In patients with nonvalvular atrial fibrillation (NVAF), the use of percutaneous left atrial appendage closure (LAAC) is associated with a reduced long-term risk of death compared with treatment with oral anticoagulation (OAC), according to the results of a meta-analysis published in the journal Structural Heart.
Researchers sought to perform an updated meta-analysis of randomized controlled trials (RCTs) that compared OAC therapy with percutaneous LAAC, and focus on individual clinical endpoints.
They conducted a systematic search of all RCTs in MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials between January 2000 and December 2021 that compared percutaneous LAAC with OAC in individuals with NVAF. In the RCTs under consideration, the OACs evaluated included both vitamin K antagonists (VKAs) and direct OACs (DOACs). For consideration, the studies needed to report clinical outcomes following randomization to LAAC or OAC. No observational studies or studies of surgical left atrial appendage occlusion were included.
The prespecified primary study endpoint was all-cause mortality. Other endpoints included cardiac death, ischemic stroke, hemorrhagic stroke, disabling stroke, all stroke, major bleeding, and nonprocedural major bleeding. Cardiac death was defined as “cardiovascular or unexplained death as defined and adjudicated in each individual trial.” Disabling stroke was defined as “strokes with a modified Rankin score of greater than 2 after the stroke, or a fatal stroke.”
Three RCTs, which randomized a total of 1516 participants, were identified. Overall, 933 patients were randomized to LAAC and 583 patients to OAC. The weighted mean follow-up was 54.7 months.
Results of the analysis showed that the use of LAAC was associated with a significantly reduced risk for all-cause mortality (hazard ratio [HR], 0.76; 95% CI, 0.59-0.96; P =.023), hemorrhagic stroke (HR, 0.24; 95% CI, 0.09-0.61; P =.003), and major nonprocedural bleeding (HR, 0.52; 95% CI, 0.37-0.74; P <.001). No statistically significant differences were observed between LAAC and OAC with respect to any of the other endpoints.
Some limitations of the study include that the OAC used in the control arm are VKAs in approximately two-thirds of the participants and DOACs in the remainder. It is well known that DOAC use, rather than VKA, is more reflective of clinical practice. Additionally, the postprocedural antithrombotic regimens evaluated in the LAAC arms are not uniform across the trials, with the definitions of clinical outcomes varying slightly among studies.
“Further large-scale RCTs are needed to validate these findings (especially compared with DOACs), and to evaluate the role of LAAC in comparison to other control groups,” the study authors wrote.
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
References:
Madhavan MV, Howard JP, Brener MI, et al. Long-term outcomes of randomized controlled trials comparing percutaneous left atrial appendage closure to oral anticoagulation for nonvalvular atrial fibrillation: a meta-analysis. Structural Heart. Published online September 24, 2022. doi:10.1016/j.shj.2022.100096