REG1, a system containing pegnivacogin and anivamersen, is a "safe strategy to anticoagulate acute coronary syndrome (ACS) patients managed invasively" and "at least fifty percent reversal is required to allow safe sheath removal after cardiac catheterization," note the authors of a study published on Aug. 2 in the European Heart Journal.

 

This is the first study to look at REG1 in invasively managed patients with ACS, and to define an optimal level of reversal allowing safe sheath removal. The study found "bleeding occurred in 65, 34, 35, 30 and 31 percent of REG1 patients with 25, 50, 75 and 100 percent reversal and heparin. Major bleeding occurred in 20, 11, 8, 7 and 10 percent of patients," while "ischaemic events occurred In 3.0 and 5.7 percent of REG1 and heparin patients, respectively."

Additional Resources Full Study Journal Scan

The RADAR trial was a phase 2 randomized, partially blinded, active-controlled study that looked at 640 non-ST-elevation ACS patients. The authors conclude, "adequately powered randomized clinical trials are warranted to determine the safety and efficacy of factor IXa inhibition with REG1 compared with other anticoagulation strategies in patients who require high-intensity, short-term anticoagulation."

< Back to Listings