Choosing between continuing vitamin K antagonists (<scp>VKA</scp>) or switching to a direct oral anticoagulant in currently well‐controlled patients on <scp>VKA</scp> for atrial fibrillation: a randomised controlled trial (<scp>GAI</scp>nN)

Miert, Jasper H A van; Kooistra, H.S.; Veeger, Nic J. G. M.; Westerterp, Annelies; Piersma-Wichers, Margriet; Meijer, Karina

doi:10.1111/bjh.15856

Cited by 9 publications

(11 citation statements)

References 9 publications

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“…However, adherence rates in our study were comparable with studies in similar patient populations, including SFK, where adherence rates in those who switched from a VKA to a DOAC were similar to our study results. To establish the generalizability of our results, we recommend confirmation of our study also because there are currently very few studies that look into this matter …”

Section: Discussionmentioning

confidence: 69%

“…A strength of our study is the unique study design, in which only patients who switched from a VKA to a DOAC were included. Despite the clinical relevance of this group of patients at a time when VKA use is rapidly declining due to the large number of people switching to a DOAC, very few studies evaluated DOAC use in this specific patient group . Another strength is that many predictors that were identified in this study have not been studied before for the purpose of DOAC adherence.…”

Section: Discussionmentioning

confidence: 98%

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Self‐reported therapy adherence and predictors for nonadherence in patients who switched from vitamin K antagonists to direct oral anticoagulants

Toorop

Rein

Nierman³

et al. 2020

Research and Practice in Thrombosis and Haemostasis

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Background Many patients who used vitamin K antagonists (VKAs) for long‐term prevention of thromboembolism are now actively switched to a direct oral anticoagulant (DOAC). Strict adherence to a DOAC is crucial for its success. However, therapy adherence and clinical factors that predict nonadherence are currently not well studied among patients who switched from a VKA to a DOAC. Methods A questionnaire was developed and sent to 2920 former patients of 3 anticoagulation clinics in the Netherlands, who switched from a VKA to a DOAC between January 2016 and December 2017. Questions concerned demographics, treatment persistence, adherence, and the occurrence of bleeding or thromboembolic events on DOACs. To identify predictors for nonadherence, logistic regression models were used to estimate crude and age/sex‐adjusted odds ratios (ORs) and 95% confidence intervals (95% CIs). Results A total of 1399 questionnaires (response rate 48%) were used for analysis. DOAC treatment persistence (94%) and adherence (86%) rates were high. Several predictors of nonadherence were identified, including young age (OR, 5.9; 95% CI, 3.6‐9.8 for <60 years compared to >75 years), low consultation frequency with a specialist (OR, 1.6; 95% CI, 1.1‐2.2), a history of minor bleeding on DOACs (OR, 1.9; 95% CI, 1.3‐2.8), and a twice‐daily dosing regimen (OR, 1.9; 95% CI, 1.3‐2.6). Conclusions Self‐reported treatment persistence and adherence were high in our study population, and several predictors of nonadherence were identified. Factors that can be influenced (low consult frequency with medical specialist, daily dosing regimen) may be used to improve therapy adherence.

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Section: Discussionmentioning

confidence: 69%

Section: Discussionmentioning

confidence: 98%

Self‐reported therapy adherence and predictors for nonadherence in patients who switched from vitamin K antagonists to direct oral anticoagulants

Toorop

Rein

Nierman³

et al. 2020

Research and Practice in Thrombosis and Haemostasis

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“…As such, we consider our results concerning AF patients staying on VKA as overall reassuring and supportive of the selection performed by physicians when choosing which patients should not be switched to DOAC therapy in clinical practice. Also, in a recent small Dutch RCT, 45 AF patients with high TTR levels on VKA therapy randomized to continued VKA therapy had comparable 1-year risks of arterial thromboembolism and bleeding to patients randomized to switch to a DOAC (mainly apixaban). Thus, this trial, as well as the results of the current review, supports that a satisfactory effectiveness and safety of oral anticoagulant therapy can likely be expected if choosing to continue VKA in AF patients presenting with high TTR levels.…”

Section: Discussionmentioning

confidence: 93%

Effectiveness and safety of direct oral anticoagulants in atrial fibrillation patients switched from vitamin K antagonists: A systematic review and meta‐analysis

