Axiostat Trauma

Simplified radial artery haemostasis: using non-compressive dressings—the Radial Artery Puncture Haemostasis Evaluation trial: results of the RAPHE trial

Publication Details

Kulyassa, P.M., Németh, B.T., Ruzsa, Z., Szűk, T., Ehrenberger, R., Balázs, B., Kákonyi, K.M., Becker, D., Merkely, B.P. and Édes, I.F., 2026. Simplified radial artery haemostasis: using non-compressive dressings—the Radial Artery Puncture Haemostasis Evaluation trial: results of the RAPHE trial. Clinical Research in Cardiology, pp.1-12.

Key Findings

  • Demonstrates the clinical safety and hemostasis efficacy of Axiostat® for radial artery puncture following transradial approach (TRA) coronary procedures
  • Highlights how Axiostat simplify the hemostasis protocol and reduced staff burden in the cath lab
  • How Axiostat supports improved patient experience and enables faster discharge pathways

Core Results

1. Hemostasis Efficacy
  • 96% of patients achieved successful hemostasis with Axiostat®
  • 95% achieved hemostasis at the first checkpoint (10 minutes of compression)
  • Demonstrated efficacy in patients receiving up to 10,000 IU heparin
  • Proven effective in patients on antiplatelet and anticoagulant therapies (including aspirin, clopidogrel, prasugrel, ticagrelor, apixaban)
  • Effective across multiple sheath sizes (5F, 6F, 7F)
2. Clinically Proven Safety — Radial Artery Preservation
  • 100% arterial patency confirmed post-application (via pulse oximetry)
  • Zero cases of radial artery dissection reported
  • No device-related allergic reactions or adverse events observed
  • 98.5% of patients free from major haematoma
  • 98.5% with no clinically significant complications (pseudoaneurysm or arteriovenous fistula)
  • 97% of patients showed no radial artery occlusion (RAO)
  • Intact radial artery observed in 97.5% of patients
3. Operational Benefits at Cath lab Simplified Workflow & Reduced Staff Burden
  • Eliminates the need for continuous patent haemostasis monitoring required with manual compression devices (MCD)
  • Significantly reduces post-procedure nursing interventions
  • Frees up clinical staff for higher-priority tasks, improving overall cath lab efficiency
4. Simplified Protocol
  • Avoids repeated adjustments typically required every 10–15 minutes with MCD
  • Requires minimal observation following application
  • Application time shorter (3 minute less) compared to conventional MCD
5. Improved Patient Experience
  • Easy and atraumatic removal (saline irrigation; no painful peel-off)
  • Shorter overall device management time with Axiostat supports earlier patient mobilisation and same-day discharge protocols.

Key Insights & Discussion

  • Clinically Proven Performance: Axiostat® delivers rapid and reliable hemostasis with high success rates, even in anticoagulated patients.
  • Superior Safety Profile: Demonstrates excellent radial artery preservation with minimal complications and no device-related adverse events.
  • Protocol Simplification: Eliminates complex patent haemostasis monitoring required with manual compression devices (MCD).
  • Reduced Staff Burden: Significantly lowers post-procedure nursing interventions, improving cath lab efficiency.