Skip to main content
Skip main navigationClose Drawer MenuOpen Drawer Menu

Radial Hemostasis Is Facilitated With a Potassium Ferrate Hemostatic Patch: The STAT2 TrialFree Access

Coronary

J Am Coll Cardiol Intv, 15 (8) 810–819
Sections

Central Illustration

Abstract

Objectives

The aim of this trial was to test whether the potassium ferrate hemostatic patch (PFHP) as an adjunct to the TR Band (TRB) facilitated an early deflation protocol.

Background

Shorter TRB compression times may reduce the rate of radial artery occlusion (RAO) and reduce observation time after transradial access.

Methods

A total of 443 patients were randomized to the TRB or PFHP + TRB, with complete TRB deflation attempted 60 minutes postprocedure. The primary outcome was the time to successful full deflation of the TRB without bleeding, with secondary outcomes of time to discharge and complications including hematoma, RAO, or bleeding requiring intervention beyond TRB reinflation.

Results

Time to complete TRB deflation was 66 ± 14 minutes with the PFHP vs 113 ± 56 minutes for the TRB alone (P < 0.001). Minor rebleeding requiring TRB reinflation was much more frequent without the PFHP (0% vs 67.7%; P < 0.001) with 2.3 ± 1.3 additional reinflation and deflation attempts needed for hemostasis. Hematomas developed in 4.0% of the PFHP group and 6.8% of the TRB group (P = 0.20). RAO was rare (<1%), although 41% of patients received <5,000 U heparin. Among percutaneous coronary intervention patients, time to TRB deflation (68 ± 15 minutes vs 138 ± 62 minutes; P < 0.001) and composite complications (10.0% vs 24.2%; P = 0.04) were reduced with the PFHP.

Conclusions

Compared with the TRB alone, the PFHP facilitated early 60-minute TRB deflation following transradial catheterization, with a numeric reduction in vascular complications. RAO occurs rarely with early deflation regardless of heparin dose. (Comparing TR Band to StatSeal in Conjunction With TR Band II [StatSeal II]; NCT04046952)

References

  • 1. Jolly S.S., Yusuf S., Cairns J., Niemelä K., et al.for the RIVAL Trial Group. "Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial". Lancet 2011;377:1409-1420.

    CrossrefMedlineGoogle Scholar
  • 2. Amin A.P., House J.A., Safley D.M., et al. "Costs of transradial percutaneous coronary intervention". J Am Coll Cardiol Intv 2013;6:827-834.

    View ArticleGoogle Scholar
  • 3. Bertrand O.F., Rao S.V., Pancholy S., et al. "Transradial approach for coronary angiography and interventions: results of the first international transradial practice survey". J Am Coll Cardiol Intv 2010;3:1022-1031.

    View ArticleGoogle Scholar
  • 4. Pancholy S.B., Patel T.M. "Effect of duration of hemostatic compression on radial artery occlusion after transradial access". Catheter Cardiovasc Interv 2012;79:1: 78-81.

    CrossrefMedlineGoogle Scholar
  • 5. Dangoisse V., Guédès A., Chenu P., et al. "Usefulness of a gentle and short hemostasis using the transradial band device after transradial access for percutaneous coronary angiography and interventions to reduce the radial artery occlusion rate (from the prospective and randomized CRASOC I, II, and III studies)". Am J Cardiol 2017;120:3: 374-379.

    CrossrefMedlineGoogle Scholar
  • 6. Aminian A., Saito S., Takahashi A., et al. "Impact of sheath size and hemostasis time on radial artery patency after transradial coronary angiography and intervention in Japanese and non-Japanese patients: a substudy from RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse Event) randomized multicenter trial". Catheter Cardiovasc Interv 2018;92:5: 844-851.

    CrossrefMedlineGoogle Scholar
  • 7. Seto A.H., Rollefson W., Patel M.P., et al. "Radial haemostasis is facilitated with a potassium ferrate haemostatic patch: the StatSeal with TR Band Assessment Trial (STAT)". EuroIntervention 2018;14:11: e1236-e1242.

    CrossrefMedlineGoogle Scholar
  • 8. Barbeau G.R., Arsenault F., Dugas L., Simard S., Larivière M.M. "Evaluation of the ulnopalmar arterial arches with pulse oximetry and plethysmography: comparison with the Allen’s test in 1010 patients". Am Heart J 2004;147:489-493.

