Safety and Efficacy of Edoxaban in Thoracoscopic Ablation

Safety and Efficacy of Edoxaban Versus Warfarin in Patients Undergoing a Thoracoscopic Ablation for Persistent Atrial Fibrillation

The aim of this study is to compare the safety and efficacy of edoxaban and warfarin for prevention of stroke during a 6-month follow up after total thoracoscopic ablation.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Anticoagulants and Bleeding Disorders
• Intervention / Treatment: Drug: Edoxaban; Drug: Warfarin

Detailed Description

In Korea, 5% of patients older than 65 years and 10% of patients older than 80 have a history of atrial fibrillation (AF), which is often associated with sudden death and stroke. Medication and percutaneous radiofrequency catheter ablation are commonly used treatment modalities. Pharmacotherapy is primarily symptomatic treatment; moreover, the effect of conversion to a normal rhythm is minimal, and mainly aimed at stabilizing heart rate. Catheter ablation is associated with a high incidence of recurrence in chronic AF, and it is difficult to treat left atrial appendage, thereby preventing discontinuation of anticoagulation therapy post procedure. Thoracoscopic ablation is known to be a less invasive and more effective modality to treat patients with chronic atrial fibrillation. However, anticoagulation therapy is mandatory in the early postoperative period due to intracardiac thromboembolism associated with atrial stunning despite conversion to a sinus rhythm and resection of the left atrial appendage. Further investigation would be required to assess the efficacy and safety of novel oral anticoagulants such as edoxaban compared to that of warfarin for stroke prevention during the early postoperative period (6 months) after a thoracoscopic procedure. The need to maintain a constant level of blood coagulation and the potential development of complications such as hemorrhages are drawbacks associated with the use of warfarin. While novel oral anticoagulants such as edoxaban do have a role in atrial fibrillation, data regarding their effectiveness and incidence of complications after arrhythmia surgery do not exist. In this study, we will compare warfarin and edoxaban with respect to safety and efficacy, after they are used for 6 months following thoracoscopic ablation in patients with chronic atrial fibrillation

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

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

Description

Inclusion Criteria:

1. Patients aged 18 years or older (not exceed 80 years old).
2. Elective thoracoscopic ablation.
3. Presence of atrial fibrillation (paroxysmal, persistent, long-standing persistent).

Exclusion Criteria:

1. Chronic obstructive pulmonary disease (COPD).
2. History of pulmonary tuberculosis.
3. Other cardiac comorbidities including valvular disease, coronary artery disease.
4. Congenital heart anomalies except for atrial septal defect.
5. Known, clinically important anemia or thrombocytopenia.
6. Pregnancy or lactation.
7. Malignancy.
8. Intracardiac mass or thrombus
9. Life expectancy less than 1 year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Edoxaban group; patients prescribed edoxaban after thoracoscopic ablation during window period to prevent stroke	Drug: Edoxaban; oral edoxaban 60mg once daily for 3 months; Other Names: Savaysa
Active Comparator: Warfarin group; patients prescribed warfarin after thoracoscopic ablation during window period to prevent stroke	Drug: Warfarin; oral warfarin once daily for 3 months according to prothrombin time; Other Names: Coumadin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative stroke	Number of patients showing thromboembolic neurologic complication after thoracoscopic ablation	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative bleeding	Number of patients showing bleeding events due to anticoagulation after thoracoscopic ablation	6 months
Postoperative pericarditis	Number of patients showing pericarditis requiring readmission after thoracoscopic ablation	6 months

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: atrial fibrillation; anticoagulation; thoracoscopic ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Arrhythmias, Cardiac; Hemostatic Disorders; Blood Coagulation Disorders; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Edoxaban; Warfarin
• Other Study ID Numbers: samsungmc_TTA_edoxaban

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No