What question did this study set out to answer?

To evaluate the safety and clinical effectiveness of left atrial appendage occlusion for secondary prevention in nonvalvular atrial fibrillation patients with a history of stroke.

January 31, 2024Clinical Research in CardiologyOpen Access

LAA occlusion is effective and safe in very high-risk atrial fibrillation patients with prior stroke: results from the multicentre German LAARGE registry

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Why the study?

Patients with nonvalvular AF and prior stroke have an increased risk of recurrent stroke, raising concern that LAAO effectiveness could be reduced in this very high-risk group.

Does left atrial appendage occlusion (LAAO) provide similar effectiveness and safety in nonvalvular atrial fibrillation patients with prior stroke compared to those without prior stroke?

Key Points

To evaluate the safety and clinical effectiveness of left atrial appendage occlusion for secondary prevention in nonvalvular atrial fibrillation patients with a history of stroke.
Prospective interventional registry study (NCT02230748) across 38 hospitals in Germany assessing N=638 consecutive patients undergoing left atrial appendage occlusion.
Compared outcomes between patients with prior stroke (n=137) and those without prior stroke (n=501) during index procedure and at 1-year follow-up.
Successful implantation was achieved in 98.5% of prior stroke patients versus 97.4% without (p = NS), with low peri-procedural MACCE (0% vs. 0.6%, p = NS) and complications (4.4% vs. 4.0%, p = NS).
One-year freedom from all-cause mortality or non-fatal stroke was 87.8% in patients with prior stroke versus 87.7% in those without (p = NS).
Follow-up rates of transient ischemic attack (0% vs. 0.5%, p = NS), systemic embolism (0.9% vs. 0%, p = NS), and post-discharge severe bleeding (0% vs. 0.7%, p = NS) remained consistently low across groups.

Structured PICO

Does left atrial appendage occlusion (LAAO) provide similar effectiveness and safety in nonvalvular atrial fibrillation patients with prior stroke compared to those without prior stroke?

Population

638 nonvalvular atrial fibrillation patients with contraindication for long-term oral anticoagulation, from 38 hospitals in Germany.

Intervention

Left atrial appendage occlusion (LAAO) in patients with a history of stroke (n=137)

Comparator

Left atrial appendage occlusion (LAAO) in patients without a history of stroke (n=501)

Outcome

Freedom from all-cause death or non-fatal stroke at 1-year follow-upcomposite

LAAO demonstrates a similar effectiveness and safety profile in nonvalvular AF patients with prior stroke compared to those without, suggesting it is a feasible alternative to OAC for secondary stroke prevention.

Implication

LAAO may yield comparable 1-year outcomes in AF patients with prior stroke; hypothesis-generating and requires randomized confirmation versus OAC.

Abstract

BACKGROUND: Interventional left atrial appendage occlusion (LAAO) mitigates the risk of thromboembolic events in nonvalvular atrial fibrillation (AF) patients with contraindication for long-term oral anticoagulation (OAC). Patients with prior stroke have a relevantly increased risk of recurrent stroke, so the effectiveness of LAAO could be reduced in this specific very high-risk patient group. AIM: This sub-study of the LAARGE registry investigates the effectiveness and safety of LAAO for secondary prevention in nonvalvular AF patients with a history of stroke. METHODS: LAARGE is a prospective, non-randomised registry on the clinical reality of LAAO. The current sub-study employs data from index procedure and 1-year follow-up. Effectiveness and safety were assessed by documentation of all-cause mortality, non-fatal thromboembolism, procedure-related complications, and bleeding events. RESULTS: A total of 638 patients were consecutively included from 38 hospitals in Germany and divided into two groups: 137 patients with a history of stroke (21.5%) and 501 patients without. Successful implantation was consistent between both groups (98.5% vs. 97.4%, p = NS), while peri-procedural MACCE and other complications were rare (0% vs. 0.6% and 4.4% vs. 4.0%, respectively; each p = NS). Kaplan-Meier estimate showed no significant difference in primary effectiveness outcome measure (freedom from all-cause death or non-fatal stroke) between both groups at follow-up (87.8% vs. 87.7%, p = NS). The incidence of transient ischemic attack or systemic embolism at follow-up was low (0% vs. 0.5% and 0.9% vs. 0%, respectively; each p = NS). Severe bleeding events after hospital discharge were rare (0% vs. 0.7%, p = NS). CONCLUSIONS: Patients with prior stroke demonstrated similar effectiveness and safety profile for LAAO as compared to patients without prior stroke. LAAO could serve as a feasible alternative to OAC for secondary stroke prevention in this selected group of nonvalvular AF patients. GOV IDENTIFIER: NCT02230748.