    CrossrefMedlineGoogle Scholar
  • 9. Bertrand O.F., Rodés-Cabau J., Larose E., et al. "One-year clinical outcome after abciximab bolus-only compared with abciximab bolus and 12-hour infusion in the Randomized Early Discharge After Transradial Stenting of Coronary Arteries (EASY) study". Am Heart J 2008;156:1: 135-140.

    CrossrefMedlineGoogle Scholar
  • 10. Shroff A.R., Gulati R., Drachman D.E., Feldman D.N., et al. "SCAI expert consensus statement update on best practices for transradial angiography and intervention". Catheter Cardiovasc Interv 2020;95:2: 245-252.

    CrossrefMedlineGoogle Scholar
  • 11. Hahalis G.N., Leopoulou M., Tsigkas G., et al. "Multicenter randomized evaluation of high versus standard heparin dose on incident radial arterial occlusion after transradial coronary angiography: the SPIRIT OF ARTEMIS study". J Am Coll Cardiol Intv 2018;11:22: 2241-2250.

    View ArticleGoogle Scholar
  • 12. Shroff A.R., Fernandez C., Vidovich M.I., et al. "Contemporary transradial access practices: Results of the second international survey". Catheter Cardiovasc Interv 2019;93:7: 1276-1287.

    CrossrefMedlineGoogle Scholar
  • 13. Bossard M., Lavi S., Rao S.V., et al. "Heparin use for diagnostic cardiac catheterization with a radial artery approach: an international survey of practice patterns". Catheter Cardiovasc Interv 2018;92:5: 854-859.

    CrossrefMedlineGoogle Scholar
  • 14. Pancholy S.B., Bertrand O.F., Patel T. "Comparison of a priori versus provisional heparin therapy on radial artery occlusion after transradial coronary angiography and patent hemostasis (from the PHARAOH study)". Am J Cardiol 2012;110:173-176.

    CrossrefMedlineGoogle Scholar
  • 15. Lavi S., Mehta S.R., Bajwa R., et al. "Short durations of radial hemostatic device after diagnostic transradial cardiac catheterization: the PRACTICAL-2 randomized trial". Can J Cardiol 2021;37:2: 276-283.

    CrossrefMedlineGoogle Scholar
  • 16. Wang D.S., Chu L.F., Olson S.E., et al. "Comparative evaluation of noninvasive compression adjuncts for hemostasis in percutaneous arterial, venous, and arteriovenous dialysis access procedures". J Vasc Interv Radiol 2008;19:1: 72-79.

    CrossrefMedlineGoogle Scholar
  • 17. Roberts J., Niu J., Pastor-Cervantes J.A. "Comparison of hemostasis times with a kaolin-based hemostatic pad (QuikClot Radial) vs. mechanical compression (TR Band) following transradial access: a pilot prospective study". J Invasive Cardiol 2017;29:10: 328-334.

    MedlineGoogle Scholar
  • 18. Roberts J.S., Niu J., Pastor-Cervantes J.A. "Comparison of hemostasis times with a chitosan-based hemostatic pad (Clo-SurPlus Radial™) vs mechanical compression (TR Band®) following transradial access: a pilot study". Cardiovasc Revasc Med 2019;20:10: 871-874.

    CrossrefMedlineGoogle Scholar
  • 19. Van Meter C., Vasudevan A., Cuccerre J.M., Schussler J.M. "Time to discharge following diagnostic coronary procedures via transradial artery approach: a comparison of Terumo band and StatSeal hemostasis". Cardiovasc Revasc Med 2018;19:7 Pt A: 759-761.

    CrossrefMedlineGoogle Scholar
  • 20. Seto A.H., Shroff A., Abu-Fadel M., et al. "Length of stay following percutaneous coronary intervention: an expert consensus document update from the society for cardiovascular angiography and interventions". Catheter Cardiovasc Interv 2018;92:4: 717-731.

    CrossrefMedlineGoogle Scholar
  • 21. Pancholy S.B., Patel V., Pancholy S.A., et al. "Comparison of diagnostic accuracy of digital plethysmography versus duplex ultrasound in detecting radial artery occlusion after transradial access". Cardiovasc Revasc Med 2021;27:52-56.

    CrossrefMedlineGoogle Scholar