Anticoagulant Adverse Reaction, Atrial Fibrillation, Left Atrial Appendage Absent
Conditions
Keywords
Atrial fibrillation, Anticoagulant treatment, Surgical left atrial appendage closure, surgical left atrial appendage occlusion
Brief summary
Left atrial appendage (LAA) closure has become a frequent addition to oral anticoagulation in patients with atrial fibrillation who undergo cardiac surgery. The procedure significantly reduces the risk of stroke and systemic embolism, which may render anticoagulation unnecessary or even harmful when considering the associated increased risk of bleeding. A clinical trial to address the need for anticoagulation after LAA closure is needed. The ATLAAC trial will enroll 1220 patients with atrial fibrillation who have previously undergone surgical LAA closure. Patients will undergo a cardiac CT-scan to determine if LAA closure was successful and patients with successful closure will be randomized to continue or discontinue anticoagulation. The trial will assess the risk of ischemic stroke, peripheral arterial embolism, and major bleeding during the randomized intervention
Interventions
DRUGOAC will be discontinued for the duration of the trial
Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban
Sponsors
Rigshospitalet, Denmark
Gødstrup Hospital
Aarhus University Hospital
Aalborg University Hospital
Population Health Research Institute
Region of Southern Denmark
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinding of patients and physicians is not possible due to different types of oral anticoagulant therapy within the same interventional arm and the need for continuous monitoring of treatment with warfarin.However, since the primary outcome is not a subjectively reported outcome, lack of blinding presents less risk of bias. The investigators responsible for data collection and the Endpoint Adjudication Committee will be blinded to the randomization.
Intervention model description
Patients will be randomized to either continue or discontinue oral anticoagulant therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Previously undergone any type of cardiac surgical procedure including any type of surgical LAA closure (use of any of the following techniques; amputation and suture closure, stapler closure, non-amputating suture closure or closure with an approved surgical occlusion device (e.g. AtriClip)) according to the NationalPatient Register (NPR), the Danish Heart Registry (DHR) or the Western Danish Heart Registry (WDHR) from January 1st 2010 til 3 months prior to inclusion in the project. * Documented history of paroxysmal, persistent, or permanent atrial fibrillation or atrial flutter according to the electronic patient record * Informed consent
Exclusion criteria
* Not receiving OAC (warfarin/DOAC) * Patient specific conditions requiring OAC (e.g.mechanical valve, previous pulmonary embolism) * Renal impairment (estimated glomerular filtration rate \< 30) * Allergy to contrast media * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with ischemic strokes, peripheral arterial embolisms and major bleedings | After 128 primary outcome events (approx 4 years) | Composite endpoint including the occurrence of ischemic stroke, peripheral arterial embolism, and major bleeding (ISTH definition) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of transient ischemic attacks | After 128 primary outcome events (approx 4 years) | — |
| Occurence of all-cause stroke | After 128 primary outcome events (approx 4 years) | — |
| Rate of all-cause mortality | After 128 primary outcome events (approx 4 years) | — |
| Rate of cardiovascular mortality | After 128 primary outcome events (approx 4 years) | — |
| Occurence of minor bleeding | After 128 primary outcome events (approx 4 years) | All types of bleeding leading to hospital contact |
| Number of participants who receive blood transfusion | After 128 primary outcome events (approx 4 years) | — |
| Severity of stroke | After 128 primary outcome events (approx 4 years) | According to Scandinavian Stroke Scale (0-58), lower scores mean worse outcomes |
| Occurence of deep venous thrombosis | After 128 primary outcome events (approx 4 years) | — |
| Occurence of pulmonary embolism | After 128 primary outcome events (approx 4 years) | — |
| Health-related Quality of Life (HRQOL) | Baseline (day 0) and 1 and 2 years after inclusion | EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) score to evaluate generic HRQOL (0-100). Higher scores mean better quality of life. |
| Patient-reported satisfaction with overall medical treatment | Baseline (day 0) and 1 and 2 years after inclusion | Treatment Satisfaction Questionnaire (TSQM) to evaluate satisfaction related to their overall medical treatment. TSQM scoring is by domain and each domain score is computed by summing the individual TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100. Higher scores indicate higher patient satisfaction with medication. |
| Patient-reported satisfaction with anticoagulant treatment | Baseline (day 0) after inclusion | Anti-Clot Treatment Scale (ACTS) questionnaire to evaluate satisfaction related to oral anticoagulant treatment. The ACTS Burdens total score ranges from 12 to 60, and the ACTS Benefits total score ranges from 3 to 15. Higher ACTS Burdens and Benefits scores indicate greater satisfaction with treatment. |
| Occurence of myocardial infarction | After 128 primary outcome events (approx 4 years) | — |
Countries
Denmark
Contacts
Primary ContactKristina Gosvig, M.D.
Backup ContactJulie Goller, M.D.
Outcome results
None listed