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Early Intervention for Atrial Fibrillation PowerPoint Presentation

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The EARLY-AF study is a clinical trial designed to investigate the effectiveness of early intervention in patients with atrial fibrillation (AF). The trial was conducted between 2016 and 2019, and the results were published in the New England Journal of Medicine in 2020.

The study enrolled patients who had recently been diagnosed with AF and were at risk of stroke. The patients were randomly assigned to either an early intervention group or a standard care group. The early intervention group received aggressive treatment for their AF, including anticoagulation therapy and ablation, within 10 days of their diagnosis. The standard care group received treatment according to usual practice guidelines, which generally involve a more conservative approach to management.

The primary endpoint of the study was the time to first recurrence of AF, atrial flutter, or atrial tachycardia. The study found that the early intervention group had a significantly longer time to first recurrence of these conditions compared to the standard care group. Specifically, the median time to recurrence was 628 days in the early intervention group and 123 days in the standard care group.

The study also found that the early intervention group had a lower rate of hospitalization for AF-related events and a lower rate of adverse events related to AF treatment compared to the standard care group.

Overall, the results of the EARLY-AF study suggest that early intervention in patients with AF may be beneficial in terms of reducing the risk of recurrence and improving outcomes. However, further research is needed to confirm these findings and to determine the optimal timing and approach for early intervention in AF management.

Tags : Early Intervention for Atrial Fibrillation, atrial fibrillation, cardiology, cardiology PowerPoint presentation

Published on : Mar 17, 2023 | Views : 1783 | Downloads : 1

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Slide 1-

Jason G. Andrade, Jean Champagne, Marc W. Deyell, Vidal Essebag, Sandra Lauck, Carlos A. Morillo, John L. Sapp, Allan Skanes, Patricia Theoret-Patrick, George Wells, Atul Verma Early Intervention for Atrial Fibrillation: The EARLY-AF Study Embargoed for 9:34am CT 11-16-20
Slide 2-

The EARLY-AF study was funded by a peer-reviewed grant from the Cardiac Arrhythmia Network of Canada [grant number SRG-15-P15-001], which is a Networks of Centres of Excellence (NCE) program funded from a joint initiative of the Natural Sciences and Engineering Research Council, the Social Sciences and Humanities Research Council, the Canadian Institutes of Health Research, Industry Canada, and Health Canada. In addition, the trial was supported by unrestricted grants from Medtronic and Baylis Medical. Disclosures
Slide 3-

Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia AF is associated with reduced quality of life and survival. Contemporary guidelines recommend a trial of antiarrhythmic drugs prior to considering catheter ablation But… Antiarrhythmic drugs have limited benefit and potential toxicity Ablation is more effective when performed early Delayed ablation is associated with worse outcomes (e.g. hospitalization) Background
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Objective To determine if first-line cryoballoon ablation was superior to first-line antiarrhythmic drug therapy, as assessed by an implantable continuous rhythm monitor. Primary Endpoint Time to first recurrence of any (symptomatic or asymptomatic) atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting ≥30 seconds between days 91 and 365 after treatment initiation. Key Secondary Endpoints Time to first recurrence of symptomatic atrial tachyarrhythmia 91 and 365 days after treatment initiation Total arrhythmia burden (% time in AF, as detected by continuous monitoring) Quality of life (disease-specific – AFEQT; generic – EQ-5D, EQ-VAS; symptoms – CCS-SAF) Emergency visit or hospitalization >24h in a health-care facility Repeat ablation procedures Serious Adverse events EARLY-AF – Objectives and Endpoints
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Patient flow *Enrollment Permitted if: 1. AAD Treatment Naive Never treated with an AAD 2. Current AAD use Treatment < 6m but below therapeutic threshold 3. Previous AAD use Treatment initiated, discontinued, and washed out >6m 4. Temporary AAD use Treatment at therapeutic dose for a period <4 weeks No adverse drug effects or inefficacy 303 patients with treatment-naïve* symptomatic AF enrolled and randomised 154 randomized to first-line ablation 149 randomized to first-line AAD Reveal LINQ implant (within 24h from AAD start/PVI) Daily Carelink Transmission (AF Events** and burden) Clinical Encounter and 12-lead ECG at 1 week, 3-, 6-, and 12-months HRQOL assessment (AFEQT, EQ-5D, EQ-VAS, CCS-SAF) at 6- and 12-months **Potential arrhythmia events detected by the device were stored for adjudication by an independent, blinded clinical end-point committee.
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Population was relatively young and healthy Average age ~58 years >2/3 men Hypertension, sleep apnea, obesity AF was significantly symptomatic and intrusive 1-year median duration from first AF diagnosis 3 symptomatic episodes per month 39% had previous cardioversion Severe impairment in HRQOL Baseline Characteristics 6
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Antiarrhythmic Drug Group Treatment Groups Antiarrhythmic-drug therapy was progressively adjusted to the maximum tolerated doses according to standardized protocols, with the goal of complete suppression of atrial fibrillation as detected by the implanted monitor.
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Antiarrhythmic Drug Group Cryoballoon Ablation Procedure Treatment Groups 8
Slide 9-

