Conditions: Severe Aortic Stenosis Transcatheter Aortic Valve Replacement Aortic Valve Replacement
Keywords: Transcatheter aortic valve replacement Aortic valve replacement Severe aortic stenosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 803
Healthy volunteers: no

Brief summary:
The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with heparin in TAVR procedures. Results for all participants enrolled into the randomized trial (BRAVO 3) are presented.

Detailed description:

Arms:
arm 1: Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram \[mg/kg\]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. arm 2: The dose of UFH adhered to the standard institutional practice. An activated clotting time (ACT) target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.

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: