0/2.0/180
n (%)
Patients 1024 1040
Major bleeding† 4 (0.4%) 13 (1.3%)
Minor bleeding† 18 (2.0%) 29 (3.0%)
Requiring transfusions‡ 11 (1.1%) 16 (1.5%)
IMPACT II
Placebo
n (%) Eptifibatide 135/0.5
n (%) Eptifibatide 135/0.75
n (%)
Patients 1285 1300 1286
Major bleeding† 55 (4.5%) 55 (4.4%) 58 (4.7%)
Minor bleeding† 115 (9.3%) 146 (11.7%) 177 (14.2%)
Requiring transfusions‡ 66 (5.1%) 71 (5.5%) 74 (5.8%)
The majority of major bleeding events in the ESPRIT study occurred at the vascular access site (1 and 8 patients, or 0.1% and 0.8% in the placebo and eptifibatide groups, respectively). Bleeding at "other" locations occurred in 0.2% and 0.4% of patients, respectively.
In the PURSUIT study, the greatest increase in major bleeding in eptifibatide-treated patients compared to placebo-treated patients was also associated with bleeding at the femoral artery access site (2.8% vs. 1.3%). Oropharyngeal (primarily gingival), genitourinary, gastrointestinal, and retroperitoneal bleeding were also seen more commonly in eptifibatide-treated patients compared to placebo-treated patients.
Among patients experiencing a major bleed in the IMPACT II study, an increase in bleeding on eptifibatide versus placebo was observed only for the femoral artery access site (3.2% vs. 2.8%).
Table 9 displays the incidence of TIMI major bleeding according to the cardiac procedures carried out in the PURSUIT study. The most common bleeding complications were related to cardiac revascularization (CABG-related or femoral artery access site bleeding). A corresponding table for ESPRIT is not presented, as every patient underwent PCI in the ESPRIT study and only 11 patients underwent CABG.
Table 9 Major Bleeding by Procedures in the PURSUIT Study Placebo
n (%) Eptifibatide 180/1.3*
n (%) Eptifibatide 180/2.0
n (%)
Note: Denominators are based on the total number of patients whose TIMI classification was resolved.
*
Administered only until the first interim analysis.
Patients 4577 1451 4604
Overall Incidence of Major Bleeding 425 (9.3%) 152 (10.5%) 498 (10.8%)
Breakdown by Procedure:
CABG 375 (8.2%) 123 (8.5%) 377 (8.2%)
Angioplasty without CABG 27 (0.6%) 16 (1.1%) 64 (1.4%)
Angiography without Angioplasty or CABG 11 (0.2%) 7 (0.5%) 29 (0.6%)
Medical Therapy Only 12 (0.3%) 6 (0.4%) 28 (0.6%)
In the PURSUIT and ESPRIT studies, the risk of major bleeding with eptifibatide increased as patient weight decreased. This relationship was most apparent for patients weighing less than 70 kg.
Bleeding adverse events resulting in discontinuation of the study drug were more frequent among patients receiving eptifibatide than placebo (4.6% vs. 0.9% in ESPRIT, 8% vs. 1% in PURSUIT, 3.5% vs. 1.9% in IMPACT II).
Intracranial Hemorrhage and Stroke
Intracranial hemorrhage was rare in the PURSUIT, IMPACT II, and ESPRIT clinical studies. In the PURSUIT study, 3 patients in the placebo group, 1 patient in the group treated with eptifibatide 180/1.3, and 5 patients in the group treated with eptifibatide 180/2.0 experienced a hemorrhagic stroke. The overall incidence of stroke was 0.5% in patients receiving eptifibatide 180/1.3, 0.7% in patients receiving eptifibatide 180/2.0, and 0.8% in placebo patients.
In the IMPACT II study, intracranial hemorrhage was experienced by 1 patie |
