A Phase 2, randomized, partially blinded, active-controlled study assessing the efficacy and safety of variable anticoagulation reversal using the REG1 system in patients with acute coronary syndromes: results of the RADAR trial
European Heart Journal, 08/23/2012
Povsic TJ et al. – At least 50% reversal is required to allow safe sheath removal after cardiac catheterization. REG1 appears a safe strategy to anticoagulate acute coronary syndromes patients managed invasively and warrants further investigation in adequately powered clinical trials of patients who require short–term high–intensity anticoagulation.Methods
- Non–ST–elevation ACS patients (n = 640) with planned early cardiac catheterization via femoral access were randomized 2:1:1:2:2 to pegnivacogin with 25, 50, 75, or 100% anivamersen reversal or heparin.
- The primary endpoint was total ACUITY bleeding through 30 days.
- Secondary endpoints included major bleeding and the composite of death, myocardial infarction, urgent target vessel revascularization, or recurrent ischaemia.
- Enrolment in the 25% reversal arm was suspended after 41 patients.
- Enrolment was stopped after three patients experienced allergic–like reactions.
- Bleeding occurred in 65, 34, 35, 30, and 31% of REG1 patients with 25, 50, 75, and 100% reversal and heparin.
- Major bleeding occurred in 20, 11, 8, 7, and 10% of patients.
- Ischaemic events occurred in 3.0 and 5.7% of REG1 and heparin patients, respectively.