Conditions: Peripheral Endovascular Interventions Bleeding
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 732
Healthy volunteers: no

Brief summary:
The primary objective of the study is to test whether anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in participants undergoing peripheral endovascular interventions (PEI). The secondary objective is to test whether there were potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.

Detailed description:

Arms:
arm 1: Bivalirudin was administered as an intravenous (IV) bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 milligrams (mg)/kilogram \[kg\]) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/hour (h) (or 1 mg/kg/h for participants with an estimated glomerular filtration rate \[eGFR\] \<30 milliliters/minute \[mL/min\]). arm 2: UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.

Interventions: intervention 1: Bivalirudin intervention 2: Unfractionated Heparin
Intervention descriptions: intervention 1: Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion. intervention 2: Unfractionated heparin is an anticoagulant.

Protocol document: