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
Effect of Mechanical Ventilation on Radiofrequency Ablation in Atrial Fibrillation
Radiofrequency ablation (RFA) for atrial fibrillation (AF) is performed under general anesthesia. The success of the procedure depends on the safe contact of the catheter electrode with the myocardium. Movement of the catheter tip due to respiratory changes can result in inadequate lesion formation and AF recurrence. The success of AF ablation depends on the adequacy of energy delivered to the myocardium and the durability of pulmonary vein isolation (PVI). Poor energy delivery and tissue heating during ablation are a major cause of procedural failure in RFA. To improve the success of the PVI procedure, efforts are underway to optimize catheter stability and contact force. However, catheter force and stability are influenced by respiration-induced thoracic motion, highlighting the importance of controlled breathing for further optimization. Fluoroscopy and ablation times during electroanatomic mapping-guided AF ablations improved with controlled mechanical ventilation. General anesthesia improved catheter contact. Low tidal volume, high respiratory rate (FCV), pressure controlled mechanical ventilation (PCV), volume controlled mechanical ventilation (VCV), pressure controlled volume assured mechanical ventilation (PRVC) can be used in investigators' hospital. The literature offers no definitive proof that one ablation procedure is superior to another.
PULSED AF Post-Approval Study
PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.