Jasper H A van Miert1, Hilde A M Kooistra2, Nic J G M Veeger3, Annelies Westerterp4, Margriet Piersma-Wichers5, Karina Meijer6. 1. Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Certe Thrombosis Service, Groningen, the Netherlands. Electronic address: j.h.a.van.miert@umcg.nl. 2. Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Certe Thrombosis Service, Groningen, the Netherlands; Currently: Department of Internal Medicine, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands. 3. Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands. 4. Certe Thrombosis Service, Groningen, the Netherlands. 5. Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Certe Thrombosis Service, Groningen, the Netherlands. 6. Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Abstract
BACKGROUND:Direct oral anticoagulants (DOAC) and vitamin K antagonists (VKA) prevent thromboembolism in atrial fibrillation (AF). DOAC have a fixed dosing regimen and obviate INR monitoring. Therefore, DOAC presumably affect quality of life (QoL) less than VKA. However, some VKA users appreciate the monitoring. A high time in the therapeutic range (TTR) leads to a lower impact on QoL. We assessed the influence of switching from well-controlled VKA to a DOAC on QoL. METHODS: In the GAInN study, 241 patients with AF, a TTR ≥ 70%, and neither bleeding nor thrombosis while on VKA were randomised to switching to DOAC (n = 121) or continuing VKA (n = 120). Health-related (SF-36) and anticoagulation-related QoL (PACT-Q) was assessed at baseline and after six and twelve months of follow-up. RESULTS AND CONCLUSION:SF-36 development did not differ between groups. After one year, average PACT-Q Convenience improvement was 2.5 (0.3-4.7) higher on DOAC. DOAC users were 6percentage points (95%CI -4-16) more likely to improve >5 points on Convenience; 22 pp. (95%CI 1-43) in patients who scored <95/100 at baseline. The probability to meaningfully improve on PACT-Q Satisfaction was 12 pp. (95%CI 0-25) higher on DOAC. However, 5 (4.1%) and 4 (3.3%) DOAC users resumed VKA because of side-effects and patient preference. Switching from well-controlled VKA to DOAC for AF leads to a higher probability of improved PACT-Q convenience and satisfaction, but also to a higher risk of side-effects. Arguably only patients who are not satisfied with VKA should switch, because they have more to gain by switching.
RCT Entities:
BACKGROUND: Direct oral anticoagulants (DOAC) and vitamin K antagonists (VKA) prevent thromboembolism in atrial fibrillation (AF). DOAC have a fixed dosing regimen and obviate INR monitoring. Therefore, DOAC presumably affect quality of life (QoL) less than VKA. However, some VKA users appreciate the monitoring. A high time in the therapeutic range (TTR) leads to a lower impact on QoL. We assessed the influence of switching from well-controlled VKA to a DOAC on QoL. METHODS: In the GAInN study, 241 patients with AF, a TTR ≥ 70%, and neither bleeding nor thrombosis while on VKA were randomised to switching to DOAC (n = 121) or continuing VKA (n = 120). Health-related (SF-36) and anticoagulation-related QoL (PACT-Q) was assessed at baseline and after six and twelve months of follow-up. RESULTS AND CONCLUSION: SF-36 development did not differ between groups. After one year, average PACT-Q Convenience improvement was 2.5 (0.3-4.7) higher on DOAC. DOAC users were 6percentage points (95%CI -4-16) more likely to improve >5 points on Convenience; 22 pp. (95%CI 1-43) in patients who scored <95/100 at baseline. The probability to meaningfully improve on PACT-Q Satisfaction was 12 pp. (95%CI 0-25) higher on DOAC. However, 5 (4.1%) and 4 (3.3%) DOAC users resumed VKA because of side-effects and patient preference. Switching from well-controlled VKA to DOAC for AF leads to a higher probability of improved PACT-Q convenience and satisfaction, but also to a higher risk of side-effects. Arguably only patients who are not satisfied with VKA should switch, because they have more to gain by switching.
Authors: Margriet Piersma-Wichers; Tessa Elling; Anne M B de Vries-Bots; Hilde A M Kooistra; Karina Meijer Journal: Res Pract Thromb Haemost Date: 2021-08-17
Authors: Roisin Bavalia; Ingrid M Bistervels; Wim G Boersma; Isabelle Quere; Dominique Brisot; Nicolas Falvo; Dominique Stephan; Francis Couturaud; Sebastian Schellong; Jan Beyer-Westendorf; Karine Montaclair; Waleed Ghanima; Marije Ten Wolde; Michiel Coppens; Emile Ferrari; Olivier Sanchez; Patrick Carroll; Pierre-Marie Roy; Susan R Kahn; Karina Meijer; Simone Birocchi; Michael J Kovacs; Amanda Hugman; Hugo Ten Cate; Hilde Wik; Gilles Pernod; Marie-Antoinette Sevestre-Pietri; Michael A Grosso; Minggao Shi; Yong Lin; Barbara A Hutten; Peter Verhamme; Saskia Middeldorp Journal: Res Pract Thromb Haemost Date: 2021-07-14