Scientific Sessions 2024  /  Redefining Arrhythmia Treatment: Pushing Boundaries  /  Blinded Randomized trial of Anticoagulation to prevent Ischemic stroke and Neurocognitive impairment in Atrial Fibrillation
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American Heart Association

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Final ID: 4158515

Blinded Randomized trial of Anticoagulation to prevent Ischemic stroke and Neurocognitive impairment in Atrial Fibrillation

Abstract Body (Do not enter title and authors here):
Background
A growing body of observational data suggests an important link between atrial fibrillation (AF) and cognitive decline. It remains unknown whether oral anticoagulation (OAC) effectively prevents cognitive decline in patients with AF and no conventional risk factor for stroke.

Hypothesis
We hypothesize that OAC will be superior to placebo in the prevention of stroke, transient ischemic attack (TIA) or cognitive decline in subjects with non-valvular AF and a low risk of stroke.

Methods
In the BRAIN-AF trial (NCT02387229), patients with AF and no CHADS-65 indication for OAC were randomized 1:1 in a double-blinded fashion to rivaroxaban 15 mg daily versus placebo. For patients with vascular disease, a double-dummy design was incorporated to ensure that they received either rivaroxaban or aspirin. Cognitive testing with MoCA was performed yearly and at the final visit, MMSE was repeated at the final visit. The composite primary efficacy outcome consisted of stroke, TIA (with a motor deficit or aphasia) or cognitive decline (reduction in MoCA score ≥2 points). The study drug was discontinued if a patient developed a CHADS-65 indication for OAC. The primary efficacy analysis was by intention-to-treat.

Results
A total of 1235 patients, mean age 53.4±7.3 years, 25.6% women, were randomized between April 2015 and November 2023 across 53 centers in Canada. AF was paroxysmal, persistent, and permanent in 78.5%, 11.2%, and 10.4% of patients, respectively. At the interim analysis, the data safety and monitoring board (DSMB) recommended early termination for futility. During a median follow-up of 3.7 years (interquartile range 1.9 – 6.0) and based on the intention-to-treat principle, the primary outcome occurred in 130 patients (7.0% per year) randomized to rivaroxaban vs. 126 (6.4% per year) randomized to placebo [hazard ratio 1.10, 95% confidence interval (0.86-1.40); P=0.46]. Major bleeding occurred in 2 patients (0.09% per year) on rivaroxaban and 5 (0.21% per year) on placebo (P=0.27).

