Left Atrial Appendage Occlusion Versus Oral Anticoagulant for Stroke Prevention in Atrial Fibrillation: A Systematic Review of Randomized Controlled Trials
Author(s)
Watanyoo Prayoonhong, B.Pharm., M.Pharm.1, Jirawit Yadee, Pharm.D., Ph.D.2, Unchalee Permsuwan, Ph.D.2.
1Pharmacy Department, Phimai Hospital, Nakhon Ratchasima, Thailand, 2Center for Medical and Health Technology Assessment (CM-HTA), Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.
1Pharmacy Department, Phimai Hospital, Nakhon Ratchasima, Thailand, 2Center for Medical and Health Technology Assessment (CM-HTA), Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.
OBJECTIVES: Left atrial appendage occlusion (LAAO) has emerged as a potential alternative to oral anticoagulation for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). This systematic review aimed to evaluate the clinical outcomes of LAAO in comparison to oral anticoagulants, including warfarin and direct oral anticoagulants (DOACs), based on evidence from randomized controlled trials (RCTs).
METHODS: A systematic literature search was conducted in PubMed, Scopus, and Embase from inception to October 2024 to identify RCTs comparing LAAO and oral anticoagulants. Included studies were assessed using the revised Cochrane Risk-of-Bias Tool for Randomized Trials (RoB 2.0). Data were extracted for qualitative synthesis. A meta-analysis was not performed due to limitations in data availability and study timepoints.
RESULTS: 3 RCTs using non-inferiority design were included. 2 trials compared LAAO with warfarin. In the PROTECT-AF trial (1,065 patient-years of follow-up), LAAO showed a lower rate of the composite outcome (all stroke, cardiovascular death, and systemic embolism) than warfarin (rate ratio 0.62; 95% credible interval [CrI]: 0.35-1.25), meeting non-inferiority criteria. Conversely, the PREVAIL trial (median follow-up: 12 months) reported a higher event rate in the LAAO group for the coprimary endpoint (rate ratio 1.07; 95% CrI: 0.57-1.89), failing to demonstrate non-inferiority. The PRAGUE-17 trial compared LAAO with DOACs over 19.9 months and found LAAO to be non-inferior for a composite endpoint, though the difference was not statistically significant (subdistribution hazard ratio 0.84; 95% CI: 0.53-1.31; p=0.44).
CONCLUSIONS: Current RCT evidence suggests that LAAO may offers a comparable alternative to OACs in NVAF patients for stroke prevention, with variable outcomes across trials.
METHODS: A systematic literature search was conducted in PubMed, Scopus, and Embase from inception to October 2024 to identify RCTs comparing LAAO and oral anticoagulants. Included studies were assessed using the revised Cochrane Risk-of-Bias Tool for Randomized Trials (RoB 2.0). Data were extracted for qualitative synthesis. A meta-analysis was not performed due to limitations in data availability and study timepoints.
RESULTS: 3 RCTs using non-inferiority design were included. 2 trials compared LAAO with warfarin. In the PROTECT-AF trial (1,065 patient-years of follow-up), LAAO showed a lower rate of the composite outcome (all stroke, cardiovascular death, and systemic embolism) than warfarin (rate ratio 0.62; 95% credible interval [CrI]: 0.35-1.25), meeting non-inferiority criteria. Conversely, the PREVAIL trial (median follow-up: 12 months) reported a higher event rate in the LAAO group for the coprimary endpoint (rate ratio 1.07; 95% CrI: 0.57-1.89), failing to demonstrate non-inferiority. The PRAGUE-17 trial compared LAAO with DOACs over 19.9 months and found LAAO to be non-inferior for a composite endpoint, though the difference was not statistically significant (subdistribution hazard ratio 0.84; 95% CI: 0.53-1.31; p=0.44).
CONCLUSIONS: Current RCT evidence suggests that LAAO may offers a comparable alternative to OACs in NVAF patients for stroke prevention, with variable outcomes across trials.
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD127
Topic Subcategory
Health & Insurance Records Systems
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory)