Trial DesignLeft atrial appendage occlusion vs novel oral anticoagulation for stroke prevention in atrial fibrillation: rationale and design of the multicenter randomized occlusion-AF trial
Section snippets
Study objective
The Occlusion-AF trial is designed to examine the hypothesis that transcatheter LAAO is non-inferior to NOAC therapy for prevention of the combined endpoint of stroke, systemic embolism, major bleeding (Bleeding Academic Research Consortium 3) or all-cause mortality in patients with AF and a recent ischemic stroke or TIA.
Study design
Occlusion-AF is an investigator-initiated multicenter, multinational, prospective randomized, open-label non-inferiority trial with blinded endpoint assessment (PROBE design) comparing the efficacy and safety of LAAO to NOAC therapy for prevention of thromboembolism and bleeding in AF.
The study will recruit patients from neurological and LAAO centers in the Nordic countries, including Denmark, Norway, Sweden and Finland. Patients aged ≥ 18 years, with non-valvular paroxysmal, persistent or
Discussion
Stroke prevention is key to reduce morbidity and mortality related to AF. Both primary and secondary prevention is crucial, particularly as ischemic stroke is the strongest predictor of recurrent ischemic events. The recent LAAOS III trial demonstrated superiority of surgical LAA ligation combined with anticoagulation over anticoagulation alone for prevention of ischemic stroke or systemic embolism in a general AF population undergoing heart surgery. These data are intriguing, and clearly
Conclusion/summary
There are limited randomized data available on the effects of LAAO compared to NOAC therapy in AF patients eligible for oral anticoagulation. The Occlusion-AF trial is an investigator-initiated randomized open-label trial designed to generate knowledge on the treatment effects of LAAO in patients with AF and a recent ischemic stroke or transient ischemic attack.
Funding
This work was funded by Novo Nordisk Foundation (NNF17OC0029510), Boston Scientific and Abbott.
Conflict of interest
Dr. Korsholm has received speaker's honorarium and institutional grants from Abbott/Boston Scientific, Dr. Odenstedt has received speaker's honorarium from Abbott/Boston Scientific and is proctor for Abbott. Dr. Karlsson has received speaker's honorarium from Bayer, DMS, Pfizer and Boehringer-Ingelheim. Professor Nielsen-Kudsk is proctor for Abbott/Boston Scientific and has received institutional grants from Abbott/Boston Scientific and Novo Nordisk.
References (41)
- et al.
Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population
Am J Cardiol
(2013) - et al.
Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation
Ann Thorac Surg
(1996) - et al.
Prospective randomized evaluation of the Watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial
J Am Coll Cardiol
(2014) - et al.
Efficacy and safety of left atrial appendage closure with WATCHMAN in patients with or without contraindication to oral anticoagulation: 1-year follow-up outcome data of the EWOLUTION trial
Heart Rhythm
(2017) - et al.
Intracardiac echocardiography from the left atrium for procedural guidance of transcatheter left atrial appendage occlusion
JACC Cardiovasc Interv
(2017) - et al.
Analysis of risk of bleeding complications after different doses of aspirin in 192,036 patients enrolled in 31 randomized controlled trials
Am J Cardiol
(2005) - et al.
Systematic review and meta-analysis of adverse events of low-dose aspirin and clopidogrel in randomized controlled trials
Am J Med
(2006) - et al.
Peridevice leak following amplatzer left atrial appendage occlusion: cardiac computed tomography classification and clinical outcomes
JACC Cardiovasc Interv
(2021) - et al.
Cardiac computed tomography for left atrial appendage occlusion: acquisition, analysis, advantages, and limitations
Interv Cardiol Clin
(2018) - et al.
Epidemiology of atrial fibrillation: european perspective
CLEP
(2014)
Global epidemiology of atrial fibrillation: an increasing epidemic and public health challenge
Int J Stroke
High prevalence of atrial fibrillation among patients with ischemic stroke
Stroke
Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study
Stroke
2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS)
Eur Heart J
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS: the task force for the management of atrial fibrillation of the European Society of Cardiology (ESC)Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESCEndorsed by the European Stroke Organisation (ESO)
Eur Heart J
Dabigatran vs warfarin in patients with atrial fibrillation
N Engl J Med
Apixaban vs warfarin in patients with atrial fibrillation
N Engl J Med
Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
N Engl J Med
Increased use of oral anticoagulants in patients with atrial fibrillation: temporal trends from 2005 to 2015 in Denmark
Eur Heart J
Cited by (9)
Use of SAFARI 2™ as workhorse wire for left-sided structural heart interventions
2024, Cardiovascular Revascularization MedicineTranscatheter Left Atrial Appendage Exclusion: Preclinical and Early Clinical Results With the Laminar Device
2023, JACC: Cardiovascular InterventionsClinical outcomes of left atrial appendage occlusion versus direct oral anticoagulation in patients with atrial fibrillation and prior ischemic stroke: A propensity-score matched study
2022, International Journal of CardiologyCitation Excerpt :We attempted to account for this through sensitivity analyses, however, risk of residual confounding should be acknowledged when interpreting results. We acknowledge that the present study should be regarded as hypothesis-generating, and the results must be confirmed in a randomized clinical trial like the ongoing Occlusion-AF trial initiated by the authors (Clinicaltrials.gov NCT03642509) [28]. This propensity-score matched study based on the Amulet Observational Study and the Danish Patient Registries, indicated a significantly lower risk of the composite outcome of ischemic stroke, major bleeding, and all-cause mortality with LAAO therapy as compared to DOAC in AF-patients with prior ischemic stroke.
Atrial Fibrillation and Ischemic Stroke despite Oral Anticoagulation
2023, Journal of Clinical MedicineNon-Pharmacological Stroke Prevention in Atrial Fibrillation
2023, Journal of Clinical MedicineImaging Modality to Guide Left Atrial Appendage Closure: Current Status and Future Perspectives
2023, Journal of Clinical Medicine