Conclusions
In patients with AF and no CHADS-65 indication for OAC, rivaroxaban does not reduce the incidence of cognitive decline, stroke, or TIA.
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  • Rivard, Lena  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Lanthier, Sylvain  ( CHUM UNIVERSITE MONTREAL , Montreal , Quebec , Canada )
  • Massoud, Fadi  ( CHUM UNIVERSITE MONTREAL , Montreal , Quebec , Canada )
  • Nault, Isabelle  ( Institut Universitaire de Cardiologie et Pneumologie de Quebec , Quebec , Quebec , Canada )
  • Dorian, Paul  ( ST MICHAELS HOSPITAL , Toronto , Ontario , Canada )
  • Kouz, Simon  ( CISSSLan-CHDL , Joliette , Quebec , Canada )
  • Racine, Normand  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Roux, Jean-francois  ( University of Sherbrooke , Sherbrooke , Quebec , Canada )
  • Greiss, Isabelle  ( CHUM UNIVERSITE MONTREAL , Montreal , Quebec , Canada )
  • Mayrand, Helene  ( CITE DE LA SANTE LAVAL , Laval , Quebec , Canada )
  • Gosselin, Gilbert  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Khairy, Paul  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Verma, Atul  ( McGill University Health Centre , Montreal , Quebec , Canada )
  • Khaykin, Yaariv  ( Southlake Regional Health Center , Richmond Hill , Ontario , Canada )
  • Parkash, Ratika  ( QEII HEALTH SCIENCES CENTER , Halifax , Nova Scotia , Canada )
  • Sandhu, Roopinder K.  ( Libin cardiovascular Institute , Calgary , Alberta , Canada )
  • Conen, David  ( McMaster University , Hamilton , Ontario , Canada )
  • Brouillette, Judith  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Robillard, Alain  ( Hopital Maisonneuve-Rosemont , Montreal , Quebec , Canada )
  • Bocti, Christian  ( University of Sherbrooke , Sherbrooke , Quebec , Canada )
  • Field, Thalia  ( UNIVERSITY OF BRITISH COLUMBIA , Vancouver , British Columbia , Canada )
  • Pelletier, Guy  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Talajic, Mario  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Chayer, Celine  ( Hopital Maisonneuve-Rosemont , Montreal , Quebec , Canada )
  • Deschaintre, Yan  ( CHUM UNIVERSITE MONTREAL , Montreal , Quebec , Canada )
  • Manlucu, Jaimie  ( London Health Sciences Centre , London , Ontario , Canada )
  • Roussin, Andre  ( University of Montreal , ST LAMBERT , Quebec , Canada )
  • Macle, Laurent  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Mondesert, Blandine  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Dyrda, Katia  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Tadros, Rafik  ( Montreal Heart Institute , Pierrefonds , Quebec , Canada )
  • Guerra, Peter  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Thibault, Bernard  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Tardif, Jean-claude  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Cadrin-tourigny, Julia  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Dubuc, Marc  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Raymond-paquin, Alexandre  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Aguilar, Martin  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Essebag, Vidal  ( McGill University Health Centre , Montreal , Quebec , Canada )
  • Nozza, Anna  ( Montreal Heart Institute MHICC , Montreal , Quebec , Canada )
  • Guertin, Marie-claude  ( Montreal Heart Institute MHICC , Montreal , Quebec , Canada )
  • Tremblay-gravel, Maxime  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • David, Louis-philippe  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Roy, Denis  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Healey, Jeff  ( McMaster University , Hamilton , Ontario , Canada )
  • Bherer, Louis  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Black, Sandra  ( SUNNYBROOK HEALTH SCIENCE CTR MED , Toronto , Ontario , Canada )
  • Nattel, Stanley  ( Montreal Heart Institute , Montreal , Quebec , Canada )
  • Andrade, Jason  ( Vancouver General Hospital , Vancouver , British Columbia , Canada )
    • Author Disclosures:
    Lena Rivard: DO have relevant financial relationships ; Research Funding (PI or named investigator):CIHR:Active (exists now) ; Advisor:Boston:Past (completed) ; Research Funding (PI or named investigator):Bayer Inc:Past (completed) ; Research Funding (PI or named investigator):FRSQ:Active (exists now) ; Research Funding (PI or named investigator):HSF:Active (exists now) | Sylvain Lanthier: No Answer | Fadi Massoud: DO have relevant financial relationships ; Advisor:Eisai:Past (completed) ; Advisor:Novo Nordisk:Past (completed) | Isabelle Nault: No Answer | Paul Dorian: No Answer | Simon Kouz: No Answer | Normand Racine: DO NOT have relevant financial relationships | Jean-Francois Roux: DO have relevant financial relationships ; Speaker:Biosense-Webster:Active (exists now) ; Speaker:Biotronik:Active (exists now) ; Speaker:Novo Nordisk:Active (exists now) ; Speaker:Medtronic:Active (exists now) | Isabelle Greiss: DO have relevant financial relationships ; Other (please indicate in the box next to the company name):Biosense Educational Grant:Past (completed) | Helene Mayrand: DO NOT have relevant financial relationships | gilbert gosselin: No Answer | Paul Khairy: DO NOT have relevant financial relationships | Atul Verma: No Answer | Yaariv Khaykin: No Answer | Ratika Parkash: DO have relevant financial relationships ; Research Funding (PI or named investigator):Medtronic:Active (exists now) ; Research Funding (PI or named investigator):Abbott:Active (exists now) | Roopinder K. Sandhu: DO NOT have relevant financial relationships | David Conen: No Answer | Judith Brouillette: No Answer | Alain Robillard: No Answer | Christian Bocti: No Answer | Thalia Field: DO have relevant financial relationships ; Advisor:Bayer :Past (completed) ; Executive