Left atrial appendage closure noninferior to DOACs in preventing AF-related CV, neurological events
Percutaneous left atrial appendage closure (LAAC) is not inferior to direct oral anticoagulants (DOACs) in the prevention of major atrial fibrillation (AF)-related cardiovascular, neurological, and bleeding events, results of a recent study have shown.
Patients with nonvalvular AF; indications for OAC; and a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA2DS2-VASc of ≥3 and HAS-BLED of >2 were randomized to receive LAAC (n=201) or DOAC (n=201).
The primary endpoint was the composite of stroke, transient ischaemic attack (TIA), systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat.
The most commonly used agent in the DOAC group was apixaban (95.5 percent). The primary outcome had annual rates of 10.99 percent with LAAC and 13.42 with DOAC (subdistribution hazard ratio [sHR], 0.84, 95 percent confidence interval [CI], 0.53–1.31; p=0.44; pnoninferiority=0.004) over a median follow-up of 19.9 months.
No significant between-group differences were evident for the individual components of the composite endpoint: all-stroke/TIA (sHR, 1.00, 95 percent CI, 0.40–2.51), clinically significant bleeding (sHR, 0.81, 95 percent CI, 0.44–1.52), and cardiovascular death (sHR, 0.75, 95 percent CI, 0.34–1.62). Of note, nine patients (4.5 percent) suffered from major LAAC-related complications.
“Percutaneous LAAC is noninferior to vitamin K antagonists (VKAs) for preventing AF-related stroke,” the investigators said. “However, DOACs have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown.”