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Effect of switching from well-controlled vitamin K antagonists to a direct oral anticoagulant for atrial fibrillation on quality of life: little to GAInN
ISTH Academy. van Miert J. 07/07/19; 263191; PB0002 Topic: Anticoagulant Therapy
Jasper H.A. van Miert
Jasper H.A. van Miert
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PB0002

Effect of Switching from Well-controlled Vitamin K Antagonists to a Direct Oral Anticoagulant for Atrial Fibrillation on Quality of Fife: Little to GAInN

J.H.A. van Miert1,2, H.A.M. Kooistra1,2, N.J.G.M. Veeger3, A. Westerterp2, M. Piersma1,2, K. Meijer1
1University of Groningen, University Medical Centre Groningen, Haematology, Groningen, the Netherlands, 2Certe Thrombosis Service, Groningen, the Netherlands, 3University of Groningen, University Medical Centre Groningen, Epidemiology, Groningen, the Netherlands

Main Topic: Arterial Thromboembolism
Category: Anticoagulant Therapy

Background: Direct oral anticoagulants (DOAC) and vitamin K antagonists (VKA) protect against thromboembolism in atrial fibrillation (AF). DOAC are non-inferior to VKA, and have the advantage of a fixed dosing regimen, without the need for international normalised ratio (INR) monitoring. Therefore, DOAC presumably affect quality of life (QoL) less than VKA.
However, the impact of VKA varies with the time a patient spends inside the therapeutic range (TTR): patients with a high TTR suffer from fewer bleeding and thrombotic events, and require less frequent INR monitoring. QoL from these patients might not improve by switching to a DOAC.
Aims: To study whether switching to a DOAC improves QoL in patients who are well-controlled on VKA.
Methods: Randomised controlled trial (GAInN study) in a first-line thrombosis service in the Netherlands. 241 adults using VKA for AF with a TTR >70% without major bleeding or thrombosis were randomised to continuing VKA (120) or switching to a DOAC (121). Questionnaires (SF-36 for health-related QoL; PACT-Q for anticoagulation-related QoL) were administered before randomisation and at six and twelve months.
Results: At baseline, overall treatment satisfaction was high (mean score 4.19/5; mean±SD PACT-Q treatment satisfaction score 63.9±15.6; PACT-Q convenience 94.8±6.5).
SF-36 scales remained constant over six and twelve months, with no difference between DOAC and VKA. Treatment convenience increased more in DOAC patients (+0.8/100 versus +2.8/100, p=0.01). Patients who did not score 5/5 for general satisfaction at baseline improved more on a DOAC (p(rank)=0.01).
During the study, 12 patients randomised to DOAC switched back to VKA, mainly over perceived side-effects. When given the choice at end of study, 105 chose to continue DOAC; 2 resumed VKA because of lower out-of-pocket expenses; 2 had died.
Conclusions: Switching to DOAC does not consistently improve QoL in patients well-controlled on VKA. Other factors should guide treatment decisions.


Scale Baseline Change at six months Change at one year
    DOAC VKA DOAC VKA P DOAC VKA P
PACT-Q Convenience 94.4 ± 7.7 95.2 ± 5.0 2.8 ± 6.9 0.8 ± 4.3 0.01 2.6 ± 7.1 -0.2 ± 9.8 0.02
  Satisfaction 64.5 ± 14.8 63.3 ± 16.5 5.2 ± 19.3 1.4 ± 17.4 0.14 3.6 ± 18.2 2.2 ± 19.2 0.59
SF-36 General Health 63.1 ± 18.7 65.1 ± 17.1 -1.4 ± 13.5 1.1 ± 13.6 0.18 -1.0 ± 13.4 0.7 ± 13.9 0.35
  Mental Health 80.1 ± 14.5 83.4 ± 13.2 0.0 ± 12.8 -1.7 ± 12.5 0.36 0.5 ± 10.8 0.2 ± 10.2 0.86
  Social Functioning 84.9 ± 18.0 86.7 ± 18.3 -1.2 ± 16.2 -2.8 ± 16.1 0.48 -3.2 ± 16.2 -3.4 ± 17.5 0.94
  Vitality 67.7 ± 19.1 72.8 ± 15.9 0.0 ± 14.1 -2.3 ± 12.1 0.22 0.2 ± 12.3 -2.1 ± 13.1 0.19
  Physical Component Score 45.5 ± 9.3 48.4 ± 9.0 -0.5 ± 7.0 -0.6 ± 6.9 0.95 -0.4 ± 6.8 -1.7 ± 7.2 0.20
  Mental Component Score 52.3 ± 8.2 53.0 ± 7.5 0.1 ± 7.9 -0.6 ± 6.8 0.50 0.6 ± 6.3 0.2 ± 7.2 0.68
[Quality of Life scores at baseline and changes since randomisation]

