Abstract 13657: The REG1 Anticoagulation System Allows for Early Arterial Sheath Removal After Cardiac Catheterization Without Increases in Time to Hemostasis or Bleeding Complications: An Analysis From the RADAR Clinical Trial.
Background: The REG1 anticoagulation system contains a novel aptamer-based factor IX inhibitor (pegnivacogin) with an active, specific, and titratable control agent (anivamersen). The use of the REG1 system for cardiac catheterization may allow for earlier sheath removal, reduced arterial compression time, and fewer bleeding complications.
Methods: RADAR was a phase 2 clinical trial of the REG1 anticoagulation system in patients with non-ST elevation ACS undergoing cardiac catheterization via femoral access. Patients were randomized to receive pegnivacogin prior to catheterization, with varying degrees of reversal with anivamersen (25%, 50%, 75%, or 100%) administered just after catheterization and sheath removal 10 minutes after reversal, or to heparin with sheath management per local standard.
Results: A total of 640 patients were randomized. The 25% reversal arm was terminated early due to excess bleeding (Table 1). By design, the median (25th, 75th) time from end of catheterization to sheath removal was substantially shorter for the combined REG1 groups [27 (18, 43) min] compared with heparin [201 (104, 324) min]. Except for the 25% reversal group, the time required to achieve hemostasis following sheath removal was similar among all groups. Lengths of stay after catheterization were also similar. Access site bleeding resulting in a hematoma ≥ 5 cm or intervention tended to be lower with higher anivamersen doses.
Conclusion: The REG1 anticoagulation system allows for early arterial sheath removal following cardiac catheterization with similar times to hemostasis and access site bleeding rates in patients receiving at least 50% reversal. Future studies will assess whether these shorter sheath removal times translate to reductions in the use of vascular closure devices, decreased vascular access complications, or shorter hospital stays among patients undergoing PCI.
- Percutaneous coronary intervention
- Acute coronary syndromes
- Interventional cardiology
- © 2011 by American Heart Association, Inc.