Role:DESTINE Health:Active (exists now) ; Advisor:HLS therapeutics:Past (completed) ; Advisor:Novartis:Past (completed) ; Advisor:AstraZeneca:Active (exists now) | Guy Pelletier: No Answer | Mario Talajic: DO NOT have relevant financial relationships | Celine Chayer: DO NOT have relevant financial relationships | Yan Deschaintre: No Answer | Jaimie Manlucu: DO NOT have relevant financial relationships | ANDRE ROUSSIN: No Answer | Laurent Macle: DO have relevant financial relationships ; Speaker:abbott:Active (exists now) ; Consultant:boston scientific:Past (completed) ; Speaker:biosense webster:Active (exists now) | Blandine Mondesert: DO NOT have relevant financial relationships | Katia Dyrda: DO NOT have relevant financial relationships | Rafik Tadros: DO have relevant financial relationships ; Research Funding (PI or named investigator):BMS Canada:Active (exists now) | Peter Guerra: No Answer | Bernard Thibault: DO NOT have relevant financial relationships | Jean-Claude Tardif: DO have relevant financial relationships ; Research Funding (PI or named investigator):Amarin:Past (completed) ; Research Funding (PI or named investigator):Boeringher-Ingelheim:Active (exists now) ; Research Funding (PI or named investigator):Novo-Nordisk:Active (exists now) ; Consultant:DalCor Pharmaceuticals:Active (exists now) ; Ownership Interest:DalCor Pharmaceuticals:Active (exists now) ; Speaker:Pfizer:Active (exists now) ; Speaker:Pendopharm:Past (completed) ; Speaker:HLS Pharmaceuticals:Past (completed) ; Research Funding (PI or named investigator):Pfizer:Active (exists now) ; Research Funding (PI or named investigator):Novartis:Active (exists now) ; Research Funding (PI or named investigator):Merck:Active (exists now) ; Research Funding (PI or named investigator):Esperion:Active (exists now) ; Research Funding (PI or named investigator):DalCor Pharmaceuticals:Active (exists now) ; Research Funding (PI or named investigator):Ceapro:Active (exists now) ; Research Funding (PI or named investigator):AstraZeneca:Past (completed) | Julia Cadrin-Tourigny: DO have relevant financial relationships ; Consultant:Biomarin:Past (completed) ; Consultant:Tenaya:Past (completed) ; Consultant:Lexeo:Past (completed) | Marc Dubuc: No Answer | Alexandre Raymond-Paquin: DO NOT have relevant financial relationships | Martin Aguilar: No Answer | Vidal Essebag: DO have relevant financial relationships ; Speaker:Bayer:Past (completed) ; Speaker:Abbott:Past (completed) ; Speaker:Biosense Webster:Past (completed) ; Speaker:Medtronic:Past (completed) | Anna Nozza: DO NOT have relevant financial relationships | Marie-Claude Guertin: DO NOT have relevant financial relationships | Maxime Tremblay-Gravel: DO NOT have relevant financial relationships | Louis-philippe David: No Answer | Denis Roy: DO have relevant financial relationships ; Research Funding (PI or named investigator):Huyabio:Past (completed) ; Consultant:Huyabio:Past (completed) | Jeff Healey: DO have relevant financial relationships ; Research Funding (PI or named investigator):BMS/Pfizer:Active (exists now) ; Research Funding (PI or named investigator):Boston Scientific:Active (exists now) ; Research Funding (PI or named investigator):Medtronic:Active (exists now) | Louis Bherer: DO NOT have relevant financial relationships | Sandra Black: DO have relevant financial relationships ; Research Funding (PI or named investigator):Contract Research: Genentech, Optina, Roche, Eli Lilly, Eisa/Biogen Idec, NovoNordisk, Lilly Avid, ICON, Aribio Co.Payments made to Institution. No personal investigator fees taken including Eli Lilly.:Active (exists now) ; Advisor:National Institute of Neurological Disorders and Stroke Advisory Boards only. No personal fees taken:Active (exists now) ; Advisor:University of Rochester Contribution to the Mission and Scientific Leadership of the Small Vessel VCID Biomarker Validation Consortium Advisory Boards only. No personal fees taken:Active (exists now) ; Advisor:World Dementia Council Advisory Boards only. No personal fees taken:Past (completed) ; Advisor:Conference Board of Canada Advisory Boards only. No personal fees taken:Past (completed) ; Advisor:Ontario Dementia Care Alliance (ODCA) Advisory Boards only. No personal fees taken:Active (exists now) ; Advisor:Cpdnetwork planning committee for AD educational program:Past (completed) ; Advisor:DSR: Diagnosis, Solutions & Results Inc.:Past (completed) ; Consultant:Eli Lilly Canada Inc.:Active (exists now) ; Consultant:Eisai Limited:Active (exists now) ; Consultant:Novo Nordisk Canada Inc:Active (exists now) ; Consultant:Biogen:Past (completed) ; Speaker:Biogen:Past (completed) ; Consultant:Hoffmann-La Roche Limited:Past (completed) ; Research Funding (PI or named investigator):Peer Reviewed: Ontario Brain Institute, CIHR, Leducq Foundation, Heart and Stroke Foundation of Canada, NIH, Alzheimer's Drug Discovery Foundation, Brain Canada, Weston Brain Institute, Canadian Partnership for Stroke Recovery, Canadian Foundation for Innovation, Focused Ultrasound Foundation, Alzheimer's Association US, Queen’s University, Compute Canada Resources for Research Groups, CANARIE, Networks of Centres of Excellence of CanadaPayments made to Institution. No personal investigator fees taken.:Active (exists now) | Stanley Nattel: DO NOT have relevant financial relationships | Jason Andrade: DO have relevant financial relationships ; Advisor:Boston Scientific:Active (exists now) ; Speaker:Abbott:Past (completed) ; Speaker:Biosense Webster:Past (completed) ; Advisor:Medtronic:Past (completed)
Meeting Info:

Scientific Sessions 2024

2024

Chicago, Illinois

Session Info:

Redefining Arrhythmia Treatment: Pushing Boundaries

Saturday, 11/16/2024 , 01:30PM - 02:45PM

Late-Breaking Science

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