What the trial was testing
The ENTRUST-AF PCI enrolled 1,506 patients with atrial fibrillation. The study was sponsored by Daiichi Sankyo Europe and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
17% lower risk of major or relevant bleeding on the edoxaban regimen.
The Lancet · 2019 · NCT02866175
These findings — that of major or relevant non-major bleeding on edoxaban vs. warfarin-based regimen — were published in the The Lancet and represent the headline result of the study.
Researchers tracked outcomes across 1,506 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with atrial fibrillation, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Edoxaban (Savaysa) is FDA-approved for atrial fibrillation and available now. After heart stenting, current guidelines support a direct oral anticoagulant like edoxaban, apixaban, or rivaroxaban combined with one antiplatelet pill instead of the older triple-therapy approach. Ask your cardiologist what regimen fits your case.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open atrial fibrillation trials
CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
Catheter ablation has become as the first-line treatment for patients with symptomatic atrial fibrillation (AF). As the cornerstone of catheter ablation for AF, the safety and efficacy of circumferential pulmonary vein isolation (CPVI) have been confirmed. However, for persistent AF, especially for long-standing persistent AF (LSPAF), the recurrence rate is still high. Whether the ethanol infusion (EI) into the vein of Marshall (EI-VOM) and linear ablation could improve the success rate remains controversial. The SINUS study is a prospective, multicenter, randomized trial, which is designed to compare the efficacy and safety between CPVI with modified linear ablation (CPVI-MLA) and CPVI only for the treatment of LSPAF.
REal-world Valued Outcomes of a noveL Balloon-in-basket pUlsed Field ablaTION Catheter for Atrial Fibrillation RegistrY
describe real-world adaption, work-flow data as well as procedural and follow-up outcomes after balloon-in-basket guided PFA for AF in early European users.