COMPARISON OF TWO RADIAL HEMOSTASIS TECHNIQUES, CATECHOL CONJUGATED CHITOSAN-BASED PAD (INNOSEAL) WITH COMPRESSION BAND: A RANDOMIZED CONTROLLED TRIAL

Background: Radial artery occlusion (RAO) after radial artery access for coronary procedures may rarely lead to severe hand ischemia and limits future use of this site. This study aims to assess the impact on RAO rate of two radial hemostasis techniques, radial compression device (RCD) (TR band, TerumoMedical, Japan) and hemostatic pad (InnoSEAL) (InnoTherapy Inc.). Methods: We conducted a randomized controlled trial at Tabba Heart Institute, Karachi Pakistan from March- August 2018. Patients undergoing trans-radial coronary diagnostic (CAG) and percutaneous coronary intervention (PCI) using 6 F sheath were randomized to InnoSEAL (catechol conjugated chitosan-based pad) or TR band. InnoSEAL technique included manual digital compression applied over a pad placed at puncture site (4 minutes for CAG & 10 minutes for PCI+ 2-3 minutes), and elasticated bandage wrapped around the wrist after this (CAG: 30 minutes, PCI: 60 minutes). TR band air was gradually released for maximum application duration of 4 hours. Outcome parameters were RAO evaluated by Doppler US and upper extremity hematoma. Results: 620 patients were randomized and data on initial580 patients is presented (288 InnoSEAL, 292 TR band). 2.6% InnoSEAL patients crossed over to TR band. Mean age was 58 ±11 years and male gender in 75%. Baseline characteristics were similar between the two groups. CAG was done in 57.6%, PCI in 18.4% and combinedCAG and PCI in 23.9%. All patients received heparin, with a mean dose of 4,900 ± 1,230 U for CAG and 7,900± 2,000 for PCI. Median compression time was 10 (6) minutes [CAG: 6(5), PCI: 12(2), CAG+PCI: 10 (3)]. RAO was found in 9.8% patients (Intention to treat, InnoSEAL: 6.9%, TR band: 12.3%, p=0.03;per protocol, InnoSEAL: 6.9%, TR band: 11.9%, p=0.04; actual treatment, InnoSEAL: 7.6%, TR band: 11.9%, p=0.07). Grade I/II forearm hematoma was seen in 2.4% (14) (InnoSEAL: 1%, TR: 3.8%, p=0.23) and grade III/IV hematoma in 1 InnoSEAL patient. Conclusion: Radial hemostasis after trans-radial coronary procedures using InnoSEAL in comparison to TR band showed lower RAO and similar bleeding complications.