PB0002

Effect of Switching from Well-controlled Vitamin K Antagonists to a Direct Oral Anticoagulant for Atrial Fibrillation on Quality of Fife: Little to GAInN

J.H.A. van Miert1,2, H.A.M. Kooistra1,2, N.J.G.M. Veeger3, A. Westerterp2, M. Piersma1,2, K. Meijer1
1University of Groningen, University Medical Centre Groningen, Haematology, Groningen, the Netherlands, 2Certe Thrombosis Service, Groningen, the Netherlands, 3University of Groningen, University Medical Centre Groningen, Epidemiology, Groningen, the Netherlands

Main Topic: Arterial Thromboembolism
Category: Anticoagulant Therapy

Background: Direct oral anticoagulants (DOAC) and vitamin K antagonists (VKA) protect against thromboembolism in atrial fibrillation (AF). DOAC are non-inferior to VKA, and have the advantage of a fixed dosing regimen, without the need for international normalised ratio (INR) monitoring. Therefore, DOAC presumably affect quality of life (QoL) less than VKA.
However, the impact of VKA varies with the time a patient spends inside the therapeutic range (TTR): patients with a high TTR suffer from fewer bleeding and thrombotic events, and require less frequent INR monitoring. QoL from these patients might not improve by switching to a DOAC.
Aims: To study whether switching to a DOAC improves QoL in patients who are well-controlled on VKA.
Methods: Randomised controlled trial (GAInN study) in a first-line thrombosis service in the Netherlands. 241 adults using VKA for AF with a TTR >70% without major bleeding or thrombosis were randomised to continuing VKA (120) or switching to a DOAC (121). Questionnaires (SF-36 for health-related QoL; PACT-Q for anticoagulation-related QoL) were administered before randomisation and at six and twelve months.
Results: At baseline, overall treatment satisfaction was high (mean score 4.19/5; mean±SD PACT-Q treatment satisfaction score 63.9±15.6; PACT-Q convenience 94.8±6.5).
SF-36 scales remained constant over six and twelve months, with no difference between DOAC and VKA. Treatment convenience increased more in DOAC patients (+0.8/100 versus +2.8/100, p=0.01). Patients who did not score 5/5 for general satisfaction at baseline improved more on a DOAC (p(rank)=0.01).
During the study, 12 patients randomised to DOAC switched back to VKA, mainly over perceived side-effects. When given the choice at end of study, 105 chose to continue DOAC; 2 resumed VKA because of lower out-of-pocket expenses; 2 had died.
Conclusions: Switching to DOAC does not consistently improve QoL in patients well-controlled on VKA. Other factors should guide treatment decisions.


Scale Baseline Change at six months Change at one year
    DOAC VKA DOAC VKA P DOAC VKA P
PACT-Q Convenience 94.4 ± 7.7 95.2 ± 5.0 2.8 ± 6.9 0.8 ± 4.3 0.01 2.6 ± 7.1 -0.2 ± 9.8 0.02
  Satisfaction 64.5 ± 14.8 63.3 ± 16.5 5.2 ± 19.3 1.4 ± 17.4 0.14 3.6 ± 18.2 2.2 ± 19.2 0.59
SF-36 General Health 63.1 ± 18.7 65.1 ± 17.1 -1.4 ± 13.5 1.1 ± 13.6 0.18 -1.0 ± 13.4 0.7 ± 13.9 0.35
  Mental Health 80.1 ± 14.5 83.4 ± 13.2 0.0 ± 12.8 -1.7 ± 12.5 0.36 0.5 ± 10.8 0.2 ± 10.2 0.86
  Social Functioning 84.9 ± 18.0 86.7 ± 18.3 -1.2 ± 16.2 -2.8 ± 16.1 0.48 -3.2 ± 16.2 -3.4 ± 17.5 0.94
  Vitality 67.7 ± 19.1 72.8 ± 15.9 0.0 ± 14.1 -2.3 ± 12.1 0.22 0.2 ± 12.3 -2.1 ± 13.1 0.19
  Physical Component Score 45.5 ± 9.3 48.4 ± 9.0 -0.5 ± 7.0 -0.6 ± 6.9 0.95 -0.4 ± 6.8 -1.7 ± 7.2 0.20
  Mental Component Score 52.3 ± 8.2 53.0 ± 7.5 0.1 ± 7.9 -0.6 ± 6.8 0.50 0.6 ± 6.3 0.2 ± 7.2 0.68
[Quality of Life scores at baseline and changes since randomisation]

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