P210 - EFFECT OF STATSEAL HEMOSTATIC DISC IN HEMOSTASIS POST TRANSRADIAL PERCUTANEOUS CORONARY INTERVENTION IN PATIENTS RECEIVING HIGH DOSE ANTICOAGULATION FOR ACUTE MYOCARDIAL INFARCTION
Clinical Research Coordinator William Osler Health System , Ontario, Canada
Background: Emergency percutaneous coronary intervention (PCI) with transradial access (TRA) is the preferred method to treat acute myocardial infarction (AMI). PCI anticoagulation includes antiplatelets, unfractionated heparin (UFH), and glycoprotein IIb/IIIa inhibitors (GPIs). A pneumatic transradial (TR) band is applied at the puncture site post-PCI for ~6 hours. Complications such as radial artery occlusion, access site, or major bleeding may occur. Statseal (hemostatic hydrophilic polymer and potassium ferrate disc) used in conjunction with a TR band, has been effective in decreasing time to hemostasis (TTH) and compression time in diagnostic interventions (from ~135 mins to 75 mins). Its use has not been evaluated in highly anticoagulated patients. We compared the effect of statseal vs standard of care (SOC), TR band alone on TTH and complication rates post-PCI for AMI patients.
METHODS AND RESULTS: TTH was evaluated in 108 AMI patients undergoing PCI. Statseal + TR Band (n=33) and SOC (n=75). Statseal was applied at the time of sheath removal. The TR band was inflated with 8cc of air (time = 0) and radial artery patency was confirmed with positive reverse Barbeau test. The deflation protocol consisted of a 1st deflation at 90 mins with removal of 3 cc of air and 2nd step with full deflation at 120 mins followed by removal of the TR band at 135 mins (hemostasis achieved). TR band was reinflated if bleeding occurred. TTH and complications were recorded. Evaluation was done with statseal removal at 24hrs. Statseal + TR bands were applied by 2 interventional cardiologists. TR band deflated by a single research nurse. RStudio was used for statistical analysis, Mann Whitney U-Test, Fischer’s Exact Test, and p-values adjusted using Bonferroni corrections.
Demographic characteristics were not significant in both groups. There were 15 STEMI (45%) and 18 NSTEMI (55%) in the statseal group. 39% (n=13) patients had previous PCI. TTH was 129 mins (IQR=44) and 280 mins (IQR=104) for the statseal and SOC groups respectively; p<.00001. In patients who received GPIs, TTH was 135 mins (IQR=24.5; n=7) in the statseal group compared to 309 mins (IQR=114; n=32) in the SOC group; p<.00001. One case of hematoma >3 cm occurred in the statseal group due to involuntary exertion of the wrist. One case of prolonged compression time (+46 mins) concomitant with mechanical trauma during the procedure.
Conclusion: Statseal reduced significant TTH compared to SOC in highly anticoagulated AMI patients undergoing PCI, with minimal complications. Future research is warranted.