Risk of myocardial infarction in patients with paroxysmal vs. non-paroxysmal atrial fibrillation: an individual patient data meta-analysis of the ENGAGE-AF and RE-LY trials

Lead Investigator: George Ntaios, University of Thesaly
Title of Proposal Research: Risk of myocardial infarction in patients with paroxysmal vs. non-paroxysmal atrial fibrillation: an individual patient data meta-analysis of the ENGAGE-AF and RE-LY trials
Vivli Data Request: 8263
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:
Atrial fibrillation (also called AFib or AF ) is an irregular heartbeat (arrhythmia) that begins in the heart’s upper chambers (atria). It can lead to blood clots, stroke, heart failure and other heart-related complications. It is estimated that 12.1 million people in the United States will have AFib in 2030. Paroxysmal AF (paroxysmal means a fit, attack, or sudden increase of symptoms that occurs, quietens down, and occurs again and again) lasts for less than a week and can come and go with periods of normal heartbeat in between. Non-paroxysmal AF can include chronic/permanent AF in which the heart never goes back to its normal rhythm despite medications and persistent AF which lasts for > 1 week and it could stop on it’s own or with medication. Myocardial infarction or heart attack happens when the muscles of the heart start dying due to an obstruction (caused by build-up of plaque) in the arteries (called coronary arteries) that supply blood to the heart. There is increasing evidence suggesting that the risk of myocardial infarction is different between patients with paroxysmal and non-paroxysmal atrial fibrillation. Goette et al. found that frequent major cardiovascular events including myocardial infarction was more commonly observed in patient with paroxysmal AF as compared to those with persistent AF. This is interesting as persistent AF has previously been associated with higher rate of stroke. This meta-analysis aims to pool individual patient data from two randomized controlled trials (ENGAGE-AF and RE-LY) in patients with atrial fibrillation to investigate this question This will help us understand the pathophysiological mechanisms between these two cardiovascular conditions and help formulate better preventative strategies in the future.

Requested Studies:
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
Data Contributor: Boehringer Ingelheim
Study ID: NCT00262600
Sponsor ID: 1160.26

A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation – Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE – AF TIMI – 48)
Data Contributor: Daiichi Sankyo
Study ID: NCT00781391
Sponsor ID: DU176b-C-U301