What the trial was testing
The ENVISAGE-TAVI AF enrolled 1,426 patients with atrial fibrillation. The study was sponsored by Daiichi Sankyo 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
Edoxaban caused 40% more major bleeding than warfarin, mainly gastrointestinal bleeding.
The New England journal of medicine · 2021 · NCT02943785
These findings — that edoxaban caused more major bleeding than warfarin, especially in the digestive tract — were published in the The New England journal of medicine and represent the headline result of the study.
Researchers tracked outcomes across 1,426 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 is FDA-approved for atrial fibrillation, but this study found it caused more bleeding than warfarin in patients after valve replacement. If you have AFib and had a TAVR procedure, talk to your cardiologist about which blood thinner is safest for you. Warfarin may be a better choice in this situation.
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
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable
This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. When this happens, blood cannot move smoothly through the heart; it can slow down or pool in one spot, which can lead to the formation of blood clots. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation. The aim of the study is to see how effective and safe REGN7508 and REGN9933, individually, are in preventing ischemic stroke or systemic embolism in people with atrial fibrillation who cannot or may choose to not take blood thinners. The study is looking at several other research questions, including: * What side effects may happen from taking REGN7508 or REGN9933 * How well does REGN7508 or REGN9933 lower the risk of having an ischemic stroke and/or systemic embolism compared to the placebo * How well does REGN7508 or REGN9933 lower the risk of having a major health problem affecting heart and blood circulation compared to placebo * How well does REGN7508 or REGN9933 lower the risk of death compared to placebo * How much REGN7508 or REGN9933 is in the blood at different times * Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the study drugs less effective or could lead to side effects)
Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator.