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Left Atrial Appendage Occlusion vs Standard of Care After Ischemic Stroke Despite Anticoagulation
abstract
This abstract is available on the publisher's site.
Access this abstract nowImportance
Patients with atrial fibrillation (AF) who have ischemic stroke despite taking oral anticoagulation therapy (OAT) have a very high risk of recurrence. Left atrial appendage occlusion (LAAO) is a mechanical stroke prevention strategy that may provide additional protection in patients with thromboembolic events under OAT.
Objective
To compare percutaneous LAAO with continuing OAT alone regarding stroke prevention in patients with AF who had a thromboembolic event despite taking OAT.
Design, Setting, and Participants
This cohort study was a propensity score–matched comparison of the STR-OAC LAAO cohort, an international collaboration of 21 sites combining patients from multiple prospective registries of patients who underwent LAAO between 2010 and 2022. STR-OAC LAAO cohort patients who had follow-up longer than 3 months were propensity score–matched to a previously published control cohort comprising patients from an established international collaboration of investigator-initiated prospective studies. This control cohort included patients with nonvalvular AF, recent ischemic stroke or transient ischemic attack, and follow-up longer than 3 months who were taking OAT before the index event. Analyses were adjusted for imbalances in gender, age, hypertension, diabetes, and CHA2 DS2-VASc score.
Exposure
Left atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group).
Main Outcomes and Measures
The primary outcome was time to first ischemic stroke.
Results
Four hundred thirty-three patients from the STR-OAC LAAO cohort (mean [SD] age, 72 [9] years; 171 [39%] females and 262 [61%] males; mean [SD] CHA2 DS2-VASc score, 5.0 [1.6]) were matched to 433 of 1140 patients (38%) from the control group. During 2-year follow-up, 50 patients experienced ischemic stroke: an annualized event rate of 2.8% per patient-year in the STR-OAC LAAO group vs 8.9% per patient-year in the control group. Left atrial appendage occlusion was associated with a lower risk of ischemic stroke (hazard ratio, 0.33; 95% CI, 0.19-0.58; P < .001) compared with the control group. After LAAO, OAT was discontinued in 290 patients (67%), and the remaining 143 patients (33%) continued OAT after LAAO as an adjunctive therapy.
Conclusions and Relevance
In patients with nonvalvular AF and a prior thromboembolic event despite taking OAT, LAAO was associated with a lower risk of ischemic stroke compared with continued OAT alone. Randomized clinical trial data are needed to confirm that LAAO may be a promising treatment option for this population with a very high risk of stroke.
Additional Info
Disclosure statements are available on the authors' profiles:
Patients with atrial fibrillation face a fivefold increase in stroke risk, along with elevated mortality and recurrence rates.1 For individuals who experience recurrent strokes despite oral anticoagulation therapy (OAT), clinical management becomes particularly challenging. Left atrial appendage occlusion (LAAO) has emerged as a promising strategy for secondary stroke prevention in these patients, mechanically preventing clot dislodgement from the left atrial appendage, a common source of emboli in patients with atrial fibrillation.2
The study by Maarse et al evaluated 433 patients who underwent successful LAAO after thromboembolic events or persistent left atrial appendage thrombi despite OAT. These patients were propensity score–matched with 433 patients who continued OAT alone. Baseline characteristics were well-balanced between the groups; however, the LAAO cohort had a higher proportion of patients with adequate anticoagulation prior to the index event (92% vs 57%; P < .001) and more frequent use of non–vitamin K antagonist oral anticoagulants (56% vs 44%; P = .001). The study demonstrated a significant reduction in ischemic stroke risk among patients undergoing LAAO, reporting an annualized event rate of 2.8% in the LAAO group versus 8.9% in the OAT alone group (HR, 0.33; 95% CI, 0.19–0.58). These findings are consistent with those of earlier trials of LAAO.3 However, the limitations inherent in those earlier studies, such as sample size, dropout rates, and potential biases, necessitate a cautious interpretation of the results.
Despite the strengths of the study, several factors need to be acknowledged. Its observational design, even with propensity score matching, limits the ability to definitively establish the superiority of LAAO. The heterogeneous patient population and varying anticoagulation management practices present challenges to the generalizability of the findings. Additionally, in the LAAO group, the absence of documentation for events prior to device implantation, along with follow-up beginning only after the procedure, excluded the high-risk early poststroke period, potentially overestimating LAAO's benefits.
When considering LAAO as a standard treatment option, it is essential to weigh its benefits against potential risks. Patient selection is crucial, as the balance between stroke and bleeding risk can vary significantly based on individual comorbidities. Although LAAO shows considerable promise, several key issues, including the risks of device-related thrombosis, management of post-treatment antithrombotic therapy, and concerns regarding peri-device leakage, remain unresolved. Further randomized clinical trials are necessary to validate these findings and establish the long-term safety and efficacy of LAAO in stroke prevention.
References