RCT: Routine Protamine Administration Enhances Hemostasis and Reduces Vascular Complications in TAVI – JAMA Cardiol

Study Design and Population: The ACE-PROTAVI trial was a double-blind, placebo-controlled randomized clinical trial conducted at three Australian hospitals. It involved 410 patients (median age 81 years) undergoing transfemoral transcatheter aortic valve implantation (TAVI). The trial evaluated the efficacy and safety of routine protamine administration versus placebo.

Main Findings: Patients receiving protamine showed a higher rate of successful hemostasis (97.9% vs. 91.6%) and a significantly shorter time to hemostasis (median 181 vs. 279 seconds). Protamine administration also led to a reduced risk of composite vascular complications (5.2% vs. 12.8%), primarily due to fewer minor vascular events. No adverse events were associated with protamine.

Implications for Practice: Routine protamine administration after TAVI improves hemostasis, reduces minor vascular complications, and shortens procedural and postprocedural recovery times, suggesting it should be considered in standard TAVI protocols.

Reference: Vriesendorp, P. A., Nanayakkara, S., Heuts, S., et al. (2024). Routine Protamine Administration for Bleeding in Transcatheter Aortic Valve Implantation: The ACE-PROTAVI Randomized Clinical Trial. JAMA Cardiology. Published online August 14, 2024. DOI: 10.1001/jamacardio.2024.2454.