For older people with irregular heart rhythms who are at high risk of stroke and bleeding, standard care (including the use of blood thinners when indicated) was found to be the better choice compared to a promising, catheter-based procedure, according to a preliminary late-breaking science presentation today at the American Heart Association's Scientific Sessions 2025. The meeting, Nov. 7-10, in New Orleans, is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science.
The trial, Left Atrial Appendage CLOSURE in Patients with Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy (CLOSURE-AF), compared a catheter-based procedure to medical therapy among patients with an irregular heart rhythm known as atrial fibrillation or AFib.
An estimated five million people in the U.S. live with AFib, and it is predicted that more than 12 million people will have it by 2030, per the Association's 2025 Heart Disease and Stroke Statistics report.
While blood thinners can be highly effective at reducing the risk of stroke among people with AFib, the medication may cause severe bleeding in some people. Due to this risk, researchers are exploring alternative treatments including this catheter-based procedure. The procedure, called a left atrial appendage closure, seals a small pouch in the heart called the left atrial appendage, or LAA, where blood clots can form. If these blood clots enter the bloodstream, it increases the risk of stroke. Closing this pouch reduces the risk of stroke. It also can allow people to stop taking blood thinners for clot prevention.
The CLOSURE AF study compared catheter-based left atrial appendage closure with physician-directed standard medical care (including timely anticoagulant blood thinning when eligible) in patients with atrial fibrillation at high risk for stroke and bleeding. The aim of the study was to demonstrate non-inferiority for catheter-based LAA closure regarding risk of stroke, systemic embolism, cardiovascular/unexplained death or major bleeding. However, this was not reached.
We expected that catheter-based LAA closure would be comparable to physician-directed standard medical care often using blood thinning anticoagulant medications. However, this was not the case in this trial of older patients at very high risk of bleeding and stroke.
Our findings indicate that standard physician-directed medical care, including blood thinners for eligible patients, remains a valid management option for those older patients with irregular heartbeat who are at very high risk for stroke and bleeding."
Ulf Landmesser, M.D., study lead researcher, chairman of the department of cardiology, angiology and intensive care medicine at Deutsche Herzzentrum Charité and professor of cardiology at Charité University Medicine, Berlin
Landmesser said that the results of the procedure are different for lower-risk patients, and studies investigating this are currently underway. Moreover, ongoing studies are comparing LAA closure in addition to blood thinning in very high-risk patients.
Because medical treatments and LAA closure for AFib remain in development the results of this study may not apply to future research, other techniques or procedures.
Study details, background and design:
- More than 900 adults with AFib who were at high risk of stroke and major bleeding participated in this study.
- Participants' average age was 78 years, and 39% were women.
- They were enrolled at 42 health care sites in Germany from March 2018 to April 2024, and they were followed for a median of 3 years.
- Participants were randomly assigned to one of two treatment groups: standard medical care (including anticoagulant blood thinners, if eligible); or LAA closure.
- Researchers compared the frequency of stroke, life-threatening blood clots, cardiovascular/unexplained death and major bleeding between the two treatment groups.
Even low PFAS in drinking water raise blood levels, California study shows