09/03/2019 | Press release | Distributed by Public on 09/03/2019 09:43
In patients with atrial fibrillation (AFib), a post PCI dual antithrombotic (DAT) regimen of edoxaban plus a P2Y12 inhibitor was noninferior to triple antithrombotic therapy (TAT) with a vitamin K antagonist (VKA) plus a P2Y12 inhibitor and aspirin, according to results of the ENTRUST-AF PCI trial. The findings were presented by Andreas Goette, MD, at ESC Congress 2019 on Sept. 3 and simultaneously published in The Lancet.
In the international, open-label masked outcome evaluation study, researchers randomized patients to DAT (n=751) or TAT (n=755). Their median age was 70 years and 26 percent were women. The median CHA2DS2-VASc score was 4.0 and the median HAS-BLED score was 3.0. A total of 30 percent had previously used VKAs and 24 percent had used a NOAC.
DAT consisted of edoxaban 60 mg once daily plus a P2Y12 inhibitor for 12 months and TAT consisted of a VKA plus a P2Y12 inhibitor and aspirin 100 mg once daily for 1-12 months. Edoxaban dosing was reduced to 30 mg daily if the patient had one or more of these were factors: creatinine clearance 15-50 mL/min, bodyweight ≤60 kg or concomitant use of specified potent P-glycoprotein inhibitors. The median time from PCI to randomization was 4.1 hours. The median duration of TAT was 66 days.
The primary endpoint was a composite of major or clinically relevant nonmajor (CRNM) bleeding within 12 months in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of their assigned study drug.
Results showed a primary endpoint event occurred in 128 (17 percent) patients in the DAT group and 152 (20 percent) patients in the TAT group. This translated to an annualized event rate of 20.7 percent with edoxaban-based DAT vs. 25.6 percent with VKA-based TAT (hazard ratio 0.83; p=0·0010 for noninferiority; margin hazard ratio 1.20; p=0.1154 for superiority).
For the main efficacy composite outcome of cardiovascular death, stroke, SEE, myocardial infarction, and definite stent thrombosis, the annualized event rate was similar between the DAT and TAT groups (7.3 percent and 6.0 percent, respectively).
According to the authors this is the first trial testing an edoxaban-based DAT against a VKA-based TAT in patients with AFib who had PCI. They conclude that the edoxaban-based regimen was noninferior for bleeding compared with the VKA-based regimen, without significant differences in ischemic events.
Clinical Topics:Anticoagulation Management, Arrhythmias and Clinical EP, Invasive Cardiovascular Angiography and Intervention, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias, Interventions and Imaging, Angiography, Nuclear Imaging
Keywords:ESC 19, ESC Congress, Atrial Fibrillation, Anticoagulants, Percutaneous Coronary Intervention, Angiography