Abstract
BackgroundThe 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.MethodsRE-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).ResultsPatients 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.ConclusionsTreatment satisfaction and convenience tended to favor dabigatran over VKAs. Regional differences in treatment expectations exist across Europe.Trial and clinical registryTrial registration number: ClinicalTrials.gov NCT02684981.Trial registration date: February 18, 2016.
Highlights
Current treatment guidelines recommend oral anticoagulant (OAC) therapy for patients with atrial fibrillation (AF) at risk of thromboembolic events or stroke [1, 2]
non-VKA oral anticoagulants (NOACs) treatment, including the direct thrombin inhibitor dabigatran, in patients with AF who are indicated for anticoagulation treatment has shown to be just as effective as vitamin K antagonists (VKAs) treatment in reducing the risk of stroke [6]
The prospective observational RE-SONANCE study, conducted using the validated Perception of Anticoagulant Treatment Questionnaire (PACT-Q), demonstrated that patients with non-valvular AF, newly initiated on dabigatran, or switching to dabigatran from long-term VKA therapy, reported improved treatment convenience and satisfaction compared with VKA therapy [12]
Summary
Current treatment guidelines recommend oral anticoagulant (OAC) therapy for patients with atrial fibrillation (AF) at risk of thromboembolic events or stroke [1, 2]. 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.
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