Gareth J Wynn1, Moloy Das1, Laura J Bonnett2, Dhiraj Gupta3. 1. The Institute of Cardiovascular Medicine and Science, Research Unit, Liverpool Heart and Chest Hospital, Thomas Drive, Liverpool L14 3PE, UK Imperial College London, London, SW7 2AZ, UK. 2. Department of Biostatistics and Department of Clinical Infection, Microbiology and Immunology, University of Liverpool, Liverpool L69 3BX, UK. 3. The Institute of Cardiovascular Medicine and Science, Research Unit, Liverpool Heart and Chest Hospital, Thomas Drive, Liverpool L14 3PE, UK Imperial College London, London, SW7 2AZ, UK dhiraj.gupta@lhch.nhs.uk.
Abstract
AIMS: The recently published SARA study was a prospective, multi-centre randomized controlled trial that compared CA to antiarrhythmic drug therapy (ADT) in 146 patients with persistent atrial fibrillation (AF). The study found that recurrence of AF or atrial flutter occurred significantly less often in the CA arm compared to the ADT arm (29.6% vs. 56.3%, p = 0.002). Despite this clear superiority in terms of efficacy, the authors were not able to demonstrate a corresponding Quality of Life (QoL) improvement. We sought to investigate this apparent disparity using alternative analytical methods. METHODS AND RESULTS: We were able to show that a high coefficient of variation existed for all QoL measures at each time point which may explain the lack of statistical difference originally reported. We reanalyzed the raw QoL data from the SARA study using paired sample t-tests for the change in QOL for individual patients between baseline and 12 month (final) follow up. For patients randomized to ADT the difference in QoL after 12 months was not significant for any of the four QoL domains (global, physical, psychological and sexual) whereas for patients randomized to CA all comparisons were significant (global, p < 0.001; physical, p = 0.001; psychological, p < 0.001; sexual, p = 0.003). CONCLUSION: In the SARA study, after 12 months' follow up, CA significantly improved QoL for patients with persistent AF whereas medical therapy had no appreciable effect. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: The recently published SARA study was a prospective, multi-centre randomized controlled trial that compared CA to antiarrhythmic drug therapy (ADT) in 146 patients with persistent atrial fibrillation (AF). The study found that recurrence of AF or atrial flutter occurred significantly less often in the CA arm compared to the ADT arm (29.6% vs. 56.3%, p = 0.002). Despite this clear superiority in terms of efficacy, the authors were not able to demonstrate a corresponding Quality of Life (QoL) improvement. We sought to investigate this apparent disparity using alternative analytical methods. METHODS AND RESULTS: We were able to show that a high coefficient of variation existed for all QoL measures at each time point which may explain the lack of statistical difference originally reported. We reanalyzed the raw QoL data from the SARA study using paired sample t-tests for the change in QOL for individual patients between baseline and 12 month (final) follow up. For patients randomized to ADT the difference in QoL after 12 months was not significant for any of the four QoL domains (global, physical, psychological and sexual) whereas for patients randomized to CA all comparisons were significant (global, p < 0.001; physical, p = 0.001; psychological, p < 0.001; sexual, p = 0.003). CONCLUSION: In the SARA study, after 12 months' follow up, CA significantly improved QoL for patients with persistent AF whereas medical therapy had no appreciable effect. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Stephan Willems; Katrin Borof; Axel Brandes; Günter Breithardt; A John Camm; Harry J G M Crijns; Lars Eckardt; Nele Gessler; Andreas Goette; Laurent M Haegeli; Hein Heidbuchel; Josef Kautzner; G André Ng; Renate B Schnabel; Anna Suling; Lukasz Szumowski; Sakis Themistoclakis; Panos Vardas; Isabelle C van Gelder; Karl Wegscheider; Paulus Kirchhof Journal: Eur Heart J Date: 2022-03-21 Impact factor: 29.983