FCR-10
Radial hemostasis and early TR band deflation is safer and faster with a potassium ferrate hemostatic patch (Statseal): results from the randomized controlled Statseal with TR Band Assessment Trial 2 (STAT2).
Presenter
Arnold H. Seto, MD, MPA, FSCAI, Long Beach VA Health Care System, Long Beach, CA
Jordan G. Safirstein, MD, FSCAI1, David M. Tehrani, MD, MS2, Jeffrey M. Schussler, MD, FSCAI, FSCAI3, Nicole Reid, RCIS1, Kush Mukerjee1, Larissa Weber1, Henry Liu, Liu4, Shea C Skendarian5, Michael Simeon6 and Arnold H. Seto, MD, MPA, FSCAI7, (1)Morristown Medical Center, Morristown, NJ, (2)The University of California, Los Angeles, Los Angeles, CA, (3)Baylor University Medical Center, Dallas, TX, (4)California University of Science and Medicine, Colton, CA, (5)University of California, Berkeley, Berkeley, CA, (6)Saint Luis University, Saint Louis, MO, (7)Long Beach VA Health Care System, Long Beach, CA
Keywords: Coronary and Vascular Access, Management, and Closure
Background
Shorter compression times with the TR band (TRB) may reduce observation time after transradial access (TRA) and the risk of radial artery occlusion (RAO). The potassium ferrate hemostatic patch (PFHP, Statseal) reduced the time to hemostasis and discharge in a pilot trial that by protocol deflated the TRB earlier when a PFHP was used.
Methods
Patients with TRA were randomized 1:1 to the TRB or PFHP+TRB. Both groups had complete TRB deflation attempted 60 minutes post-procedure. Heparin dose was by operator preference. Radial patency was measured by plethysmography. The primary outcome was the time to successful full deflation of the TRB, with secondary outcomes of time to discharge and complications including hematomas, RAO, or bleeding requiring intervention beyond TRB reinflation.
Results
Across 3 centers, 443 patients (27.5% with PCI) were randomized. The time to complete TRB deflation was 65.9 ± 14.1 min with the PFHP vs. 112.8 ± 56.3 min for TRB alone (P<0.001). Minor rebleeding requiring TRB reinflation was much more frequent without the PFHP (0% vs. 67.3%, p<0.001) with 2.3 ± 1.3 additional reinflation/delayed deflation attempts needed for hemostasis. Hematomas developed in 4.0% (N=9) of the PFHP group and 6.8% (N=15) of the TRB group (p=0.20). RAO was rare (1 with PFHP+TRB, 2 with TRB, p=0.55) despite 41% of patients receiving < 5000 units of heparin. There was a non-significant reduction in a composite of complications including bleeding requiring intervention, hematoma, or RAO in the PFHP compared with the TRB group [4.5% (N=10) vs. 8.6% (N=19), p=0.08]. Among outpatients, there was no difference in time to discharge with the PFHP vs TRB group (186.8 ± 118.6 vs. 204.4 ± 116.6 min, p=0.95) likely due to preexisting policies on length of stay. Among PCI patients, time to TRB deflation (68.1 ± 15.3 min vs 138.2 ± 62.0, P<0.001) and composite complications [10.0% (N=6) vs. 24.2% (N=15), p=0.04] were reduced in the PFHP group.
Conclusions
The adjunctive use of the PFHP safely facilitates early deflation of the TRB after TRA without an excess of hematomas or RAO. Early TRB deflation without a PFHP is associated with increased rebleeding requiring longer compression. RAO occurs rarely with early deflation regardless of heparin dose.