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Observational Study
. 2021 Nov;52(4):1195-1206.
doi: 10.1007/s11239-021-02450-2. Epub 2021 Apr 30.

Patient perceptions of anticoagulant treatment with dabigatran or a vitamin K antagonist for stroke prevention in atrial fibrillation according to region and age: an exploratory analysis from the RE-SONANCE study

Dragos Vinereanu  1 , Dmitry Napalkov  2 , Jutta Bergler-Klein  3 , Bela Benczur  4 , Martin Ciernik  5 , Nina Gotcheva  6 , Alexey Medvedchikov  5 , Pentti Põder  7 , Dragan Simić  8 , Andris Skride  9 , Wenbo Tang  10 , Maria Trusz-Gluza  11 , Jiří Vesely  12
Affiliations
Observational Study

Patient perceptions of anticoagulant treatment with dabigatran or a vitamin K antagonist for stroke prevention in atrial fibrillation according to region and age: an exploratory analysis from the RE-SONANCE study

Dragos Vinereanu et al. J Thromb Thrombolysis. 2021 Nov.

Abstract

Background: The oral anticoagulant dabigatran offers an effective alternative to vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF), yet patient preference data are limited. The prospective observational RE-SONANCE study demonstrated that patients with AF, newly initiated on dabigatran, or switching to dabigatran from long-term VKA therapy, reported improved treatment convenience and satisfaction compared with VKA therapy. This pre-specified sub-study aimed to assess the impact of country and age on patients' perceptions of dabigatran or VKA therapy in AF.

Methods: RE-SONANCE was an observational, prospective, multi-national study (NCT02684981) that assessed treatment satisfaction and convenience in patients switching from VKAs to dabigatran (Cohort A), or newly diagnosed with AF receiving dabigatran or VKAs (Cohort B), using the PACT-Q questionnaire. Pre-specified exploratory outcomes: variation in PACT-Q2 scores by country and age (< 65, 65 to < 75, ≥ 75 years) (both cohorts); variation in PACT-Q1 responses at baseline by country and age (Cohort B).

Results: Patients from 12 countries (Europe/Israel) were enrolled in Cohort A (n = 4103) or B (n = 5369). In Cohort A, mean (standard deviation) PACT-Q2 score increase was highest in Romania (convenience: 29.6 [23.6]) and Hungary (satisfaction: 26.0 [21.4]) (p < 0.001). In Cohort B, mean (standard error) increase in PACT-Q2 scores between dabigatran and VKAs was highest in Romania (visit 3: 29.0 [1.3]; 24.5 [0.9], p < 0.001). Mean PACT-Q2 score increase by age (all p < 0.001) was similar across ages. PACT-Q1 responses revealed lowest expectations of treatment success in Romania and greatest concerns about payment in Estonia, Latvia, and Romania, but were similar across ages.

Conclusions: Treatment satisfaction and convenience tended to favor dabigatran over VKAs. Regional differences in treatment expectations exist across Europe.

Trial and clinical registry: Trial registration number: ClinicalTrials.gov NCT02684981. Trial registration date: February 18, 2016.

Keywords: Atrial fibrillation; Dabigatran; Non‐vitamin K antagonist oral anticoagulant; Patient perception; Stroke prevention; Warfarin.

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Conflict of interest statement

Dragos Vinereanu received grants and personal fees from Boehringer Ingelheim during the conduct of the study; grants and personal fees from Bristol-Myers Squibb, Pfizer, Bayer, Johnson & Johnson, and Daiichi Sankyo outside the submitted work. Dmitry Napalkov received research grants and has participated in scientific advisory boards for Boehringer Ingelheim and has received speaker’s honoraria from Bayer, Boehringer Ingelheim, Pfizer, and Takeda. Bela Benczur received speaker’s/consultancy fees from Bayer, Berlin-Chemie/Menarini, Boehringer Ingelheim, Krka Pharma, Novartis, Pfizer, Sandoz, and Sanofi. Martin Ciernik, Alexey Medvedchikov, and Wenbo Tang are employees of Boehringer Ingelheim. Pentti Põder received educational grants from Boehringer Ingelheim. Maria Trusz-Gluza received personal fees from Boehringer Ingelheim (null during the conduct of the study), personal fees and non-financial support from Boehringer Ingelheim, and personal fees from Bayer outside the submitted work. Jiří Vesely received personal fees and non-financial support from Bayer, Boehringer Ingelheim, Pfizer, MSD, and PRO.MED.CS outside the submitted work. All other authors report no conflicts of interest.

Figures

Fig. 1
Fig. 1
PACT-Q2 score changes in treatment convenience and satisfaction by country (Cohort A, main analysis set; Cohort B, propensity score matched set). a Cohort A: patients switched from a VKA to dabigatran; change from V1 to V3. b Cohort B: patients newly initiated on dabigatran or a VKA; difference between dabigatran and VKA at V3. Data for the Czech Republic and Hungary are not presented in Fig. 1b because patient numbers meant that changes were statistically inconclusive. All changes were p < 0.001 and in favor of the dabigatran sub-group. PACT-Q, Perception of Anticoagulant Treatment Questionnaire; SD, standard deviation; SE, standard error; V1, baseline; V2, initiation period; V3, continuation period; VKA, vitamin K antagonist
Fig. 2
Fig. 2
PACT-Q2 score changes in treatment convenience and satisfaction by age group (Cohort A, analysis set; Cohort B, propensity score matched set). a Cohort A: patients switched from a VKA to dabigatran; change from V1 to V3. b Cohort B: patients newly initiated on dabigatran or a VKA; difference between dabigatran and VKA at V3. All changes were p < 0.001 and in favor of the dabigatran sub-group. PACT-Q, Perception of Anticoagulant Treatment Questionnaire; SD, standard deviation; SE, standard error; V1, baseline; V2, initiation period; V3, continuation period; VKA, vitamin K antagonist
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