Freedom from any atrial tachyarrhythmia on continuous cardiac monitoring Primary Outcome 9 57.1% 32.2% Absolute reduction 24.9% Number needed to treat 4
Slide 10-

Freedom from symptomatic arrhythmia Secondary Outcome 10 89.0% 73.8% Hazard ratio 0.39 (95% CI, 0.22 to 0.68); P<0.001 Absolute reduction 15.2% Number needed to treat 6.5
Slide 11-

Atrial fibrillation burden Secondary Outcome 11 Ablation Group had a 3.3% ± 1.0% lower mean AF burden (P=0.002)
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Secondary Outcome 12 Arrhythmia
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Quality of Life and symptom status Secondary Outcome 13 *LSMD ± SE **RR (95% CI)
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Secondary Outcome 14 Healthcare utilisation
Slide 15-

Serious Adverse Events - HR 0.81 (0.25–2.59) Ablation – 5 (3.2%) 3 phrenic nerve injuries 2 pacemakers for bradycardia Antiarrhythmic drugs – 6 (4.0%) 2 wide-complex tachycardia 2 pacemakers for bradycardia 1 heart failure 1 syncope Any Safety Endpoint - HR 0.59 (0.29–1.21) Ablation – 14 (9.1%) Antiarrhythmics – 24 (16.1%) Adverse Events 15
Slide 16-

First-line ablation was associated with significant reductions in arrhythmia outcomes: Time to first recurrence of any AF/AFL/AT Time to first recurrence of any AF Time to first recurrence of symptomatic AF/AFL/AT Time to first recurrence of symptomatic AF Total AF burden Days with AF First-line ablation was associated with meaningful improvements in quality of life and symptoms Adverse events were similar between contemporary cryoballoon ablation and AAD therapy Conclusions 16 Continuous cardiac monitoring with implantable loop recorders
Slide 17-

STEERING COMMITTEE Jason Andrade (Chair, Principal Investigator), Jean Champagne, Marc W. Deyell Vidal Essebag, Sandra Lauck, Carlos Morillo, John Sapp, Allan Skanes George A. Wells, Atul Verma COORDINATING CENTRE – CARDIOVASCULAR RESEARCH METHODS CENTER: Patricia Theoret-Patrick (Project management), Li Chen (Statistician) INVESTIGATORS: Royal Jubilee Hospital, Victoria, BC: Paul Novak Vancouver General Hospital, Vancouver, BC: Matthew Bennett St. Paul’s Hospital, Vancouver, BC: Zachary Laksman Royal Alexandra Hospital, Edmonton, Alberta: Evan Lockwood University of Calgary, Calgary, Alberta: Jacques Rizkallah University of Saskatchewan, Saskatoon, Saskatchewan: Stephen Wardell University of Western Ontario, London, Ontario: Peter Leong-Sit St. Mary’s Hospital, Kitchener, Ontario: Umjeet Jolly McMaster University, Hamilton, Ontario: Guy Amit Southlake Hospital, Newmarket, Ontario: Yaariv Khaykin Rouge Valley, Ajax, Ontario: Derek Yung St Michael’s Hospital, Toronto, Ontario: Paul Angaran University of Ottawa, Ottawa, Ontario: Dr. Girish Nair Laval University, Quebec City, Quebec: Jean Champagne McGill University, Montreal, Quebec: Vidal Essebag Sacre Coeur, Montreal, Quebec: Marcio Sturmer CHUS, Sherbrooke, Quebec: Jean-Francois Roux Dalhousie University, Halifax, Nova Scotia: John Sapp CLINICAL EVENTS COMMITTEE: Laurent Macle (Co-Chair), Simon Kochhaeuser (Co-Chair) Julia Cadrin-Tourigny, Chris Cheung, Jeff Healey, Corinne Pearce, Rose Pfeffer DATA MONITORING COMMITTEE: Paul Dorian (Chair), Ben Glover, Lehana Thabane Thank you! 17