Radial haemostasis is facilitated with a potassium ferrate haemostatic patch: the Statseal with TR Band assessment trial (STAT)

EuroIntervention 2018;14:e1236-e1242 published online May 2018 published online e-edition December 2018. DOI: 10.4244/EIJ-D-18-00101

Arnold Seto
Arnold H. Seto1*, MD, MPA; William Rollefson2, MD; Mitul P. Patel3, MD; William M. Suh4, MD; David M. Tehrani5, MD, MS; Jacqueline A. Nguyen1, BS; Daniel G. Amador1, BA; Omid Behnamfar2, MD; Vinisha Garg4, MD; Mauricio G. Cohen6, MD
1. Division of Cardiology, Department of Medicine, Tibor Rubin VA Medical Center, Long Beach, CA, USA; 2. Arkansas Heart Hospital, Little Rock, AR, USA; 3. University of California, San Diego, San Diego, CA, USA; 4. University of California, Los Angeles Medical Center, Los Angeles, CA, USA; 5. University of Chicago, Chicago, IL, USA; 6. University of Miami, Miami, FL, USA

Aims: Haemostasis is a limiting factor for discharge after uncomplicated transradial procedures. The purpose of this study was to determine whether a potassium ferrate haemostatic patch (PFHP) could serve as an adjunct to the air-bladder TR Band (TRB) to facilitate implementation of a rapid deflation protocol.

Methods and results: This was a prospective multicentre randomised controlled trial comparing radial haemostatic protocols. Deflation of the TRB was attempted at 40 minutes with PFHP and at 120 minutes without the PFHP. The primary outcome was time to full deflation of the TRB with haemostasis. At four US sites, 180 patients were enrolled after receiving a minimum of 5,000 units of unfractionated heparin or bivalirudin. Interventions comprised 30% of procedures. Successful TRB deflation occurred at 43±14 minutes with PFHP and 160±43 minutes without PFHP (p<0.001). Minor haematomas occurred in nine (10.3%) of the TRB patients and 16 (17.2%) of the PFHP patients (p=0.20). Radial artery occlusion occurred in 2% of patients in the PFHP group (p=NS). Outpatients randomised to PFHP were discharged 51±83.5 minutes earlier than control.

Conclusions: The PFHP haemostatic patch facilitated early deflation of the TRB with a non-significant increase in forearm haematomas. Use of the PFHP may improve patient throughput and allow earlier discharge following transradial procedures. NCT03028025

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