Hellfritzsch

Adelborg

Damkier

et al. 2019

Basic Clin Pharma Tox

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A substantial proportion of atrial fibrillation patients initiating direct oral anticoagulants (DOAC) are vitamin K antagonists (VKA)-experienced, for example switchers from VKA to DOAC. With this study, we aimed to summarize available evidence on the effectiveness and safety of DOAC vs VKA in real-life VKA-experienced atrial fibrillation patients. We searched EMBASE, MEDLINE and Cochrane Library systematically for English-language studies indexed any time before October 2018. We included studies of VKA-experienced atrial fibrillation patients initiating DOAC therapy, with continued VKA therapy as comparator. Outcomes included arterial thromboembolism and bleeding. When appropriate, meta-analysis was performed by calculating pooled, weighted and adjusted hazard ratios (aHR) with 95% confidence intervals (CI). Eight cohort studies comparing VKA-experienced DOAC (dabigatran or rivaroxaban) users with continued VKA users were included. When comparing DOAC to VKA, an increased risk of ischaemic stroke and myocardial infarction was found for dabigatran (pooled aHR of 1.61 [95% CI 1.19-2.19, I 2 = 65%] and 1.29 [95% CI 1.10-1.52, I 2 = 0%], respectively), but not for rivaroxaban. The use of dabigatran in VKA-experienced users was associated with an increased risk of gastrointestinal bleeding (pooled aHR 1.63 [95% CI 1.36-1.94, I 2 = 30%]), but a decreased risk of intracranial bleeding (pooled aHR 0.45 [95% CI 0.32-0.64, I 2 = 0%]). In conclusion, the use of dabigatran in prior VKA users in clinical practice was associated with a slightly increased risk of arterial thromboembolism and gastrointestinal bleeding, but a decreased risk of intracranial bleeding. Importantly, observational studies of real-life VKA-experienced oral anticoagulant users may be confounded by the reason for switching. K E Y W O R D Santicoagulation treatment, atrial fibrillation, meta-analysis, pharmacoepidemiology, thromboembolismThis is an open access article under the terms of the Creat ive Commo ns Attri bution-NonCo mmercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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“…A decrease in TTR would put them in a gray area, where the TTR is suboptimal but the incidence of adverse events is only mildly increased 2 . In a previous study, we found no evidence to advise against switching patients with a high previous TTR to a DOAC 21 …”

Section: Discussionmentioning

confidence: 61%

Is the time in therapeutic range on coumarins predicted by previous time in therapeutic range?

Miert

Veeger

Meijer

2020

Research and Practice in Thrombosis and Haemostasis

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Background The benefit of vitamin K antagonists depends on the time within the therapeutic range (TTR). A patient’s previous TTR could be a factor in the decision to change the anticoagulation regimen. However, the predictive value of a previous TTR for a future TTR is not well established, nor is it clear which TTR should prompt action. Objectives To investigate the predictive performance of a TTR and identify a threshold below which no recovery of TTR should be expected. Patients/Methods From 18 031 patients who used acenocoumarol in a first‐line anticoagulation clinic, a TTR was calculated over multiple periods of 90, 180, and 365 days each. We assessed the correlation between baseline and later TTR and the separation between groups by quintile of baseline TTR. We describe the proportion of patients who obtain a TTR≥ 70% conditional on baseline TTR. Results The correlation between baseline and later TTR was 0.25 (95% confidence interval [CI], 0.24‐0.26), 0.27 (95% CI, 0.26‐0.28) and 0.34 (95% CI, 0.32‐0.35) for analyses over 90, 180, and 365 days. Corresponding c statistics for discrimination by baseline group were 0.60, 0.61, and 0.63. The probability to obtain a TTR ≥70% increased with baseline TTR: from 42% with a baseline TTR of 50%‐65% when TTR was 100% (TTR calculated over 180 days). Conclusions We conclude that a current TTR hardly predicts a future TTR. Physicians and patients should deliberate together which probabilities to accept, take measures to improve TTR, and consider potential alternatives.

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Choosing between continuing vitamin K antagonists (VKA) or switching to a direct oral anticoagulant in currently well‐controlled patients on VKA for atrial fibrillation: a randomised controlled trial (GAInN)

Cited by 9 publications

References 9 publications

Self‐reported therapy adherence and predictors for nonadherence in patients who switched from vitamin K antagonists to direct oral anticoagulants

Self‐reported therapy adherence and predictors for nonadherence in patients who switched from vitamin K antagonists to direct oral anticoagulants

Effectiveness and safety of direct oral anticoagulants in atrial fibrillation patients switched from vitamin K antagonists: A systematic review and meta‐analysis

Is the time in therapeutic range on coumarins predicted by previous time in therapeutic range?

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