LAA Excision With AF Ablation Versus Oral Anticoagulants for Secondary Prevention of Stroke (5A)

Evaluation of Thoracoscopic Left Atrial Appendage Excision Plus Atrial Fibrillation Ablation Versus Oral Anticoagulants for Secondary Prevention of Stroke and Non-central Nervous Systemic Embolism in Patients With AF: 5A Pilot Cohort

This cohort study aims to evaluate thoracoscopic left atrial appendage excision plus atrial fibrillation ablation versus oral anticoagulants for the prevention of stroke and non-central nervous systemic embolism in patients with atrial fibrillation and thromboembolism.

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation; Systemic Embolism
• Intervention / Treatment: Procedure: Thoracoscopic LAA Excision plus AF Ablation; Drug: Warfarin or Novel Oral Anticoagulants

Detailed Description

Brief Summary: This cohort study aims to compare thoracoscopic left atrial appendage excision plus atrial fibrillation ablation versus oral anticoagulants for secondary prevention of stroke and non-central nervous systemic embolism in patients with atrial fibrillation and thromboembolism.

Detailed Description: BACKGROUND: Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and has been shown to be an important cause of stroke. AF is responsible for 15% of all strokes. Most strokes in AF are caused by cardioembolism. The left atrial appendage (LAA) is the dominant source of cardioembolism. The greatest priority in treating AF is stroke prevention. There are now 3 main approaches for prevention: (1) oral anticoagulation (OAC), (2) eradication of AF, and (3) exclusion of the LAA from the systemic circulation. OAC therapy, including warfarin and novel oral anticoagulants, effectively reduces the risk of stroke in AF and is currently the first line of treatment in patients with AF and one or more risk factors. Despite the advancements in medical therapy, the risk of stroke in patients with AF who undergo optimal anticoagulation therapy still remains between 2% and 5% per year, regardless of the agent used. The limitations of OAC include (1) patient unsuitability for OAC, (2) increased risk of bleeding, (3) need for monitoring optimal international normalized ratio (INR) levels (with warfarin), and (4) patient noncompliance. Percutaneous methods of ablation are widely used to attempt to eliminate AF. Approximately 20% of patients who underwent ablation had AF recurrence. It is because of this well-demonstrated occurrence that the guidelines do not recommend discontinuation of warfarin or equivalent therapies after ablation. Since at least 90% of all left atrial thrombi are found within the LAA, it is plausible that its occlusion will lead to a decreased risk of stroke in patients with AF. However, the evidence for surgical excision is extremely limited.

AIM OF THE STUDY: The primary objective of this study is to evaluate whether thoracoscopic LAA excision plus atrial fibrillation ablation for the purpose of prevention of thromboembolism in patients with AF and thromboembolism is more effective and safer compared with OACs for reducing the composite endpoint of stroke, TIA and systemic embolism. The primary end point was the composite of ischemic stroke/systemic embolism/transient ischemic attack (TIA), major bleeding, or all-cause mortality. The secondary end point is defined as ischemic strokes, all strokes (including ischemic and hemorrhagic), major and fatal bleeding events, minor bleeding complication, all-cause mortality, cardiovascular death, and hospitalization due to cardiovascular or cerebral diseases.

STUDY DESIGN: This is a single-center prospective cohort study. Adult patients with non-valvular AF and a previous history of ischemic stroke/systemic embolism/ TIA are eligible for inclusion of this study. Approximately 300 patients with paroxysmal or persistent AF and previous thromboembolic events will receive novel oral anticoagulant or warfarin treatment with a targeted INR between 2.0 and 3.0 or surgical LAA excision plus AF ablation. Follow-up for these patients includes visits at 3 m, 6 m, 9 m, 12 m, and every additional 6 months there after.

• Study Type: Observational
• Enrollment (Actual): 474

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 201129
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with non-valvular AF and a previous history of embolic events are eligible for inclusion of this study.

Description

Inclusion Criteria:

• 18-80 years
• Have documented AF episodes
• The occurrence of ischemic stroke, TIA or systemic thromboembolism at least one month before enrollment
• Capable of understanding and signing the CRF

Exclusion Criteria:

• Reversible AF
• Modified Rankin score ≥4
• Having a history of rheumatic, severe valvular heart disease or heart valve replacement
• Having symptomatic carotid artery disease
• Having another disease which requires lifelong warfarin therapy
• Medical conditions limiting expected survival to <1 year
• Women of childbearing potential (unless post-menopausal or surgically sterile)
• Participation in any other clinical mortality trial
• Unable to give informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the surgical intervention group; Thoracoscopic LAA Excision plus AF Ablation. Patients receiving thoracoscopic left atrial appendage excision plus atrial fibrillation alation	Procedure: Thoracoscopic LAA Excision plus AF Ablation; In this group, patients receive thoracoscopic LAA excision plus AF ablation, which means thoracoscopic left atrial appendage excision plus atrial fibrillation ablation.
oral anticoagulant treatment group; Warfarin or Novel Oral Anticoagulants. Patients receiving warfarin treatment (INR 2.0-3.0) or novel oral anticoagulants	Drug: Warfarin or Novel Oral Anticoagulants; In this group, patients receive warfarin or novel oral anticoagulants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the composite of ischemic stroke/systemic embolism/transient ischemic attack (TIA), major bleeding, or all-cause mortality.	at least 3 month follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
ischemic strokes	at least 3 month follow-up
all strokes (including ischemic and hemorrhagic)	at least 3 month follow-up
Major and fatal bleeding events	at least 3 month follow-up
Minor bleeding complication	at least 3 month follow-up
all-cause mortality	at least 3 month follow-up
cardiovascular death	at least 3 month follow-up
hospitalization due to cardiovascular or cerebral diseases	at least 3 month follow-up

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 21, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Stroke; Atrial Fibrillation; Warfarin; Systemic embolism; Left atrial appendage excision
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Stroke; Embolism; Atrial Fibrillation; Warfarin; Anticoagulants
• Other Study ID Numbers: 2014-SR-113