Comparing left atrial appendage occlusion and novel oral anticoagulants in patients with atrial fibrillation undergoing PCI

Left Atrial Appendage Occlusion Versus Novel Oral Anti-coagulation in Patients with Atrial Fibrillation and Percutaneous Coronary Intervention: a Randomized, Multicentre, Open-label, Non-inferiority Trial

This study is testing whether a device that blocks a part of the heart can work better than blood thinners for people with atrial fibrillation who have had heart procedures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1386 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xijing Hospital (Academic / other)
• Locations: 1 site (Xi'an, Shannxi)
• Trial ID: NCT05353140 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of left atrial appendage occlusion (LAAO) compared to novel oral anticoagulants (NOACs) in patients with atrial fibrillation (AF) who have undergone percutaneous coronary intervention (PCI). It aims to balance the risks of ischemic events and bleeding complications, which are heightened in this patient population due to shared risk factors. The study will involve patients who meet specific inclusion criteria, including successful PCI and the presence of certain comorbidities. Participants will be treated with either the WATCHMAN device or a combination of anticoagulant and antiplatelet medications.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with non-valvular atrial fibrillation who have successfully undergone PCI and have at least one additional risk factor such as congestive heart failure or diabetes.

Not a fit: Patients who are under 18, unable to provide informed consent, or have a life expectancy of less than three years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for AF patients undergoing PCI, potentially reducing the risk of bleeding and ischemic events.

How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Successful PCI for unstable angina or CCS
2. Non-valvular atrial fibrillation
3. Concomitant at least one of the following conditions: congestive heart failure, hypertension, ≥65yrs, diabetes, previous stroke, TIA or thromboembolism
4. Eligible for long-term novel oral anti-coagulation (NOAC) therapy
5. Able to understand and provide informed consent and comply with all study procedures/medications

Exclusion Criteria:

Patients who meet any of the following criteria will be disqualified from participation in the study:

Clinical exclusion criteria:

1. Under the age of 18
2. Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint
3. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
4. Concurrent medical condition with a life expectancy of less than 3 years
5. Haemodynamical unstable
6. Known contraindication to medications such as heparin, antiplatelet or anticoagulation drugs, or contrast
7. PCI for ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI), or experienced a peri-procedural myocardial infarction (MI) caused by PCI
8. Known contraindication to LAAO or LAAO is not required
9. Comorbidities other than atrial fibrillation that required long term use of anticoagulation (such as implanted a mechanical valve)
10. The patient had or is planning to have any cardiac (excluding the current PCI procedure) or non-cardiac interventional or surgical procedure within 30 days prior to or 60 days after the WATCHMAN device implant (e.g., cardioversion, ablation, cataract surgery)
11. Ongoing overt bleeding
12. Previous stroke/TIA within 30 days of enrolment
13. Symptomatic carotid artery disease
14. Severe renal insufficiency (CrCl≤30ml/min)

Imaging Exclusion Criteria:

1. Left atrial appendage (LAA) thrombus
2. High risk patent foramen ovale or atrial septal defect requiring invasive treatment
3. Anatomical unsuitable for LAAO
4. Rheumatic heart valve disease, mitral valve stenosis (valve area \<1.5cm2)

Where this trial is running

Xi'an, Shannxi

• Ling Tao — Xi'an, Shannxi, China (Recruiting)

Study contacts

• Study coordinator: Chao Gao, M.D., Ph.D.

Conditions Atrial Fibrillation; Percutaneous Coronary Intervention; Left atrial appendage occlusion; Percutaneous coronary intervention; Novel oral anti-coagulation