The left atrial appendage exclusion for prophylactic stroke reduction (LEAAPS) trial: Rationale and design.

Area of Science:

• Cardiology
• Neurology
• Vascular Surgery

Background:

• Left atrial appendage exclusion (LAAE) is proven to reduce ischemic stroke in patients with atrial fibrillation (AF) undergoing cardiac surgery.
• Many patients without pre-existing AF undergoing cardiac surgery are still at risk for stroke.

Purpose of the Study:

• To evaluate the effectiveness of LAAE in preventing ischemic stroke or systemic embolism in patients undergoing cardiac surgery who are at increased risk of AF and stroke.
• To assess the safety of LAAE during cardiac surgery.

Main Methods:

• The Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) trial is a prospective, randomized, multicenter, blinded study.
• 6500 patients at increased risk for stroke and AF (but without pre-existing AF) will be randomized 1:1 to receive LAAE with AtriClip or no LAAE during cardiac surgery.
• Follow-up is for a minimum of 5 years, with primary analysis upon 469 primary endpoint events.

Main Results:

• Primary effectiveness endpoint: first occurrence of ischemic stroke, systemic arterial embolism, or surgical/endovascular LAA closure.
• Powered secondary effectiveness endpoint: ischemic stroke or systemic arterial embolism.
• Primary safety endpoint includes pericardial effusion, major bleeding, deep sternal wound infection, or myocardial infarction within 30 days.

Conclusions:

• The LeAAPS trial will determine if LAAE with AtriClip during cardiac surgery reduces stroke or systemic embolism in high-risk patients without pre-existing AF.
• Results will inform prophylactic stroke reduction strategies in a broader surgical population.