Left atrial appendage occlusion vs novel oral anticoagulation for stroke prevention in atrial fibrillation: rationale and design of the multicenter randomized occlusion-AF trial - 26/11/21
Résumé |
Background |
The prevalence of atrial fibrillation (AF) is increasing globally, which is a major clinical and public health concern due to the 5-fold increased risk of stroke. Oral anticoagulation with novel oral anticoagulants (NOACs) is the current primary option for stroke prevention in patients with AF, although it increases the risk of major bleeding. Patients with prior ischemic cerebrovascular events are at particularly high risk of both recurrent ischemic events and major bleeding. Left atrial appendage occlusion (LAAO) provides an alternative option for stroke prevention in high-risk patients, however, with currently limited evidence. Thus, randomized trials comparing LAAO to NOACs are needed.
Objective |
The Occlusion-AF trial is designed to assess whether LAAO is non-inferior to NOAC therapy for reduction of the combined endpoint of stroke, systemic embolism, major bleeding (Bleeding Academic Research Consortium 
3) and all-cause mortality in patients with AF and a recent ischemic stroke or transient ischemic attack (TIA).
Methods and analysis |
Investigator-initiated multicenter, multinational, randomized open-label non-inferiority trial with blinded outcome evaluation (PROBE design). Patients with documented AF, and an ischemic stroke or TIA within 6 months will be eligible for enrollment. Major exclusion criteria are modified Rankin Scale > 3 at enrollment, glomerular filtration rate < 15 ml/min, and life-expectancy less than 2 years. A total of 750 patients will be randomized 1:1 to receive either a NOAC or LAAO using the Amplatzer Amulet (Abbott, MN, USA) or Watchman FLX (Boston Scientific, MN, USA) with subsequent life-long aspirin 75 mg daily. Follow-up will be based on in-office and telephone follow-up in combination with long-term follow-up (10 years) through national hospital discharge registries in the individual Nordic countries. The primary outcome will be a composite endpoint of stroke, systemic embolism, major bleeding (BARC 3) and all-cause mortality at 2-year follow-up.
Conclusions |
The Occlusion-AF trial is designed to compare LAAO to NOAC therapy for secondary stroke prevention in AF patients with a high risk of recurrent thromboembolic events, i.e. with previous ischemic stroke or TIA, and otherwise eligible for anticoagulation. The results are expected to contribute significantly to the understanding of the effects of LAAO compared to the standard contemporary pharmacological treatment in these patients.
Le texte complet de cet article est disponible en PDF.Plan
Vol 243
P. 28-38 - janvier 2022 Retour au numéro
Article précédent
- Rationale and pathways forward in the implementation of coronary artery calcium-based enrichment of randomized trials
- Miguel Cainzos-Achirica, Dixitha Anugula, Reed Mszar, Gowtham Grandhi, Kershaw V. Patel, Marcio S. Bittencourt, Ron Blankstein, Michael J. Blaha, Roger S. Blumenthal, Kausik K. Ray, Deepak L. Bhatt, Khurram Nasir
- The NHLBI Study on Long-ter Otcomes after the Multisystem nflammatory yndrome n hildren (MUSIC): Design and Objectives
- Dongngan T. Truong, Felicia L. Trachtenberg, Gail D. Pearson, Audrey Dionne, Matthew D. Elias, Kevin Friedman, Kerri H. Hayes, Lynn Mahony, Brian W. McCrindle, Matthew E. Oster, Victoria Pemberton, Andrew J. Powell, Mark W. Russell, Lara S. Shekerdemian, Mary Beth Son, Michael Taylor, Jane W. Newburger, for the MUSIC Study Investigators (Supplement 1), Audrey Dionne, Matthew D. Elias, Therese M. Giglia, Kimberly E. McHugh, Andrew M. Atz, Scott A. Pletzer, Dongngan T. Truong, Mark W. Russell, Sean M. Lang, R. Mark Payne, Jyoti K. Patel, Matthew?E. Oster, Lara S. Shekerdemian, Ricardo H. Pignatelli, Kristen Sexson, Brian W. McCrindle, Christopher Lam, Andreea Dragulescu, Rae SM Young, Beth Gamulka, Anita Krishnan, Brett R. Anderson, Kanwal M. Farooqi, Divya Shakti, Aimee S. Parnell, Onyekachukwu J Osakwe, Michelle C. Sykes, Lerraughn Morgan, Carl Y. Owada, Daniel Forsha, Michael R. Carr, Kae Watanabe, Michael A. Portman, Kristen B. Dummer, Jane C. Burns, Adriana H. Tremoulet, Kavita Sharma, Pei-Ni Jone, Michelle Hite Heather Heizer, Keren Hasbani, Shubhika Srivastava, Elizabeth C Mitchell, Camden L. Hebson, Jacqueline R. Szmuszkovicz, Pierre C. Wong, Andrew L. Cheng, Jodie K. Votava-Smith, Shuo Wang, Sindhu Mohandas, Gautam K. Singh, Sanjeev Aggarwal, Yamuna Sanil, Tamara T. Bradford, Juan Carlos G. Muniz, Jennifer S. Li, Michael Jay Campbell, Stephanie S. Handler, J Ryan Shea, Timothy M. Hoffman, Wayne J. Franklin, Arash A. Sabati, Todd T. Nowlen, Maryanne Chrisant
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?