In a prespecified sub-analysis of the CHAMPION-AF trial, investigators found similar rates of stroke, systemic embolism and cardiovascular death, regardless of age, among atrial fibrillation (AF) patients randomised to undergo either left atrial appendage closure (LAAC) or to receive direct oral anticoagulants (DOACs).
The study included 3,000 patients, 1,499 undergoing LAAC with the Watchman FLX (Boston Scientific) device—currently indicated and US Food and Drug Administration (FDA)-approved for use in patients with AF who cannot tolerate or take long-term anticoagulants due to previous bleeding episodes or a high risk of bleeding—and 1,501 receiving DOACs. Patients enrolled in the trial were suitable for treatment with either approach.
Primary results, reported at the American College of Cardiology’s (ACC) annual scientific session in March (28–30 March 2026, New Orleans, USA), demonstrated that the device was as effective as medication in reducing the combined primary endpoint of all-cause stroke, cardiovascular death and systemic embolism at three years and at the same time substantially reduced major and clinically relevant non-major bleeding. This prompted investigators to suggest that the procedure may be a reasonable alternative to anticoagulation even among patients who are suitable for medical therapy.
The latest analysis, presented as one of the major late-breaking trials at the 2026 EuroPCR meeting (19–22 May, Paris, France) by Jens Erik Nielsen-Kudsk (Aarhus University Hospital, Aarhus, Denmark), sought to establish any potential differences in the safety and efficacy of the treatment in younger patients, those aged <75 years, and an older cohort, those aged ≥75 years, at the three-year timepoint.
CHAMPION-AF participants had an average age of 72 years, with around two thirds of patients falling into the younger age bracket. Of these, 953 were assigned to receive DOACs on an intention to treat basis, with 962 assigned to undergo LAAC. The older age group comprised of 548 patients predetermined for DOACs and 537 patients for LAAC. Patients in the younger age cohorts were aged on average around 67.5 years, whereas the older patients had an average age of close to 79 years.
Detailing the differences in baseline characteristics between the two groups, Nielsen-Kudsk noted a higher CHA2DS2-VASc score among the older patients (which stood at around 4.2), compared to those in the younger cohort (3.1), largely driven by their older age. Younger patients were more likely to have undergone previous AF ablation (with more than 50% having done so), compared to the older groups (where this was closer to 40%).
Among LAAC patients, procedural success was high in both groups, with successful deployment of the device achieved in 98.5% of patients regardless of age. There were no procedure-related deaths and only one stroke within seven days of the procedure.
Reporting the primary efficacy endpoint, the combined occurrence of cardiovascular death, stroke, and systemic embolism, Nielsen-Kudsk noted that among the younger aged patients, rates were virtually identical at around 3%, whereas among patients aged 75-years and above, there was a slightly higher event rate at three years.
Looking at the primary safety endpoint, non-procedural major and clinically relevant non-major bleeding, Nielsen-Kudsk reported a higher bleeding rate amongst older patients with DOAC compared to LAAC (22.4% vs. 13.5%), with a similar pattern found for the lower age group (17.2% vs. 9.5%).
Breaking down the primary efficacy endpoint on a per-protocol basis, Nielsen-Kudsk detailed that rates of ischaemic stroke were similar for the two approaches in younger patients (1.5% for DOACs vs. 2.2% LAAC) whereas in the older cohort the stroke rate was higher in the LAAC cohort (4.1%) compared to DOACs (2%). Disabling strokes were <1% across all four cohorts.
Rates of major bleeding stood at 5% vs. 4.7% for patients in the younger age group receiving DOACs and LAAC, respectively, and 7% for DOAC patients vs. 5.7% for LAAC patients in the older cohort.
“This sub-analysis supports LAAC as an alternative stroke prevention strategy in both younger and older patients,” Nielsen-Kudsk said in his concluding remarks. “Age alone should not preclude LAAC in otherwise suitable candidates, individualised treatment selection and shared decision making with patients.”
Commenting on the data in discussion that followed the presentation at EuroPCR, Philippe Garot (Institut Cardiovasculaire Paris Sud, Paris, France) noted that CHAMPION-AF is one of several recent trials comparing LAAC to anticoagulation, with mixed results.
“This has introduced some confusion among the community, and I think one of the most important points to be discussed today is to look at the landscape of this strong prevention strategy,” said Garot, who pointed out that the trials, including OPTION-AF and CLOSURE-AF, had markedly different populations. He highlighted that the CHAMPION-AF sub-analysis showed consistent results in both age ranges, adding: “The younger population in this trial derived greater benefit from LAAC, resulting in a smaller difference between LAAC and DOACs. In my view there’s no contradiction between these trials, we should look at these differences as supporting the use of LAAC in patients with reasonable life expectancy seeking an alternative to long-term oral anticoagulation.”
Also commenting following the study’s presentation at EuroPCR, Martin Leon (Columbia University Medical Center, New York, USA) said that LAAC procedures are increasing in the USA, even with the procedure currently restricted only to those not suitable for anticoagulation, with these data potentially opening to door to more cases down the line.
“If these data are to be adhered to, and if a significant proportion of patients would be treated, it would increase the treatable population by three to five times. So it has major implications in terms of what we do clinically,” Leon said. Leon praised the investigators for adding more evidence to the question as to which subgroups may benefit from the procedure.
