A randomised controlled trial to determine if screening for paroxysmal atrial fibrillation reduces stroke and mortality: SAFER Trial - Screening for Atrial Fibrillation with ECG to Reduce stroke

Conference:

SAPC ASM 2020 - cancelled due to pandemic

Talk Code:

D.12

Presenter:

Jonathan Mant

Twitter:

@prof_mant

Co-authors:

Jonathan Mant, Jenni Burt, Simon Griffin, Richard Hobbs, Richard McManus, Kate Williams, Andrew Dymond, Jenny Lund, Duncan Edwards - on behalf of the SAFER investigators

Author institutions:

University of Cambridge, University of Oxford

Problem

Atrial Fibrillation (AF) is a major risk factor for ischaemic stroke unless treated with an anticoagulant. Detecting AF can be difficult because it is often paroxysmal and asymptomatic. Many clinicians support AF screening. The UK National Screening Committee and the US Preventive Services Task Force have highlighted a lack of evidence that screening for AF is beneficial. The 8-year NIHR-funded SAFER Programme aims to identify the benefits and harms of screening for AF in people ≥70yrs and estimate the overall cost-effectiveness. Following a successful feasibility study the cluster randomised trial internal pilot started in 2020.

Approach

Patients will attend their GP practice for instruction in the use of a handheld single-lead ECG device. They will continue screening at home over a 3 week period. Treatment for AF will follow national guidelines. 1. Internal pilot trial - ongoingCluster randomising practices (12 screening, 24 control) to determine AF detection rate and inform power calculation for main trial. 2. Main trial – 2021Cluster randomising practices (120 screening, 240 control; 126,000 patients). 5-year follow-up of electronic medical records will determine if screening leads to fewer strokes, heart attacks and deaths, and whether it increases the risk of serious bleeding.3. QualitativeInterviews and observations with patients and staff to clarify how to best carry out screening. 4. Health economicsA within trial analysis and decision modelling analysis to determine whether screening is cost effective.

Findings

The trial is due to report in 2027.

Consequences

This will be the world’s largest planned AF screening trial to date and will inform the decision to implement a national AF screening programme.

Submitted by:

Kate Williams

Funding acknowledgement:

This project is funded by the National Institute for Health Research (NIHR) School for Primary Care Research and Programme Grant for Applied Research (Grant Reference Number RP-PG-0217-20007). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.