass who were treated with aspirin within 48 hours of surgery. The mean total blood loss (1209.7 mL vs. 2532.3 mL) and the mean number of units of packed red blood cells transfused (1.6 units vs 4.3 units) were significantly less (p<0.008) in the Trasylol® group compared to the placebo group. In a U.S. randomized study of Trasylol® Regimen A and Regimen B versus the placebo regimen in 212 patients undergoing primary aortic and/or mitral valve replacement or repair, no benefit was found for Trasylol® in terms of the need for transfusion or the number of units of blood required.

Bookmark this page: