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
The Evaluation for Prognostic Factors After Catheter Ablation of Atrial Fibrillation: Cohort Study
1\. Purpose of the study 1\) To explore clinical recurrence associated clinical factors including age, sex, clinical, electrophysiological, anatomical, imaging, and serologic characteristics. 2\) To develop simulation model to predict clinical recurrence and the efficacy of catheter ablation 2. Scientific evidence of the study 1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality. 2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed. 3. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy. 4. clinical outcome after catheter ablation is affected not only by age, sex and underlying disease, but also by electrophysiologic, imaging, serologic and electroanatomical remodeling of the heart. However, there are few studies concerning these multifactorial variables. 3\. Study population
Surgical Ablation of AF Efficacy Trial
SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.