A randomised controlled trial comparing a 100% chitosan haemostatic dressing and a manual compression device...

Haemostasis at radial access sites following transradial coronary intervention (TRCI) is usually achieved using manual compression devices (MCDs). Despite their widespread use, MCDs have limitations, including prolonged compression and haemostasis times as well as increased risk of radial artery occlusion (RAO), thus highlighting the need for alternative strategies to achieve faster and safer radial haemostasis.

We sought to compare the safety and efficacy of a 100% chitosan haemostatic dressing (CHD) with an MCD in achieving radial access site haemostasis following TRCI.

A total of 258 patients were randomly assigned to receive either a CHD (n=130; Axiostat) or an MCD (n=128; TR Band) for radial haemostasis following TRCI. Time to haemostasis, post-application pain, and access site complications - including rebleeding, haematoma, RAO, and allergic reactions - were assessed.

Both groups had similar baseline and procedural characteristics. The CHD significantly reduced haemostasis time (5.84±2.19 min) compared with the MCD (120.2±21.88 min; p<0.001). Post-application pain scores were low and comparable between both groups. The CHD was associated with lower rates of haematoma and rebleeding. RAO occurred in 3.12% of MCD patients, while no RAO events were observed with the CHD. No serious adverse events or device-related complications were reported.

The CHD provided rapid haemostasis with a shorter compression time, lower RAO risk, and reduced patient-reported pain, along with minimal rebleeding, few haematomas, and no allergic events compared with MCD, without compromising safety. This clearly illustrates that the CHD is a safe and effective alternative for achieving haemostasis following TRCI, potentially enabling earlier patient ambulation and discharge.