Abstract Background Transradial approach (TRA) is widely accepted as a method of choice for coronary procedures. Modern puncture site haemostasis involves application of mechanical compression devices (MCD), using the patent haemostasis method with or without active dressing facilitation to avoid haematoma formation and radial artery occlusion. The Radial Artery Puncture Haemostasis Evaluation (RAPHE) study sought to determine whether the standalone use of two novel dressings, the 100% chitosan sponge and potassium ferrate disc, was non-inferior to the current gold standard pneumatic balloon MCD. Methods Six hundred patients were randomized in a 1:1:1 ratio to the three arms of the trial after a TRA procedure. The primary objective of the study was to assess the non-inferiority of the device-oriented composite endpoint (DOCE), comprising radial artery occlusion or damage, as well as haematoma formation. Secondary outcomes encompassed haemostasis times affecting human resource management, as well as the number of utilized haemostasis devices and eventual bail-out requirements. Results Collected DOCE rates did not differ between the three groups, thus the chitosan and potassium ferrate dressings were non-inferior to the control MCD and each other. Secondary endpoints showed that both active dressings required fewer medical manipulations after application, thus alleviating staff, with potassium ferrate requiring marginally lower tourniquet times and the chitosan method requiring slightly more secondary devices and repeat tourniquets. Conclusions Our trial showed that standalone application of either dressing is equal in primary outcomes to the control MCD and may require less medical management to achieve similar results. Trial registration ClinicalTrials.gov identifier: NCT04857385.
Kulyassa et al. (Tue,) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: