Left atrial appendage closure noninferior to anticoagulation in AF
ACC.26 – In CHAMPION-AF among patients with non-valvular AF, left atrial appendage closure was noninferior to DOAC therapy for lowering the risk of CV death, stroke, or systemic embolism at 3 years.
This summary is based on the presentation of Saibal Kar, MD (Thousand Oaks, CA, USA) at the ACC.26 Scientific Session - Left Atrial Appendage Closure or Anticoagulation for Atrial Fibrillation: The CHAMPION Clinical Trial.
Introduction and methods
Non-vitamin K antagonist oral anticoagulants (NOACs or also referred as direct oral anticoagulants (DOACs)) reduce thromboembolic events in patients with AF, but uptake have been limited due to compliance, cost and bleeding. Left atrial appendage closure (LAAC) may be considered in patients with AF who are poor candidates for long-term oral anticoagulant therapy, but whether LAAC is a reasonable alternative for AF patients who are eligible for DOACs remains to be established.
CHAMPION-AF (Watchman Flx versus NOAC for Embolic Protection in the Management of Patients with Non-Valvular Atrial Fibrillation) is an ongoing, prospective, international, randomized trial in which 3000 patients with non-valvular AF who were suitable for long-term DOAC and at increased risk of stroke (CHA2DS2-VASc score of ≥2 for males or ≥3 for females) were randomized in a 1:1 ratio to LAAC with the Watchman FLX device or DOAC therapy. Patients in the LAAC group were treated with DOAC monotherapy, DOAC plus aspirin, or DAPT for 3 months, followed by just aspirin alone for the remainder of the study.
The primary efficacy outcome (tested for non-inferiority) was a composite of CV death, stroke, or systemic embolism at 3 years. The primary safety outcome (tested for superiority) was non-procedural ISHT major and modified ISTH clinically relevant non-major bleeding at 3 years. The third primary endpoint, which is a composite of ischemic stroke and systemic embolism, will be assessed at 5 years.
Main results
- At 3 years, the primary efficacy endpoint occurred in 5.7% of the patients in the LAAC group and in 4.8% of the patients in the DOAC group (between-group difference: 0.9%; P for non-inferiority<0.001).
- The annual average difference in ischemic stroke and systemic embolism rate was 0.33% per year higher in the LAAC group compared with the DOAC group.
- At 3 years, non-procedural bleeding occurred in 10.9% of the patients in the LAAC group and in 19.0% of the patients in the DOAC group (HR: 0.55; 95%CI: 0.45–0.67; P for superiority<0.001).
- The rates of ISHT major bleeding were similar between the groups at 3 years (5.9% vs. 6.4%; P for non-inferiority<0.001).
- At 3 years, a composite of CV death, stroke, systemic embolism, or non-procedure bleeding occurred in 15.1% of patients in the LAAC group and in 21.8% patients in the DOAC group (between-group difference: -6.7%; P for non-inferiority<0.001).
Conclusion
In CHAMPION-AF trial among patients with non-valvular AF deemed suitable for long-term anticoagulation, LAAC was noninferior to DOACs regarding the primary efficacy endpoint of CV death, stroke or systemic embolism at 3 years. LAAC was superior to DOAC therapy for non-procedural bleeding at 3 years.
- Our reporting is based on the information provided at the ACC.26 Scientific Session -