STroke Secondary Prevention With Catheter ABLation and EDoxaban for Patients With Non-valvular Atrial Fibrillation: STABLED Study

Nippon Medical School

Status and phase: Active, not recruiting; Phase 3

Conditions: Atrial Fibrillation Non-Rheumatic; Ischemic Stroke

Treatments: Procedure: Catheter ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03777631

LIX-DS-16018

Details and patient eligibility

About

Catheter ablation (CA) has been reported to reduce risk of stroke in patients with nonvalvular atrial fibrillation (NVAF) in retrospective studies, but risk and benefit of CA has not been well elucidated in NVAF with recent cerebral infarction in prospective randomized trials.

Full description

In patients with NVAF, stroke is an independent risk factor for a subsequent cerebral infarction. Although anticoagulant therapy can effectively reduce thromboembolic events, the reported annual recurrence rate in NVAF and previous stroke patients in the "real-world" is not low even with appropriate antithrombotic treatment; 8.6% in patients with "guideline adherent" antithrombotic therapy and around 5% in patients treated with anticoagulant therapy. NVAF and recent stroke is high-risk population for stroke recurrence even with anticoagulant therapy, and developing optimal secondary prevention strategy is an urgent task.

Catheter ablation (CA) is now widely used to treat symptoms related to NVAF. Some retrospective studies showed a beneficial effect of CA for stroke prevention using age-/sex-matching or propensity-score matching. Moreover, CA have a potential to improve survival or prevent heart failure development in patients with AF. However, the effect of CA for secondary stroke prevention or impact of CA for NVAF patients with recent ischemic stroke for survival or developing heart failure has not been evaluated in a prospective randomized trial. Therefore, in the present study, we intend to compare two groups of patients with NVAF with a history of cerebral infarction: a group receiving standard medical therapy (control group) and a group receiving standard medical therapy plus CA (CA group).

Enrollment: 251 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥20 or ≤85 years at time of giving informed consent
• Nonvalvular atrial fibrillation
• History of stroke in previous 6 months
• Current or planned treatment with edoxaban
• Modified Rankin scale ≤3

Exclusion criteria

• Symptomatic paroxysmal AF resistant to anti-arrhythmic drugs
• Presence of left atrial thrombus and left atrial appendage on transthoracic echocardiography, computed tomography or magnetic resonance imaging
• Unable to take anticoagulation therapy for any reason, including tendency to bleed or considered at high risk for bleeding from anticoagulation therapy.
• Presence of severe renal disorder (estimated creatinine clearance <30 mL/min by Cockroft-Gault equation)
• Previous CA or surgical intervention for AF
• History of treatment with a left atrial appendage closure device
• Left atrial diameter ≥55 mm on transthoracic echocardiography
• Ejection fraction ≤35% on transthoracic echocardiography
• Persistent AF for ≥10 years
• Pregnant or possibility of pregnancy
• Unlikely to complete the study, such as due to progressive malignant tumor
• Participating or planning to participate in another clinical trial
• Unwilling to participates
• Judged as incompatible for the study by the investigators

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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251 participants in 2 patient groups

Standard medical therapy group

No Intervention group

Description:

The preferred anticoagulant is edoxaban. Antiarrhythmic drugs are administered as needed for the patient by well-trained cardiologists.

Catheter ablation group

Active Comparator group

Description:

Catheter ablation (CA) should be performed within 1-6 months from the onset of cerebral infarction. CA is based on pulmonary vein isolation, with atrial ablation as required. For conducting CA by a trained and experienced cardiologist, only institutions in which performed \>100 CA annually were participated in the present study in principle.

Treatment:

Procedure: Catheter ablation